WorldWideScience

Sample records for one-center randomized prospective

  1. Colon and rectal surgery for cancer without mechanical bowel preparation: one-center randomized prospective trial.

    Science.gov (United States)

    Scabini, Stefano; Rimini, Edoardo; Romairone, Emanuele; Scordamaglia, Renato; Damiani, Giampiero; Pertile, Davide; Ferrando, Valter

    2010-04-30

    Mechanical bowel preparation is routinely done before colon and rectal surgery, aimed at reducing the risk of postoperative infectious complications. The aim of the study was to assess whether elective colon and rectal surgery can be safely performed without preoperative mechanical bowel preparation. Patients undergoing elective colon and rectal resections with primary anastomosis were prospectively randomized into two groups. Group A had mechanical bowel preparation with polyethylene glycol before surgery, and group B had their surgery without preoperative mechanical bowel preparation. Patients were followed up for 30 days for wound, anastomotic, and intra-abdominal infectious complications. Two hundred forty four patients were included in the study, 120 in group A and 124 in group B. Demographic characteristics, type of surgical procedure and type of anastomosis did not significantly differ between the two groups. There was no difference in the rate of surgical infectious complications between the two groups but the overall infectious complications rate was 20.0% in group A and 11.3% in group B (p .05). Wound infection (p = 0.18), anastomotic leak (p = 0.52), and intra-abdominal abscess (p = 0.36) occurred in 9.2%, 5.8%, and 5.0% versus 4.8%, 4.0%, and 2.4%, respectively. No mechanical bowel preparation seems to be safe also in rectal surgery. These results suggest that elective colon and rectal surgery may be safely performed without mechanical preparation.

  2. Randomized, interventional, prospective, comparative study to ...

    African Journals Online (AJOL)

    Randomized, interventional, prospective, comparative study to evaluate the antihypertensive efficacy and tolerability of ramipril versus telmisartan in stage 1 hypertensive patients with diabetes mellitus.

  3. A prospective randomized trial of Kotase ® (Bromelain + Trypsin) in ...

    African Journals Online (AJOL)

    International Journal of Medicine and Health Development. Journal Home · ABOUT THIS ... A prospective randomized trial of Kotase® (Bromelain + Trypsin) in the management of post-operative abdominal wounds at the University of Nigeria Teaching Hospital Enugu, Nigeria. Emmanuel R Ezeome, Aloy E Aghaji ...

  4. The starting dose of levothyroxine in primary hypothyroidism treatment: a prospective, randomized, double-blind trial

    NARCIS (Netherlands)

    Roos, Annemieke; Linn-Rasker, Suzanne P.; van Domburg, Ron T.; Tijssen, Jan P.; Berghout, Arie

    2005-01-01

    BACKGROUND: The treatment of hypothyroidism with levothyroxine is effective and simple; however, recommendations for the starting dose vary considerably. To our knowledge, the levothyroxine starting dose has never been studied prospectively. METHODS: We conducted a prospective, randomized,

  5. Intrapartum amnioinfusion in women with oligohydramniosis. A prospective randomized trial.

    Science.gov (United States)

    Persson-Kjerstadius, N; Forsgren, H; Westgren, M

    1999-02-01

    To evaluate the effects of amnioinfusion in oligohydramniosis. During a 20-month period, patients at term with oligohydramniosis (amniotic fluid index less than 5 cm) at Huddinge University and Norrköping Hospitals were recruited for a prospective randomized study to evaluate amnioinfusion. Informed consent was obtained from 112 patients who met the entry criteria. Sixty subjects were randomized to amnioinfusion and 52 to the control group. Outcome parameters included fetal heart rate abnormalities, mode of delivery, Apgar score, pH in umbilical artery blood and need for neonatal intensive care. The cesarean section rate was significantly reduced in the amnio-infusion group (29% versus 13%, p=0.043). No difference in time from randomization to delivery was detected between the two groups. The frequency of ominous fetal heart rate tracings with a cervical dilatation of 0-3 cm was the same in the two groups. The frequency of such heart rate patterns after amnioinfusion was significantly lower than in the control group. Neonatal outcome, pH in the umbilical artery blood and need for neonatal intensive care did not differ between the two groups. The present study confirms the findings of other authors that amnioinfusion effectively reduces the number of cesarean sections in cases of oligohydramniosis.

  6. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    , dialysis-related complications, dialysis-related expenses. RESULTS: The quality-of-life studies showed that significantly more time for work, family, and social activities was available to patients on APD compared to those on CAPD (p ...) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included...... were assessed at baseline and after 6 months by the self-administered short-form SF-36 generic health survey questionnaire supplemented with disease- and treatment-specific questions. Therapy costs were compared by evaluating dialysis-related expenses. MAIN OUTCOME MEASURES: Quality-of-life parameters...

  7. Selective decontamination in pediatric liver transplants. A randomized prospective study.

    Science.gov (United States)

    Smith, S D; Jackson, R J; Hannakan, C J; Wadowsky, R M; Tzakis, A G; Rowe, M I

    1993-06-01

    Although it has been suggested that selective decontamination of the digestive tract (SDD) decreases postoperative aerobic Gram-negative and fungal infections in orthotopic liver transplantation (OLT), no controlled trials exist in pediatric patients. This prospective, randomized controlled study of 36 pediatric OLT patients examines the effect of short-term SDD on postoperative infection and digestive tract flora. Patients were randomized into two groups. The control group received perioperative parenteral antibiotics only. The SDD group received in addition polymyxin E, tobramycin, and amphotericin B enterally and by oropharyngeal swab postoperatively until oral intake was tolerated (6 +/- 4 days). Indications for operation, preoperative status, age, and intensive care unit and hospital length of stay were no different in SDD (n = 18) and control (n = 18) groups. A total of 14 Gram-negative infections (intraabdominal abscess 7, septicemia 5, pneumonia 1, urinary tract 1) developed in the 36 patients studied. Mortality was not significantly different in the two groups. However, there were significantly fewer patients with Gram-negative infections in the SDD group: 3/18 patients (11%) vs. 11/18 patients (50%) in the control group, P < 0.001. There was also significant reduction in aerobic Gram-negative flora in the stool and pharynx in patients receiving SDD. Gram-positive and anaerobic organisms were unaffected. We conclude that short-term postoperative SDD significantly reduces Gram-negative infections in pediatric OLT patients.

  8. Resistant metatarsus adductus: prospective randomized trial of casting versus orthosis.

    Science.gov (United States)

    Herzenberg, John E; Burghardt, Rolf D

    2014-03-01

    Metatarsus adductus is a common pediatric foot deformity related to intrauterine molding. It is usually a mild deformity that responds well to simple observation or minimal treatment with a home program of stretching. Resistant cases may need a more aggressive approach such as serial casting or special bracing to avoid the need for surgical intervention. We compared clinical outcomes using serial casting with orthoses for resistant metatarsus adductus. We prospectively treated 27 infants (43 feet) between the ages 3 and 9 months who failed home stretching treatment. Patients were randomized to either serial plaster casting or Bebax orthoses. Footprints and simulated weight-bearing anteroposterior and lateral view radiographs were made at entry and follow-up. There was no statistical difference between casting and Bebax for the following parameters: age at study entry, length of treatment, number of clinic visits, follow-up, and follow-up maintenance treatments. Both groups showed improvement in footprint and radiographic measurements post-treatment, without worsening of heel valgus. The Bebax group had greater improvement in the footprint heel bisector measurement than the casting group. The Bebax treatment requires more active parental cooperation. A simulated cost analysis of materials and office visit charges, however, revealed that Bebax treatment was significantly less expensive, about half the cost of casting. Because of the cost savings and virtually identical clinical results, we recommend the Bebax orthosis for resistant metatarsus in pre-walking infants with parents who are compliant. Other considerations include specific insurance plans, which may pay for casts but not orthoses.

  9. Sugammadex versus neostigmine in pediatric patients: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Turhan Kara

    2014-12-01

    Full Text Available Background and objectives: Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. Methods: 80 patients, aged 2-12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6 mgkg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mgkg−1 neostigmine, Group RS (n = 40 received 2 mgkg−1 sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation, train-of-four ratio during this time, time to reach train-of-four > 0.9, and probable complications were recorded. Results: There was no significant difference between the patients' characteristics. Extubation time and time to reach train-of-four > 0.9 were significantly higher in Group RN (p = 0.001, p = 0.002. Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p = 0.020. Extubation train-of-four ratio was significantly lower in Group RN (p = 0.002. Conclusion: Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures.

  10. Occlusion of the pancreatic duct versus pancreaticojejunostomy: a prospective randomized trial.

    NARCIS (Netherlands)

    K.T. Tran; C.H.J. van Eijck (Casper); V. di Carlo (Valerio); W.C.J. Hop (Wim); A. Zerbi (Alessandro); G. Balzano (Gianpaolo); J. Jeekel (Hans)

    2002-01-01

    textabstractOBJECTIVE: Using a prospective randomized study to assess postoperative morbidity and pancreatic function after pancreaticoduodenectomy with pancreaticojejunostomy and duct occlusion without pancreaticojejunostomy. SUMMARY BACKGROUND DATA: Postoperative complications

  11. Random forest predictive modeling of mineral prospectivity with small number of prospects and data with missing values in Abra (Philippines)

    Science.gov (United States)

    Carranza, Emmanuel John M.; Laborte, Alice G.

    2015-01-01

    Machine learning methods that have been used in data-driven predictive modeling of mineral prospectivity (e.g., artificial neural networks) invariably require large number of training prospect/locations and are unable to handle missing values in certain evidential data. The Random Forests (RF) algorithm, which is a machine learning method, has recently been applied to data-driven predictive mapping of mineral prospectivity, and so it is instructive to further study its efficacy in this particular field. This case study, carried out using data from Abra (Philippines), examines (a) if RF modeling can be used for data-driven modeling of mineral prospectivity in areas with a few (i.e., individual layers of evidential data. Furthermore, RF modeling can handle missing values in evidential data through an RF-based imputation technique whereas in WofE modeling values are simply represented by zero weights. Therefore, the RF algorithm is potentially more useful than existing methods that are currently used for data-driven predictive mapping of mineral prospectivity. In particular, it is not a purely black-box method like artificial neural networks in the context of data-driven predictive modeling of mineral prospectivity. However, further testing of the method in other areas with a few mineral occurrences is needed to fully investigate its usefulness in data-driven predictive modeling of mineral prospectivity.

  12. Sugammadex versus neostigmine in pediatric patients: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Turhan Kara

    2014-11-01

    Full Text Available Background and objectives: Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. Methods: 80 patients, aged 2–12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6 mg kg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mg kg−1 neostigmine, Group RS (n = 40 received 2 mg kg−1 sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation, train-of-four ratio during this time, time to reach train-of-four > 0.9, and probable complications were recorded. Results: There was no significant difference between the patients’ characteristics. Extubation time and time to reach train-of-four > 0.9 were significantly higher in Group RN (p = 0.001, p = 0.002. Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p = 0.020. Extubation train-of-four ratio was significantly lower in Group RN (p = 0.002. Conclusion: Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures. Resumo: Justificativa e objetivos: Os inibidores da acetilcolinesterase podem causar curarização residual no p

  13. Prospective randomized clinical studies involving reirradiation. Lessons learned

    International Nuclear Information System (INIS)

    Nieder, Carsten; Langendijk, Johannes A.; Guckenberger, Matthias; Grosu, Anca L.

    2016-01-01

    Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [de

  14. Prospective randomized clinical studies involving reirradiation. Lessons learned

    Energy Technology Data Exchange (ETDEWEB)

    Nieder, Carsten [Nordland Hospital, Department of Oncology and Palliative Medicine, Bodoe (Norway); University of Tromsoe, Department of Clinical Medicine, Faculty of Health Sciences, Tromsoe (Norway); Langendijk, Johannes A. [University Medical Centre Groningen, Department of Radiation Oncology, Groningen (Netherlands); Guckenberger, Matthias [University Hospital Zuerich, Department of Radiation Oncology, Zuerich (Switzerland); Grosu, Anca L. [University Hospital Freiburg, Department of Radiation Oncology, Freiburg (Germany)

    2016-10-15

    Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [German] Eine Rebestrahlung kann fuer viele Patienten mit rezidivierenden Malignomen eine nuetzliche Option bieten. Der Zweck dieser Studie bestand darin, alle in der juengeren Vergangenheit publizierten randomisierten Studien zu beurteilen, da deren methodische Staerken und Schwaechen, Ergebnisse und resultierende Implikationen bzw. offene Fragen die Planung kuenftiger Studien wesentlich beeinflussen koennen. Systematische Uebersicht aller zwischen 2000 und 2015 veroeffentlichten Studien (Literatursuche ueber PubMed, Scopus und Web of Science). Ausgewertet wurden 9 Studien, in die vor allem Patienten mit Kopf-Hals-Tumoren eingeschlossen waren. Im Median hatten 69 Patienten teilgenommen. Das

  15. Compression Stockings after Endovenous Laser Ablation of the Great Saphenous Vein : A Prospective Randomized Controlled Trial

    NARCIS (Netherlands)

    Bakker, N. A.; Schieven, L. W.; Bruins, R. M. G.; van den Berg, M.; Hissink, R. J.

    2013-01-01

    Objectives: To determine if the duration of wearing compression stockings after endovenous laser ablation (EVLA) of the great saphenous vein (GSV) has influence on pain and quality of life. Methods: This was a prospective randomized controlled trial. Between December 2006 and February 2008, 109

  16. Treatment of traumatic thoracolumbar spine fractures : A multicenter prospective randomized study of operative versus nonsurgical treatment

    NARCIS (Netherlands)

    Siebenga, Jan; Leferink, Vincent J. M.; Segers, Michiel J. M.; Elzinga, Matthijs J.; Bakker, Fred C.; Haarman, Henk J. Th. M.; Rommens, Pol M.; ten Duis, Henk-Jan; Patka, Peter

    2006-01-01

    Study Design. Multicenter prospective randomized trial. Objective. To test the hypotheses that thoracolumbar AO Type A spine fractures without neurologic deficit, managed with short-segment posterior stabilization will show an improved radiographic outcome and at least the same functional outcome as

  17. One-day versus 3-day suprapubic catheterization after vaginal prolapse surgery : a prospective randomized trial

    NARCIS (Netherlands)

    Van der Steen, Annemarie; Detollenaere, Renee; Den Boon, Jan; Van Eijndhoven, Hugo

    For prolonged catheterization after vaginal prolapse surgery with anterior colporrhaphy, the optimal duration to prevent overdistention of the bladder remains unknown. We designed this study to determine the optimal length of catheterization. We conducted a prospective randomized trial in which 179

  18. A prospective, randomized, double-blind clinical trial of one nano ...

    African Journals Online (AJOL)

    Abstract. Background: Recently, manufacturers have introduced bulk‑fill composite resins that reportedly can be placed in increments of 4 mm or greater. Objective: The purpose of this article was to report the results of 12 months prospective randomized clinical trial that evaluated the clinical performance of one ...

  19. Ultrasonic root-end preparation in apical surgery : a prospective randomized study

    NARCIS (Netherlands)

    de Lange, Jan; Putters, Thomas; Baas, Erik M.; van Ingen, Johan M.

    2007-01-01

    Objective. The purpose of this study was to evaluate the potential benefit of an ultrasonic device in apical surgery on the outcome of treatment. Study design. A randomized prospective design was used in a standardized treatment protocol. Patients were allocated to treatment with an ultrasonic

  20. A Prospective, Randomized, Double-blind Clinical Trial of One Nano ...

    African Journals Online (AJOL)

    2015-12-16

    Dec 16, 2015 ... prospective randomized clinical trial that evaluated the clinical performance of one high‑viscosity bulk‑fill composite resin in Class II cavities of posterior teeth. .... amount of glass ionomer needed was used to cover the calcium ...

  1. Nonoperative Treatment of Thoracic and Lumbar Spine Fractures : A Prospective Randomized Study of Different Treatment Options

    NARCIS (Netherlands)

    Stadhouder, Agnita; Buskens, Erik; Vergroesen, Diederik A.; Fidler, Malcolm W.; de Nies, Frank; Oner, F. C.

    Objectives: To evaluate and compare nonoperative treatment methods for traumatic thoracic and lumbar compression fractures and burst fractures. Design: Prospective randomized controlled trial with long-term follow-up. Setting: Two general hospitals in the Netherlands. Patients/Participants: Patients

  2. Glove failure in elective thyroid surgery: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Dariusz Timler

    2015-06-01

    Full Text Available Objectives: To analyze perforation rate in sterile gloves used by surgeons in the operating theatre of the Department of Endocrinological and General Surgery of Medical University of Lodz. Material and Methods: Randomized and controlled trial. This study analyses the incidents of tears in sterile surgical gloves used by surgeons during operations on 3 types of thyroid diseases according to the 10th revision of International Statistical Classification of Diseases and Related Health Problems (ICD-10 codes. Nine hundred seventy-two pairs (sets of gloves were collected from 321 surgical procedures. All gloves were tested immediately following surgery using the water leak test (EN455-1 to detect leakage. Results: Glove perforation was detected in 89 of 972 glove sets (9.2%. Statistically relevant more often glove tears occurred in operator than the 1st assistant (p < 0.001. The sites of perforation were localized mostly on the middle finger of the non-dominant hand (22.5%, and the non-dominant ring finger (17.9%. Conclusions: This study has proved that the role performed by the surgeon during the procedure (operator, 1st assistant has significant influence on the risk of glove perforations. Nearly 90% of glove perforations are unnoticed during surgery.

  3. TVT versus TOT, 2-year prospective randomized study.

    Science.gov (United States)

    Wadie, Bassem S; El-Hefnawy, Ahmed S; Elhefnawy, Ahmed S

    2013-06-01

    To evaluate in a comprehensive way TVT in comparison with TOT, the results of a single-center RCT are presented. Many studies addressed efficacy and safety of TVT and TOT. Women included were adults having predominant SUI with positive stress test. They were randomized to get either TVT (Gynecare(®)) or TOT (Aris(®)). All women were seen 1 week, 3, 6, 12, 18, and 24 months. Seventy-one women completed 2-year follow-up. Median age was 47 (range 33-60 years). Mean ± SD BMI in TVT group was 34 ± 5 while in TOT group was 32 ± 5 kg/m(2). POP of any degree was seen in 50 % (35 women). At 1 year, pad test-negative women were 31 and 29 for TVT and TOT, respectively. At 2 years, figures became 28 in TVT group and 27 in TOT. At 1 year, UDI 6 and IIQ 7 decreased by 78.5 and 81 % for TVT and by 69 % and 75 % for TOT group. At 2 year, comparable percentages were 73 and 79 % for TVT and 69 and 82 % for TOT. Fifteen unique patients had adverse events, 10 of them had TOT. Both tapes have similar efficacy, regarding cure of incontinence. TVT is more effective, albeit insignificantly, than TOT at 2 years. However, serious adverse events were more frequent with TVT, yet TOT has more unique adverse events.

  4. Efficacy of Arthroscopic Teaching Methods: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Robinson, Luke; Spanyer, Jonathon; Yenna, Zachary; Burchell, Patrick; Garber, Andrew; Riehl, John

    Arthroscopic education research recently has been focused on the use of skills labs to facilitate resident education and objective measure development to gauge technical skill. This study evaluates the effectiveness of three different teaching methods. Medical students were randomized into three groups. The first group received only classroom-based lecture. The second group received the same lecture and 28 minutes of lab-based hands-off arthroscopy instruction using a cadaver and arthroscopy setup. The final group received the same lecture and 7 minutes of hands-on arthroscopy instruction in the lab on a cadaver knee. The arthroscopic knee exam that followed simulated a diagnostic knee exam and subjects were measured on task completion and by the number of look downs. The number of look downs and the number of tasks completed did not achieve statistical significance between groups. Posttest survey results revealed that the hands-on group placed significantly more value on their educational experience as compared with the other two groups. (Journal of Surgical Orthopaedic Advances.

  5. Acupuncture intervention in ischemic stroke: a randomized controlled prospective study.

    Science.gov (United States)

    Shen, Peng-Fei; Kong, Li; Ni, Li-Wei; Guo, Hai-Long; Yang, Sha; Zhang, Li-Li; Zhang, Zhi-Long; Guo, Jia-Kui; Xiong, Jie; Zhen, Zhong; Shi, Xue-Min

    2012-01-01

    Stroke is one of the most common causes of death and few pharmacological therapies show benefits in ischemic stroke. In this study, 290 patients aged 40-75 years old with first onset of acute ischemic stroke (more than 24 hours but within 14 days) were treated with standard treatments, and then were randomly allocated into an intervention group (treated with resuscitating acupuncture) and a control group (treated using sham-acupoints). Primary outcome measures included Barthel Index (BI), relapse and death up to six months. For the 290 patients in both groups, one case in the intervention group died, and two cases in the control group died from the disease (p = 0.558). Six patients of the 144 cases in the intervention group had relapse, whereas 34 of 143 patients had relapse in the control group (p two groups, respectively (p two groups for the National Institute of Health Stroke Scale (NIHSS), not at two weeks (7.03 ± 3.201 vs. 8.13 ± 3.634; p = 0.067), but at four weeks (4.15 ± 2.032 vs. 6.35 ± 3.131, p Stroke Scale (CSS) at four weeks showed more improvement in the intervention group than that in the control group (9.40 ± 4.51 vs. 13.09 ± 5.80, p Stroke Specific Quality of Life Scale (SS-QOL) at six months was higher in the intervention group (166.63 ± 45.70) than the control group (143.60 ± 50.24; p < 0.01). The results of this clinical trial showed a clinically relevant decrease of relapse in patients treated with resuscitating acupuncture intervention by the end of six months, compared with needling at the sham-acupoints. The resuscitating acupuncture intervention could also improve self-care ability and quality of life, evaluated with BI, NIHSS, CSS, Oxford Handicap Scale (OHS), and SS-QOL.

  6. Conventional versus computer-navigated TKA: a prospective randomized study.

    Science.gov (United States)

    Todesca, Alessandro; Garro, Luca; Penna, Massimo; Bejui-Hugues, Jacques

    2017-06-01

    The purpose of this study was to assess the midterm results of total knee arthroplasty (TKA) implanted with a specific computer navigation system in a group of patients (NAV) and to assess the same prosthesis implanted with the conventional technique in another group (CON); we hypothesized that computer navigation surgery would improve implant alignment, functional scores and survival of the implant compared to the conventional technique. From 2008 to 2009, 225 patients were enrolled in the study and randomly assigned in CON and NAV groups; 240 consecutive mobile-bearing ultra-congruent score (Amplitude, Valence, France) TKAs were performed by a single surgeon, 117 using the conventional method and 123 using the computer-navigated approach. Clinical outcome assessment was based on the Knee Society Score (KSS), the Hospital for Special Surgery Knee Score and the Western Ontario Mac Master University Index score. Component survival was calculated by Kaplan-Meier analysis. Median follow-up was 6.4 years (range 6-7 years). Two patients were lost to follow-up. No differences were seen between the two groups in age, sex, BMI and side of implantation. Three patients of CON group referred feelings of instability during walking, but clinical tests were all negative. NAV group showed statistical significant better KSS Score and wider ROM and fewer outliers from neutral mechanical axis, lateral distal femoral angle, medial proximal tibial angle and tibial slope in post-operative radiographic assessment. There was one case of early post-operative superficial infection (caused by Staph. Aureus) successfully treated with antibiotics. No mechanical loosening, mobile-bearing dislocation or patellofemoral complication was seen. At 7 years of follow-up, component survival in relation to the risk of aseptic loosening or other complications was 100 %. There were no implant revisions. This study demonstrates superior accuracy in implant positioning and statistical significant

  7. Adhesive strip wound closure after thyroidectomy/parathyroidectomy: a prospective, randomized controlled trial.

    LENUS (Irish Health Repository)

    O'Leary, D Peter

    2013-03-01

    Conventional collar incision closure in thyroid and parathyroid surgery involves the insertion of an epidermal layer of subcutaneous absorbable sutures that are reinforced by a deep layer of sutures. Adhesive strips offer an alternative method to close the epidermal layer. The aim of this study was to compare adhesive strip closure with absorbable sutures for collar incisions in a prospective, single-blinded, randomized controlled trial.

  8. Rapid, easy, and cheap randomization: prospective evaluation in a study cohort

    Directory of Open Access Journals (Sweden)

    Parker Melissa J

    2012-06-01

    Full Text Available Abstract Background When planning a randomized controlled trial (RCT, investigators must select randomization and allocation procedures based upon a variety of factors. While third party randomization is cited as being among the most desirable randomization processes, many third party randomization procedures are neither feasible nor cost-effective for small RCTs, including pilot RCTs. In this study we present our experience with a third party randomization and allocation procedure that utilizes current technology to achieve randomization in a rapid, reliable, and cost-effective manner. Methods This method was developed by the investigators for use in a small 48-participant parallel group RCT with four study arms. As a nested study, the reliability of this randomization procedure was prospectively evaluated in this cohort. The primary outcome of this nested study was the proportion of subjects for whom allocation information was obtained by the Research Assistant within 15 min of the initial participant randomization request. A secondary outcome was the average time for communicating participant group assignment back to the Research Assistant. Descriptive information regarding any failed attempts at participant randomization as well as costs attributable to use of this method were also recorded. Statistical analyses included the calculation of simple proportions and descriptive statistics. Results Forty-eight participants were successfully randomized and group allocation instruction was received for 46 (96% within 15 min of the Research Assistant placing the initial randomization request. Time elapsed in minutes until receipt of participant allocation instruction was Mean (SD 3.1 +/− 3.6; Median (IQR 2 (2,3; Range (1–20 for the entire cohort of 48. For the two participants for whom group allocation information was not received by the Research Assistant within the 15-min pass threshold, this information was obtained following a second

  9. Prospective randomized controlled trial of an injectable esophageal prosthesis versus a sham procedure for endoscopic treatment of gastroesophageal reflux disease

    NARCIS (Netherlands)

    Fockens, P.; Cohen, L.; Edmundowicz, S.A.; Binmoeller, K.; Rothstein, R.I.; Smith, D.; Lin, E.; Nickl, N.; Overholt, B.; Kahrilas, P.J.; Vakil, N.; Abdel Aziz Hassan, A.M.; Lehman, G.A.

    2010-01-01

    This study aimed to assess whether endoscopic implantation of an injectable esophageal prosthesis, the Gatekeeper Reflux Repair System (GK), is a safe and effective therapy for controlling gastroesophageal reflux disease (GERD). A prospective, randomized, sham-controlled, single-blinded,

  10. Pylorus preserving pancreaticoduodenectomy versus standard Whipple procedure: a prospective, randomized, multicenter analysis of 170 patients with pancreatic and periampullary tumors

    NARCIS (Netherlands)

    K.T. Tran; H.G. Smeenk; C.H.J. van Eijck (Casper); G. Kazemier (Geert); W.C.J. Hop (Wim); J.W. Greve (Jan Willem); O.T. Terpstra (Onno); J.A. Zijlstra (Jan); P. Klinkert; J. Jeekel (Hans)

    2004-01-01

    textabstractOBJECTIVE: A prospective randomized multicenter study was performed to assess whether the results of pylorus-preserving pancreaticoduodenectomy (PPPD) equal those of the standard Whipple (SW) operation, especially with respect to duration of surgery, blood loss,

  11. Prospective randomized trial of sclerotherapy vs standard treatment for epistaxis due to hereditary hemorrhagic telangiectasia.

    Science.gov (United States)

    Boyer, Holly; Fernandes, Patricia; Le, Chap; Yueh, Bevan

    2015-05-01

    Our previous studies have demonstrated the tolerability and low side-effect profile of office-based sclerotherapy with sodium tetradecyl sulfate (STS) for treating recurrent epistaxis due to hereditary hemorrhagic telangiectasia (HHT). The objective of this study was to use a prospective randomized trial to determine the effectiveness of sclerotherapy with STS vs standard treatment. This prospective randomized trial (conducted from November 1, 2011, through January 31, 2014) involved 17 patients with recurrent epistaxis due to HHT. We defined standard treatment as continuation of any treatment that the patient had previously undergone, such as moisturization, packing, and cautery. We used a crossover design, so study participants were randomized to either sclerotherapy or standard treatment during the first time period, and then to the other during the second period. The primary outcome measure was frequency and severity of epistaxis, as measured by the epistaxis severity score (ESS). The ESS is a 10-point scale, with higher scores corresponding to more bleeding. After controlling for treatment order, bleeding was substantially better controlled after sclerotherapy; the ESS after sclerotherapy was nearly one point lower than after standard treatment (-0.95, 1-sided p = 0.027). Treatment order, baseline ESS, the number of lesions, moisturization practices, and a history of previous blood transfusions did not significantly affect the results. This trial demonstrated that sclerotherapy with STS (vs standard treatment) significantly reduced epistaxis due to HHT. © 2015 ARS-AAOA, LLC.

  12. Oncology E-Learning for Undergraduate. A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    da Costa Vieira, René Aloisio; Lopes, Ana Helena; Sarri, Almir José; Benedetti, Zuleica Caulada; de Oliveira, Cleyton Zanardo

    2017-06-01

    The e-learning education is a promising method, but there are few prospective randomized publications in oncology. The purpose of this study was to assess the level of retention of information in oncology from undergraduate students of physiotherapy. A prospective, controlled, randomized, crossover study, 72 undergraduate students of physiotherapy, from the second to fourth years, were randomized to perform a course of physiotherapy in oncology (PHO) using traditional classroom or e-learning. Students were offered the same content of the subject. The teacher in the traditional classroom model and the e-learning students used the Articulate® software. The course tackled the main issues related to PHO, and it was divided into six modules, 18 lessons, evaluated by 126 questions. A diagnosis evaluation was performed previous to the course and after every module. The sample consisted of 67 students, allocated in groups A (n = 35) and B (n = 32), and the distribution was homogeneous between the groups. Evaluating the correct answers, we observed a limited score in the pre-test (average grade 44.6 %), which has significant (p e-learning, a fact that encourages the use of e-learning in oncology. REBECU1111-1142-1963.

  13. A prospective randomized comparison of curved array and radial echoendoscopy in patients with esophageal cancer

    DEFF Research Database (Denmark)

    Siemsen, Mette; Svendsen, Lars Bo; Knigge, Ulrich

    2003-01-01

    BACKGROUND: Both curved array and radial scanning echoendoscopy are used for locoregional staging of cancer arising in the esophagus or cardia. The accuracy of TNM staging of these malignancies by curved array and radial EUS was compared in a prospective, randomized study. METHODS: Patients...... with cancer of the esophagus or cardia were examined by both curved array and radial echoendoscopy in randomized order by the same endosonographer in an unblinded fashion. The staging results and the examination time for the two echoendoscopies were compared and statistically analyzed, and finally compared......, respectively, 15 and 12 minutes (pcancer of the esophagus or cardia. The choice of echoendoscope for TNM staging in patients with these malignancies is, therefore, a question...

  14. The Ex-PRESS glaucoma shunt versus trabeculectomy in open-angle glaucoma: a prospective randomized study

    NARCIS (Netherlands)

    de Jong, Leo A. M. S.

    2009-01-01

    The purpose of this study was to establish the efficacy and safety of the Ex-PRESS (Optonol Ltd., Neve Ilan, Israel) mini glaucoma shunt in open-angle glaucoma. This was a prospective, randomized trial. Eyes from enrolled patients were randomly assigned to either Ex-PRESS implantation under a

  15. Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

    Science.gov (United States)

    Merkely, Bela; Kosztin, Annamaria; Roka, Attila; Geller, Laszlo; Zima, Endre; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z; Moss, Arthur J; Goldenberg, Ilan; Kutyifa, Valentina

    2017-09-01

    There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. NCT02270840. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  16. Prospective, randomized evaluation of a personal digital assistant-based research tool in the emergency department

    Directory of Open Access Journals (Sweden)

    Dinizio Anthony

    2008-01-01

    Full Text Available Abstract Background Personal digital assistants (PDA offer putative advantages over paper for collecting research data. However, there are no data prospectively comparing PDA and paper in the emergency department. The aim of this study was to prospectively compare the performance of PDA and paper enrollment instruments with respect to time required and errors generated. Methods We randomized consecutive patients enrolled in an ongoing prospective study to having their data recorded either on a PDA or a paper data collection instrument. For each method, we recorded the total time required for enrollment, and the time required for manual transcription (paper onto a computer database. We compared data error rates by examining missing data, nonsensical data, and errors made during the transcription of paper forms. Statistical comparisons were performed by Kruskal-Wallis and Poisson regression analyses for time and errors, respectively. Results We enrolled 68 patients (37 PDA, 31 paper. Two of 31 paper forms were not available for analysis. Total data gathering times, inclusive of transcription, were significantly less for PDA (6:13 min per patient compared to paper (9:12 min per patient; p Conclusion Using a PDA-based data collection instrument for clinical research reduces the time required for data gathering and significantly improves data integrity.

  17. A prospective randomized clinical trial to evaluate methods of postoperative care of hypospadias.

    Science.gov (United States)

    McLorie, G; Joyner, B; Herz, D; McCallum, J; Bagli, D; Merguerian, P; Khoury, A

    2001-05-01

    Hypospadias repair is a common operation performed by pediatric urologists. Perhaps the greatest variable and source of controversy of postoperative care is the surgical dressing. We hypothesized that using no dressing would achieve surgically comparable results to those traditionally achieved by a postoperative dressing and it would also simplify postoperative parent delivered home care. Accordingly we designed a prospective randomized clinical trial to compare surgical outcome and postoperative care after hypospadias repair in boys with no dressing and those who received 1 of the 2 most common types of dressing. In a 12-month period 120 boys with an average age of 2.2 years underwent primary 1-stage hypospadias repair at a single center with 4 participating surgeons. Repair was performed in 60 boys with proximal and 60 with distal hypospadias on an outpatient basis. Ethics and Internal Review Board approval, and informed consent were obtained. Boys were then prospectively randomized to receive no dressing, an adhesive biomembrane dressing or a compressive wrap dressing. Comprehensive instructions on postoperative care were distributed to all families and a questionnaire was distributed to the parents at the initial followup. Surgical outcome was evaluated and questionnaire responses were analyzed. Fisher's exact test was done to test the significance of differences in surgical outcomes and questionnaire responses. A total of 117 boys completed the prospective randomized trial. Surgical staff withdrew 3 cases from randomized selection to place a dressing for postoperative hemostasis. We obtained 101 questionnaires for response analysis. The type or absence of the dressing did not correlate with the need for repeat procedures, urethrocutaneous fistula, or meatal stenosis or regression. Analysis revealed less narcotic use in the no dressing group and fewer telephone calls to the urology nurse, or on-call resident and/or fellow. These findings were statistically

  18. Membrane versus centrifuge-based therapeutic plasma exchange: a randomized prospective crossover study.

    Science.gov (United States)

    Hafer, Carsten; Golla, Paulina; Gericke, Marion; Eden, Gabriele; Beutel, Gernot; Schmidt, Julius J; Schmidt, Bernhard M W; De Reys, Stef; Kielstein, Jan T

    2016-01-01

    Therapeutic plasma exchange (TPE) is either performed using a highly permeable filter with standard multifunctional renal replacement equipment (mTPE) or a centrifugation device (cTPE). Although both techniques are well established in clinical practice, performance of these two modes of TPE was never compared in a prospective randomized fashion. Thus we aimed to compare two commercially available therapeutic apheresis systems: mTPE (Octonova with Plasmaflo filter) and cTPE (Spectra Optia apheresis system). Twenty-one patients (age 51.6 ± 13.5 years; 10 F/11 M; BMI 25.1 ± 5.0 kg/m(2)) were enrolled in this randomized, prospective, paired, crossover study performed in the Hannover Medical School, Germany. First treatment (either mTPE or cTPE) was chosen by an online randomization list. The primary endpoints were plasma removal efficiency with 1.2× of the total plasma volume exchanged. Secondary endpoints were total amount of plasma substances removed, such as IgG and fibrinogen. Further, the treatment effect on platelet count and complications were evaluated. Despite a comparable volume of the processed plasma, mTPE treatment time was 10.5 % longer than cTPE treatment time (p centrifugal procedures were conducted using flow rates that could easily be obtained using peripheral access, plasma removal efficiency was significantly higher and treatment time was significantly lower in cTPE as compared to mTPE. Despite this lower treatment time, the decline in markers of procedure efficacy was comparable. Especially in centers performing many procedures per year, cTPE in contrast to mTPE can reduce treatment time without compromising treatment efficacy.

  19. A prospective, randomized study addressing the need for physical simulation following virtual simulation

    International Nuclear Information System (INIS)

    Valicenti, Richard K.; Waterman, Frank M.; Corn, Benjamin W.; Curran, Walter J.

    1997-01-01

    Purpose: To accurately implement a treatment plan obtained by virtual or CT simulation, conventional or physical simulation is still widely used. To evaluate the need for physical simulation, we prospectively randomized patients to undergo physical simulation or no additional simulation after virtual simulation. Methods and Materials: From July 1995 to September 1996, 75 patients underwent conformal four-field radiation therapy planning for prostate cancer with a commercial grade CT simulator. The patients were randomized to undergo either port filming immediately following physical simulation or port filming alone. The precision of implementing the devised plan was evaluated by comparing simulator radiographs and/or port films against the digitally reconstructed radiographs (DRRs) for x, y, and z displacements of the isocenter. Changes in beam aperture were also prospectively evaluated. Results: Thirty-seven patients were randomized to undergo physical simulation and first day port filming, and 38 had first day treatment verification films only without a physical simulation. Seventy-eight simulator radiographs and 195 first day treatment port films were reviewed. There was no statistically significant reduction in treatment setup error (>5 mm) if patients underwent physical simulation following virtual simulation. No patient required a resimulation, and there was no significant difference in changes of beam aperture. Conclusions: Following virtual simulation, physical simulation may not be necessary to accurately implement the conformal four-field technique. Because port filming appears to be sufficient to assure precise and reliable execution of a devised treatment plan, physical simulation may be eliminated from the process of CT based planning when virtual simulation is available

  20. Cardiac effects of granisetron in a prospective crossover randomized dose comparison trial.

    Science.gov (United States)

    Cakir, F B; Yapar, O; Canpolat, C; Akalin, F; Berrak, S G

    2012-10-01

    Cardiac side effects of granisetron have been studied mostly in adult patients that are using cardiotoxic chemotherapeutics. There is limited evidence in pediatric age group and no information in pediatric oncology patients with non-cardiotoxic chemotherapeutics. In this prospective, crossover randomized study, the cardiac side effects of granisetron are compared in pediatric oncology patients who had carboplatin based chemotherapy. They were randomized to receive either 10 or 40 μg kg(-1) dose(-1) of granisetron before each cycle of chemotherapy. We drew blood for creatine phosphokinase (CPK), CPK-muscle band (MB) and Troponin-T before and 24 h after administering granisetron. Electrocardiography (ECG) tracings were taken at 0, 1, 2, 3, 6 and 24 h of granisetron. Twenty-four hours Holter ECG monitorisation was performed after each granisetron infusion. A total of 16 patients (median 8.7 years of age) were treated with weekly consecutive courses of carboplatin. There was bradycardia (p = 0.000) in patients that had granisetron at 40 μg/kg and PR interval was shortened in patients that had granisetron at 10 μg/kg dose (p = 0.021). At both doses of granisetron, QTc interval and dispersion were found to be similar. CPK, CK-MB and Troponin-T values were found to be normal before and 24 h after granisetron infusion. As the first study that has studied cardiac side effects of granisetron in patients that are not using cardiotoxic chemotherapeutics, we conclude that granisetron at 40 μg kg(-1) dose(-1) causes bradycardia only. We have also demonstrated that granisetron does not cause any clinically cardiac side effects either at 10 or 40 μg kg(-1) dose(-1). However, our results should be supported by prospective randomized studies with larger samples of patient groups.

  1. Prospective randomized trial compares suction versus water seal for air leaks.

    Science.gov (United States)

    Cerfolio, R J; Bass, C; Katholi, C R

    2001-05-01

    Surgeons treat air leaks differently. Our goal was to evaluate whether it is better to place chest tubes on suction or water seal for stopping air leaks after pulmonary surgery. A second goal was to evaluate a new classification system for air leaks that we developed. Patients were prospectively randomized before surgery to receive suction or water seal to their chest tubes on postoperative day (POD) #2. Air leaks were described and quantified daily by a classification system and a leak meter. The air-leak meter scored leaks from 1 (least) to 7 (greatest). The group randomized to water seal stayed on water seal unless a pneumothorax developed. On POD #2, 33 of 140 patients had an air leak. Eighteen patients had been preoperatively randomized to water seal and 15 to suction. Air leaks resolved in 12 (67%) of the water seal patients by the morning of POD #3. All 6 patients whose air leak did not stop had a leak that was 4/7 or greater (p leak meter. Of the 15 patients randomized to suction, only 1 patient's air leak (7%) resolved by the morning of POD #3. The randomization aspect of the trial was ended and statistical analysis showed water seal was superior (p = 0.001). The remaining 14 patients were then placed to water seal and by the morning of POD #4, 13 patients' leaks had stopped. Of the 32 total patients placed to seal, 7 (22%) developed a pneumothorax and 6 of these 7 patients had leaks that were 4/7 or greater (p = 0.001). Placing chest tubes on water seal seems superior to wall suction for stopping air leaks after pulmonary resection. However, water seal does not stop expiratory leaks that are 4/7 or greater. Pneumothorax may occur when chest tubes are placed on seal with leaks this large.

  2. Prone position as prevention of lung injury in comatose patients: a prospective, randomized, controlled study.

    Science.gov (United States)

    Beuret, Pascal; Carton, Marie-Jose; Nourdine, Karim; Kaaki, Mahmoud; Tramoni, Gerard; Ducreux, Jean-Claude

    2002-05-01

    Comatose patients frequently exhibit pulmonary function worsening, especially in cases of pulmonary infection. It appears to have a deleterious effect on neurologic outcome. We therefore conducted a randomized trial to determine whether daily prone positioning would prevent lung worsening in these patients. Prospective, randomized, controlled study. Sixteen-bed intensive care unit. Fifty-one patients who required invasive mechanical ventilation because of coma with Glascow coma scores of 9 or less. In the prone position (PP) group: prone positioning for 4 h once daily until the patients could get up to sit in an armchair; in the supine position (SP) group: supine positioning. The primary end point was the incidence of lung worsening defined by an increase in the Lung Injury Score of at least 1 point since the time of randomization. The secondary end point was the incidence of ventilator-associated pneumonia (VAP). A total of 25 patients were randomly assigned to the PP group and 26 patients to the SP group. The characteristics of the patients from the two groups were similar at randomization. The incidence of lung worsening was lower in the PP group (12%) than in the SP group (50%) ( p=0.003). The incidence of VAP was 20% in the PP group and 38.4% in the SP group ( p=0.14). There was no serious complication attributable to prone positioning, however, there was a significant increase of intracranial pressure in the PP. In a selected population of comatose ventilated patients, daily prone positioning reduced the incidence of lung worsening.

  3. Randomized, Prospective Comparison of Ursodeoxycholic Acid for the Prevention of Gallstones after Sleeve Gastrectomy.

    Science.gov (United States)

    Adams, Lindsay B; Chang, Craig; Pope, Janet; Kim, Yeonsoo; Liu, Pei; Yates, Amy

    2016-05-01

    Several studies have examined the role of ursodeoxycholic acid (UDCA) for the prevention of cholelithiasis (gallstones) following rapid weight loss from restrictive diets, vertical band gastroplasty, and Roux-en-Y gastric bypass. However, to date, there have been no prospective, controlled studies examining the role of UDCA for the prevention of gallstones following sleeve gastrectomy (SG). This study was conducted to identify the effectiveness of UDCA for prevention of gallstones after SG. Following SG, eligible patients were randomized to a control group who did not receive UDCA treatment or to a group who were prescribed 300 mg UDCA twice daily for 6 months. Gallbladder ultrasounds were performed preoperatively and at 6 and 12 months postoperatively. Patients with positive findings preoperatively were excluded from the study. Compliance with UDCA was assessed. Between December 2011 and April 2013, 37 patients were randomized to the UDCA treatment arm and 38 patients were randomized to no treatment. At baseline, the two groups were similar. At 6 months, the UDCA group had a statistically significant lower incidence of gallstones (p = 0.032). Analysis revealed no significant difference in gallstones between the two groups at 1 year (p = 0.553 and p = 0.962, respectively). The overall gallstone formation rate was 29.8%. The incidence of gallstones is higher than previously estimated in SG patients. UDCA significantly lowers the gallstone formation rate at 6 months postoperatively.

  4. Tolerance and diagnostic accuracy of an abbreviated adenosine infusion for myocardial scintigraphy: a randomized, prospective study.

    Science.gov (United States)

    Treuth, M G; Reyes, G A; He, Z X; Cwajg, E; Mahmarian, J J; Verani, M S

    2001-01-01

    The objectives of this study were 2-fold: (1) to determine the tolerance of adenosine perfusion tomography with the use of an abbreviated (3-minute) infusion in comparison to the standard (6-minute) infusion, and (2) to assess the relative diagnostic accuracy of a 3-minute adenosine infusion in patients referred for arteriography. An abbreviated adenosine infusion may decrease the frequency and duration of side effects and be a more cost-effective alternative. We prospectively randomized 599 patients undergoing adenosine myocardial perfusion tomography to either a 3-minute or 6-minute adenosine infusion at 140 microg/kg per minute. Among the 599 enrolled patients, 142 subsequently underwent coronary angiography. Patients randomized to the 3-minute adenosine infusion tolerated the procedure better than those randomized to the standard infusion (P <.01). Flushing, headache, neck pain, and atrioventricular block were all significantly less frequent (P <.01) with the abbreviated infusion. Moreover, patients receiving the abbreviated infusion had less hypotension and tachycardia (P <.05). The sensitivity of the test for detection of coronary artery disease was 88% for both the 3- and 6-minute infusions. In patients with abnormal scan results, perfusion defect size was slightly larger in those receiving a 6-minute infusion versus those receiving a 3-minute infusion (P =.05). An abbreviated 3-minute adenosine infusion, in combination with perfusion tomography, has similar sensitivity for detection of coronary artery disease and is better tolerated than the standard 6-minute infusion.

  5. Randomized prospective study comparing vancomycin with teicoplanin in the treatment of infections associated with Hickman catheters.

    Science.gov (United States)

    Smith, S R; Cheesbrough, J; Spearing, R; Davies, J M

    1989-08-01

    In 72 episodes of suspected or proven Hickman-catheter-associated infection occurring in 59 patients with various hematological disorders, patients were assigned to treatment with either vancomycin or teicoplanin in a randomized nonblinded prospective study. Of 60 episodes evaluable for response, 28 were treated with vancomycin and 32 were treated with teicoplanin. Sixteen infective episodes were microbiologically documented in the vancomycin group, and twenty-one were microbiologically documented in the teicoplanin group. Microbiologically and clinically documented infections treated with vancomycin had an 80% response rate, compared with a 69% response rate for those treated with teicoplanin (P = 0.316). Adverse events occurred in nine (25%) of the episodes in the vancomycin group, compared with three (8%) in the teicoplanin group (P = 0.044). Teicoplanin may provide an effective alternative to vancomycin in the treatment of Hickman-catheter-associated infection in patients with hematological malignancies.

  6. Prospective, Randomized, Multinational Study of Prostatic Urethral Lift Versus Transurethral Resection of the Prostate

    DEFF Research Database (Denmark)

    Sønksen, Jens; Barber, Neil J; Speakman, Mark J

    2015-01-01

    BACKGROUND: Transurethral resection of the prostate (TURP) is considered the gold standard for male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). However, TURP may lead to sexual dysfunction and incontinence, and has a long recovery period. Prostatic urethral...... lift (PUL) is a treatment option that may overcome these limitations. OBJECTIVE: To compare PUL to TURP with regard to LUTS improvement, recovery, worsening of erectile and ejaculatory function, continence and safety (BPH6). DESIGN, SETTING, AND PARTICIPANTS: Prospective, randomized, controlled trial...... at 10 European centers involving 80 men with BPH LUTS. INTERVENTION: PUL or TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The BPH6 responder endpoint assesses symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation...

  7. Calcipotriol versus coal tar: a prospective randomized study in stable plaque psoriasis

    Energy Technology Data Exchange (ETDEWEB)

    Sharma, V.; Kaur, I.; Kumar, B. [Postgraduate Institute of Medicinal Education & Research, Chandigarh (India)

    2003-10-01

    Topical therapies are the first line of treatment for patients with stable plaque psoriasis (SPP) affecting a limited body surface area. Very few trials comparing newer agents, such as 0.005% topical calcipotriol, with conventional modes of therapy, such as coal tar ointment, have been reported. A prospective, right-left randomized, investigator-blinded study with a 12-week treatment period and an 8-week follow-up period was performed. It was found that 0.005% calcipotriol ointment produced a faster initial response and had better cosmetic acceptability in patients, although after a long period of treatment, i.e. 12 weeks, 5% coal tar ointment had comparable efficacy. There was no statistically significant difference in the relapse rates between the two modalities.

  8. Anterior cervical discectomy with or without fusion with ray titanium cage: a prospective randomized clinical study

    DEFF Research Database (Denmark)

    Hauerberg, J.; Kosteljanetz, M.; Bøge-Rasmussen, Torben

    2008-01-01

    STUDY DESIGN: A prospective randomized clinical study. OBJECTIVE: To compare 2 surgical methods in the treatment of cervical radiculopathy caused by hard or soft disc herniation; namely, simple discectomy versus discectomy with an additional interbody fusion with a Ray titanium cage. SUMMARY...... by fusion with a Ray titanium cage (40 patients) or to discectomy alone (46 patients). Clinical and radiologic follow-up was performed 3, 12, and 24 months after surgery. RESULTS: There was no statistically significant difference between the 2 groups concerning self-reported satisfaction or severity of pain...... adjacent disc degeneration or spondylosis were the same in both groups. CONCLUSION: This study showed no statistically significant difference between simple discectomy and discectomy followed by interbody fusion with a titanium cage in the surgical treatment of cervical radiculopathy caused by disc...

  9. Continuous spinal anesthesia versus combined spinal epidural block for major orthopedic surgery: prospective randomized study

    Directory of Open Access Journals (Sweden)

    Luiz Eduardo Imbelloni

    Full Text Available CONTEXT AND OBJECTIVES: In major orthopedic surgery of the lower limbs, continuous spinal anesthesia (CSA and combined spinal epidural anesthesia (CSE are safe and reliable anesthesia methods. In this prospective randomized clinical study, the blockading properties and side effects of CSA were compared with single interspace CSE, among patients scheduled for major hip or knee surgery. DESIGN AND SETTING: Prospective clinical study conducted at the Institute for Regional Anesthesia, Hospital de Base, São José do Rio Preto. METHODS: 240 patients scheduled for hip arthroplasty, knee arthroplasty or femoral fracture treatment were randomly assigned to receive either CSA or CSE. Blockades were performed in the lateral position at the L3-L4 interspace. Puncture success, technical difficulties, paresthesia, highest level of sensory and motor blockade, need for complementary doses of local anesthetic, degree of technical difficulties, cardiocirculatory changes and postdural puncture headache (PDPH were recorded. At the end of the surgery, the catheter was removed and cerebrospinal fluid leakage was evaluated. RESULTS: Seven patients were excluded (three CSA and four CSE. There was significantly lower incidence of paresthesia in the CSE group. The resultant sensory blockade level was significantly higher with CSE. Complete motor blockade occurred in 110 CSA patients and in 109 CSE patients. Arterial hypotension was observed significantly more often in the CSE group. PDPH was observed in two patients of each group. CONCLUSION: Our results suggest that both CSA and CSE provided good surgical conditions with low incidence of complications. The sensory blockade level and hemodynamic changes were lower with CSA.

  10. Peyton's four-step approach for teaching complex spinal manipulation techniques - a prospective randomized trial.

    Science.gov (United States)

    Gradl-Dietsch, Gertraud; Lübke, Cavan; Horst, Klemens; Simon, Melanie; Modabber, Ali; Sönmez, Tolga T; Münker, Ralf; Nebelung, Sven; Knobe, Matthias

    2016-11-03

    The objectives of this prospective randomized trial were to assess the impact of Peyton's four-step approach on the acquisition of complex psychomotor skills and to examine the influence of gender on learning outcomes. We randomly assigned 95 third to fifth year medical students to an intervention group which received instructions according to Peyton (PG) or a control group, which received conventional teaching (CG). Both groups attended four sessions on the principles of manual therapy and specific manipulative and diagnostic techniques for the spine. We assessed differences in theoretical knowledge (multiple choice (MC) exam) and practical skills (Objective Structured Practical Examination (OSPE)) with respect to type of intervention and gender. Participants took a second OSPE 6 months after completion of the course. There were no differences between groups with respect to the MC exam. Students in the PG group scored significantly higher in the OSPE. Gender had no additional impact. Results of the second OSPE showed a significant decline in competency regardless of gender and type of intervention. Peyton's approach is superior to standard instruction for teaching complex spinal manipulation skills regardless of gender. Skills retention was equally low for both techniques.

  11. Malignant astrocytoma: hyperfractionated and standard radiotherapy with chemotherapy in a randomized prospective clinical trial

    International Nuclear Information System (INIS)

    Payne, D.G.; Simpson, W.J.; Keen, C.; Platts, M.E.

    1982-01-01

    A prospective randomized trial of 157 patients with malignant astrocytomas (Grade III or IV) was carried out at a single institution. The minimization technique ensured balanced distribution of prognostic factors between the treatment groups. All received oral lomustine (CCNU, 80 mg/m 2 ) six weekly and hydroxyurea (HU, 3.5 gm/m 2 over 5 days) three weekly, for one year or until recurrence, with doses adjusted for myelosuppression. Patients were randomized to daily (5000 rad in 25 fractions (fr) in 5 weeks) or Q3h (every 3 hours) Cobalt 60 irradiation (3600-4000 rad in 36-40 fr of 100 rad each, given 4 fr per day at 3-hour intervals over two weeks). Steroid therapy (up to 16 mg day dexamethasone) was permitted. Complications were moderate and equivalent in the two groups. No significant survival or toxicity differences were seen between the two groups. Age, initial performance status, and extent of surgical resection were found to be significant (P<0.01) prognostic factors for survival. Median survival of the whole group was 48 weeks with a minimum follow-up of one year. There was no advantage to large radiation fields. The hyperfractionation and daily regimes had similar efficacy and toxicity. Hyperfractionation with chemotherapy offers a useful alternative approach in the management of this disease

  12. Laparoscopic versus open cholecystectomy in cirrhotic patients: a prospective randomized study.

    Science.gov (United States)

    El-Awadi, Saleh; El-Nakeeb, Ayman; Youssef, Tamer; Fikry, Amir; Abd El-Hamed, Tito M; Ghazy, Hosam; Foda, Elyamany; Farid, Mohamed

    2009-02-01

    Improved laparoscopic experience and techniques have made laparoscopic cholecystectomy (LC) feasible options in cirrhotic patients. This study was designed to compare the risk and benefits of open cholecystectomy (OC) versus LC in compensated cirrhosis. A randomized prospective study, in the period from October 2002 till December 2006, where 110 cirrhotic patients with symptomatic gallstone were randomly divided into OC group (55 patients) and LC group (55 patients). There was no operative mortality. In LC group 4 (7.33%) patients were converted to OC. Mean surgical time was significantly longer in OC group than LC group (96.13+17.35 min versus 76.13+15.12) P<0.05, associated with significantly higher intraoperative bleeding in OC group (P<0.01), necessitating blood transfusions to 7 (12.72%) patients in OC group. The time to resume diet was 18.36+8.18 h in LC group which is significantly earlier than in OC group 47.84+14.6h P<0.005. Hospital stay was significantly longer in OC group than LC group (6+1.74 days versus 1.87+1.11 days) P<0.01 with low postoperative morbidity. LC in cirrhotics is still complicated and highly difficult which associates with significant morbidity compared with that of patients without cirrhosis. However, it offers lower morbidity, shorter operative time; early resume dieting with less need for blood transfusion and reducing hospital stay than OC.

  13. PRK and butterfly LASEK: prospective, randomized, contralateral eye comparison of epithelial healing and ocular discomfort.

    Science.gov (United States)

    Ghanem, Vinícius C; Souza, Giselle C; Souza, Denise C; Viese, Juliana M Z; Weber, Sarah L P; Kara-José, Newton

    2008-06-01

    To compare corneal reepithelialization, pain scores, ocular discomfort, and tear production after photorefractive keratectomy (PRK) and butterfly laser epithelial keratomileusis (LASEK). This prospective, randomized, double-masked study comprised 102 eyes of 51 patients who underwent laser refractive surgery. Each patient was randomized to have one eye operated on with PRK and the other with butterfly LASEK. Patients were followed for 1 year. The mean reepithelialization time in the PRK group was 4.35+/-0.48 days (range: 4 to 5 days) and 4.75+/-0.72 days (range: 4 to 6 days) in the butterfly LASEK group (PPRK was noted (3.31+/-4.09 vs 4.43+/-4.27; P=.18). Schirmer test values were significantly reduced from preoperative levels through 12 months with both PRK (23.6+/-8.1 vs 19.4+/-10.1; P<.002) and butterfly LASEK (22.4+/-8.7 vs 18.9+/-9.7; P=.01); however, no difference between groups was noted at any time. Photorefractive keratectomy showed a modest but statistically significant shorter reepithelialization time and a tendency towards lower pain scores than butterfly LASEK. The reepithelialization time was strongly associated with the duration of surgery in both techniques. A similar reduction of Schirmer test values was observed up to 1 year postoperatively in both groups.

  14. Custom vs conventional PRK: a prospective, randomized, contralateral eye comparison of postoperative visual function.

    Science.gov (United States)

    Mifflin, Mark D; Hatch, Bryndon B; Sikder, Shameema; Bell, James; Kurz, Christopher J; Moshirfar, Majid

    2012-02-01

    To determine whether VISX S4 (VISX Inc) custom photorefractive keratectomy (PRK) results in better visual outcomes than VISX S4 conventional PRK. Photorefractive keratectomy was performed on 80 eyes from 40 patients in this randomized, prospective, contralateral eye study. Dominant eyes were randomized to one group with the fellow eye receiving the alternate treatment. Primary outcome measures included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), contrast sensitivity, and root-mean-square (RMS) higher order aberrations. Mean UDVA was -0.023±0.099 (20/19) in the custom group and -0.044±0.080 (20/18) in the conventional group 6 months after surgery (P=.293). Mean CDVA was -0.073±0.067 (20/17) in the custom group and -0.079±0.071 (20/17) in the conventional group 6 months after surgery (P=.659). Total higher order aberration RMS and spherical aberration increased in both groups compared to preoperative values (PPRK were shown to be safe and effective with excellent visual acuity and contrast sensitivity performance at 6 and 12 months. Conventional PRK induced more coma than custom PRK; however, this did not seem to correlate with clinical outcomes. Copyright 2012, SLACK Incorporated.

  15. Comparison of torsional and microburst longitudinal phacoemulsification: a prospective, randomized, masked clinical trial.

    Science.gov (United States)

    Vasavada, Abhay R; Raj, Shetal M; Patel, Udayan; Vasavada, Vaishali; Vasavada, Viraj

    2010-01-01

    To compare intraoperative performance and postoperative outcome of three phacoemulsification technologies in patients undergoing microcoaxial phacoemulsification through 2.2-mm corneal incisions. The prospective, randomized, single-masked study included 360 eyes randomly assigned to torsional (Infiniti Vision System; Alcon Laboratories, Fort Worth, TX), microburst with longitudinal (Infiniti), or microburst with longitudinal (Legacy Everest, Alcon Laboratories) ultrasound. Assessments included surgical clock time, fluid volume, and intraoperative complications, central corneal thickness on day 1 and months 1 and 3 postoperatively, and endothelial cell density at 3 months postoperatively. Comparisons among groups were conducted. Torsional ultrasound required significantly less surgical clock time and fluid volume than the other groups. There were no intraoperative complications. Change in central corneal thickness and endothelial cell loss was significantly lower in the torsional ultrasound group at all postoperative visits (P < .001, Kruskal-Wallis test) compared to microburst longitudinal ultrasound modalities. Torsional ultrasound demonstrated quantitatively superior intraoperative performance and showed less increase in corneal thickness and less endothelial cell loss compared to microburst longitudinal ultrasound. Copyright 2010, SLACK Incorporated.

  16. Intraoperative discomfort associated with the use of a rotary or reciprocating system: a prospective randomized clinical

    Directory of Open Access Journals (Sweden)

    Aline Cristine Gomes

    2017-05-01

    Full Text Available Objectives The aim of this randomized, controlled, prospective clinical study was to evaluate patients' intraoperative discomfort during root canal preparations in which either multi-file rotary (Mtwo or single-file reciprocating (Reciproc systems were used. Materials and Methods Fifty-five adult patients, aged between 25 and 69 years old, with irreversible pulpitis or pulp necrosis participated in this study. Either the mesiobuccal or the distobuccal canals for maxillary molars and either the mesiobuccal or the mesiolingual canals for mandibular molars were randomly chosen to be instrumented with Mtwo multi-file rotary or Reciproc single-file reciprocating systems. Immediately after each canal instrumentation under anesthesia, patient discomfort was assessed using a 1 - 10 visual analog scale (VAS, ranging from ‘least possible discomfort’ (1 to ‘greatest possible discomfort’ (10. The Wilcoxon signed-rank test was used to determine significant differences at p< 0.05. Results Little intraoperative discomfort was found in all cases. No statistically significant differences in intraoperative discomfort between the 2 systems were found (p = 0.660. Conclusions Root canal preparation with multi-file rotary or single-file reciprocating systems had similar and minimal effects on patients' intraoperative discomfort.

  17. Intrapleural chemo- and hyperthermotherapies for malignant pleural effusion: a randomized prospective study.

    Science.gov (United States)

    Chen, Wen-Jun; Yuan, Shao-Fei; Yan, Qing-Yuan; Xiong, Jian-Ping; Wang, Sen-Ming; Zheng, Wei-E; Zhang, Wu; Sun, Hong-Yu; Chen, Hua; Wu, Li-Li

    2012-02-01

    The current prospective randomized study was designed to evaluate the safety and efficacy of combined intrapleural cisplatin and OK-432 (picibanil) plus hyperthermotherapy in patients with malignant pleural effusion (MPE). A total of 358 patients with MPE due to end-stage malignancies were enrolled and randomly divided into two groups, A and B: the intrapleural combination of cisplatin and OK-432 with hyperthermotherapy (n = 179) or without hyperthermotherapy (n = 179), respectively. Mild toxicities such as nausea, vomiting or anorexia, bone marrow depression, and pyrexia were similar in both groups. Patients in Group A (with hyperthermotherapy) showed a significantly higher overall response (93.4%) compared to those in Group B (79.8%, χ(2) = 43.11, p .05). After treatment, the quality of life scores were significantly increased in both groups as compared to prior treatment (p < .05). In conclusion, our study suggests that combined intrapleural cisplatin and OK-432 followed by hyperthermotherapy are more effective in the control of MPE and improve patients' quality of life.

  18. A prospective randomized study comparing unipolar versus bipolar hysteroscopic myomectomy in infertile women

    Directory of Open Access Journals (Sweden)

    Kallol K Roy

    2017-01-01

    Full Text Available Study Objective: To compare the operative and reproductive outcome of hysteroscopic myomectomy using unipolar resectoscope versus bipolar resectoscope in patients with infertility and menorrhagia. Design: Randomized, prospective, parallel, comparative, single-blinded study. Design Classification: Canadian Task Force classification I. Setting: Tertiary care institute. Patients: Sixty women with submucous myoma and infertility. Interventions: Hysteroscopic myomectomy performed with unipolar resectoscope or bipolar resectoscope. Measurements: Primary outcome measures were the pregnancy-related indicators. Secondary outcome measures were the operative parameters, harmful outcomes related to the procedure, and comparison of improvement levels in the menstrual pattern after surgery between the two groups. Main Results: A total of 60 patients were randomized into two groups of equal size. Baseline characteristics were not significantly different between the two groups. Reduction in sodium level from pre- to postsurgery was significantly (P = 0.001 higher in the unipolar group. Nine patients (30% in the unipolar group had hyponatremia in the postoperative period compared to none in the bipolar group (P = 0.002. However, there was no significant difference in the other operative parameters between the two groups. In both the groups, a significant improvement in the menstrual symptoms was observed after myomectomy. Pregnancy-related outcomes were similar in both the groups. Conclusion: The use of bipolar resectoscope for hysteroscopic myomectomy is associated with lesser risk of hyponatremia compared to unipolar resectoscope. Bipolar resectoscopic myomectomy is found to be an effective and safer alternative to unipolar resectoscopy with similar reproductive outcome.

  19. Effect of cryotherapy after elbow arthrolysis: a prospective, single-blinded, randomized controlled study.

    Science.gov (United States)

    Yu, Shi-yang; Chen, Shuai; Yan, He-de; Fan, Cun-yi

    2015-01-01

    To investigate the effect of cryotherapy after elbow arthrolysis on elbow pain, blood loss, analgesic consumption, range of motion, and long-term elbow function. Prospective, single-blinded, randomized controlled study. University hospital. Patients (N=59; 27 women, 32 men) who received elbow arthrolysis. Patients were randomly assigned into a cryotherapy group (n=31, cryotherapy plus standard care) or a control group (n=28, standard care). Elbow pain at rest and in motion were measured using a visual analog scale (VAS) on postoperative day (POD) 1 to POD 7 and at 2 weeks and 3 months after surgery. Blood loss and analgesic consumption were recorded postoperatively. Elbow range of motion (ROM) was measured before surgery and on POD 1, POD 7, and 3 months after surgery. The Mayo Elbow Performance Score (MEPS) was evaluated preoperatively and 3 months postoperatively. VAS scores were significantly lower in the cryotherapy group during the first 7 PODs, both at rest and in motion (Pcryotherapy group than the control group for pain relief (P.05). Cryotherapy is effective in relieving pain and reducing analgesic consumption for patients received elbow arthrolysis. The application of cryotherapy will not affect blood loss, ROM, or elbow function. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  20. Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

    Science.gov (United States)

    Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

    2013-03-01

    Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

  1. Improving Prospective Memory in Persons With Parkinson Disease: A Randomized Controlled Trial.

    Science.gov (United States)

    Foster, Erin R; McDaniel, Mark A; Rendell, Peter G

    2017-05-01

    Prospective memory (PM) is essential for productive and independent living and necessary for compliance with prescribed health behaviors. Parkinson disease (PD) can cause PM deficits that are associated with activity limitations and reduced quality of life. Forming implementation intentions (IIs) is an encoding strategy that may improve PM in this population. To determine the effect of IIs on PM performance in PD. This was a laboratory-based randomized controlled trial. Participants with mild to moderate PD without dementia (n = 62) performed a computerized PM test (Virtual Week) under standard instructions. One week later they were randomly allocated to perform it again while using either IIs or a rehearsal (RR) encoding strategy. PM performance was better with the use of both strategies relative to standard instructions. This effect was larger for tasks with event-based compared with time-based cues. In addition, IIs resulted in a larger effect than RR for the nonrepeated tasks. Strategies that support full encoding of PM cues and actions can improve PM performance among people with PD, particularly for tasks with cues that are readily available in the environment. IIs may be more effective than RR for nonrepeated tasks, but this finding warrants verification. Future work should address transfer of strategy use from the laboratory to everyday life. Targeted strategies to manage PM impairment could improve function and quality of life and significantly affect clinical care for people with PD.

  2. Randomized prospective study of olecranon fracture fixation: cable pin system versus tension band wiring.

    Science.gov (United States)

    Liu, Q-H; Fu, Z-G; Zhou, J-L; Lu, T; Liu, T; Shan, L; Liu, Y; Bai, L

    2012-01-01

    This prospective, randomized study compared the effectiveness of the cable pin system (CPS) versus tension band wiring (TBW) for olecranon fracture fixation. Patients with acute transverse or slight oblique olecranon fractures were randomly divided into two groups: one fixed by CPS and the other by TBW. Clinical outcome data were collected and analysed following a mean duration of 21 months. The mean ± SD fracture healing time was significantly shorter in the CPS group (n = 30; 9.73 ± 2.02 weeks) compared with the TBW group (n = 32; 11.13 ± 2.21 weeks). One patient in the CPS group and seven patients in the TBW group experienced postoperative complications; this difference was statistically significant. The mean ± SD Mayo Elbow Performance Score in the CPS group was significantly higher (88.67 ± 6.42) than that in the TBW group (80.78 ± 11.99). Logistic regression analysis showed an association between fixation method and fracture healing time, complications and elbow function. Internal fixation by CPS is an effective method for olecranon fracture and is associated with a shorter healing time, fewer complications and better function than TBW.

  3. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    OpenAIRE

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2012-01-01

    INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60)...

  4. Prophylactic amnioinfusion in preganancies complicated by chorioamnionitis: a prospective randomized trial.

    Science.gov (United States)

    Parilla, B V; McDermott, T M

    1998-01-01

    The objective of this article is to prospectively investigate the efficacy of amnioinfusion as a means to reduce febrile morbidity in pregnancies complicated by chorioamnionitis. All laboring patients with a temperature > or =100.1 degrees F were approached for study participation. Exclusion criteria included amnionitis diagnosed at greater than 8 cm dilation, multiple gestation, placental abruption, or a nonreassuring fetal heart rate tracing. Consenting patients were randomized to receive antibiotics (ampicillin or penicillin with gentamicin) and acetaminophen with or without amnioinfusion. All patients received intrauterine pressure catheter placement. For study patients, normal saline at room temperature was infused at 10 mL/min for 60 min, then 3 mL/min until delivery. Postpartum endometritis was defined as a temperature = 100.4 degrees F accompanied by uterine tenderness more than 12 hr after delivery. Statistical analysis was performed using the Student's t-test for continuous data and Chi-square for discrete variables. Thirty-six patients were enrolled, and complete data were available for 34 patients (17 in each group). There were no differences between groups with respect to maternal age, gravidity, race, or gestational age. There were also no differences between groups in duration of rupture of membranes, temperature at randomization, interval from randomization to delivery, cesarean section rate, or umbilical cord arterial pH. The mean temperature at the time of delivery was 99.8+/-0.9 degrees F for the amnioinfusion group versus 100.5+/-1.0 degrees F for the control group (p=0.046). Three of 17 amnioinfusion patients and 3 of 17 control patients had postpartum endometritis. There was 1 neonatal infection in the treatment group and no neonatal infections among the control patients. Prophylactic amnioinfusion was associated with a decline in temperature at the time of delivery. No untoward effects from the amnioinfusion were identified.

  5. Gentamicin-collagen sponge reduces sternal wound complications after heart surgery : A controlled, prospectively randomized, double-blind study

    NARCIS (Netherlands)

    Schimmer, Christoph; Oezkur, Mehmet; Sinha, Bhanu; Hain, Johannes; Gorski, Armin; Hager, Benjamin; Leyh, Rainer

    Objective: Prophylactic retrosternal placement of a gentamicin-collagen sponge has been the subject of several recent clinical studies and is a matter of controversy. The present study is the first controlled, prospective, randomized, double-blind, single-center study to investigate the efficacy of

  6. Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II

    NARCIS (Netherlands)

    Versyck, B.; Geffen, G.J. van; Houwe, P. Van

    2017-01-01

    STUDY OBJECTIVE: The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. DESIGN: A prospective randomized double blind placebo-controlled study. SETTING:

  7. Immediate loading versus immediate provisionalization of maxillary single-tooth replacements: a prospective randomized study with BioComp implants

    NARCIS (Netherlands)

    Lindeboom, Jerome A.; Frenken, Joost W.; Dubois, Leander; Frank, Michael; Abbink, Ingmar; Kroon, Frans H.

    2006-01-01

    PURPOSE: The aim of this prospective randomized study was to evaluate the clinical outcome of immediately loaded solid plasma sprayed (TPS) BioComp (BioComp Industries BV, Vught, The Netherlands) implants versus immediate provisionalized but non-loaded BioComp implants in the anterior and premolar

  8. EFFICACY OF SPINAL-CORD STIMULATION AS ADJUVANT THERAPY FOR INTRACTABLE ANGINA-PECTORIS - A PROSPECTIVE, RANDOMIZED CLINICAL-STUDY

    NARCIS (Netherlands)

    DEJONGSTE, MJL; HAUTVAST, RWM; HILLEGE, HL; LIE, KI

    Objectives. In a prospective, randomized study with an 8-week follow-up period, we evaluated the efficacy of spinal cord stimulation an exercise capacity and quality of life in patients with intractable angina. Background. Despite important achievements in therapy for ischemic heart disease, there

  9. YAG laser peripheral iridotomy for the prevention of pigment dispersion glaucoma a prospective, randomized, controlled trial.

    Science.gov (United States)

    Scott, Andrew; Kotecha, Aachal; Bunce, Catey; Balidis, Miltos; Garway-Heath, David F; Miller, Michael H; Wormald, Richard

    2011-03-01

    To test the hypothesis that neodymium:yttrium-aluminum-garnet (Nd:YAG) laser peripheral iridotomy (LPI) significantly reduces the incidence of conversion from pigment dispersion syndrome (PDS) with ocular hypertension (OHT) to pigmentary glaucoma (PG). Prospective, randomized, controlled 3-year trial. One hundred sixteen eyes of 116 patients with PDS and OHT. Patients were assigned randomly either to Nd:YAG LPI or to a control group (no laser). The primary outcome measure was conversion to PG within 3 years, based on full-threshold visual field (VF) analysis using the Ocular Hypertension Treatment Study criteria. Secondary outcome measures were whether eyes required topical antiglaucoma medications during the study period and the time to conversion or medication. Fifty-seven patients were randomized to undergo laser treatment and 59 were randomized to no laser (controls). Age, gender, spherical equivalent refraction, and intraocular pressure at baseline were similar between groups. Outcome data were available for 105 (90%) of recruited subjects, 52 in the laser treatment group and 53 in the no laser treatment group. Patients were followed up for a median of 35.9 months (range, 10-36 months) in the laser arm and 35.9 months (range, 1-36 months) in the control arm. Eight eyes (15%) in the laser group and 3 eyes (6%) in the control group converted to glaucoma in the study period. The proportion of eyes started on medical treatment was similar in the 2 groups: 8 eyes (15%) in the laser group and 9 eyes (17%) in the control group. Survival analyses showed no evidence of any difference in time to VF progression or commencement of topical therapy between the 2 groups. Cataract extraction was performed on 1 patient in the laser group and in 1 patient in the control group during the study period (laser eye at 18 months; control eye at 34 months). This study suggests that there was no benefit of Nd:YAG LPI in preventing progression from PDS with OHT to PG within 3 years of

  10. Preoperative Radiotherapy in Resectable Rectal Cancer: A Prospective Randomized Study of Two Different Approaches

    International Nuclear Information System (INIS)

    EITTA, M.A.; EL- WAHIDI, G.F.; FOUDA, M.A.; ABO EL-NAGA, E.M.; GAD EL-HAK, N.

    2010-01-01

    Preoperative radiotherapy in resectable rectal cancer has a number of potential advantages, most importantly reducing local recurrence, increasing survival and down-staging effect. Purpose: This prospective study was designed to compare between two different approaches of preoperative radiotherapy, either short course or long course radiotherapy. The primary endpoint is to evaluate the local recurrence rate, overall survival (OS) and disease free survival (DFS). The secondary endpoint is to evaluate down staging, treatment toxicity and ability to do sphincter sparing procedure (SSP), aiming at helping in the choice of the optimal treatment modality. Patients and Methods: This is a prospective randomized study of patients with resectable rectal cancer who presented to the department of Clinical Oncology and Nuclear Medicine, Mansoura University during the time period between June 2007 and September 2009. These patients received preoperative radiotherapy and were randomized into two arms: Arm 1, short course (SCRT) 25Gy/week/5 fractions followed by surgery within one week, and arm 2, long course preoperative radiotherapy (LCRT) 45Gy/5 weeks/25 fractions followed by surgery after 4-6 weeks. Adjuvant chemotherapy was given 4-6 weeks after surgery according to the postoperative pathology. Results: After a median follow-up of 18 months (range 6 to 28 months), we studied the patterns of recurrence. Three patients experienced local recurrence (LR), two out of 14 (14.2%) in arm 1 and one out of 15 patients (6.7%) in arm 2, (p=0.598). Three patients developed distant metastases [two in arm 1 (14.2%) and one in arm 2 (6.7%), p=0.598]. Two-year OS rate was 64±3% and 66±2%, (p= 0.389), and the 2-year DFS rate was 61±2% and 83±2% for arms 1 and 2, respectively (p=0.83). Tumor (T) downstaging was more achieved in LCRT arm with a statistically significant difference, but did not reach statistical significance in node (N) down-staging. SSP was more available in LCRT but with no

  11. Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure

    Directory of Open Access Journals (Sweden)

    Tojo Katsuyoshi

    2008-05-01

    Full Text Available Abstract Background The large clinical trials proved that Basal-Bolus (BB insulin therapy was effective in the prevention of diabetic complications and their progression. However, BB therapy needs multiple insulin injections per a day. In this regard, a biphasic insulin analogue needs only twice-daily injections, and is able to correct postprandial hyperglycemia. Therefore it may achieve the blood glucose control as same as that of BB therapy and prevent the diabetic complications including macroangiopathy. Methods In PROBE (Prospective, Randomized, Open, Blinded-Endpoint design, forty-two type 2 diabetic patients (male: 73.8%, median(inter quartile range age: 64.5(56.8~71.0years with secondary failure of sulfonylurea (SU were randomly assigned to BB therapy with a thrice-daily insulin aspart and once-daily basal insulin (BB group or to conventional therapy with a twice-daily biphasic insulin analogue (30 Mix group, and were followed up for 6 months to compare changes in HbA1c, daily glycemic profile, intima-media thickness (IMT of carotid artery, adiponectin levels, amounts of insulin used, and QOL between the two groups. Results After 6 months, HbA1c was significantly reduced in both groups compared to baseline (30 Mix; 9.3(8.1~11.3 → 7.4(6.9~8.7%, p Conclusion Both BB and 30 mix group produced comparable reductions in HbA1c in type 2 diabetic patients with secondary failure. There was no significant change in IMT as an indicator of early atherosclerotic changes between the two groups. The basal-bolus insulin therapy may not be necessarily needed if the type 2 diabetic patients have become secondary failure. Trial registration Current Controlled Trials number, NCT00348231

  12. Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage: a prospective, randomized, controlled trial (LUMAS).

    Science.gov (United States)

    Al-Tamimi, Yahia Z; Bhargava, Deepti; Feltbower, Richard G; Hall, Gregory; Goddard, Anthony J P; Quinn, Audrey C; Ross, Stuart A

    2012-03-01

    A single-center prospective randomized controlled trial has been conducted to determine if lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage reduces the prevalence of delayed ischemic neurological deficit and improves clinical outcome. Patients with World Federation of Neurological Surgeons Grade 1 to 3 aneurysmal subarachnoid hemorrhage and modified Fisher Grades 2, 3, 4, and 3+4 were randomized to either the study group of standard therapy plus insertion of a lumbar drain or the control group of standard therapy alone. The primary outcome measure was the prevalence of delayed ischemic neurological deficit. Two hundred ten patients with aneurysmal subarachnoid hemorrhage (166 female, 44 male; median age, 54 years; interquartile range, 45-62 years) were recruited into the control (n=105) and study (n=105) groups of the trial. World Federation of Neurological Surgeons grade was: 1 (n=139), 2 (n=60), and 3 (n=11); Fisher grade was: 2 (n=87), 3 (n=85), and 4 (n=38). The prevalence of delayed ischemic neurological deficit was 35.2% and 21.0% in the control and study groups, respectively (P=0.021). The prevalence of a modified Rankin Scale score of 4, 5, or 6 at Day 10 and 6 months, respectively, was 62.5% and 18.6% in the control group and 44.8% and 19.8% in the study group (P=0.009 and 0.83, respectively). Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage has been shown to reduce the prevalence of delayed ischemic neurological deficit and improve early clinical outcome but failed to improve outcome at 6 months after aneurysmal subarachnoid hemorrhage. URL: www.clinicaltrials.gov. Unique identifier: NCT00842049.

  13. Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study.

    Science.gov (United States)

    Tuakli-Wosornu, Yetsa A; Terry, Alon; Boachie-Adjei, Kwadwo; Harrison, Julian R; Gribbin, Caitlin K; LaSalle, Elizabeth E; Nguyen, Joseph T; Solomon, Jennifer L; Lutz, Gregory E

    2016-01-01

    To determine whether single injections of autologous platelet-rich plasma (PRP) into symptomatic degenerative intervertebral disks will improve participant-reported pain and function. Prospective, double-blind, randomized controlled study. Outpatient physiatric spine practice. Adults with chronic (≥6 months), moderate-to-severe lumbar diskogenic pain that was unresponsive to conservative treatment. Participants were randomized to receive intradiskal PRP or contrast agent after provocative diskography. Data on pain, physical function, and participant satisfaction were collected at 1 week, 4 weeks, 8 weeks, 6 months, and 1 year. Participants in the control group who did not improve at 8 weeks were offered the option to receive PRP and subsequently followed. Functional Rating Index (FRI), Numeric Rating Scale (NRS) for pain, the pain and physical function domains of the 36-item Short Form Health Survey, and the modified North American Spine Society (NASS) Outcome Questionnaire were used. Forty-seven participants (29 in the treatment group, 18 in the control group) were analyzed by an independent observer with a 92% follow-up rate. Over 8 weeks of follow-up, there were statistically significant improvements in participants who received intradiskal PRP with regards to pain (NRS Best Pain) (P = .02), function (FRI) (P = .03), and patient satisfaction (NASS Outcome Questionnaire) (P = .01) compared with controls. No adverse events of disk space infection, neurologic injury, or progressive herniation were reported following the injection of PRP. Participants who received intradiskal PRP showed significant improvements in FRI, NRS Best Pain, and NASS patient satisfaction scores over 8 weeks compared with controls. Those who received PRP maintained significant improvements in FRI scores through at least 1 year of follow-up. Although these results are promising, further studies are needed to define the subset of participants most likely to respond to biologic intradiskal

  14. Prospective, randomized, controlled trial using best-selling smoking-cessation book.

    Science.gov (United States)

    Foshee, James P; Oh, Anita; Luginbuhl, Adam; Curry, Joseph; Keane, William; Cognetti, David

    2017-07-01

    Our prospective, randomized, controlled trial aimed to evaluate the efficacy of the self-help book, The Easy Way to Stop Smoking, by Allen Carr, in promoting smoking cessation in patients with head and neck cancer. We assessed active smokers for their willingness to read a smoking cessation book. Participants were randomized to either receive the book from our department or recommended to purchase the book. All patients received smoking cessation counseling at recruitment. Phone surveys were conducted at short- and long-term intervals to determine if the patients had purchased and/or read the book and whether they were still smoking. One hundred twelve patients were recruited, 52 of whom completed follow-up surveys. Those who received the book for free were more likely to read the book (p = 0.05). Reading the book did not correlate with successful smoking cessation (p = 0.81). Some 26% of the 27 patients who received the book quit smoking compared with 32% of the 25 patients who were recommended the book (p = 0.76). Patients who indicated motivation to quit smoking were more likely to succeed. In our study, smoking cessation did not appear to be influenced by reading The Easy Way to Stop Smoking. Despite 80.8% of the cohort indicating at least a readiness to quit smoking at recruitment, only 28.8% of patients managed to achieve successful smoking cessation at long-term follow-up. Patient motivation remains an important factor in achieving long-term smoking abstinence. Quitting smoking remains a daunting challenge for patients, with multiple interventions likely needed to achieve cessation.

  15. Tamsulosin versus tadalafil as a medical expulsive therapy for distal ureteral stones: A prospective randomized study.

    Science.gov (United States)

    Kc, Hari Bahadur; Shrestha, Anil; Acharya, Ganesh Bhakta; Basnet, Robin Bahadur; Shah, Arvind Kumar; Shrestha, Parash Mani

    2016-09-01

    This study aimed to compare the safety and efficacy of tamsulosin and tadalafil as medical expulsive therapy for distal ureteral stones. This prospective randomized study was conducted at the Department of Urology of Bir Hospital over a period of 12 months in patients with distal ureteral stones sized 5 to 10 mm. Patients were randomly divided into 2 groups: group A received tamsulosin 0.4 mg and group B received tadalafil 10 mg at bedtime for 2 weeks. Stone expulsion rate, number of ureteric colic episodes and pain score, analgesic requirements, and adverse drug effects were noted in both groups. Statistical analyses were performed by using Student t-test and chi-square test. Altogether 85 patients, 41 in group A and 44 in group B, were enrolled in the study. The patients' average age was 31.72±12.63 years, and the male-to-female ratio was 1.5:1. Demographic profiles, stone size, and baseline investigations were comparable between the 2 groups. The stone expulsion rate was significantly higher in the tadalafil group than in the tamsulosin group (84.1% vs. 61.0%, p=0.017). Although the occurrence of side effects was higher with tadalafil, this difference was not significant (p=0.099). There were no serious adverse effects. Tadalafil has a significantly higher stone expulsion rate than tamsulosin when used as a medical expulsive therapy for distal ureteral stones sized 5-10 mm. Both drugs are safe, effective, and well tolerated with minor side effects.

  16. Radiotherapy for calcaneodynia. Results of a single center prospective randomized dose optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Jeremias, C.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

    2013-04-15

    The aim of this work was to compare the efficacy of two different dose fractionation schedules for radiotherapy of patients with calcaneodynia. Between February 2006 and April 2010, 457 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy using the orthovoltage technique. One radiotherapy series consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, immediately after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 87 % directly after and 88 % 6 weeks after radiotherapy. The mean VAS values before, immediately after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 65.5 {+-} 22.1 and 64.0 {+-} 20.5 (p = 0.188), 34.8 {+-} 24.7 and 39.0 {+-} 26.3 (p = 0.122), and 25.1 {+-} 26.8 and 28.9 {+-} 26.8 (p = 0.156), respectively. The mean CPS before, immediately after, and 6 weeks after treatment was 10.1 {+-} 2.7 and 10.0 {+-} 3.0 (p = 0.783), 5.6 {+-} 3.7 and 6.0 {+-} 3.9 (p = 0.336), 4.0 {+-} 4.1 and 4.3 {+-} 3.6 (p = 0.257), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.216) and delayed response (p = 0.080) were found. Radiotherapy is an effective treatment option for the management of calcaneodynia. For radiation protection reasons, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  17. Open release versus radiofrequency microtenotomy in the treatment of lateral epicondylitis: a prospective randomized controlled trial.

    Science.gov (United States)

    Hamlin, Katharine; Munro, Christopher; Barker, Scott L; McKenna, Sean; Kumar, Kapil

    2018-01-01

    Optimal surgical treatment of lateral epicondylitis remains uncertain. Recently, radiofrequency microtenotomy (RFMT) has been proposed as a suitable treatment. We compared RFMT with standard open release (OR) in this prospective randomized controlled trial. In total, 41 patients with symptoms for at least 6 months were randomized into two groups: 23 patients had RFMT and 18 had OR. Two patients from RFMT withdrew. Each patient underwent Numerical Rating Scale (NRS) pain score, grip strength and Disabilities of the Arm, Shoulder and Hand (DASH) scores pre-operatively and at 6 weeks. Pain and DASH scores were repeated at 6 months and 12 months. NRS pain scores improved by 4.8 points for RFMT and by 3.9 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Grip strength improved by 31% in the RFMT group compared to 38% in OR. There was no significant difference between the initial and 6 weeks scores or between treatments. At 1 year, DASH was 39.8 points for RFMT and 24.4 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Both groups showed significant improvements and similar benefit to the patient. The results of the present study do not show any benefit of RFMT over the standard OR. As a result of the extra expense of RFMT, we therefore recommend that OR is offered as the standard surgical management.

  18. Vapocoolant Anesthesia for Cosmetic Facial Rejuvenation Injections: A Randomized, Prospective, Split-Face Trial.

    Science.gov (United States)

    Zeiderman, Matthew R; Kelishadi, Shahrooz Sean; Tutela, John Paul; Rao, Arun; Chowdhry, Saeed; Brooks, Ronald M; Wilhelmi, Bradon J

    2018-01-01

    Background: Minimally invasive cosmetic procedures are the most commonly performed aesthetic techniques by plastic surgeons. Patients are interested in a pain-free experience. Surgeons desire patient satisfaction and time-efficient utilization of office staff and resources. Clinical evidence exists for use of vapocoolant technology to reduce pain associated with intravenous cannulation in the pediatric population and in hemodialysis patients. Applying vapocoolant technology to facial rejuvenation is a novel approach to decrease pain associated with neurotoxin or filler injection. Methods: A randomized, prospective study was conducted, testing 15 subjects receiving filler injections and another 15 patients receiving neurotoxin injections using a split-face model. The vapocoolant spray used was composed of a 95:5 ratio of 1,1,1,3,3-pentafluoropropane and 1,1,1,2-tetrafluoroethane. Within each group, individual patients randomly received injection (filler or neurotoxin) alone versus injection (filler or neurotoxin) plus vapocoolant on an equivalent half of his or her face. An independent examiner recorded from each patient on a scale of 1 to 10 perceived pain for injection alone versus injection plus vapocoolant spray. Results were calculated as a percentage change of pain scores experienced after injection for each person between the control (nonvapocoolant) and treatment (vapocoolant) sides of the face. Results: Vapocoolant spray at the time of cosmetic facial injections leads to a 59% decrease in perceived pain score with neurotoxin injections (range, 0%-100% change) and 64% decrease in perceived pain score with filler injections (range, 0%-100% change). These results were statistically significant with P reduces pain associated with facial rejuvenation procedures.

  19. Timing of urinary catheter removal after uncomplicated total abdominal hysterectomy: a prospective randomized trial.

    Science.gov (United States)

    Ahmed, Magdy R; Sayed Ahmed, Waleed A; Atwa, Khaled A; Metwally, Lobna

    2014-05-01

    To assess whether immediate (0h), intermediate (after 6h) or delayed (after 24h) removal of an indwelling urinary catheter after uncomplicated abdominal hysterectomy can affect the rate of re-catheterization due to urinary retention, rate of urinary tract infection, ambulation time and length of hospital stay. Prospective randomized controlled trial conducted at Suez Canal University Hospital, Egypt. Two hundred and twenty-one women underwent total abdominal hysterectomy for benign gynecological diseases and were randomly allocated into three groups. Women in group A (73 patients) had their urinary catheter removed immediately after surgery. Group B (81 patients) had the catheter removed 6h post-operatively while in group C (67 patients) the catheter was removed after 24h. The main outcome measures were the frequency of urinary retention, urinary tract infections, ambulation time and length of hospital stay. There was a significantly higher number of urinary retention episodes requiring re-catheterization in the immediate removal group compared to the intermediate and delayed removal groups (16.4% versus 2.5% and 0% respectively). Delayed urinary catheter removal was associated with a higher incidence of urinary tract infections (15%), delayed ambulation time (10.3h) and longer hospital stay (5.6 days) compared to the early (1.4%, 4.1h and 3.2 days respectively) and intermediate (3.7%, 6.8h and 3.4 days respectively) removal groups. Removal of the urinary catheter 6h postoperatively appears to be more advantageous than early or late removal in cases of uncomplicated total abdominal hysterectomy. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  20. Transverse vs torsional ultrasound: prospective randomized contralaterally controlled study comparing two phacoemulsification-system handpieces.

    Science.gov (United States)

    Assil, Kerry K; Harris, Lindsay; Cecka, Jeannie

    2015-01-01

    To compare surgical efficiency and multiple early clinical outcome variables in eyes undergoing phacoemulsification using either transversal or torsional ultrasound systems. Assil Eye Institute, Beverly Hills, CA, USA. Prospective, randomized, clinician-masked, contralaterally controlled single-center evaluation. Patients seeking cataract removal in both eyes with implantation of multifocal intraocular lenses were randomly assigned to one of two treatment rooms for phacoemulsification with either a transverse ultrasound system or torsional handpiece system. The contralateral eye was treated at a later date with the alternate device. A total of 54 eyes of 27 patients having similar degrees of cataract, astigmatism, and visual potential were included. All operative data were collected for analysis, and patients were followed for 3 months after surgery. Similar visual acuity was reported at all postoperative visits between the two groups. Mean phacoemulsification time and total power required were both significantly lower with the transverse system than with the torsional technique (Ptransverse system vs torsional (Ptransverse vs torsional. Macular swelling was less at 1 week, 1 month, and 3 months with transverse vs torsional, although the difference did not achieve significance (P=0.1) at any single time point. Clinically detectable corneal edema was reported less frequently at all postoperative time points with the transverse system. The transverse ultrasound system was found to be possibly associated with less balanced salt-solution use, less phacoemulsification time, and less power required than the torsional phaco system. Postoperative data suggested that improved phaco efficiency may translate to a better overall safety profile for the patient.

  1. Syndesmotic fixation in supination-external rotation ankle fractures: a prospective randomized study.

    Science.gov (United States)

    Pakarinen, Harri J; Flinkkilä, Tapio E; Ohtonen, Pasi P; Hyvönen, Pekka H; Lakovaara, Martti T; Leppilahti, Juhana I; Ristiniemi, Jukka Y

    2011-12-01

    This study was designed to assess whether transfixion of an unstable syndesmosis is necessary in supination-external rotation (Lauge-Hansen SE/Weber B)-type ankle fractures. A prospective study of 140 patients with unilateral Lauge-Hansen supination-external rotation type 4 ankle fractures was done. After bony fixation, the 7.5-Nm standardized external rotation (ER) stress test for both ankles was performed under fluoroscopy. A positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs. If the stress test was positive, the patient was randomized to either syndesmotic transfixion with 3.5-mm tricortical screws or no syndesmotic fixation. Clinical outcome was assessed using the Olerud-Molander scoring system, RAND 36-Item Health Survey, and Visual Analogue Scale (VAS) to measure pain and function after a minimum 1-year of followup. Twenty four (17%) of 140 patients had positive standardized 7.5-Nm ER stress tests after malleolar fixation. The stress view was positive three times on tibiotalar clear space, seven on tibiofibular clear space, and 14 times on both tibiotalar and tibiofibular clear spaces. There was no significant difference between the two randomization groups with regards to Olerud-Molander functional score, VAS scale measuring pain and function, or RAND 36-Item Health Survey pain or physical function at 1 year. Relevant syndesmotic injuries are rare in supination-external rotation ankle fractures, and syndesmotic transfixion with a screw did not influence the functional outcome or pain after the 1-year followup compared with no fixation.

  2. Effects of platelet-rich plasma on lateral epicondylitis of the elbow: prospective randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Evandro Pereira Palacio

    2016-02-01

    Full Text Available ABSTRACT OBJECTIVE: To evaluate the effects of platelet-rich plasma (PRP infiltration in patients with lateral epicondylitis of the elbow, through analysis of the Disabilities of the Arm, Shoulder and Hand (DASH and Patient-Rated Tennis Elbow Evaluation (PRTEE questionnaires. METHODS: Sixty patients with lateral epicondylitis of the elbow were prospectively randomized and evaluated after receiving infiltration of three milliliters of PRP, or 0.5% neocaine, or dexamethasone. For the scoring process, the patients were asked to fill out the DASH and PRTEE questionnaires on three occasions: on the day of infiltration and 90 and 180 days afterwards. RESULTS: Around 81.7% of the patients who underwent the treatment presented some improvement of the symptoms. The statistical tests showed that there was evidence that the cure rate was unrelated to the substance applied (p = 0.62. There was also intersection between the confidence intervals of each group, thus demonstrating that the proportions of patients whose symptoms improved were similar in all the groups. CONCLUSION: At a significance level of 5%, there was no evidence that one treatment was more effective than another, when assessed using the DASH and PRTEE questionnaires.

  3. Percutaneous CT-guided lung biopsy: sequential versus spiral scanning. A randomized prospective study

    International Nuclear Information System (INIS)

    Ghaye, B.; Dondelinger, R.F.; Dewe, W.

    1999-01-01

    The aim of this study was to evaluate in a prospective and randomized study spiral versus sequential scanning in the guidance of percutaneous lung biopsy. Fifty thoracic lesions occurring in 48 patients were biopsied by a senior and a junior operator. Six different time segments of the procedure were measured. Scanning mode versus length of procedure, pathological results, irradiation and complications were evaluated. Total duration of the procedure and of the first sampling was significantly longer with spiral CT for the senior operator (p < 0.004). No significant time difference was observed for the junior operator. Diameter of the lesion, depth of location, position of the patient and needle entry site did not influence the results. The sensitivity was 90.9, specificity 100, positive predictive value 100 and negative predictive value 60 % for spiral CT, and 94.7, 100, 100 and 85.7 % for sequential CT, respectively. Eleven pneumothoraces and ten perinodular hemorrhages were seen with spiral CT and six and ten, respectively, with sequential CT. The mean dose of irradiation was 4027 mAs for spiral CT and 2358 mAs for conventional CT. Spiral CT does neither reduce procedure time nor the rate of complications. Pathological results do not differ compared with sequential CT, and total dose of irradiation is higher with spiral scanning. (orig.)

  4. Frequency format diagram and probability chart for breast cancer risk communication: a prospective, randomized trial

    Directory of Open Access Journals (Sweden)

    Wahner-Roedler Dietlind

    2008-10-01

    Full Text Available Abstract Background Breast cancer risk education enables women make informed decisions regarding their options for screening and risk reduction. We aimed to determine whether patient education regarding breast cancer risk using a bar graph, with or without a frequency format diagram, improved the accuracy of risk perception. Methods We conducted a prospective, randomized trial among women at increased risk for breast cancer. The main outcome measurement was patients' estimation of their breast cancer risk before and after education with a bar graph (BG group or bar graph plus a frequency format diagram (BG+FF group, which was assessed by previsit and postvisit questionnaires. Results Of 150 women in the study, 74 were assigned to the BG group and 76 to the BG+FF group. Overall, 72% of women overestimated their risk of breast cancer. The improvement in accuracy of risk perception from the previsit to the postvisit questionnaire (BG group, 19% to 61%; BG+FF group, 13% to 67% was not significantly different between the 2 groups (P = .10. Among women who inaccurately perceived very high risk (≥ 50% risk, inaccurate risk perception decreased significantly in the BG+FF group (22% to 3% compared with the BG group (28% to 19% (P = .004. Conclusion Breast cancer risk communication using a bar graph plus a frequency format diagram can improve the short-term accuracy of risk perception among women perceiving inaccurately high risk.

  5. Thermal welding versus cold knife tonsillectomy: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Metin Yilmaz

    2012-05-01

    Full Text Available This is a prospective randomized study conducted in a group of children who underwent two methods of tonsillectomy: thermal welding or cold knife tonsillectomy. Parameters, such as postoperative pain scores, intraoperative blood loss, operation time, and postoperative bleeding rates, were analyzed to find out which technique is better. Ninety-one children (aged between 2 years and 13 years with recurrent tonsillitis, obstructive sleep apnea syndrome, or both were included in the study. According to the type of tonsillectomy procedure, the patients were divided into two groups: cold knife and thermal welding procedure. The two groups were compared on the basis of postoperative pain scores, intraoperative blood loss, operation time, and postoperative bleeding. Fifty-seven patients underwent thermal welding tonsillectomy and 34 had cold knife tonsillectomy. The mean pain score in thermal welding group was significantly lower (p<0.001. There was no remarkable blood loss intraoperatively in the thermal welding procedure. The operation time was not significantly different between two groups. No postoperative bleeding was encountered in the thermal welding group. Compared with the cold knife technique, thermal welding was found to be a relatively new and safe technique for tonsillectomy as it results in significantly less postoperative pain and no remarkable blood loss.

  6. Perioperative hyperoxygenation and wound site infection following surgery for acute appendicitis: a randomized, prospective, controlled trial.

    Science.gov (United States)

    Bickel, Amitai; Gurevits, Michael; Vamos, Ronny; Ivry, Simon; Eitan, Arieh

    2011-04-01

    To assess the influence of hyperoxygenation on surgical site infection by using the most homogeneous study population. A randomized, prospective, controlled trial. Department of surgery in a government hospital. A total of 210 patients who underwent open surgery for acute appendicitis. In the study group, patients received 80% oxygen during anesthesia, followed by high-flow oxygen for 2 hours in the recovery room. The control group received 30% oxygen, as usual. Open appendectomy via incision in the right lower quadrant of the abdomen. Surgical site infection, mainly assessed by the ASEPSIS (additional treatment, serous discharge, erythema, purulent discharge, separation of deep tissues, isolation of bacteria, and stay in hospital prolonged >14 days) system score. Surgical site infections were recorded in 6 of 107 patients (5.6%) in the study group vs 14 of 103 patients (13.6%) in the control group (P = .04). Significant differences in the ASEPSIS score were also found. The mean hospital stay was longer in the control group (2.92 days) compared with the study group (2.51 days) (P = .01). The use of supplemental oxygen is advantageous in operations for acute appendicitis by reducing surgical site infection rate and hospital stay. clinicaltrials.gov Identifier: NCT01002365.

  7. Prospective, randomized, controlled trial of polymer cable ties versus standard wire closure of midline sternotomy.

    Science.gov (United States)

    Marasco, Silvana F; Fuller, Louise; Zimmet, Adam; McGiffin, David; Seitz, Michael; Ch'ng, Stephanie; Gangahanumaiah, Shivanand; Bailey, Michael

    2018-04-16

    Midline sternotomy remains the most common access incision for cardiac operations. Traditionally, the sternum is closed with stainless steel wires. Wires are well known to stretch and break, however, leading to pain, nonunion, and potential deep sternal wound infection. We hypothesized that biocompatible plastic cable ties would achieve a more rigid sternal fixation, reducing postoperative pain and analgesia requirements. A prospective, randomized study compared the ZIPFIX (De Puy Synthes, West Chester, Pa) sternal closure system (n = 58) with standard stainless steel wires (n = 60). Primary outcomes were pain and analgesia requirements in the early postoperative period. Secondary outcome was sternal movement, as assessed by ultrasound at the postoperative follow-up visit. Groups were well matched in demographic and operative variables. There were no significant differences between groups in postoperative pain, analgesia, or early ventilatory requirements. Patients in the ZIPFIX group had significantly more movement in the sternum and manubrium on ultrasound at 4 weeks. ZIPFIX sternal cable ties provide reliable closure but no demonstrable benefit in this study in pain or analgesic requirements relative to standard wire closure after median sternotomy. Crown Copyright © 2018. Published by Elsevier Inc. All rights reserved.

  8. Prospective, randomized, blinded evaluation of donor semen quality provided by seven commercial sperm banks.

    Science.gov (United States)

    Carrell, Douglas T; Cartmill, Deborah; Jones, Kirtly P; Hatasaka, Harry H; Peterson, C Matthew

    2002-07-01

    To evaluate variability in donor semen quality between seven commercial donor sperm banks, within sperm banks, and between intracervical insemination and intrauterine insemination. Prospective, randomized, blind evaluation of commercially available donor semen samples. An academic andrology laboratory. Seventy-five cryopreserved donor semen samples were evaluated. Samples were coded, then blindly evaluated for semen quality. Standard semen quality parameters, including concentration, motility parameters, World Health Organization criteria morphology, and strict criteria morphology. Significant differences were observed between donor semen banks for most semen quality parameters analyzed in intracervical insemination samples. In general, the greatest variability observed between banks was in percentage progressive sperm motility (range, 8.8 +/- 5.8 to 42.4 +/- 5.5) and normal sperm morphology (strict criteria; range, 10.1 +/- 3.3 to 26.6 +/- 4.7). Coefficients of variation within sperm banks were generally high. These data demonstrate the variability of donor semen quality provided by commercial sperm banks, both between banks and within a given bank. No relationship was observed between the size or type of sperm bank and the degree of variability. The data demonstrate the lack of uniformity in the criteria used to screen potential semen donors and emphasize the need for more stringent screening criteria and strict quality control in processing samples.

  9. Comparison of intravenous versus topical tranexamic acid in total knee arthroplasty: a prospective randomized study.

    Science.gov (United States)

    Patel, Jay N; Spanyer, Jonathon M; Smith, Langan S; Huang, Jiapeng; Yakkanti, Madhusudhan R; Malkani, Arthur L

    2014-08-01

    The purpose of this study was to compare the efficacy of topical Tranexamic Acid (TXA) versus Intravenous (IV) Tranexamic Acid for reduction of blood loss following primary total knee arthroplasty (TKA). This prospective randomized study involved 89 patients comparing topical administration of 2.0g TXA, versus IV administration of 10mg/kg. There were no differences between the two groups with regard to patient demographics or perioperative function. The primary outcome measure, perioperative change in hemoglobin level, showed a decrease of 3.06 ± 1.02 in the IV group and 3.42 ± 1.07 in the topical group (P = 0.108). There were no statistical differences between the groups in preoperative hemoglobin level, lowest postoperative hemoglobin level, or total drain output. One patient in the topical group required blood transfusion (P = 0.342). Based on our study, topical Tranexamic Acid has similar efficacy to IV Tranexamic Acid for TKA patients. Copyright © 2014 Elsevier Inc. All rights reserved.

  10. Small bowel preparations for capsule endoscopy with mannitol and simethicone: a prospective, randomized, clinical trial.

    Science.gov (United States)

    Chen, Hong-bin; Huang, Yue; Chen, Su-yu; Song, Hui-wen; Li, Xiao-lin; Dai, Dong-lin; Xie, Jia-tia; He, Song; Zhao, Yuan-yuan; Huang, Chun; Zhang, Sheng-jun; Yang, Lin-na

    2011-04-01

    There is no consensus concerning small bowel preparation before capsule endoscopy (CE). This study evaluated the effects of 4 regimens on small bowel cleansing and diagnostic yield. Patients were randomly divided into 4 groups. Group A consumed a clear liquid diet after lunch on the day before CE, followed by overnight fasting. Group B took 250 mL 20% mannitol and 1 L 0.9% saline orally at 05:00 hours on the day of the procedure. In group C, the same regimen was taken at 20:00 hours on the day before and at 05:00 hours on the day of CE. In group D, in addition to the group C regimen, 20 mL oral simethicone was taken 30 minutes before CE. Two hundred patients were prospectively enrolled, and 7 were excluded from the final analysis because of incomplete small bowel transit. No significant difference was noted among the 4 groups for small bowel transit time. Bowel preparation in group D was significantly better than for the other regimens for overall cleansing of the proximal small bowel, and showed improved overall cleansing of the distal small bowel when compared with 10-hours overnight fasting. Pathological lesions of the proximal and distal small bowel were, respectively, achieved in 82 and 74 patients, mostly distributed in group D. Small bowel preparation that involves split-dose oral mannitol plus single-dose simethicone for CE can improve mucosal visualization and subsequent diagnostic yield when compared with 10-hours overnight fasting.

  11. Topical sucralfate for pain after oral CO2 laser surgery: a prospective, randomized, controlled trial.

    Science.gov (United States)

    Guo, Chau-Shiang; Chuang, Hui-Ching; Chien, Chih-Yen

    2012-01-01

    The aim of this study was to assess the effect of topical sucralfate on postoperative pain scores and other secondary outcomes including the frequency and duration of analgesic use and postoperative bleeding episodes after CO(2) laser treatment of oral leukoplakia. In this prospective trial, a total of 80 patients were randomized into the sucralfate group (n = 40) or the control group (n = 40). Postoperative pain scores, the frequency and duration of analgesic requirements, and postoperative wound bleeding episodes were compared between the 2 groups from the operative day to postoperative day 6. Patients in the sucralfate group experienced significantly less postoperative pain on postoperative days 1 and 2. Although there was no significant difference in frequency and duration of analgesic use between the 2 groups, a trend toward lower frequency and fewer days of analgesic use in the sucralfate group was observed. This study demonstrated the efficacy of topical sucralfate application in diminishing postoperative pain after CO(2) laser therapy for oral leukoplakia. Topical sucralfate can be considered a feasible adjuvant medication for the control of pain after CO(2) laser treatment of oral leukoplakia. Copyright © 2012 Elsevier Inc. All rights reserved.

  12. The efficiency of sucralfate in corrosive esophagitis: a randomized, prospective study.

    Science.gov (United States)

    Gümürdülü, Yüksel; Karakoç, Emre; Kara, Banu; Taşdoğan, Burçak Evren; Parsak, Cem Kaan; Sakman, Gürhan

    2010-03-01

    Ingestion of a chemical agent is a serious problem, and several treatment protocols to prevent stricture formation have been proposed. We conducted a randomized prospective study to evaluate the effectiveness of oral intensive sucralfate plus conventional therapy compared to conventional therapy alone. Fifteen patients with stage 2b and 3 corrosive esophagitis admitted to our gastroenterology, general surgery and intensive care units between 2004 and 2007 were included. Patients were divided into two groups. The patients in the first group (n=8) received intensive sucralfate therapy plus conventional therapy, while the other group (n=7) received only conventional therapy. We performed upper endoscopic procedures on days: 0, 21, 45, 90 and 180 to identify the emergent complications. In the first group, only one patient had stricture formation, allowing passage of a 9.2 mm endoscope and causing no dysphagia, on day 45. There was no progression in the stricture on follow-ups at the 3rd and 6th months. In the second group, 6 patients had stricture formation causing narrowing and dysphagia. Intensive sucralfate therapy may decrease the frequency of stricture formation in patients with advanced corrosive esophagitis. Further studies with large groups of patients are required to confirm our findings.

  13. [Do double gloves protect against contamination during cannulation of blood vessels? A prospective randomized study].

    Science.gov (United States)

    Szarpak, Łukasz; Kurowski, Andrzej

    2014-01-01

    Undamaged medical gloves protect medical personnel from contact with physiological fluids of the patient. Thus they protect the assistance provider from hand skin contamination with potentially infectious biological materials. The aim of the study was to evaluate the occurrence of pierce, perforations or damage of medical gloves during cannulation of blood vessels. In the prospective randomized study 303 pairs of gloves, used during cannulation of blood vessels under simulated resuscitation, were analyzed. Gloves were tested by the water leak test. The water test revealed 44 cases of damage to the gloves used during cannulation of blood vessels. Significant differences were noted in the frequency of damage to both the outer and single pairs of gloves and the inner pair of gloves. The study showed that the use of double gloves provides a higher level of security for a paramedic than the use of a single pair of gloves, however, double gloves reduce the manual dexterity of a paramedic. A large number of damages to gloves are not noticed by medical personnel during surgery.

  14. Behavioral measures to reduce non-adherence in renal transplant recipients: a prospective randomized controlled trial.

    Science.gov (United States)

    Garcia, Márcia Fátima Faraldo Martinez; Bravin, Ariane Moyses; Garcia, Paula Dalsoglio; Contti, Mariana Moraes; Nga, Hong Si; Takase, Henrique Mochida; de Andrade, Luis Gustavo Modelli

    2015-11-01

    Solid-organ transplant recipients present a high rate of non-adherence to drug treatment. Few interventional studies have included approaches aimed at increasing adherence. The objective of this study was to evaluate the impact of an educational and behavioral strategy on treatment adherence of kidney transplant recipients. In a randomized prospective study, incident renal transplant patients (n = 111) were divided into two groups: control group (received usual transplant patient education) and treatment group (usual transplant patient education plus ten additional weekly 30-min education/counseling sessions about immunosuppressive drugs and behavioral changes). Treatment adherence was assessed using ITAS adherence questionnaire after 3 months. Renal function at 3, 6, and 12 months, and the incidence of transplant rejection were evaluated. The non-adherence rates were 46.4 and 14.5 % in the control and treatment groups (p = 0.001), respectively. The relative risk for non-adherence was 2.59 times (CI 1.38-4.88) higher in the control group. Multivariate analysis demonstrated a 5.84 times (CI 1.8-18.8, p = 0.003) higher risk of non-adherence in the control group. There were no differences in renal function and rejection rates between groups. A behavioral and educational strategy addressing the patient's perceptions and knowledge about the anti-rejection drugs significantly improved the short-term adherence to immunosuppressive therapy.

  15. TVT and TVT-O for surgical treatment of primary stress urinary incontinence: prospective randomized trial.

    Science.gov (United States)

    Krofta, Ladislav; Feyereisl, Jaroslav; Otcenásek, Michal; Velebil, Petr; Kasíková, Eva; Krcmár, Michal

    2010-02-01

    A study was conducted to compare the efficacy and complications of TVT and TVT-O. This study is a prospective randomized trial involving 300 women with primary SUI; 149 received TVT, and 151 patients were treated with TVT-O. At the 1 year follow-up, 141 TVT patients and 147 TVT-O patients (dropout, 5.3% and 2.6%) were evaluated using urodynamic studies, validated questionnaires, and a 1-h pad test. The mean operating time was shorter in the TVT-O group (p 0.05). Inner thigh discomfort was reported by 5.4% of TVT-O patients. In the TVT and the TVT-O groups, respectively, 90.1% and 88.4% women were objectively cured. The satisfaction with the surgical outcome reflects the significant decrease in the questionnaire mean symptom scores in both groups. Postoperative de novo urgency was significantly more common in the TVT-O patients (p = 0.015). The groups showed comparable objective and subjective cure rates.

  16. [Ambulatory laparoscopic cholecystectomy by minilaparoscopy versus traditional multiport ambulatory laparoscopic cholecystectomy. Prospective randomized trial].

    Science.gov (United States)

    Planells Roig, Manuel; Arnal Bertomeu, Consuelo; Garcia Espinosa, Rafael; Cervera Delgado, Maria; Carrau Giner, Miguel

    2016-02-01

    Difference analysis of ambulatorization rate, pain, analgesic requirements and daily activities recovery in patients undergoing laparoscopic cholecystectomy with standard multiport access (CLMP) versus a minilaparoscopic, 3mm size, technique. Prospective randomized trial of 40 consecutive patients undergoing laparoscopic cholecystectomy. Comparison criteria included predictive ultrasound factors of difficult cholecystectomy, previous history of complicated biliary disease and demographics. Results are analyzed in terms of ambulatorization rate, pain, analgesic requirements, postoperative recovery, technical difficulty, hemorrhage intensity, overnight stay, readmission rate and total or partial conversion. Both procedures were similar in surgery time, technical score and hemorrhage score. MLC was associated with similar ambulatorization rate, 85%, and over-night stay 15%, with only 15% partial conversion rate. MLC showed less postoperative pain (P=.026), less analgesic consumption (P=.006) and similar DAR (P=.879). MLC is similar to CLMP in terms of ambulatorization with less postoperative pain and analgesic requirements without differences in postoperative recovery. Copyright © 2014 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  17. Comparison of natural drainage group and negative drainage groups after total thyroidectomy: prospective randomized controlled study.

    Science.gov (United States)

    Woo, Seung Hoon; Kim, Jin Pyeong; Park, Jung Je; Shim, Hyun Seok; Lee, Sang Ha; Lee, Ho Joong; Won, Seong Jun; Son, Hee Young; Kim, Rock Bum; Son, Young-Ik

    2013-01-01

    The aim of this study was to compare a negative pressure drain with a natural drain in order to determine whether a negative pressure drainage tube causes an increase in the drainage volume. Sixty-two patients who underwent total thyroidectomy for papillary thyroid carcinoma (PTC) were enrolled in the study between March 2010 and August 2010 at Gyeongsang National University Hospital. The patients were prospectively and randomly assigned to two groups, a negative pressure drainage group (n=32) and natural drainage group (n=30). Every 3 hours, the volume of drainage was checked in the two groups until the tube was removed. The amount of drainage during the first 24 hours postoperatively was 41.68 ± 3.93 mL in the negative drain group and 25.3 ± 2.68 mL in the natural drain group (pdrain group was 35.19 ± 4.26 mL and natural drain groups 21.53 ± 2.90 mL (pdrain may increase the amount of drainage during the first 24-48 hours postoperatively. Therefore, it is not necessary to place a closed suction drain when only a total thyroidectomy is done.

  18. Tribulus terrestris versus placebo in the treatment of erectile dysfunction: A prospective, randomized, double blind study.

    Science.gov (United States)

    Santos, C A; Reis, L O; Destro-Saade, R; Luiza-Reis, A; Fregonesi, A

    2014-05-01

    To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels. Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way. The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914). At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total

  19. Impact of Targeted Preoperative Optimization on Clinical Outcome in Emergency Abdominal Surgeries: A Prospective Randomized Trial.

    Science.gov (United States)

    Sethi, Ashish; Debbarma, Miltan; Narang, Neeraj; Saxena, Anudeep; Mahobia, Mamta; Tomar, Gaurav Singh

    2018-01-01

    Perforation peritonitis continues to be one of the most common surgical emergencies that need a surgical intervention most of the times. Anesthesiologists are invariably involved in managing such cases efficiently in perioperative period. The assessment and evaluation of Acute Physiology and Chronic Health Evaluation II (APACHE II) score at presentation and 24 h after goal-directed optimization, administration of empirical broad-spectrum antibiotics, and definitive source control postoperatively. Outcome assessment in terms of duration of hospital stay and mortality in with or without optimization was also measured. It is a prospective, randomized, double-blind controlled study in hospital setting. One hundred and one patients aged ≥18 years, of the American Society of Anesthesiologists physical Status I and II (E) with clinical diagnosis of perforation peritonitis posted for surgery were enrolled. Enrolled patients were randomly divided into two groups. Group A is optimized by goal-directed optimization protocol in the preoperative holding room by anesthesiology residents whereas in Group S, managed by surgery residents in the surgical wards without any fixed algorithm. The assessment of APACHE II score was done as a first step on admission and 24 h postoperatively. Duration of hospital stay and mortality in both the groups were also measured and compared. Categorical data are presented as frequency counts (percent) and compared using the Chi-square or Fisher's exact test. The statistical significance for categorical variables was determined by Chi-square analysis. For continuous variables, a two-sample t -test was applied. The mean APACHE II score on admission in case and control groups was comparable. Significant lowering of serial scores in case group was observed as compared to control group ( P = 0.02). There was a significant lowering of mean duration of hospital stay seen in case group (9.8 ± 1.7 days) as compared to control group ( P = 0

  20. Succinylcholine versus rocuronium for rapid sequence intubation in intensive care: a prospective, randomized controlled trial

    Science.gov (United States)

    2011-01-01

    Introduction Succinylcholine and rocuronium are widely used to facilitate rapid sequence induction (RSI) intubation in intensive care. Concerns relate to the side effects of succinylcholine and to slower onset and inferior intubation conditions associated with rocuronium. So far, succinylcholine and rocuronium have not been compared in an adequately powered randomized trial in intensive care. Accordingly, the aim of the present study was to compare the incidence of hypoxemia after rocuronium or succinylcholine in critically ill patients requiring an emergent RSI. Methods This was a prospective randomized controlled single-blind trial conducted from 2006 to 2010 at the University Hospital of Basel. Participants were 401 critically ill patients requiring emergent RSI. Patients were randomized to receive 1 mg/kg succinylcholine or 0.6 mg/kg rocuronium for neuromuscular blockade. The primary outcome was the incidence of oxygen desaturations defined as a decrease in oxygen saturation ≥ 5%, assessed by continuous pulse oxymetry, at any time between the start of the induction sequence and two minutes after the completion of the intubation. A severe oxygen desaturation was defined as a decrease in oxygen saturation ≥ 5% leading to a saturation value of ≤ 80%. Results There was no difference between succinylcholine and rocuronium regarding oxygen desaturations (succinylcholine 73/196; rocuronium 66/195; P = 0.67); severe oxygen desaturations (succinylcholine 20/196; rocuronium 20/195; P = 1.0); and extent of oxygen desaturations (succinylcholine -14 ± 12%; rocuronium -16 ± 13%; P = 0.77). The duration of the intubation sequence was shorter after succinycholine than after rocuronium (81 ± 38 sec versus 95 ± 48 sec; P = 0.002). Intubation conditions (succinylcholine 8.3 ± 0.8; rocuronium 8.2 ± 0.9; P = 0.7) and failed first intubation attempts (succinylcholine 32/200; rocuronium 36/201; P = 1.0) did not differ between the groups. Conclusions In critically ill

  1. Inspiratory muscle training in bronchiectasis patients: a prospective randomized controlled study.

    Science.gov (United States)

    Liaw, Mei-Yun; Wang, Yi-Hsi; Tsai, Yu-Chin; Huang, Kuo-Tung; Chang, Pei-Wen; Chen, Yung-Che; Lin, Meng-Chih

    2011-06-01

    To investigate the efficacy and feasibility of home-based inspiratory muscle training in patients with bronchiectasis. A prospective, single-blind, randomized, controlled study. Outpatient clinic of a tertiary care medical centre. Twenty-six patients with bronchiectasis were randomly divided into inspiratory muscle training and control groups. In the inspiratory muscle training group (n = 13), the training programme started with an intensity of 30% maximal inspiratory pressure (MIP), which was increased by 2 cmH(2)O each week, for 30 minutes daily, 5 days a week for eight weeks. The control group (n = 13) did not receive inspiratory muscle training. Main outcome measures included spirometry, resting oxyhaemoglobin saturation by pulse oximetry (SpO(2)), lowest SpO(2) and Borg Scale during 6-minute walking tests, 6-minute walking distance (6MWD), 6-minute walking work (6M(work)), MIP, maximal expiratory pressure (MEP) and St George's Respiratory Questionnaire. There were significant differences in change from baseline in 6MWD (411.9 (133.5) vs. 473.2 (117.2) m, P = 0.021), 6M(work) (21 051.0 (8286.7) vs. 23 915.5 (8343.0) kg-m, P = 0.022), MIP (60.8 (21.8) vs. 84.6 (29.0) cmH(2)O, P = 0.004), and MEP (72.3 (31.1) vs. 104.2 (35.7) cmH(2)O, P = 0.004) in the inspiratory muscle training group. Significant improvements in both MIP (23.8 (25.3) vs. 2.3 (16.4) cmH(2)O, adjusted P-value = 0.005) and MEP (31.9 (30.8) vs. 11.5 (20.8) cmH(2)O, adjusted P-value = 0.038) levels after adjusting for age by linear regression analysis were observed between groups. An eight-week home-based inspiratory muscle training is feasible and effective in improving both inspiratory and expiratory muscle strength, but has no effect on respiratory function and quality of life in patients with bronchiectasis.

  2. Comparative analysis of conventional and eversion carotid endarterectomy: Prospective randomized study

    Directory of Open Access Journals (Sweden)

    Marković Dragan M.

    2008-01-01

    Full Text Available INTRODUCTION Studies completed in the last decade of the 20th century showed benefits of carotid endarterectomy in the prevention of stroke in patients with a high-grade stenosis of the internal carotid artery. OBJECTIVE The aim of this prospective, randomized study was the comparison of early and long-term results between the conventional and eversion carotid endarterectomy, and literature review. METHOD By the method of random choice, 103 patients were operated on using the eversion carotid endarterectomy and 98 patients using the conventional technique. Operative treatment was carried out under general anaesthesia. Following the clammping of the carotid artery, retrograde blood pressure was determined by a direct puncture of the internal carotid artery above the stenotic lesions. In patients with retrograde pressure below 20 mm Hg intraluminal shunting was routinely performed. Early results were estimated (during the first seven postoperative days based on mortality, central neurological complications (stroke, TIA and cranial or cervical nerve lesions. Long-term results were estimated (after at least two years based on long-term survival rate, central neurological complications (stroke, TIA and the incidence of haemodynamically significant restenosis of the carotid artery treated by endarterectomy. RESULTS The average time of clamming of the internal carotid artery in the eversion carotid anderectomy group was 5.36 minutes shorter than in the group treated by the conventional technique. Student's t-test showed a statistically highly significant difference in the time needed for clamming of the internal carotid artery between the two groups. The average duration of eversion endarterectomy (82 minutes was most often 19 minutes shorter than the duration of the conventional endarterectomy (101 minutes. Student's t-test showed a statistically highly significant difference in the average length of surgeries. The distal intimal fixation was more

  3. Optimal scheme of postoperative chemoradiotherapy in rectal cancer: phase III prospective randomized trial

    International Nuclear Information System (INIS)

    Kim, Young Seok; Kim, Jong Hoon; Choi, Eun Kyung

    2002-01-01

    To determine the optimal scheme of postoperative chemoradiotherapy in rectal cancer by comparing survival, patterns of failure, toxicities in early and late radiotherapy groups using a phase III randomized prospective clinical trial. From January 1996 to March 1999, 307 patients with curatively resected AJCC stage II and III rectal cancer were assigned randomly to an 'early (151 patients, arm I)' or a 'late (156 patients, arm II)' and were administered combined chemotherapy (5-FU 375 mg/m 2 /day, leucovorin 20 mg/m 2 , IV bolus daily, for 3 days with RT, 5 days without RT, 8 cycles with 4 weeks interval) and radiation therapy (whole pelvis with 45 Gy/25 fractions/5 weeks). Patients of arm I received radiation therapy from day 1 of the first cycle of chemotherapy and those of arm II from day 57 with a third cycle of chemotherapy. The median follow-up period of living patients was 40 months. Of the 307 patients enrolled, fifty patients did not receive scheduled radiation therapy or chemotherapy. The overall survival rate and disease free survival rate at 5 years were 78.3% and 68.7% in arm I, and 78.4% and 67.5% in arm II. The local recurrence rate was 6.6% and 6.4% (ρ = 0.46) in arms I and II, respectively, no significant difference was observed between the distant metastasis rates of the two arms (23.8% and 29.5%, ρ = 0.16). During radiation therapy, grade 3 diarrhea or more, by the NCI common toxicity criteria, was observed in 63.0% and 58.2% of the respective arms (ρ = N.S.), but most were controlled with supportive care. Hematologic toxicity (leukopenia) greater than RTOG grade 2 was found in only 1.3% and 2.6% of patients in each respective arm. There was no significant difference in survival, patterns of failure or toxicities between the early and late radiation therapy arms. Postoperative adjuvant chemoradiation was found to be a relatively safe treatment but higher compliance is needed

  4. Design, rationale, and baseline demographics of SEARCH I: a prospective cluster-randomized study

    Directory of Open Access Journals (Sweden)

    Albers F

    2012-07-01

    Full Text Available Frank Albers,1 Asif Shaikh,2 Ahmar Iqbal,31Medical Affairs Respiratory, 2Clinical Development and Medical Affairs, Field Based Medicine-Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Respiratory Medical Affairs, Pfizer Inc, New York, NY, USAAbstract: Questionnaires are available to identify patients at risk for several chronic diseases, including COPD, but are infrequently utilized in primary care. COPD is often underdiagnosed, while at the same time the US Preventive Services Task Force recommends against spirometric screening for COPD in asymptomatic adults. Use of a symptom-based questionnaire and subsequent handheld spirometric device depending on the answers to the questionnaire is a promising approach to identify patients at risk for COPD. Screening, Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 (SEARCH I was a prospective cluster-randomized study in 168 US primary care practices evaluating the effect of the COPD-Population Screener (COPD-PS™ questionnaire. The effect of this questionnaire alone or sequentially with the handheld copd-6TM device was evaluated on new diagnoses of COPD and on respiratory diagnostic practice patterns (including referrals for pulmonary function testing, referrals to pulmonologists, new diagnoses of COPD, and new respiratory medication prescriptions. Participating practices entered a total of 9704 consecutive consenting subjects aged ≥ 40 years attending primary care clinics. Study arm results were compared for new COPD diagnosis rates between usual care and (1 COPD-PS plus copd-6 and (2 COPD-PS alone. A cluster-randomization design allowed comparison of the intervention effects at the practice level instead of individuals being the subjects of the intervention. Regional principal investigators controlled the flow of study information to sub-investigators at participating practices to reduce observation bias (Hawthorne effect. The

  5. A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors

    Directory of Open Access Journals (Sweden)

    Cinnamon S. Bloss

    2016-01-01

    Full Text Available Background. Mobile health and digital medicine technologies are becoming increasingly used by individuals with common, chronic diseases to monitor their health. Numerous devices, sensors, and apps are available to patients and consumers–some of which have been shown to lead to improved health management and health outcomes. However, no randomized controlled trials have been conducted which examine health care costs, and most have failed to provide study participants with a truly comprehensive monitoring system. Methods. We conducted a prospective randomized controlled trial of adults who had submitted a 2012 health insurance claim associated with hypertension, diabetes, and/or cardiac arrhythmia. The intervention involved receipt of one or more mobile devices that corresponded to their condition(s (hypertension: Withings Blood Pressure Monitor; diabetes: Sanofi iBGStar Blood Glucose Meter; arrhythmia: AliveCor Mobile ECG and an iPhone with linked tracking applications for a period of 6 months; the control group received a standard disease management program. Moreover, intervention study participants received access to an online health management system which provided participants detailed device tracking information over the course of the study. This was a monitoring system designed by leveraging collaborations with device manufacturers, a connected health leader, health care provider, and employee wellness program–making it both unique and inclusive. We hypothesized that health resource utilization with respect to health insurance claims may be influenced by the monitoring intervention. We also examined health-self management. Results & Conclusions. There was little evidence of differences in health care costs or utilization as a result of the intervention. Furthermore, we found evidence that the control and intervention groups were equivalent with respect to most health care utilization outcomes. This result suggests there are not large

  6. Early loading of plalatal implants (ortho-type II a prospective multicenter randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Gedrange Tomasz

    2007-09-01

    Full Text Available Abstract Background In orthodontic treatment, anchorage control is a fundamental aspect. Usually conventional mechanism for orthodontic anchorage control can be either extraoral or intraoral that is headgear or intermaxillary elastics. Their use are combined with various side effects such as tipping of occlusal plane or undesirable movements of teeth. Especially in cases, where key-teeth are missing, conventional anchorage defined as tooth-borne anchorage will meet limitations. Therefore, the use of endosseous implants for anchorage purposes are increasingly used to achieve positional stability and maximum anchorage. Methods/Design The intended study is designed as a prospective, multicenter randomized controlled trial (RCT, comparing and contrasting the effect of early loading of palatal implant therapy versus implant loading after 12 weeks post implantation using the new ortho-implant type II anchor system device (Orthosystem Straumann, Basel, Switzerland. 124 participants, mainly adult males or females, whose diagnoses require temporary stationary implant-based anchorage treatment will be randomized 1:1 to one of two treatment groups: group 1 will receive a loading of implant standard therapy after a healing period of 12 week (gold standard, whereas group 2 will receive an early loading of orthodontic implants within 1 week after implant insertion. Participants will be at least followed for 12 months after implant placement. The primary endpoint is to investigate the behavior of early loaded palatal implants in order to find out if shorter healing periods might be justified to accelerate active orthodontic treatment. Secondary outcomes will focus e.g. on achievement of orthodontic treatment goals and quantity of direct implant-bone interface of removed bone specimens. As tertiary objective, a histologic and microtomography evaluation of all retrieved implants will be performed to obtain data on the performance of the SLA surface in human bone

  7. Phase II prospective randomized trial of weight loss prior to radical prostatectomy.

    Science.gov (United States)

    Henning, Susanne M; Galet, Colette; Gollapudi, Kiran; Byrd, Joshua B; Liang, Pei; Li, Zhaoping; Grogan, Tristan; Elashoff, David; Magyar, Clara E; Said, Jonathan; Cohen, Pinchas; Aronson, William J

    2017-12-04

    Obesity is associated with poorly differentiated and advanced prostate cancer and increased mortality. In preclinical models, caloric restriction delays prostate cancer progression and prolongs survival. We sought to determine if weight loss (WL) in men with prostate cancer prior to radical prostatectomy affects tumor apoptosis and proliferation, and if WL effects other metabolic biomarkers. In this Phase II prospective trial, overweight and obese men scheduled for radical prostatectomy were randomized to a 5-8 week WL program consisting of standard structured energy-restricted meal plans (1200-1500 Kcal/day) and physical activity or to a control group. The primary endpoint was apoptotic index in the radical prostatectomy malignant epithelium. Secondary endpoints were proliferation (Ki67) in the radical prostatectomy tissue, body weight, body mass index (BMI), waist to hip ratio, body composition, and serum PSA, insulin, triglyceride, cholesterol, testosterone, estradiol, leptin, adiponectin, interleukin 6, interleukin 8, insulin-like growth factor 1, and IGF binding protein 1. In total 23 patients were randomized to the WL intervention and 21 patients to the control group. Subjects in the intervention group had significantly more weight loss (WL:-3.7 ± 0.5 kg; Control:-1.6 ± 0.5 kg; p = 0.007) than the control group and total fat mass was significantly reduced (WL:-2.1 ± 0.4; Control: 0.1 ± 0.3; p = 0.015). There was no significant difference in apoptotic or proliferation index between the groups. Among the other biomarkers, triglyceride, and insulin levels were significantly decreased in the WL compared with the control group. In summary, this short-term WL program prior to radical prostatectomy resulted in significantly more WL in the intervention vs. the control group and was accompanied by significant reductions in body fat mass, circulating triglycerides, and insulin. However, no significant changes were observed in malignant

  8. A prospective randomized single blind trial of Fleet phosphate enema versus glycerin suppositories as preparation for flexible sigmoidoscopy.

    Science.gov (United States)

    Underwood, D; Makar, R R; Gidwani, A L; Najfi, S M; Neilly, P; Gilliland, R

    2010-03-01

    This study compared the efficacy and patient acceptability of two methods of bowel preparation for flexible sigmoidoscopy. Patients attending for outpatient flexible sigmoidoscopy were prospectively randomized to receive one Fleet ready-to-use enema or 2 x 4 g glycerin suppositories, 2 h preprocedure. Patient and endoscopist questionnaires were used to compare the outcomes. From November 2000 to August 2001, 203 (male = 95; female = 108) patients were randomized. Patient data available for 163 patients (enema = 93; suppository = 70) revealed: ease of use (enema = 52; suppository = 25; P suppositories.

  9. Treatment of lateral epicondilitis using three different local injection modalities: a randomized prospective clinical trial.

    Science.gov (United States)

    Dogramaci, Yunus; Kalaci, Aydiner; Savaş, Nazan; Duman, I Gokhan; Yanat, A Nedim

    2009-10-01

    To determine the effectiveness of three different local injection modalities in the treatment of lateral epicondilitis. In a prospective randomized study on lateral epicondilitis, 75 patients were divided into three equal groups A, B and C (n = 25) and were treated using three different method of local injection. The patients in group A were treated with local injection of a steroid (1 mL triamcinolone) combined with local anaesthetic (1 mL lidocaine), those in group B were treated with injection of local anaesthetic (1 mL lidocaine) combined with peppering technique and those in group C with local injection of a steroid (1 mL triamcinolone) combined with local anaesthetic (1 mL lidocaine) and peppering technique. The outcome was defined by measuring the elbow pain during the activity using a 10-cm visual analogue scale (VAS) and satisfaction with the treatment using a scoring system based on the criteria of the Verhaar et al. at 3 weeks and 6 months after the injection and compared with the pre-treatment condition. There were significant (P = 0.006) differences in the successful outcomes between the three groups at 6 months. In group C in which local steroid + peppering injection technique were used; excellent results were obtained in 84% of patients comparing to 36% and 48% for patients in groups A and B, respectively. The successful outcomes were statistically higher in group C comparing to group A (P = 0.002) and group B (P = 0.011). In all groups, there was a significantly lower pain (VAS) at the 3-week and 6-month follow-ups comparing to the pre-treatment condition. VAS measured at 6-month follow-up were significantly lower in group C comparing to other groups (P = 0.002). In the treatment of lateral epicondilitis, combination of corticosteroid injections with peppering is more effective than corticosteroid injections or peppering injections alone and produces better clinical results.

  10. A randomized prospective pilot trial of Web-delivered epilepsy stigma reduction communications in young adults.

    Science.gov (United States)

    Sajatovic, Martha; Herrmann, Lynn K; Van Doren, Jamie R; Tatsuoka, Curtis; Welter, Elisabeth; Perzynski, Adam T; Bukach, Ashley; Needham, Kelley; Liu, Hongyan; Berg, Anne T

    2017-11-01

    Epilepsy is a common neurological condition that is often associated with stigmatizing attitudes and negative stereotypes among the general public. This randomized controlled trial (RCT) tested two new communication approaches targeting epilepsy stigma versus an education-alone approach. Two brief stigma-reduction videos were developed, informed by community stakeholder input; one highlighted role competency in people with epilepsy; the other highlighted social inclusion of people with epilepsy. A control video was also developed. A Web-based survey using a prospective RCT design compared effects of experimental videos and control on acceptability, perceived impact, epilepsy knowledge, and epilepsy stigma. Epilepsy knowledge and stigma were measured with the Epilepsy Knowledge Questionnaire (EKQ) and Attitudes and Beliefs about Living with Epilepsy (ABLE), respectively. A total of 295 participants completed the study. Mean age was 23.1 (standard deviation = 3.27) years; 59.0% were male, and 71.4% were white. Overall, respondents felt videos impacted their epilepsy attitudes. EKQ scores were similar across videos, with a trend for higher knowledge in experimental videos versus control (p = 0.06). The role competency and control videos were associated with slightly better perceived impact on attitudes. There were no differences between videos on ABLE scores (p = 0.568). There were subgroup differences suggesting that men, younger individuals, whites, and those with personal epilepsy experience had more stigmatizing attitudes. This RCT tested communication strategies to improve knowledge and attitudes about epilepsy. Although this initial effort will require follow-up, we have demonstrated the acceptability, feasibility, and potential of novel communication strategies to target epilepsy stigma, and a Web-based approach for assessing them. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

  11. Comparative evaluation of left ventricular mass regression after aortic valve replacement: a prospective randomized analysis

    Directory of Open Access Journals (Sweden)

    Kiessling Arndt H

    2011-10-01

    Full Text Available Abstract Background We assessed the hemodynamic performance of various prostheses and the clinical outcomes after aortic valve replacement, in different age groups. Methods One-hundred-and-twenty patients with isolated aortic valve stenosis were included in this prospective randomized randomised trial and allocated in three age-groups to receive either pulmonary autograft (PA, n = 20 or mechanical prosthesis (MP, Edwards Mira n = 20 in group 1 (age 75. Clinical outcomes and hemodynamic performance were evaluated at discharge, six months and one year. Results In group 1, patients with PA had significantly lower mean gradients than the MP (2.6 vs. 10.9 mmHg, p = 0.0005 with comparable left ventricular mass regression (LVMR. Morbidity included 1 stroke in the PA population and 1 gastrointestinal bleeding in the MP subgroup. In group 2, mean gradients did not differ significantly between both populations (7.0 vs. 8.9 mmHg, p = 0.81. The rate of LVMR and EF were comparable at 12 months; each group with one mortality. Morbidity included 1 stroke and 1 gastrointestinal bleeding in the stentless and 3 bleeding complications in the MP group. In group 3, mean gradients did not differ significantly (7.8 vs 6.5 mmHg, p = 0.06. Postoperative EF and LVMR were comparable. There were 3 deaths in the stented group and no mortality in the stentless group. Morbidity included 1 endocarditis and 1 stroke in the stentless compared to 1 endocarditis, 1 stroke and one pulmonary embolism in the stented group. Conclusions Clinical outcomes justify valve replacement with either valve substitute in the respective age groups. The PA hemodynamically outperformed the MPs. Stentless valves however, did not demonstrate significantly superior hemodynamics or outcomes in comparison to stented bioprosthesis or MPs.

  12. Prophylactic beclomethasone spray to the skin during postoperative radiotherapy of carcinoma breast: a prospective randomized study

    International Nuclear Information System (INIS)

    Shukla, P.N.; Gairola, M.; Mohanti, B.K.; Rath, G.K.

    2006-01-01

    Background and aims: Radiation induced wet desquamation of skin in carcinoma breast patients is a painful condition. In this study topical beclomethasone dipropionate spray was used as prophylaxis with the purpose of reducing risk of the wet desquamation of skin in irradiated field. Materials and methods: sixty patients of carcinoma breast were planned for postoperative loco regional radiotherapy (50 Gy in 25 fraction over five weeks) were prospectively randomized into two groups (1) steroid group-patients were advised to use beclomethasone dipropionate spray in irradiated axilla from day one of radiotherapy, (2) control group-patients were not allowed to use any topical agent in irradiated area. Radiation induced skin reaction was noted in terms of erythema, dry desquamation and wet desquamation weekly till end of prescribed 50Gy dose of the radiation therapy. Statistical method: Chi-square test was used to see the statistical significance of the difference in wet desquamation between two arms of the study. Chi-square value and P-value was calculated for the difference of wet desquamation in two study arms. Result: In steroid group 4/30 (13.33%) patients developed wet desquamation of the axillary skin at the end of the radiotherapy. For the control group, this figure was 11/30 (36.66%). The difference in wet desquamation of the axillary skin in the two groups was statistically significant (P-value=0.0369). Conclusion: Topical steroid (beclomethasone dipropionate spray) for skin during radiotherapy significantly reduces the risk of wet desquamation of the skin. (author)

  13. Prospective randomized comparison of mitomycin C application in endoscopic and external dacryocystorhinostomy.

    Science.gov (United States)

    Mudhol, Rekha R; Zingade, N D; Mudhol, R S; Harugop, Anil S; Das, Amal T

    2013-08-01

    The aim of the study is to compare the subjective (relief of symptoms) and objective (endoscopic visualization of ostium patency at the time of syringing) outcomes at the end of two procedures-Endonasal DCR versus External DCR with Mitomycin C and to assess the role of Mitomycin C in maintaining patency of nasolacrimal drainage system. Prospective randomized comparative study was performed. Thirty-five patients were enrolled in each endoscopic and external dacryocystorhinostomy groups with Mitomycin C (MMC) application. The 37 eyes underwent endonasal DCR (28 unilateral primary eyes + 1 bilateral primary eyes + 5 unilateral revision eyes + 1 bilateral revision eye) while 35 eyes underwent external DCR (34 unilateral primary eyes + 1 unilateral revision eye). Mitomycin C 0.2 mg/ml was applied intra-operatively for 5 min to the ostium site at the end of endonasal or external DCR procedure. Objective assessment by syringing at the end of 1 year in the endonasal group showed 35 eyes (94%) were patent, 1 (3%) was partially blocked and 1(3%) was completely blocked; while in external group all 35 eyes (100%) were patent. Endoscopic visualization of the ostium at the time of syringing showed only one eye (3%) in the endonasal group was blocked while all the other eyes in both groups were patent. Both groups had a mean follow-up of 6-36 months. No complications were associated with use of Mitomycin C. In conclusion, intra-operative use of Mitomycin C in both endoscopic DCR and external DCR is safe and effective in increasing the success rate.

  14. Partial splenic embolization using polyvinyl alcohol particles for hypersplenism in cirrhosis: A prospective randomized study

    Energy Technology Data Exchange (ETDEWEB)

    Zhu Kangshun [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: zhksh010@163.com; Meng Xiaochun [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: mengxiaochun1972@163.com; Li Zhengran [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: andyreede@21cn.com; Huang Mingsheng [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: laom502@tom.com; Guan Shouhai [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: guanshouhai@163.com; Jiang Zaibo [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: jiangzaibo@yahoo.com.cn; Shan Hong [Department of Radiology, Third Affiliated Hospital, Sun Yat-sen University, 600 Tianhe Road, Guangzhou, Guangdong Province 510630 (China)], E-mail: gzshsums@public.guangzhou.gd.cn

    2008-04-15

    Purpose: To prospectively evaluate the efficacy and safety of partial splenic embolization (PSE) using polyvinyl alcohol (PVA) particles for hypersplenism in cirrhosis, as compared to PSE using gelfoam particles. Materials and methods: PSE was performed in 60 consecutive patients with hypersplenism caused by cirrhosis. The patients were randomly assigned into 2 groups: gelfoam group, 32 patients received PSE using gelfoam particles as the embolic material; PVA group, 28 patients received PSE using PVA particles. The follow-up contents included peripheral blood cell counts (leukocyte, platelet and red blood cell) and complications associated with PSE. Results: Prior to PSE, there was no significant difference between the two groups in sex, age, Child-Pugh grade, the extent of embolization and peripheral blood cell counts. After PSE, no matter in which group, leukocyte and platelet counts kept significantly higher than pre-PSE during the 3-year follow-up period (P < .0001), but the post-PSE improvement of leukocyte and platelet counts was significantly better in PVA group than in gelfoam group (P < .05). Red blood cell counts showed no remarkable changes after PSE (P > .05). Severe complications occurred in 8 patients (25.0%) in gelfoam group and 6 patients (21.4%) in PVA group (P > .05), but the degree of abdominal pain was higher in the latter than in the former (P < .05). Among 17 patients who received more than 70% embolization of spleen, 10 (58.8%) developed severe complications, while among 43 patients who received 70% or less embolization of spleen, only four (9.3%) had severe complications. This difference was statistically significant (P < .05). Conclusion: PVA particles could be used as the embolic material in PSE; in comparison with PSE using gelfoam particles, PSE using PVA particles can achieve even better efficacy in alleviating hypersplenism, but the extent of embolization should be strictly limited to not more than 70% of splenic volume.

  15. Fast-track rehabilitation following video-assisted pulmonary sublobar wedge resection: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Christos Asteriou

    2016-01-01

    Full Text Available Background: Postoperative morbidity and inhospital length of stay are considered major determinants of total health care expenditure associated with thoracic operations. The aim of this study was to prospectively evaluate the role of video-assisted thoracic surgery (VATS compared to mini-muscle-sparing thoracotomy in facilitating early recovery and hospital discharge after pulmonary sublobar wedge resections. Patients and Methods: A total number of 120 patients undergoing elective pulmonary sublobar wedge resection were randomly assigned to VATS (n = 60 or mini-muscle-sparing thoracotomy (n = 60. The primary endpoint was time to hospital discharge. Postoperative complications, cardiopulmonary morbidity and 30-day mortality served as secondary endpoints. Results: Patients' baseline demographic and clinical data did not differ among study arms as well as the number of pulmonary segments resected and the morphology of the nodular lesions. Total hospital stay was significantly shorter in patients assigned to the thoracoscopic technique as opposed to those who were operated using the mini-muscle-sparing thoracotomy approach (4 ± 0.6 versus 4.4 ± 0.6 days respectively, P = 0.006. Multivariate analysis revealed that VATS approach was inversely associated with longer inhospital stay whereas the number of resected segments was positively associated with an increased duration of hospitalization. Patients in the VATS group were less likely to develop atelectasis (≥1 lobe compared to those who underwent thoracotomy (0% versus 6.7% respectively, P = 0.042. Kaplan-Meier analysis revealed similar 30-day mortality rates in both study arms (Log-rank P = 0.560. Conclusion: VATS was associated with shorter duration of hospitalization positively affecting the patients' quality of life and satisfaction. Significant suppression of the total cost of recovery after thoracoscopic pulmonary resections is expected.

  16. Influence of Gender on the Performance of Cardiopulmonary Rescue Teams: A Randomized, Prospective Simulator Study.

    Science.gov (United States)

    Amacher, Simon Adrian; Schumacher, Cleo; Legeret, Corinne; Tschan, Franziska; Semmer, Norbert Karl; Marsch, Stephan; Hunziker, Sabina

    2017-07-01

    Little is known about the influence of gender on resuscitation performance which may improve future education in resuscitation. The aim of this study was to compare female and male rescuers in regard to cardiopulmonary resuscitation and leadership performance. Prospective, randomized simulator study. High-fidelity patient simulator center of the medical ICU, University Hospitals Basel (Switzerland). Two hundred sixteen volunteer medical students (108 females and 108 males) of two Swiss universities in teams of three. None. We analyzed data on the group and the individual level separately. The primary outcome on the group level was the hands-on time within the first 180 seconds after the onset of the cardiac arrest. Compared with male-only teams, female-only teams showed less hands-on time (mean ± SD) (87 ± 41 vs 109 ± 33 s; p = 0.037) and a longer delay before the start of chest compressions (109 ± 77 vs 70 ± 56 s; p = 0.038). Additionally, female-only teams showed a lower leadership performance in different domains and fewer unsolicited cardiopulmonary resuscitation measures compared with male-only teams. On the individual level, which was assessed in mixed teams only, female gender was associated with a lower number of secure leadership statements (3 ± 2 vs 5 ± 3; p = 0.027). Results were confirmed in regression analysis adjusted for team composition. We found important gender differences, with female rescuers showing inferior cardiopulmonary resuscitation performance, which can partially be explained by fewer unsolicited cardiopulmonary resuscitation measures and inferior female leadership. Future education of rescuers should take gender differences into account.

  17. Prospective, randomized comparative study between single-port laparoscopic appendectomy and conventional laparoscopic appendectomy.

    Science.gov (United States)

    Villalobos Mori, Rafael; Escoll Rufino, Jordi; Herrerías González, Fernando; Mias Carballal, M Carmen; Escartin Arias, Alfredo; Olsina Kissler, Jorge Juan

    2014-01-01

    Laparoscopic appendectomy is probably the technique of choice in acute appendicitis. Single port laparoscopic surgery (SILS) has been proposed as an alternative technique. The objective of this study is to compare the safety and efficacy of SILS against conventional laparoscopic appendectomy (LA). From January 2011 to September 2012, 120 patients with acute appendicitis were prospectively randomized; 60 for SILS and 60 for LA. Patients between 15 to 65 years were selected, with onset of symptoms less than 48h. We compared BMI, surgery time, start of oral intake, hospital stay, postoperative pain, pathology and costs. The median age, BMI, sex and time of onset of symptoms to diagnosis were similar. There were no statistically significant differences in the operative time, start of oral intake or hospital stay. There was a significant difference in postoperative pain being higher in SILS (4±1.3) than in LA (3.3±0.5) with a P=.004. Flemonous appendicitis predominated in both groups in a similar percentage. A total of 3 cases with intra-abdominal abscess (SILS 2, LA 1) required readmission and resolved spontaneously with intravenous antibiotic treatment. One case of SILS required assistance by a 5mm trocar in the RLC for drainage placement. The cost was higher in SILS due the single port device. SILS appendectomy is safe, effective and has similar results to LA in selected patients, and although the cost is greater, the long term results will determine the future of this technique. Copyright © 2013 AEC. Published by Elsevier Espana. All rights reserved.

  18. Next-generation narrow band imaging system for colonic polyp detection: a prospective multicenter randomized trial.

    Science.gov (United States)

    Horimatsu, Takahiro; Sano, Yasushi; Tanaka, Shinji; Kawamura, Takuji; Saito, Shoichi; Iwatate, Mineo; Oka, Shiro; Uno, Koji; Yoshimura, Kenichi; Ishikawa, Hideki; Muto, Manabu; Tajiri, Hisao

    2015-07-01

    Previous studies have yielded conflicting results on the colonic polyp detection rate with narrow-band imaging (NBI) compared with white-light imaging (WLI). We compared the mean number of colonic polyps detected per patient for NBI versus WLI using a next-generation NBI system (EVIS LUCERA ELITE; Olympus Medical Systems) used with standard-definition (SD) colonoscopy and wide-angle (WA) colonoscopy. this study is a 2 × 2 factorial, prospective, multicenter randomized controlled trial. this study was conducted at five academic centers in Japan. patients were allocated to one of four groups: (1) WLI with SD colonoscopy (H260AZI), (2) NBI with SD colonoscopy (H260AZI), (3) WLI with WA colonoscopy (CF-HQ290), and (4) NBI with WA colonoscopy (CF-HQ290). the mean numbers of polyps detected per patient were compared between the four groups: WLI with/without WA colonoscopy and NBI with/without WA colonoscopy. Of the 454 patients recruited, 431 patients were enrolled. The total numbers of polyps detected by WLI with SD, NBI with SD, WLI with WA, and NBI with WA were 164, 176, 188, and 241, respectively. The mean number of polyps detected per patient was significantly higher in the NBI group than in the WLI group (2.01 vs 1.56; P = 0.032). The rate was not higher in the WA group than in the SD group (1.97 vs 1.61; P = 0.089). Although WA colonoscopy did not improve the polyp detection, next-generation NBI colonoscopy represents a significant improvement in the detection of colonic polyps.

  19. Use of music to reduce anxiety during office hysteroscopy: prospective randomized trial.

    Science.gov (United States)

    Angioli, Roberto; De Cicco Nardone, Carlo; Plotti, Francesco; Cafà, Ester Valentina; Dugo, Nella; Damiani, Patrizio; Ricciardi, Roberto; Linciano, Francesca; Terranova, Corrado

    2014-01-01

    To investigate the effects of music on anxiety and perception of pain during office hysteroscopy. Prospective randomized trial (Canadian Task Force classification I). Major university medical center. Three hundred fifty-six patients were enrolled between July 2012 and January 2013. Hysteroscopy was performed in a dedicated ambulatory room, using vaginoscopy and without any type of anesthesia. A Bettocchi hysteroscope 5 mm in diameter was used. All procedures were performed by the same surgeon, a gynecologist with special interest in hysteroscopy. Data collected included age, body mass index, number of vaginal deliveries, educational achievement level, and history of endometrial surgery (curettage and/or hysteroscopy). For each patient, vital parameters such as blood pressure, heart rate, and respiratory rate were recorded 15 minutes before the procedure and during hysteroscopy after traversing the cervix. Wait time before surgery and the duration of the procedure were also recorded. A completed Italian version of the state anxiety questionnaire (State-Trait Anxiety Inventory) and a visual analog scale (VAS) were administered to each patient before and after the procedure. The t test and Mann-Whitney U test was used when appropriate to compare the 2 groups. Statistical significance was accepted at p = .05. During surgery, systolic blood pressure and heart rate were significantly lower in the music group compared with the no music group. Women in the music group experienced significantly lower anxiety after hysteroscopy and less pain during the procedure, and a significant decrease in both anxiety and pain scores after hysteroscopy. Postoperative State-Trait Anxiety Inventory form Y1 and VAS scores were significantly lower in the music group. Music can be useful as a complementary method to control anxiety and reduce perception of pain. The patient is more relaxed and experiences less discomfort. Copyright © 2014. Published by Elsevier Inc.

  20. A prospective randomized peri- and post-operative comparison of the minimally invasive anterolateral approach versus the lateral approach

    OpenAIRE

    Stefan Landgraeber; Henning Quitmann; Sebastian Güth; Marcel Haversath; Wojciech Kowalczyk; Andrés Kecskeméthy; Hansjörg Heep; Marcus Jäger

    2013-01-01

    There is still controversy as to whether minimally invasive total hip arthroplasty enhances the postoperative outcome. The aim of this study was to compare the outcome of patients who underwent total hip replacement through an anterolateral minimally invasive (MIS) or a conventional lateral approach (CON). We performed a randomized, prospective study of 75 patients with primary hip arthritis, who underwent hip replacement through the MIS (n=36) or CON (n=39) approach. The Western Ontario and ...

  1. Influence of the pneumatic tourniquet on patella tracking in total knee arthroplasty: a prospective randomized study in 100 patients

    DEFF Research Database (Denmark)

    Husted, Henrik; Toftgaard Jensen, T

    2005-01-01

    One hundred consecutive patients with osteoarthritis of the knee joint and scheduled for primary total knee arthroplasty performed in a bloodless field were prospectively randomized to have the tourniquet inflated on either straight leg or maximally flexed knee. There was no difference in the num...... deflation led to better patella tracking and saved 5 (31%) of 16 releases with no difference between groups. We recommend tourniquet deflation and reevaluation of patella tracking before performing lateral release in patellar maltracking....

  2. Ketamine as an Adjunct to Postoperative Pain Management in Opioid Tolerant Patients After Spinal Fusions: A Prospective Randomized Trial

    OpenAIRE

    Urban, Michael K.; Ya Deau, Jacques T.; Wukovits, Barbara; Lipnitsky, Jane Y.

    2007-01-01

    Management of acute postoperative pain is challenging, particularly in patients with preexisting narcotic dependency. Ketamine has been used at subanesthetic doses as a N-methyl d-aspartate (NMDA) receptor antagonist to block the processing of nociceptive input in chronic pain syndromes. This prospective randomized study was designed to assess the use of ketamine as an adjunct to acute pain management in narcotic tolerant patients after spinal fusions. Twenty-six patients for 1–2 level poster...

  3. Photorefractive keratectomy versus laser in situ keratomileusis for moderate to high myopia. A randomized prospective study.

    Science.gov (United States)

    Hersh, P S; Brint, S F; Maloney, R K; Durrie, D S; Gordon, M; Michelson, M A; Thompson, V M; Berkeley, R B; Schein, O D; Steinert, R F

    1998-08-01

    This report presents the results of a randomized clinical trial of photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK). A randomized, prospective multicenter clinical trial. A total of 220 eyes of 220 patients entered the study cohort: 105 randomized to PRK and 115 to LASIK. The mean preoperative manifest refraction spherical equivalent was -9.23 diopters (D) in the PRK group and -9.30 D in the LASIK group. All patients received a one-pass, multizone excimer laser ablation as part of either a PRK or LASIK procedure using the Summit Apex excimer laser. Attempted corrections ranged from 6.00 to 15.00 D. Data on uncorrected and spectacle-corrected visual acuity, predictability,and stability of refraction, corneal haze, and flap complications were analyzed. Patients were observed for up to 6 months. One day after surgery, 0 (0.0%) and 3 (4.5%) eyes in the PRK group saw 20/20 and 20/40 or better uncorrected, respectively, while 7 (10%) and 48 (68.6%) eyes in the LASIK group saw 20/20 and 20/40 or better, respectively. At 6 months after PRK, 13 (19.1%) and 45 (66.2%) eyes saw 20/20 and 20/40 or better, respectively, while after LASIK, 16 (26.2%) and 34 (55.7%) eyes saw 20/20 and 20/40 or better, respectively (odds ratio = 0.56 for likelihood of uncorrected visual acuity PRK vs. LASIK, 95% confidence interval [CI] = 0.31-1.19). After PRK, 39 eyes (57.4%) were within 1.0 D of attempted correction compared with 24 eyes (40.7%) in the LASIK group (odds ratio = 0.50 for likelihood fo undercorrection 1.0 D for PRK vs. LASIK, 95% CI = 0.24-1.04); however, the standard deviation of the predictability was similar between groups: 1.01 D for PRK and 1.22 D for LASIK. From months 1 to 6, there was an average regression of 0.89 D in the PRK group and 0.55 D in the LASIK group. After PRK, eight eyes (11.8%) had a decrease in spectacle-corrected visual acuity of two Snellen lines or more; after LASIK, two eyes (3.2%) had a decrease of two lines or more

  4. Comparative prospective randomized trial: laparoscopic versus open common bile duct exploration

    Directory of Open Access Journals (Sweden)

    Vladimir Grubnik

    2011-06-01

    Full Text Available Introduction: Single-stage laparoscopic procedures for common bile duct (CBD stones are an alternative treatmentoption to two-stage endo-laparoscopic treatment and to open choledocholithotomy. Several reports have demonstratedthe feasibility, safety, efficiency and cost-effectiveness of laparoscopic techniques.Aim: To analyse the safety and benefits of laparoscopic compared to open common bile duct (CBD exploration.Material and methods: The prospective randomized trial included a total of 256 patients with CBD stones operated from2005 to 2009 in a single centre. The male/female ratio was 82/174, with a median age 62.3 ±5.8 years (range 27 to 87years. There were two groups of patients. Group I: laparoscopic CBD exploration (138 patients. Group II: open CBD exploration(118 patients. Patient comorbidity was assessed by means of the American Society of Anesthesiologists (ASA classification;ASA II – 109 patients, ASA III – 59 patients. Bile duct stones were visualized preoperatively by means of US examinationin 129 patients, by means of ERCP in 26 patients, and by magnetic resonance cholangiopancreatography (MRCPin 72 patients. Preoperative evaluation was done through medical history, biochemical tests and ultrasonography.Results: The mean duration of laparoscopic procedures was 82 min (range 40-160 min. The mean duration of openprocedures was 90 min (range 60-150 min. Mean blood loss was much lower in the laparoscopic group than in theopen group (20 ±2 v.s 285 ±27, p < 0.01. Postoperative complications were observed in 7 patients of the laparoscopicgroup and in 15 patients in the open group (p < 0.01. Laparoscopic common bile duct exploration was performedthrough a trans-cystic approach in 76 patients and via choledochotomy in 62 patients. The transcystic approach wassuccessful in 76 patients (74.5%. External drainage was used in 25 (32.8% patients with the transcystic approach.Conclusions: Laparoscopic CBD exploration can be performed with

  5. Use of Play Therapy in Nursing Process: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Sezici, Emel; Ocakci, Ayse Ferda; Kadioglu, Hasibe

    2017-03-01

    Play therapy is a nursing intervention employed in multidisciplinary approaches to develop the social, emotional, and behavioral skills of children. In this study, we aim to determine the effects of play therapy on the social, emotional, and behavioral skills of pre-school children through the nursing process. A single-blind, prospective, randomized controlled study was undertaken. The design, conduct, and reporting of this study adhere to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The participants included 4- to 5-year-old kindergarten children with no oral or aural disabilities and parents who agreed to participate in the study. The Pre-school Child and Family Identification Form and Social Competence and the Behavior Evaluation Scale were used to gather data. Games in the play therapy literature about nursing diagnoses (fear, social disturbance, impaired social interactions, ineffective coping, anxiety), which were determined after the preliminary test, constituted the application of the study. There was no difference in the average scores of the children in the experimental and control groups in their Anger-Aggression (AA), Social Competence (SC), and Anxiety-Withdrawal (AW) scores beforehand (t = 0.015, p = .988; t = 0.084, p = .933; t = 0.214, p = .831, respectively). The difference between the average AA and SC scores in the post-test (t = 2.041, p = .045; t = 2.692, p = .009, respectively), and the retests were statistically significant in AA and SC average scores in the experimental and control groups (t = 4.538, p = .000; t = 4.693; p = .000, respectively). In AW average scores, no statistical difference was found in the post-test (t = 0.700, p = .486), whereas in the retest, a significant difference was identified (t = 5.839, p = .000). Play therapy helped pre-school children to improve their social, emotional, and behavioral skills. It also provided benefits for the children to decrease their fear and anxiety levels, to improve

  6. Multidisciplinary intervention reducing readmissions in medical inpatients: a prospective, non-randomized study

    Directory of Open Access Journals (Sweden)

    Torisson G

    2013-09-01

    Full Text Available Gustav Torisson,1 Lennart Minthon,1 Lars Stavenow,2 Elisabet Londos1 1Clinical Memory Research Unit, Department of Clinical Sciences, Lund University, 2Department of Internal Medicine, Skåne University Hospital, Malmö, Sweden Background: The purpose of this study was to examine whether a multidisciplinary intervention targeting drug-related problems, cognitive impairment, and discharge miscommunication could reduce readmissions in a general hospital population. Methods: This prospective, non-randomized intervention study was carried out at the department of general internal medicine at a tertiary university hospital. Two hundred medical inpatients living in the community and aged over 60 years were included. Ninety-nine patients received interventions and 101 received standard care. Control/intervention allocation was determined by geographic selection. Interventions consisted of a comprehensive medication review, improved discharge planning, post-discharge telephone follow-up, and liaison with the patient's general practitioner. The main outcome measures recorded were readmissions and hospital nights 12 months after discharge. Separate analyses were made for 12-month survivors and from an intention-to-treat perspective. Comparative analyses were made between groups as well as within groups over time. Results: After 12 months, survivors in the control group had 125 readmissions in total, compared with 58 in the intervention group (Mann–Whitney U test, P = 0.02. For hospital nights, the numbers were 1,228 and 492, respectively (P = 0.009. Yearly admissions had increased from the previous year in the control group from 77 to 125 (Wilcoxon signed-rank test, P = 0.002 and decreased from 75 to 58 in the intervention group (P = 0.25. From the intention-to-treat perspective, the same general pattern was observed but was not significant (1,827 versus 1,008 hospital nights, Mann–Whitney test, P = 0.054. Conclusion: A multidisciplinary approach

  7. Hospital cost analysis of a prospective, randomized trial of early vs interval appendectomy for perforated appendicitis in children.

    Science.gov (United States)

    Myers, Adrianne L; Williams, Regan F; Giles, Kim; Waters, Teresa M; Eubanks, James W; Hixson, S Douglas; Huang, Eunice Y; Langham, Max R; Blakely, Martin L

    2012-04-01

    The methods of surgical care for children with perforated appendicitis are controversial. Some surgeons prefer early appendectomy; others prefer initial nonoperative management followed by interval appendectomy. Determining which of these two therapies is most cost-effective was the goal of this study. We conducted a prospective, randomized trial in children with a preoperative diagnosis of perforated appendicitis. Patients were randomized to early or interval appendectomy. Overall hospital costs were extracted from the hospital's internal cost accounting system and the two treatment groups were compared using an intention-to-treat analysis. Nonparametric data were reported as median ± standard deviation (or range) and compared using a Wilcoxon rank sum test. One hundred thirty-one patients were randomized to either early (n = 64) or interval (n = 67) appendectomy. Hospital charges and costs were significantly lower in patients randomized to early appendectomy. Total median hospital costs were $17,450 (range $7,020 to $55,993) for patients treated with early appendectomy vs $22,518 (range $4,722 to $135,338) for those in the interval appendectomy group. Median hospital costs more than doubled in patients who experienced an adverse event ($15,245 vs $35,391, p < 0.0001). Unplanned readmissions also increased costs significantly and were more frequent in patients randomized to interval appendectomy. In a prospective randomized trial, hospital charges and costs were significantly lower for early appendectomy when compared with interval appendectomy. The increased costs were related primarily to the significant increase in adverse events, including unplanned readmissions, seen in the interval appendectomy group. Copyright © 2012. Published by Elsevier Inc.

  8. Intrathecal pressure monitoring and cerebrospinal fluid drainage in acute spinal cord injury: a prospective randomized trial.

    Science.gov (United States)

    Kwon, Brian K; Curt, Armin; Belanger, Lise M; Bernardo, Arlene; Chan, Donna; Markez, John A; Gorelik, Stephen; Slobogean, Gerard P; Umedaly, Hamed; Giffin, Mitch; Nikolakis, Michael A; Street, John; Boyd, Michael C; Paquette, Scott; Fisher, Charles G; Dvorak, Marcel F

    2009-03-01

    Ischemia is an important factor in the pathophysiology of secondary damage after traumatic spinal cord injury (SCI) and, in the setting of thoracoabdominal aortic aneurysm repair, can be the primary cause of paralysis. Lowering the intrathecal pressure (ITP) by draining CSF is routinely done in thoracoabdominal aortic aneurysm surgery but has not been evaluated in the setting of acute traumatic SCI. Additionally, while much attention is directed toward maintaining an adequate mean arterial blood pressure (MABP) in the acute postinjury phase, little is known about what is happening to the ITP during this period when spinal cord perfusion pressure (MABP - ITP) is important. The objectives of this study were to: 1) evaluate the safety and feasibility of draining CSF to lower ITP after acute traumatic SCI; 2) evaluate changes in ITP before and after surgical decompression; and 3) measure neurological recovery in relation to the drainage of CSF. Twenty-two patients seen within 48 hours of injury were prospectively randomized to a drainage or no-drainage treatment group. In all cases a lumbar intrathecal catheter was inserted for 72 hours. Acute complications of headache/nausea/vomiting, meningitis, or neurological deterioration were carefully monitored. Acute Spinal Cord Injury motor scores were documented at baseline and at 6 months postinjury. On insertion of the catheter, mean ITP was 13.8 +/- 1.3 mm Hg (+/- SD), and it increased to a mean peak of 21.7 +/- 1.5 mm Hg intraoperatively. The difference between the starting ITP on catheter insertion and the observed peak intrathecal pressure after decompression was, on average, an increase of 7.9 +/- 1.6 mm Hg (p drainage group was 30.6 +/- 2.3 mm Hg, which was significantly higher than the peak intraoperative ITP (p = 0.0098). During the same period, the peak recorded ITP in patients randomized to receive drainage was 28.1 +/- 2.8 mm Hg, which was not statistically higher than the peak intraoperative ITP (p = 0.15). The

  9. Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer : Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses

    NARCIS (Netherlands)

    Khankari, Nikhil K.; Shu, Xiao Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I.; Easton, Douglas; Eeles, Rosalind A.; Gruber, Stephen B.; Haiman, Christopher A.; Hunter, David J.; Chanock, Stephen J.; Pierce, Brandon L.; Zheng, Wei; Blalock, Kendra; Campbell, Peter T.; Casey, Graham; Conti, David V.; Edlund, Christopher K.; Figueiredo, Jane; James Gauderman, W.; Gong, Jian; Green, Roger C.; Harju, John F.; Harrison, Tabitha A.; Jacobs, Eric J.; Jenkins, Mark A.; Jiao, Shuo; Li, Li; Lin, Yi; Manion, Frank J.; Moreno, Victor; Mukherjee, Bhramar; Raskin, Leon; Schumacher, Fredrick R.; Seminara, Daniela; Severi, Gianluca; Stenzel, Stephanie L.; Thomas, Duncan C.; Hopper, John L.; Southey, Melissa C.; Makalic, Enes; Schmidt, Daniel F.; Fletcher, Olivia; Peto, Julian; Gibson, Lorna; dos Santos Silva, Isabel; Ahsan, Habib; Whittemore, Alice; Waisfisz, Quinten; Meijers-Heijboer, Hanne; Adank, Muriel; van der Luijt, Rob B.; Uitterlinden, Andre G.; Hofman, Albert; Meindl, Alfons; Schmutzler, Rita K.; Müller-Myhsok, Bertram; Lichtner, Peter; Nevanlinna, Heli; Muranen, Taru A.; Aittomäki, Kristiina; Blomqvist, Carl; Chang-Claude, Jenny; Hein, Rebecca; Dahmen, Norbert; Beckman, Lars; Crisponi, Laura; Hall, Per; Czene, Kamila; Irwanto, Astrid; Liu, Jianjun; Easton, Douglas F.; Turnbull, Clare; Rahman, Nazneen; Eeles, Rosalind; Kote-Jarai, Zsofia; Muir, Kenneth; Giles, Graham; Neal, David; Donovan, Jenny L.; Hamdy, Freddie C.; Wiklund, Fredrik; Gronberg, Henrik; Haiman, Christopher; Schumacher, Fred; Travis, Ruth; Riboli, Elio; Hunter, David; Gapstur, Susan; Berndt, Sonja; Chanock, Stephen; Han, Younghun; Su, Li; Wei, Yongyue; Hung, Rayjean J.; Brhane, Yonathan; McLaughlin, John; Brennan, Paul; McKay, James D.; Rosenberger, Albert; Houlston, Richard S.; Caporaso, Neil; Teresa Landi, Maria; Heinrich, Joachim; Wu, Xifeng; Ye, Yuanqing; Christiani, David C.

    2016-01-01

    Background: Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using

  10. A randomized, prospective cross-over trial comparing methylene blue-directed biopsy and conventional random biopsy for detecting intestinal metaplasia and dysplasia in Barrett's esophagus.

    Science.gov (United States)

    Ragunath, K; Krasner, N; Raman, V S; Haqqani, M T; Cheung, W Y

    2003-12-01

    The value of methylene blue-directed biopsies (MBDB) in detecting specialized intestinal metaplasia and dysplasia in Barrett's esophagus remains unclear. The aim of this study was to compare the accuracy of MBDB with random biopsy in detecting intestinal metaplasia and dysplasia in patients with Barrett's esophagus. A prospective, randomized, cross-over trial was undertaken to compare MBDB with random biopsy in patients with Barrett's esophagus segments 3 cm or more in length without macroscopic evidence of dysplasia or cancer. Dysplasia was graded as: indefinite for dysplasia, low-grade dysplasia, high-grade dysplasia, or carcinoma, and was reported in a blinded fashion. Fifty-seven patients were recruited, 44 of whom were male. A total of 1,269 biopsies were taken (MBDB-651, random biopsie-618). Analysis of the results by per-biopsy protocol showed that the MBDB technique diagnosed significantly more specialized intestinal metaplasia (75 %) compared to the random biopsy technique (68 %; P = 0.032). The sensitivity and specificity rates of MBDB for diagnosing specialized intestinal metaplasia were 91 % (95 % CI, 88 - 93 %) and 43 % (95 % CI, 36 - 51 %), respectively. The sensitivity and specificity rates of MBDB for diagnosing dysplasia or carcinoma were 49 % (95 % CI, 38 - 61 %) and 85 % (95 % CI, 82 - 88 %), respectively. There were no significant differences in the diagnosis of dysplasia and carcinoma - MBDB 12 %, random biopsy 10 %. The methylene blue staining pattern appeared to have an influence on the detection of specialized intestinal metaplasia and dysplasia/carcinoma. Dark blue staining was associated with increased detection of specialized intestinal metaplasia (P biopsies. Although MBDB prolongs the endoscopy procedure slightly, it is a safe and well-tolerated procedure. Further clinical studies on the MBDB technique exclusively in endoscopically normal dysplastic Barrett's esophagus are needed.

  11. Topical silver sulfadiazine vs collagenase ointment for the treatment of partial thickness burns in children: a prospective randomized trial.

    Science.gov (United States)

    Ostlie, Daniel J; Juang, David; Aguayo, Pablo; Pettiford-Cunningham, Janine P; Erkmann, Erin A; Rash, Diane E; Sharp, Susan W; Sharp, Ronald J; St Peter, Shawn D

    2012-06-01

    The 2 most commonly used topical agents for partial thickness burns are silver sulfadiazine (SSD) and collagenase ointment (CO). Silver sulfadiazine holds antibacterial properties, and eschar separation occurs naturally. Collagenase ointment is an enzyme that cleaves denatured collagen facilitating separation but has no antibacterial properties. Currently, there are no prospective comparative data in children for these 2 agents. Therefore, we conducted a prospective randomized trial. After institutional review board approval, patients were randomized to daily debridement with SSD or CO. Primary outcome was the need for skin grafting. Patients were treated for 2 days with SSD with subsequent randomization. Polymyxin was mixed with CO for antibacterial coverage. Debridements were performed daily for 10 days or until the burn healed. Grafting was performed after 10 days if not healed. From January 2008 to January 2011, 100 patients were enrolled, with no differences in patient characteristics. There were no differences in clinical course, outcome, or need for skin grafting. Wound infections occurred in 7 patients treated with CO and 1 patient treated with SSD (P = .06). Collagenase ointment was more expensive than SSD (P burns results. Copyright © 2012 Elsevier Inc. All rights reserved.

  12. Treatment of benign esophageal stricture by Eder-Puestow or balloon dilators: a comparison between randomized and prospective nonrandomized trials.

    Science.gov (United States)

    Yamamoto, H; Hughes, R W; Schroeder, K W; Viggiano, T R; DiMagno, E P

    1992-03-01

    To determine whether the natural history of strictures is affected by the type of dilator used to treat newly diagnosed peptic strictures, we designed a prospective randomized trial to compare the results after Eder-Puestow or Medi-Tech balloon dilation. We entered 31 patients into the trial. We also prospectively followed up all 92 nonrandomized patients who underwent their first dilation for a benign stricture during the same period as the prospective randomized trial. The nonrandomized patients also underwent dilation with either the Eder-Puestow or the balloon technique at the discretion of the gastroenterologist performing the endoscopy. We found no statistically significant differences in the immediate or long-term results of the two methods among the randomized, nonrandomized, and overall combined groups. All but 1 of the 123 patients had immediate relief of dysphagia. Within each group of patients, the probability of remaining free of dysphagia 1 year after the initial dilation was approximately 20%, and the probability of not requiring a second dilation was approximately 65% with either technique. Major (esophageal rupture) and minor (bleeding or chest pain) complications occurred in 1% and 5% of the patients and 0.4% and 3% of the total dilation procedures, respectively. The esophageal rupture and four of six minor complications occurred after repeated dilations. Five of the six minor complications occurred with use of the Eder-Puestow dilators. We conclude that Eder-Puestow and balloon dilations of benign esophageal strictures are associated with similar outcomes, but repeated dilations and the Eder-Puestow technique may be associated with an increased risk of complications.

  13. BLEEDING PEPTIC ULCER, NONSTEROIDAL ANTIINFLAMMATORY DRUGS AND HELICOBACTER PYLORI INFECTION – A PROSPECTIVE, CONTROLLED, RANDOMIZED STUDY

    Directory of Open Access Journals (Sweden)

    Pavel Skok

    2002-06-01

    Full Text Available Background. The explanation of peptic ulcer etiology has changed significantly in the past decade after the clarification of the significance of Helicobacter pylori infection.Aim. To evaluate the effectiveness of Helicobacter pylori eradication in patients with hemorrhaging peptic ulcer and patients with peptic ulcer without complications.Study ethics. The study was approved in 1998 by the Medical Ethics Committee of the Republic of Slovenia (No. 90/09/98.Type of study. Prospective, controlled and randomized study, carried out between 1998–2000.Patients and methods. The study included 80 patients (50 male and 30 female, av.age 57.5 years, SD ± 17.1, range 22– 80 in which endoscopy confirmed hemorrhage from peptic ulcer of stomach or duodenum and Helicobacter pylori infection. In all cases endoscopic hemostasis was performed: injection sclerotherapy with diluted adrenalin 1:10,000 and 1% polidocanol or argon plasma coagulation. The control group was made up of 80 patients (50 male and 30 female, av.age 56.8 years, SD ± 16.8, range 19–80 with peptic ulcer of stomach or duodenum and Helicobacter pylori infection. Infection was confirmed by a rapid urease test and histologic investigation of the gastric mucosa. In all cases the recommended drug combinations were used in the treatment of the infection: a proton pump inhibitor, omeprazol (4 weeks, and combination of antibiotics, claritromycin and metronidazole or with regard to the antibiogram (1 week. The therapeutic success was ascertained endoscopically four weeks after inclusion in the study. Infection eradication was confirmed by the rapid urease test and histologic investigation of the gastric mucosa.Results. Four weeks after inclusion in the study the success of infection eradication was 92.5% in the study group, in the control group it was 91.3% (p > 0.05. In 6 patients (7.5%, 6/ 80 from the study group and in 7 (8.8%, 7/80 from the control group we introduced a replacement treatment

  14. Arthroscopic cartilage debridement by excimer laser in chondromalacia of the knee joint. A prospective randomized clinical study.

    Science.gov (United States)

    Raunest, J; Löhnert, J

    1990-01-01

    A new operative technique in arthroscopic treatment of chondromalacia using ultraviolet laser systems is introduced. The postoperative results are evaluated in a prospective and randomized clinical trial. One hundred and forty patients stage II or III chondromalacia according to Outerbridge were randomly assigned to arthroscopic operation using either laser or mechanical instruments. After a 6-month follow-up period the clinical results were compared, guided by a specially designed modification of the Lysholm scoring scale. In the short-term follow-up laser surgery gave superior results in regard to reducing pain (P less than 0.05) and leading to a lower incidence of reactive synovitis (P less than 0.01). No difference was found in respect of disability and functional impairment. Our results lead to the conclusion that arthroscopic laser application seems to be a successful procedure in the treatment of degenerative cartilage disorders, providing precise ablation of tissue without significant thermal damage to the remaining cartilage.

  15. The analgesic effect of dexketoprofen when added to lidocaine for intravenous regional anaesthesia: a prospective, randomized, placebo-controlled study.

    Science.gov (United States)

    Yurtlu, S; Hanci, V; Kargi, E; Erdoğan, G; Köksal, B G; Gül, Ş; Okyay, R D; Ayoğlu, H; Turan, I Ö

    2011-01-01

    This prospective, randomized, placebo-controlled study evaluated the effects of dexketoprofen as an adjunct to lidocaine in intravenous regional anaesthesia (IVRA) or as a supplemental intravenous (i.v.) analgesic. Patients scheduled for elective hand or forearm soft-tissue surgery were randomly divided into three groups. All 45 patients received 0.5% lidocaine as IVRA. Dexketoprofen was given either i.v. or added into the IVRA solution and the control group received an equal volume of saline both i.v. and as part of the IVRA. The times of sensory and motor block onset, recovery time and postoperative analgesic consumption were recorded. Compared with controls, the addition of dexketoprofen to the IVRA solution resulted in more rapid onset of sensory and motor block, longer recovery time, decreased intra- and postoperative pain scores and decreased paracetamol use. It is concluded that coadministration of dexketoprofen with lidocaine in IVRA improves anaesthetic block and decreases postoperative analgesic requirements.

  16. A prospective randomized study comparing percutaneous nephrolithotomy under combined spinal-epidural anesthesia with percutaneous nephrolithotomy under general anesthesia.

    Science.gov (United States)

    Singh, Vishwajeet; Sinha, Rahul Janak; Sankhwar, S N; Malik, Anita

    2011-01-01

    A prospective randomized study was executed to compare the surgical parameters and stone clearance in patients who underwent percutaneous nephrolithotomy (PNL) under combined spinal-epidural anesthesia (CSEA) versus those who underwent PNL under general anesthesia (GA). Between January 2008 to December 2009, 64 patients with renal calculi were randomized into 2 groups and evaluated for the purpose of this study. Group 1 consisted of patients who underwent PNL under CSEA and Group 2 consisted of patients who underwent PNL under GA. The operative time, stone clearance rate, visual pain analog score, mean analgesic dose and mean hospital stay were compared amongst other parameters. The difference between visual pain analog score after the operation and the dose of analgesic requirement was significant on statistical analysis between both groups. PNL under CSEA is as effective and safe as PNL under GA. Patients who undergo PNL under CESA require lesser analgesic dose and have a shorter hospital stay. Copyright © 2011 S. Karger AG, Basel.

  17. Combined impact of negative lifestyle factors on cardiovascular risk in children: a randomized prospective study

    OpenAIRE

    Meyer, Ursina; Schindler, Christian; Bloesch, Tamara; Schmocker, Eliane; Zahner, Lukas; Puder, Jardena J; Kriemler, Susi

    2014-01-01

    PURPOSE: Negative lifestyle factors are known to be associated with increased cardiovascular risk (CVR) in children, but research on their combined impact on a general population of children is sparse. Therefore, we aimed to quantify the combined impact of easily assessable negative lifestyle factors on the CVR scores of randomly selected children after 4 years. METHODS: Of the 540 randomly selected 6- to 13-year-old children, 502 children participated in a baseline health assessment, and ...

  18. A prospective randomized study of use of drain versus no drain after burr-hole evacuation of chronic subdural hematoma.

    Science.gov (United States)

    Singh, Amit Kumar; Suryanarayanan, Bhaskar; Choudhary, Ajay; Prasad, Akhila; Singh, Sachin; Gupta, Laxmi Narayan

    2014-01-01

    Chronic subdural hematoma (CSDH) recurs after surgical evacuation in 5-30% of patients. Inserting subdural drain might reduce the recurrence rate, but is not commonly practiced. There are few prospective studies to evaluate the effect of subdural drains. A prospective randomized study to investigate the effect of subdural drains in the on recurrence rates and clinical outcome following burr-hole drainage (BHD) of CSDH was undertaken. During the study period, 246 patients with CSDH were assessed for eligibility. Among 200 patients fulfilling the eligibility criteria, 100 each were assigned to "drain group" (drain inserted into the subdural space following BHD) and "without drain group" (subdural drain was not inserted following BHD) using random allocation software. The primary end point was recurrence needing re-drainage up to a period of 6 months from surgery. Recurrence occurred in 9 of 100 patients with a drain, and 26 of 100 patients in without drain group (P = 0.002). The mortality was 5% in patients with drain and 4% in patients without drain group (P = 0.744). The medical and surgical complications were comparable between the two study groups. Use of a subdural drain after burr-hole evacuation of a CSDH reduces the recurrence rate and is not associated with increased complications.

  19. Laparoscopic Dor versus Toupet fundoplication following Heller myotomy for achalasia: results of a multicenter, prospective, randomized-controlled trial.

    Science.gov (United States)

    Rawlings, Arthur; Soper, Nathaniel J; Oelschlager, Brant; Swanstrom, Lee; Matthews, Brent D; Pellegrini, Carlos; Pierce, Richard A; Pryor, Aurora; Martin, Valeria; Frisella, Margaret M; Cassera, Maria; Brunt, L Michael

    2012-01-01

    The type of fundoplication that should be performed in conjunction with Heller myotomy for esophageal achalasia is controversial. We prospectively compared anterior fundoplication (Dor) with partial posterior fundoplication (Toupet) in patients undergoing laparoscopic Heller myotomy. A multicenter, prospective, randomized-controlled trial was initiated to compare Dor versus Toupet fundoplication after laparoscopic Heller myotomy. Outcome measures were symptomatic GERD scores (0-4, five-point Likert scale questionnaire) and 24-h pH testing at 6-12 months after surgery. Data are mean ± SD. Statistical analysis was by Mann-Whitney U test, Wilcoxon signed rank test, and Freidman's test. Sixty of 85 originally enrolled and randomized patients who underwent 36 Dor and 24 Toupet fundoplications had follow-up data per protocol for analysis. Dor and Toupet groups were similar in age (46.8 vs. 51.7 years) and gender (52.8 vs. 62.5% male). pH studies at 6-12 months in 43 patients (72%: Dor n = 24 and Toupet n = 19) showed total DeMeester scores and % time pH Heller myotomy provides significant improvement in dysphagia and regurgitation symptoms in achalasia patients regardless of the type of partial fundoplication. Although a higher percentage of patients in the Dor group had abnormal 24-h pH test results compared to those of patients who underwent Toupet, the differences were not statistically significant.

  20. Comparison of Tension-Band Wiring With the Cable Pin System in Patella Fractures: A Randomized Prospective Study.

    Science.gov (United States)

    Tian, Qing-xian; Hai, Yong; Du, Xin-ru; Xu, Zi-yu; Lu, Tie; Shan, Lei; Liu, Yang; Zhou, Jun-lin

    2015-12-01

    To compare the outcome of tension-band wiring (TBW) with the cable pin system (CPS) for transverse fractures of the patella. Randomized prospective study. Academic Level I trauma center. From February 2008 to December 2011, 73 consecutive patients with transverse fractures of the patella were prospectively enrolled in this study. The patients were randomly divided into 2 groups: one group was treated using the CPS, and the other group was treated using the modified TBW. The clinical outcome assessment included analyses of the radiographic images, the modified Hospital for Special Surgery scoring system, and complications. The follow-up time ranged from 12 to 29 months. All fractures healed, with a union rate of 100%. The fracture healing time was significantly shorter in the CPS group (8.51 ± 2.59 weeks, n = 34) compared with the TBW group (11.79 ± 3.04 weeks, n = 39). Postoperative complications in the CPS and TBW groups were observed in 1 and 9 patients, respectively, a difference that was statistically significant. The mean Hospital for Special Surgery score for the CPS group (90.53 ± 5.19 points) was significantly higher than that for the TBW group (81.36 ± 12.71 points). The CPS is a viable option for transverse fractures of the patella and is associated with a shorter healing time, fewer complications, and better function than TBW. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  1. Use of cinacalcet in nephrolithiasis associated with normocalcemic or hypercalcemic primary hyperparathyroidism: results of a prospective randomized pilot study

    Directory of Open Access Journals (Sweden)

    Simone Brardi

    2015-03-01

    Full Text Available Objectives: To evaluate, by means of a prospective randomized study, the efficacy of cinacalcet in the forms of nephrolithiasis associated with primary hyperparathyroidism in both the hypercalcemic and normocalcemic variant. Materials and Methods: Ten patients suffering from active nephrolithiasis associated with primary hyperparathyroidism (4 hypercalcemics and 6 normocalcemics, equally divided between males and females, were randomly but not blindly addressed to treatment with potassium citrate and allopurinol, or to the same therapeutic regimen in combination with cinacalcet. The dosage of cinacalcet was optimized for each patient in order to obtain a reduction of parathyroid hormone (PTH within normal limits while enabling the maintenance of adequate calcemic values. All study participants were given the same diet based on a reduction in sodium intake, oxalate-rich foods and animal protein with standardized intake of calcium and an increase in hydration. After a follow up period of 10 months , cinacalcet was associated to standard therapy and diet in patients who were not taken it, conversely cinacalcet was withdrawn in the remaining patients who remained on standard therapeutic regimen and diet. Follow up was continued for a second period of observation of the same duration of the first. Results: At the end of the period of treatment with cinacalcet, for both variants of hyperparathyroidism, a statistically significant reduction in the overall number and in the diameter of renal stones was found. Conclusions: This prospective randomized study shows the effectiveness of cinacalcet used in combination with a diet with normalized calcium intake, in reducing the number and size of urinary stones in hypercalemic and normocalcemic forms of primary hyperparathyroidism.

  2. Prospective randomized trial to assess effects of continuing hormone therapy on cerebral function in postmenopausal women at risk for dementia.

    Directory of Open Access Journals (Sweden)

    Natalie L Rasgon

    Full Text Available The objective of this study was to examine the effects of estrogen-based hormone therapy (HT on regional cerebral metabolism in postmenopausal women (mean age = 58, SD = 5 at risk for development of dementia. The prospective clinical trial design included pre- and post-intervention neuroimaging of women randomized to continue (HT+ or discontinue (HT- therapy following an average of 10 years of use. The primary outcome measure was change in brain metabolism during the subsequent two years, as assessed with fluorodeoxyglucose-18 positron emission tomography (FDG-PET. Longitudinal FDG-PET data were available for 45 study completers. Results showed that women randomized to continue HT experienced relative preservation of frontal and parietal cortical metabolism, compared with women randomized to discontinue HT. Women who discontinued 17-β estradiol (17βE-based HT, as well as women who continued conjugated equine estrogen (CEE-based HT, exhibited significant decline in metabolism of the precuneus/posterior cingulate cortical (PCC area. Significant decline in PCC metabolism was additionally seen in women taking concurrent progestins (with either 17βE or CEE. Together, these findings suggest that among postmenopausal subjects at risk for developing dementia, regional cerebral cortical metabolism is relatively preserved for at least two years in women randomized to continue HT, compared with women randomized to discontinue HT. In addition, continuing unopposed 17βE therapy is associated specifically with preservation of metabolism in PCC, known to undergo the most significant decline in the earliest stages of Alzheimer's disease.ClinicalTrials.gov NCT00097058.

  3. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial.

    LENUS (Irish Health Repository)

    McDonnell, John G

    2007-01-01

    The transversus abdominis plane (TAP) block is a novel approach for blocking the abdominal wall neural afferents via the bilateral lumbar triangles of Petit. We evaluated its analgesic efficacy in patients during the first 24 postoperative hours after abdominal surgery, in a randomized, controlled, double-blind clinical trial.

  4. Effects of Aromatherapy Massage on Pregnant Women's Stress and Immune Function: A Longitudinal, Prospective, Randomized Controlled Trial.

    Science.gov (United States)

    Chen, Pao-Ju; Chou, Cheng-Chen; Yang, Luke; Tsai, Yu-Lun; Chang, Yue-Cune; Liaw, Jen-Jiuan

    2017-10-01

    This study's aims are to examine the effects of aromatherapy massage on women's stress and immune function during pregnancy. This longitudinal, prospective, randomized controlled trial recruited 52 healthy pregnant women from a prenatal clinic in Taipei using convenience sampling. The participants were randomly assigned to the intervention (n = 24) or control (n = 28) group using Clinstat block randomization. The intervention group received 70 min of aromatherapy massage with 2% lavender essential oil every other week (10 times in total) for 20 weeks; the control group received only routine prenatal care. In both groups, participants' salivary cortisol and immunoglobulin A (IgA) levels were collected before and after the intervention group received aromatherapy massage (every month from 16 to 36 weeks gestation) and were analyzed using enzyme-linked immunosorbent assay. The pregnant women in the intervention group had lower salivary cortisol (p aromatherapy massage than those in the control group, which did not receive massage treatment. Comparing the long-term effects of aromatherapy massage on salivary IgA levels between groups at different times, the study found that the pretest salivary IgA levels at 32 (p = 0.002) and 36 (p aromatherapy massage could significantly decrease stress and enhance immune function in pregnant women. The findings can guide clinicians or midwives in providing aromatherapy massage to women throughout the pregnancy.

  5. High dose Senna or Poly Ethylene Glycol (PEG for elective colonoscopy preparation: a prospective randomized investigator-blinded clinical trial

    Directory of Open Access Journals (Sweden)

    Ahmad Shavakhi

    2011-01-01

    Full Text Available Background: The aim of this study was to determine the efficacy of two methods of colon preparation for colon cleansing in a randomized controlled trial. Methods: In this prospective randomized investigator-blinded trial, consecutive outpatients indicated for elective colonoscopy were randomized into two groups. Patients in Senna group took 24 tablets of 11 mg Senna in two divided doses 24 hour before colonoscopy. In Poly Ethylene Glycol (PEG group they solved 4 sachets in 4 liters of water the day before the procedure and were asked to drink 250 ml every 15 minutes. The overall quality of colon cleansing was evaluated using the Aronchick scoring scale. Difficulty of the procedure, patients′ tolerance and compliance and adverse events were also evaluated. Results: 322 patients were enrolled in the study. There was no significant difference in the quality of colon cleansing, patients′ tolerance, compliance and the difficulty of the procedure between two groups (p > 0.05. The incidence of adverse effects was similar between two groups except for abdominal pain that was more severe in Senna group (p < 0.05 and nausea and vomiting that was more common in PEG group (p < 0.05 Conclusions: In conclusion we deduce that Senna has the same efficacy and patient′s acceptance as Polyethylene glycol-electrolyte solution (PEG-ES and it could be prescribed as an alternative method for bowel preparation.

  6. Reduction of shunt obstructions by using a peel-away sheath technique? A multicenter prospective randomized trial.

    Science.gov (United States)

    Kehler, Uwe; Langer, Niels; Gliemroth, Jan; Meier, Ullrich; Lemcke, Johannes; Sprung, Christian; Schlosser, Hans-Georg; Kiefer, Michael; Eymann, Regina; Heese, Oliver

    2012-05-01

    Shunt obstructions may partly be caused by brain debris, which intrude into the ventricular catheter during ventricle puncture. Avoiding contact between the catheter and brain tissue, by using a peel-away sheath, should reduce the number of shunt failures caused by obstruction. To test this hypothesis, we conducted a randomized, prospective multicenter study. 201 patients from 6 different neurosurgical centers in Germany receiving a ventriculo-peritoneal shunt were included in this study. Of these, 177 patients completed a 1-year follow-up period. Surgery was randomized in a 1 to 1 fashion, such that out of 177 procedures, 91 were performed using a peel-away sheath and 86 were performed without. The rate of surgical re-interventions and shunt obstructions within a 12-month period was recorded. Within 1 year post-surgery, 17 shunt obstructions (9.6%) leading to shunt revisions were recorded. However, no difference was found between surgeries performed using a peel-away sheath (9.9%) or not (9.3%). The overall shunt infection rate was 2.8% and the shunt revision rate for overdrainage was 3.9%. The theoretical advantages attributed to the use of a peel-away sheath to introduce a ventricular catheter could not be confirmed in this randomized study, suggesting that the proposed role of brain debris in shunt obstructions may be overestimated. Copyright © 2011 Elsevier B.V. All rights reserved.

  7. Epidemiology, epigenetics and the 'Gloomy Prospect': embracing randomness in population health research and practice.

    Science.gov (United States)

    Smith, George Davey

    2011-06-01

    Epidemiologists aim to identify modifiable causes of disease, this often being a prerequisite for the application of epidemiological findings in public health programmes, health service planning and clinical medicine. Despite successes in identifying causes, it is often claimed that there are missing additional causes for even reasonably well-understood conditions such as lung cancer and coronary heart disease. Several lines of evidence suggest that largely chance events, from the biographical down to the sub-cellular, contribute an important stochastic element to disease risk that is not epidemiologically tractable at the individual level. Epigenetic influences provide a fashionable contemporary explanation for such seemingly random processes. Chance events-such as a particular lifelong smoker living unharmed to 100 years-are averaged out at the group level. As a consequence population-level differences (for example, secular trends or differences between administrative areas) can be entirely explicable by causal factors that appear to account for only a small proportion of individual-level risk. In public health terms, a modifiable cause of the large majority of cases of a disease may have been identified, with a wild goose chase continuing in an attempt to discipline the random nature of the world with respect to which particular individuals will succumb. The quest for personalized medicine is a contemporary manifestation of this dream. An evolutionary explanation of why randomness exists in the development of organisms has long been articulated, in terms of offering a survival advantage in changing environments. Further, the basic notion that what is near-random at one level may be almost entirely predictable at a higher level is an emergent property of many systems, from particle physics to the social sciences. These considerations suggest that epidemiological approaches will remain fruitful as we enter the decade of the epigenome.

  8. Results of a prospective randomized controlled trial of early ambulation for patients with lower extremity autografts.

    Science.gov (United States)

    Lorello, David John; Peck, Michael; Albrecht, Marlene; Richey, Karen J; Pressman, Melissa A

    2014-01-01

    It is common practice to keep those patients with lower extremity autografts immobile until post-operative day (POD) 5. There is however inherent risks associated with even short periods of immobility. As of now there are no randomized controlled trials looking at early ambulation of patients with lower extremity autografts in the burn community.The objective of this study was to show that patients who begin ambulation within 24 hours of lower extremity autografting will have no increased risk of graft failure than those patients who remain immobile until POD 5. Thirty-one subjects who received autografts to the lower extremity were randomized after surgery into either the early ambulation group (EAG;17 subjects) or the standard treatment group (STG;14 subjects). Those subjects randomized to the EAG began ambulating with physical therapy on POD 1. Subjects in the STG maintained bed rest until POD 5. There was no difference in the number of patients with graft loss in either the EAG or STG on POD 5, and during any of the follow-up visits. No subjects required regrafting. There was a significant difference in the mean minutes of ambulation, with the EAG ambulating longer than the STG (EAG 23.4 minutes [SD 12.03], STG 14.1 [SD 9.00], P=.0235) on POD 5. Burn patients with lower extremity autografts can safely ambulate on POD 1 without fear of graft failure compared with those patients that remain on bed rest for 5 days.

  9. Impact of more intensive written information in patients having radical radiation therapy: Results of a prospective randomized phase III trial

    International Nuclear Information System (INIS)

    Zissiadis, Yvonne; Harper, Emily; Kearney, Elizabeth

    2010-01-01

    Background and purpose: A diagnosis of malignancy and its treatment is a very stressful time for patients and their families. This study was conducted to determine the impact of more intensive written information on patients' anxiety levels. The secondary aim was to determine the impact of this information on patients' satisfaction levels. Materials and methods: This prospective randomized trial consisted of patients with a pathological diagnosis of cancer having radical radiotherapy (RT). Patients were randomized to receive the more intensive information (including written information and a telephone call from the research nurse) or not to receive the more intensive information at the time of their initial consultation with the radiation oncologist. Study questionnaires measuring anxiety (STAI form) were completed prior to their first consultation (baseline) at the time of simulation (pre-RT) and at the completion of radiotherapy. A second questionnaire assessing satisfaction with the information given (ISQ) was completed at the time of simulation prior to commencing RT. Results: One hundred and ninety-four patients were enrolled in the study. The mean age of the patients was 58.5 years and 70% of patients were female. Breast cancer (67%) was the commonest cancer. One hundred and two patients were randomized to receive the intensive information package and 92 patients received the standard consultation. There was no significant difference in mean State or Trait anxiety scores between any of the time intervals and no difference between the two information groups. There was no significant difference between the groups with regard to mean satisfaction scores with the overall information given, nor with any individual question. The satisfaction scores with lifestyle information given were lower than those for any other type of information in both randomization arms. Conclusion: More intensive information did not significantly change patients' anxiety scores or

  10. Strength and Functional Improvement Using Pneumatic Brace with Extension Assist for End-Stage Knee Osteoarthritis: A Prospective, Randomized trial.

    Science.gov (United States)

    Cherian, Jeffrey J; Bhave, Anil; Kapadia, Bhaveen H; Starr, Roland; McElroy, Mark J; Mont, Michael A

    2015-05-01

    Pneumatic unloader bracing with extension assists have been proposed as a non-operative modality that may delay the need for knee surgery by reducing pain and improving function. This prospective, randomized trial evaluated 52 patients who had knee osteoarthritis for changes in: (1) muscle strength; (2) objective functional improvements; (3); subjective functional improvements; (4) pain; (5) quality of life; and (6) conversion to total knee arthroplasty (TKA) compared to standard of care. Patient outcomes were evaluated at a minimum 3 months. Braced patient's demonstrated significant improvements in muscle strength, several functional tests, and patient reported outcomes when compared to the matched cohort. These results are encouraging and suggest that this device may represent a promising alternative to standard treatment methods for knee osteoarthritis. Copyright © 2014 Elsevier Inc. All rights reserved.

  11. Continuous vs. blocks of physiotherapy for motor development in children with cerebral palsy and similar syndromes: A prospective randomized study.

    Science.gov (United States)

    Brunner, Anne-Louise; Rutz, Erich; Juenemann, Stephanie; Brunner, Reinald

    2014-12-01

    To determine whether physiotherapy is more effective when applied in blocks or continuously in children with cerebral palsy (CP). A prospective randomized cross-over design study compared the effect of regular physiotherapy (baseline) with blocks of physiotherapy alternating with no physiotherapy over one year. Thirty-nine institutionalized children with CP and clinically similar syndromes (6-16 years old, Gross Motor Function Classification Scale II-IV) were included. During the first scholastic year, group A received regular physiotherapy, group B blocks of physiotherapy and vice versa in the second year. The Gross Motor Function Measure 66 (GMFM-66) was the outcome measure. Thirteen children in each group completed the study. GMFM-66 improved (p Physiotherapy may be more effective when provided regularly rather than in blocks.

  12. Is Electrocautery of Patella Useful in Patella Non-Resurfacing Total Knee Arthroplasty?: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Kwon, Sae Kwang; Nguku, Levis; Han, Chang Dong; Koh, Yong-Gon; Kim, Dong-Wook; Park, Kwan Kyu

    2015-12-01

    There is controversy over the need for electrocauterization of the patella in non-resurfacing total knee arthroplasty (TKA). We investigated whether this procedure is beneficial through a prospective randomized controlled trial. Fifty patients who underwent electrocautery were compared with 50 patients who did not undergo this procedure. We determined cartilage status, preoperative and postoperative American Knee Society (AKS) score, the Western Ontario and McMaster Universities score (WOMAC) and the Patellofemoral (PF) scores for a minimum of 5 years. The two groups did not differ significantly in demographics, intraoperative cartilage status, or preoperative or postoperative outcomes. No complications were detected in either group. We found no benefits of electrocautery of the patella in patellar non-resurfacing TKA up to 5 years. Copyright © 2015 Elsevier Inc. All rights reserved.

  13. What Is the Outcome of an Incision and Drainage Procedure in Endodontic Patients? A Prospective, Randomized, Single-blind Study.

    Science.gov (United States)

    Beus, Hannah; Fowler, Sara; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike; Jatana, Courtney

    2018-02-01

    There are no prospective endodontic studies to determine the outcome of an incision and drainage (I&D) procedure for swelling in healthy, endodontic patients. The purpose of this prospective, randomized, single-blind study was to compare the postoperative course of I&D with drain placement versus a mock I&D procedure with mock drain placement after endodontic debridement in swollen emergency patients with symptomatic teeth and a pulpal diagnosis of necrosis. Eighty-one adult emergency patients presenting with clinical swelling received either penicillin or, if allergic, clindamycin and complete endodontic debridement, and then were randomly divided into 2 treatment groups: I&D with drain placement or a mock I&D procedure with mock drain placement. At the end of the appointment, all patients received a combination of ibuprofen/acetaminophen and, if needed, an opioid-containing escape medication. Patients recorded their pain and medication use for 4 days postoperatively. Success was defined as no or mild postoperative pain and no use of an opioid-containing escape medication. Success was evaluated using repeated measure mixed model logistic regression. Both groups had a decrease in postoperative pain and medication use over the 4 days. The mock I&D group had significantly higher success than the I&D group (odds ratio = 2.00; 95% confidence interval, 1.16-3.41). The success rate was 45% with the mock I&D and 33% with the I&D. After endodontic debridement, patients who received a mock I&D procedure with mock drain placement had more success than patients who received I&D with drain placement. Both groups clinically improved over 4 days. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  14. A randomized, blinded, prospective clinical trial of postoperative rehabilitation in dogs after surgical decompression of acute thoracolumbar intervertebral disc herniation.

    Science.gov (United States)

    Zidan, Natalia; Sims, Cory; Fenn, Joe; Williams, Kim; Griffith, Emily; Early, Peter J; Mariani, Chris L; Munana, Karen R; Guevar, Julien; Olby, Natasha J

    2018-05-01

    Experimental evidence shows benefit of rehabilitation after spinal cord injury (SCI) but there are limited objective data on the effect of rehabilitation on recovery of dogs after surgery for acute thoracolumbar intervertebral disc herniations (TL-IVDH). Compare the effect of basic and intensive post-operative rehabilitation programs on recovery of locomotion in dogs with acute TL-IVDH in a randomized, blinded, prospective clinical trial. Thirty non-ambulatory paraparetic or paraplegic (with pain perception) dogs after decompressive surgery for TL-IVDH. Blinded, prospective clinical trial. Dogs were randomized (1:1) to a basic or intensive 14-day in-house rehabilitation protocol. Fourteen-day open field gait score (OFS) and coordination (regulatory index, RI) were primary outcomes. Secondary measures of gait, post-operative pain, and weight were compared at 14 and 42 days. Of 50 dogs assessed, 32 met inclusion criteria and 30 completed the protocol. There were no adverse events associated with rehabilitation. Median time to walking was 7.5 (2 - 37) days. Mean change in OFS by day 14 was 6.13 (confidence intervals: 4.88, 7.39, basic) versus 5.73 (4.94, 6.53, intensive) representing a treatment effect of -0.4 (-1.82, 1.02) which was not significant, P=.57. RI on day 14 was 55.13 (36.88, 73.38, basic) versus 51.65 (30.98, 72.33, intensive), a non-significant treatment effect of -3.47 (-29.81, 22.87), P = .79. There were no differences in secondary outcomes between groups. Early postoperative rehabilitation after surgery for TL-IVDH is safe but doesn't improve rate or level of recovery in dogs with incomplete SCI. Copyright © 2018 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  15. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

    International Nuclear Information System (INIS)

    Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing; Lee, J. Jack; Heymach, John V.; Swisher, Stephen G.; Welsh, James W.; Zhang, Jianjun; Lin, Steven H.; Gomez, Daniel R.

    2017-01-01

    Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

  16. The effect of tourniquet use on fixation quality in cemented total knee arthroplasty a prospective randomized clinical controlled RSA trial.

    Science.gov (United States)

    Molt, Mats; Harsten, Andreas; Toksvig-Larsen, Sören

    2014-03-01

    A concern that arises with any change in technique is whether it affects the long-term implant stability. The objective of this study was to evaluate the early migration, measured by radiostereometric analysis (RSA), and the functional outcome of the Triathlon™ cemented knee prosthesis, operated on with or without a tourniquet. During the last decades RSA has emerged as a way to assess prosthetic fixation and long time prognosis. The method has been used extensively in both hip and knee arthroplasty. This was a single centre prospective study including 60 patients randomized into two groups operated on either with or without tourniquet. RSA investigation was done within 2-3 days postoperatively after full weight bearing, and then at 3 months, 1 year and 2 years postoperatively. There were no differences between the groups regarding the translation along or rotation around the three coordinal axes, or in maximum total point motion (MTPM). At 2 years the mean MTPM (SD) was 0.71 mm (0.64) for the tourniquet-group and 0.53 mm (0.21) for the non-tourniquet-group. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability whether operated on with or without tourniquet. Level I. Article focus: A safety study for total knee replacement operated on with or without perioperative tourniquet regarding the prosthetic fixation. Strengths and limitations: Strength of this study is that it is a randomized prospective trial using an objective measuring tool. The sample size of 25-30 patients is reportedly sufficient for the screening of implants using RSA (1-3). Clinical trials NCT01604382, Ethics Committee approval D-nr: 144/20085. © 2013.

  17. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

    Energy Technology Data Exchange (ETDEWEB)

    Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lee, J. Jack [Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Heymach, John V. [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Swisher, Stephen G. [Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Welsh, James W. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Zhang, Jianjun [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lin, Steven H. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Gomez, Daniel R., E-mail: dgomez@mdanderson.org [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)

    2017-03-15

    Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

  18. Effects of epidural lidocaine analgesia on labor and delivery: A randomized, prospective, controlled trial

    Directory of Open Access Journals (Sweden)

    Nafisi Shahram

    2006-12-01

    Full Text Available Abstract Background Whether epidural analgesia for labor prolongs the active-first and second labor stages and increases the risk of vacuum-assisted delivery is a controversial topic. Our study was conducted to answer the question: does lumbar epidural analgesia with lidocaine affect the progress of labor in our obstetric population? Method 395 healthy, nulliparous women, at term, presented in spontaneous labor with a singleton vertex presentation. These patients were randomized to receive analgesia either, epidural with bolus doses of 1% lidocaine or intravenous, with meperidine 25 to 50 mg when their cervix was dilated to 4 centimeters. The duration of the active-first and second stages of labor and the neonatal apgar scores were recorded, in each patient. The total number of vacuum-assisted and cesarean deliveries were also measured. Results 197 women were randomized to the epidural group. 198 women were randomized to the single-dose intravenous meperidine group. There was no statistical difference in rates of vacuum-assisted delivery rate. Cesarean deliveries, as a consequence of fetal bradycardia or dystocia, did not differ significantly between the groups. Differences in the duration of the active-first and the second stages of labor were not statistically significant. The number of newborns with 1-min and 5-min Apgar scores less than 7, did not differ significantly between both analgesia groups. Conclusion Epidural analgesia with 1% lidocaine does not prolong the active-first and second stages of labor and does not increase vacuum-assisted or cesarean delivery rate.

  19. 2D vs. 3D imaging in laparoscopic surgery-results of a prospective randomized trial.

    Science.gov (United States)

    Buia, Alexander; Stockhausen, Florian; Filmann, Natalie; Hanisch, Ernst

    2017-12-01

    3D imaging is an upcoming technology in laparoscopic surgery, and recent studies have shown that the modern 3D technique is superior in an experimental setting. However, the first randomized controlled clinical trial in this context dates back to 1998 and showed no significant difference between 2D and 3D visualization using the first 3D generation technique, which is now more than 15 years old. Positive results measured in an experimental setting considering 3D imaging on surgical performance led us to initiate a randomized controlled pragmatic clinical trial to validate our findings in daily clinical routine. Standard laparoscopic operations (cholecystectomy, appendectomy) were preoperatively randomized to a 2D or 3D imaging system. We used a surgical comfort scale (Likert scale) and the Raw NASA Workload TLX for the subjective assessment of 2D and 3D imaging; the duration of surgery was also measured. The results of 3D imaging were statistically significant better than 2D imaging concerning the parameters "own felt safety" and "task efficiency"; the difficulty level of the procedures in the 2D and 3D groups did not differ. Overall, the Raw NASA Workload TLX showed no significance between the groups. 3D imaging could be a possible advantage in laparoscopic surgery. The results of our clinical trial show increased personal felt safety and efficiency of the surgeon using a 3D imaging system. Overall of the procedures, the findings assessed using Likert scales in terms of own felt safety and task efficiency were statistically significant for 3D imaging. The individually perceived workload assessed with the Raw NASA TLX shows no difference. Although these findings are subjective impressions of the performing surgeons without a clear benefit for 3D technology in clinical outcome, we think that these results show the capability that 3D laparoscopy can have a positive impact while performing laparoscopic procedures.

  20. rhBMP-2 for posterolateral instrumented lumbar fusion: a multicenter prospective randomized controlled trial.

    Science.gov (United States)

    Hurlbert, R John; Alexander, David; Bailey, Stewart; Mahood, James; Abraham, Ed; McBroom, Robert; Jodoin, Alain; Fisher, Charles

    2013-12-01

    Multicenter randomized controlled trial. To evaluate the effect of recombinant human bone morphogenetic protein (rhBMP-2) on radiographical fusion rate and clinical outcome for surgical lumbar arthrodesis compared with iliac crest autograft. In many types of spinal surgery, radiographical fusion is a primary outcome equally important to clinical improvement, ensuring long-term stability and axial support. Biologic induction of bone growth has become a commonly used adjunct in obtaining this objective. We undertook this study to objectify the efficacy of rhBMP-2 compared with traditional iliac crest autograft in instrumented posterolateral lumbar fusion. Patients undergoing 1- or 2-level instrumented posterolateral lumbar fusion were randomized to receive either autograft or rhBMP-2 for their fusion construct. Clinical and radiographical outcome measures were followed for 2 to 4 years postoperatively. One hundred ninety seven patients were successfully randomized among the 8 participating institutions. Adverse events attributable to the study drug were not significantly different compared with controls. However, the control group experienced significantly more graft-site complications as might be expected. 36-Item Short Form Health Survey, Oswestry Disability Index, and leg/back pain scores were comparable between the 2 groups. After 4 years of follow-up, radiographical fusion rates remained significantly higher in patients treated with rhBMP-2 (94%) than those who received autograft (69%) (P = 0.007). The use of rhBMP-2 for instrumented posterolateral lumbar surgery significantly improves the chances of radiographical fusion compared with the use of autograft. However, there is no associated improvement in clinical outcome within a 4-year follow-up period. These results suggest that use of rhBMP-2 should be considered in cases where lumbar arthrodesis is of primary concern.

  1. Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial.

    Science.gov (United States)

    Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A

    2016-12-01

    To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO 2 ), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. Sirolimus Associated with Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Kojima, Cristiane Akemi; Nga, Hong Si; Takase, Henrique Mochida; Bravin, Ariane Moyses; Martinez Garcia, Márcia de Fátima Faraldo; Garcia, Paula Dalsoglio; Contti, Mariana Moraes; de Andrade, Luis Gustavo Modelli

    2018-06-01

    There is no consensus on the best immunosuppressive regimen for elderly renal transplant recipients. The objective of this study was to assess cytomegalovirus infection incidence and kidney transplant outcomes in elderly recipients treated with mammalian target of rapamycin inhibitors sirolimus/ tacrolimus at low doses compared with those receiving tacrolimus/mycophenolate sodium. In this single-center prospective randomized study (Trial Registration No. NCT02683291), kidney transplant recipients over 60 years of age were randomly allocated into 2 groups: tacrolimus-sirolimus (21 patients) and tacrolimus-mycophenolate (23 patients). Cytomegalovirus infection rate and patient survival, biopsy-proven acute rejection, and renal function at 12 months were assessed. Cytomegalovirus infection rate was higher in the mycophenolate group (60.9%) than in the sirolimus group (16.7%; P = .004). The rates of biopsy-proven acute rejection, patient survival, graft survival, and estimated glomerular filtration rate over 12 months did not significantly differ between groups. The incidence of cytomegalovirus infection was significantly lower in the sirolimus group. The use of tacrolimus combined with sirolimus in elderly kidney transplant recipients is safe.

  3. Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial.

    Science.gov (United States)

    Ishibashi, Keiichiro; Ishida, Hideyuki; Kuwabara, Kouki; Ohsawa, Tomonori; Okada, Norimichi; Yokoyama, Masaru; Kumamoto, Kensuke

    2014-04-01

    To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery. A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7% in group 1 and 13.6% in group 2 (difference [95% confidence interval]: -0.2% [-0.9 to 0.7%]). The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.

  4. Pharmacological strategies to reduce pruritus during postoperative epidural analgesia after lumbar fusion surgery - a prospective randomized trial in 150 patients

    Directory of Open Access Journals (Sweden)

    Robinson Yohan

    2011-05-01

    Full Text Available Abstract Background Epidural analgesia with bupivacain, epinephrine and fentanyl provides excellent pain control after lumbar fusion surgery, but pruritus and motor block are frequent side effects. Theoretically epidural ropivacain combined with oral oxycodone could decrease the incidence of these side effects. The two regimens were compared in a prospective randomized trial. Patients and methods 150 patients (87 women treated with posterior instrumented lumbar fusion were included. The mean age was 51 +/- 11 years. 76 were randomized to bupivacain, epinephrine and fentanyl (group B and 74 to ropivacain and oxycodone (group R. Pruritus, motor block and pain were measured 6 hours after surgery, thereafter 6 times per day for 5 days. Any pain breakthrough episode was registered whenever it occurred. Results The epidural treatment could be performed in 143 patients (72 in group B and 71 in group R. Disturbing pruritus occurred in 53 patients in group B compared to 12 in group R (p Conclusions Pruritus could be reduced with a combination of epidural ropivacain and oral oxycodone, at the price of a slightly higher pain level. Ropivacaine was not found to be superior to bupivacaine with regard to motor blocks.

  5. Stenting or not prior to extracorporeal shockwave lithotripsy for ureteral stones? Results of a prospective randomized study.

    Science.gov (United States)

    Sfoungaristos, Stavros; Polimeros, Nikolaos; Kavouras, Adamantios; Perimenis, Petros

    2012-06-01

    To determine the need for pre-treatment stenting in patients undergoing extracorporeal shockwave lithotripsy (ESWL) for ureteral stones sized 4-10 mm. A prospective randomized study was conducted between September 2009 and March 2011. Included 156 patients randomized in stented and non-stented groups and underwent a maximum of 3 ESWL sessions. Radiographic follow-up was used to assess the stone fragmentation and clearance. Results were compared in terms of stone-free rates, post-treatment morbidity and complications. Overall efficacy was 76.9%. Stone-free rates were statistically significantly lower (P = 0.026) in the stented group (68.6%) compared to the non-stented ones (83.7%). Furthermore, stenting was significantly correlated with post-treatment lower urinary tract symptoms (P ≤ 0.001), need for more ESWL sessions (P = 0.019) and possibility for operation due to ESWL failure (P = 0.026). A multivariate analysis was conducted to identify the parameters which may predict complete stone removal after ESWL. Stone size (P = 0.026), stone location (P = 0.011) and stenting (P = 0.007) were the most significant factors. ESWL is an efficient and safe treatment for 4- to 10-mm ureteral stones. Pre-treatment stenting is limiting stone-free rates and is significantly influencing post-ESWL morbidity and quality of life in a negative manner, while it contributes minimally to the prophylaxis of complications.

  6. Procalcitonin guided antibiotic therapy and hospitalization in patients with lower respiratory tract infections: a prospective, multicenter, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Henzen Christoph

    2007-07-01

    Full Text Available Abstract Background: Lower respiratory tract infections like acute bronchitis, exacerbated chronic obstructive pulmonary disease and community-acquired pneumonia are often unnecessarily treated with antibiotics, mainly because of physicians' difficulties to distinguish viral from bacterial cause and to estimate disease-severity. The goal of this trial is to compare medical outcomes, use of antibiotics and hospital resources in a strategy based on enforced evidence-based guidelines versus procalcitonin guided antibiotic therapy in patients with lower respiratory tract infections. Methods and design: We describe a prospective randomized controlled non-inferiority trial with an open intervention. We aim to randomize over a fixed recruitment period of 18 months a minimal number of 1002 patients from 6 hospitals in Switzerland. Patients must be >18 years of age with a lower respiratory tract infections Discussion: Use of and prolonged exposure to antibiotics in lower respiratory tract infections is high. The proposed trial investigates whether procalcitonin-guidance may safely reduce antibiotic consumption along with reductions in hospitalization costs and antibiotic resistance. It will additionally generate insights for improved prognostic assessment of patients with lower respiratory tract infections. Trial registration: ISRCTN95122877

  7. [Assessment of nociceptive suppression in laparoscopic postoperative status: prospective, randomized and comparative study with a control group].

    Science.gov (United States)

    Jaime, A; Hernández-Favela, P; Zamora, R; Nava, E; Barroso, G; Kably, A

    2001-08-01

    In recent years endoscopic surgery has became a highly demanded procedure because it is an easy method for diagnosis and treatment in gynecological field. Post-operative pain is considered as a condition in the morbidity status. The objective of this study was to evaluate the nociceptive suppression in laparoscopic surgery. A prospective randomized trial was performed in order to evaluate this condition. A total of 45 patients were included. Three groups were randomized using two different anesthetics applied in the cult-de-sac and uterine-bladder union. Group A (n-15) received bupivacaine, group B (n = 15) ropivacaine and group C (control) saline solution was instilled. The pain was scored using the visual analog scale as same as blood pressure and heart rate in a 15 minute intervals in the recovery room. For study design there were no differences in age, weight, height and body mass index (EMI). The surgical and anesthetic times were similar among groups. However there were significant differences when pain was evaluated. For a less toxic effects and good preventive analgesia we recommend to use ropivacaine in the postoperative status.

  8. Treatment for premenstrual syndrome with Vitex agnus castus: A prospective, randomized, multi-center placebo controlled study in China.

    Science.gov (United States)

    He, Zhong; Chen, Rong; Zhou, Yingfang; Geng, Li; Zhang, Zhenyu; Chen, Shuling; Yao, Yanjun; Lu, Junli; Lin, Shouqing

    2009-05-20

    To investigate the efficacy and safety of VAC BNO 1095 extract in Chinese women suffering from moderate to severe premenstrual syndrome (PMS). Prospective, double-blind, placebo controlled, parallel-group, multi-center clinical trial design was employed. After screening and preparation phase lasting three cycles, Eligible patients were randomly assigned into treatment or placebo groups and had treatment with VAC extract or placebo for up to three cycles. Efficacy was assessed using the Chinese version PMS-diary (PMSD) and PMTS. Two hundred and seventeen women were eligible to enter the treatment phase (TP) and were randomly assigned into the treatment group (108) or the placebo group (109), 208 provided the efficacy data (treatment 104, placebo 104), and 202 completed the treatment phase (treatment 101, placebo 101). The mean total PMSD score decreased from 29.23 at baseline (0 cycle) to 6.41 at the termination (3rd cycle) for the treatment group and from 28.14 at baseline (0 cycle) to 12.64 at the termination (3rd cycle) for the placebo group. The total PMSD score of 3rd cycle was significantly lower than the baseline in both groups (pVitex agnus castus (VAC BNO 1095 corresponding to 40mg herbal drug) is a safe, well tolerated and effective drug of the treatment for Chinese women with the moderate to severe PMS.

  9. Brief report: pulmonary auscultation in the operating room: a prospective randomized blinded trial comparing electronic and conventional stethoscopes.

    Science.gov (United States)

    Hoffmann, Clement; Falzone, Elisabeth; Verret, Catherine; Pasquier, Pierre; Leclerc, Thomas; Donat, Nicolas; Jost, Daniel; Mérat, Stephane; Maurice, Guillaume de Saint; Lenoir, Bernard; Auroy, Yves; Tourtier, Jean-Pierre

    2013-09-01

    We compared the subjective quality of pulmonary auscultation between 2 acoustic stethoscopes (Holtex Ideal® and Littmann Cardiology III®) and an electronic stethoscope (Littmann 3200®) in the operating room. A prospective double-blind randomized study with an evaluation during mechanical ventilation was performed in 100 patients. After each examination, the listeners using a numeric scale (0-10) rated the quality of auscultation. Auscultation quality was compared in patients among stethoscopes with a multilevel mixed-effects linear regression with random intercept (operator effect), adjusted on significant factors in univariate analysis. A significant difference was defined as P auscultation were performed. The quality of auscultation was rated 8.2 ± 1.6 for the electronic stethoscope, 7.4 ± 1.8 for the Littmann Cardiology III, and 4.6 ± 1.8 for the Holtex Ideal. Compared with Holtex Ideal, auscultation quality was significantly higher with other stethoscopes (P auscultation quality was significantly higher with Littmann 3200 electronic stethoscope (β = 0.9 [95% confidence interval, 0.5-1.3]). An electronic stethoscope can provide a better quality of pulmonary auscultation than acoustic stethoscopes in the operating room, yet with a magnitude of improvement marginally higher than that provided with a high performance acoustic stethoscope. Whether this can translate into a clinically relevant benefit requires further studies.

  10. Effectiveness of Topical Sucralfate in the Management of Pressure Ulcer in Hospitalized Patients: A Prospective, Randomized, Placebo-Controlled Trial.

    Science.gov (United States)

    Ala, Shahram; Saeedi, Majid; Gholipour, Afshin; Ahmadi, Motahareh; Asoodeh, Ali; Shiva, Afshin

    2018-04-10

    The aim of this study was to evaluate the effectiveness of topical sucralfate in the management of pressure ulcer (PU) in hospitalized patients. Forty hospitalized patients with stage II PU were included in this prospective, double-blind, randomized, placebo-controlled trial and were randomly divided into 2 groups receiving either sucralfate gel or placebo, on a daily basis. The patients were visited every day for 14 days, the ulcer was evaluated using the Pressure Ulcer Scale for Healing (PUSH) and changes to the measured scores over time were used as an indicator of wound healing. There were no statistically significant differences in any of the demographic characteristics between both groups. Both of the interventions reduced the average PUSH score, and at the end of the trial, all but 2 patients were healed. One in each group discontinued the trial because of exacerbation of the ulcer. No significant between-group difference in the average PUSH score reduction was observed (6.36 ± 2.11 vs. 5.89 ± 1.41, P = 0.42). Although the average healing time was less in the sucralfate group (6.05 ± 2.17 vs. 7.78 ± 3.42), the difference was not statistically significant (P = 0.07). Sucralfate gel does not improve healing of PU compared with placebo.

  11. A Prospective, Randomized Trial in the Emergency Department of Suggestive Audio-Therapy under Deep Sedation for Smoking Cessation.

    Science.gov (United States)

    Rodriguez, Robert M; Taylor, Opal; Shah, Sushma; Urstein, Susan

    2007-08-01

    In a sample of patients undergoing procedural deep sedation in the emergency department (ED), we conducted a prospective, randomized, single-blinded trial of audio-therapy for smoking cessation. We asked subjects about their smoking, including desire to quit (0-10 numerical scale) and number of cigarettes smoked per day. Subjects were randomized to either a control tape (music alone) or a tape with repeated smoking-cessation messages over music. Tapes were started with first doses of sedation and stopped with patient arousal. Telephone follow-up occurred between two weeks and three months to assess the number of cigarettes smoked per day. Study endpoints were self-reported complete cessation and decrease of half or more in total cigarettes smoked per day. One hundred eleven patients were enrolled in the study, 54 to intervention and 57 to control. Mean desire to quit was 7.15 +/- 2.6 and mean cigarettes per day was 17.5 +/- 12.1. We successfully contacted 69 (62%) patients. Twenty-seven percent of intervention and 26% of control patients quit (mean difference = 1%; 95% CI: -22.0% to 18.8%). Thirty-seven percent of intervention and 51% of control patients decreased smoking by half or more (mean difference = 14.6%; 95% CI: -8.7% to 35.6%). Suggestive audio-therapy delivered during deep sedation in the ED did not significantly decrease self-reported smoking behavior.

  12. Postoperative pain after foraminal enlargement in anterior teeth with necrosis and apical periodontitis: a prospective and randomized clinical trial.

    Science.gov (United States)

    Silva, Emmanuel João Nogueira Leal; Menaged, Karyne; Ajuz, Natasha; Monteiro, Maria Rachel Figueiredo Penalva; Coutinho-Filho, Tauby de Souza

    2013-02-01

    The aim of this randomized, controlled, prospective clinical study was to determine if foraminal enlargement instrumentation during endodontic treatment is associated with more postoperative pain compared with standard nonenlargement instrumentation. Forty volunteers with a single root canal were diagnosed with asymptomatic necrosis with apical periodontitis and randomized into 2 experimental groups (ie, the control group and the foraminal enlargement group). Endodontic treatment was performed in a single visit, and volunteers were instructed to record pain intensity (ie, none, slight, moderate, and severe). Scores from 1 to 4 were attributed to each kind of pain after 12, 24, and 48 hours. The Kolmogorov-Smirnov and Student's t tests were used to determine significant differences at P .05, Student's t test). Postoperative pain showed no statistically significant difference between the groups at any observation period (P > .05). Also, no significant difference was observed in the mean number of analgesic tablets used between the groups (P > .05). The foraminal enlargement and nonenlargement techniques resulted in the same postoperative pain and necessity for analgesic medication. This may suggest that the use of foraminal enlargement should be performed for endodontic treatment previsibility without increasing postoperative pain. Copyright © 2013 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  13. Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Etén-Bergqvist, Christina; Persson, Jan

    2011-07-01

    The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

  14. Peyton’s four-step approach for teaching complex spinal manipulation techniques – a prospective randomized trial

    Directory of Open Access Journals (Sweden)

    Gertraud Gradl-Dietsch

    2016-11-01

    Full Text Available Abstract Background The objectives of this prospective randomized trial were to assess the impact of Peyton’s four-step approach on the acquisition of complex psychomotor skills and to examine the influence of gender on learning outcomes. Methods We randomly assigned 95 third to fifth year medical students to an intervention group which received instructions according to Peyton (PG or a control group, which received conventional teaching (CG. Both groups attended four sessions on the principles of manual therapy and specific manipulative and diagnostic techniques for the spine. We assessed differences in theoretical knowledge (multiple choice (MC exam and practical skills (Objective Structured Practical Examination (OSPE with respect to type of intervention and gender. Participants took a second OSPE 6 months after completion of the course. Results There were no differences between groups with respect to the MC exam. Students in the PG group scored significantly higher in the OSPE. Gender had no additional impact. Results of the second OSPE showed a significant decline in competency regardless of gender and type of intervention. Conclusions Peyton’s approach is superior to standard instruction for teaching complex spinal manipulation skills regardless of gender. Skills retention was equally low for both techniques.

  15. PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study

    Directory of Open Access Journals (Sweden)

    Debasis Banerjee

    2014-01-01

    Full Text Available Background: postoperative nausea and vomiting (PONV frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62 receiving (IV Ondansetron (4 mg] and Group B [(n=62 receiving IV Ramosetron (0.3 mg] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6 , 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P <0.05 was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity. Conclusion: it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg has better efficacy than single dose IV Ondansetron (4 mg in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia.

  16. Sleep quality in patients with xerostomia: a prospective and randomized case-control study.

    Science.gov (United States)

    Lopez-Jornet, Pia; Lucero Berdugo, Maira; Fernandez-Pujante, Alba; C, Castillo Felipe; Lavella C, Zamora; A, Pons-Fuster; J, Silvestre Rangil; Silvestre, Francisco Javier

    2016-01-01

    Objectives To investigate sleep quality, anxiety/depression and quality-of-life in patients with xerostomia. Materials and methods This prospective, observational, cross-sectional study was conducted among a group of xerostomia patients (n = 30) compared with 30 matched control subjects. The following evaluation scales were used to assess the psychological profile of each patient: the Hospital Anxiety and Depression Scale, the Oral Health Impact Profile-14 (OHIP-14), the Xerostomia Inventory, the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS). Results The PSQI obtained 5.3 3 ± 1.78 for patients with xerostomia compared with 4.26 ± 1.01 for control subjects (p = 0.006); ESS obtained 5.7 ± 2.1 for test patients vs 4.4 0 ± 1 for control subjects (p = 0.010). Statistical regression analysis showed that xerostomia was significantly associated with depression (p = 0.027). Conclusions Patients with xerostomia exhibited significant decreases in sleep quality compared with control subjects.

  17. Treating major depression with yoga: A prospective, randomized, controlled pilot trial.

    Directory of Open Access Journals (Sweden)

    Sudha Prathikanti

    Full Text Available Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression.Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI. At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22-72, and mean BDI score 22.4 (SD = 4.5. Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES and Rosenberg Self-Esteem Scale (RSES at baseline and at 8 weeks.In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034. In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018. Effect size of yoga in reducing BDI scores was large, per Cohen's d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for either the GSES or

  18. Treatment of varicocele: a prospective randomized comparison of laparoscopy versus antegrade sclerotherapy.

    Science.gov (United States)

    Sautter, T; Sulser, T; Suter, St; Gretener, H; Hauri, D

    2002-04-01

    To compare the therapeutic success, the morbidity and the costs of antegrade sclerotherapy versus laparoscopic varicocelectomy. Seventy-six consecutive varicocele patients were randomly assigned to two treatment arms. Preoperative and 3 month postoperative sperm density, motility and morphology were analysed. The diagnosis of the varicocele was established clinically and with Doppler ultrasonography. Fifty-eight patients treated by either of the two methods were followed up. The recurrence rate increased progressively with the size of the varicocele in both groups. The postoperative incidence of complications particularly hydrocele formation was significantly higher in the laparoscopic group. The costs of the disposable material for laparoscopic varicocelectomy was twice as high as for sclerotherapy. Antegrade sclerotherapy is the less invasive treatment method of male varicocele with lower costs and better outcome and should therefore be the preferred treatment method for male varicocele.

  19. A prospective randomized study of the effectiveness of aromatherapy for relief of postoperative nausea and vomiting.

    Science.gov (United States)

    Hodge, Nancy S; McCarthy, Mary S; Pierce, Roslyn M

    2014-02-01

    Postoperative nausea and vomiting (PONV) is a major concern for patients having surgery under general anesthesia as it causes subjective distress along with increased complications and delays in discharge from the hospital. Aromatherapy represents a complementary and alternative therapy for the management of PONV. The objective of this study was to compare the effectiveness of aromatherapy (QueaseEase, Soothing Scents, Inc, Enterprise, AL) versus an unscented inhalant in relieving PONV. One hundred twenty-one patients with postoperative nausea were randomized into a treatment group receiving an aromatic inhaler and a control group receiving a placebo inhaler to evaluate the effectiveness of aromatherapy. Initial and follow-up nausea assessment scores in both treatment and placebo groups decreased significantly (P aromatherapy was significantly higher in the treatment group (P Aromatherapy was favorably received by most patients and represents an effective treatment option for postoperative nausea. Published by Elsevier Inc.

  20. Microlaparoscopic vs conventional laparoscopic cholecystectomy: a prospective randomized double-blind trial

    DEFF Research Database (Denmark)

    Bisgaard, T; Klarskov, B; Trap, R

    2002-01-01

    cholecystectomy using two 10-mm and two 5-mm trocars (LC). Incisional pain at each port incision and overall pain were recorded for 1 week after the operation. Fatigue, nausea and vomiting, pulmonary function, and cosmetic results were also measured. RESULTS: Data from 52 patients were analyzed; eight patients......BACKGROUND: Downsizing the port incisions may reduce pain after laparoscopic cholecystectomy. METHODS: In a double-blind controlled study, 60 patients were randomized to undergo either microlaparoscopic cholecystectomy using one 10-mm and three 3.5-mm trocars (3.5-mm LC) or traditional laparoscopic.......01). In both groups, pain scores at the supraumbilical 10-mm port were significantly higher compared with other port sites (p

  1. Duration of antimicrobial prophylaxis in patients undergoing hepatectomy: a prospective randomized controlled trial using flomoxef.

    Science.gov (United States)

    Togo, Shinji; Tanaka, Kuniya; Matsuo, Kenichi; Nagano, Yasuhiko; Ueda, Michio; Morioka, Daisuke; Endo, Itaru; Shimada, Hiroshi

    2007-05-01

    Although the usefulness of antimicrobial prophylaxis for clean-contaminated surgery has been recognized, only a few randomized controlled studies on the duration of administration after hepatectomy have been performed. We investigated the duration of antimicrobial prophylaxis after hepatectomy. The subjects were 180 patients who underwent hepatectomy without reconstruction of the biliary or intestinal tract between April 2003 and March 2006 at our department. The patients were randomly allocated to groups to be treated with flomoxef sodium as antimicrobial prophylaxis for 2 days (89 patients) or 5 days (91 patients), including the operation day. The presence or absence of systemic inflammatory response syndrome (SIRS) and infections was investigated. No significant differences were noted in patient background between the two groups. Infections occurred in seven and six patients in the 2 day and 5 day treatment groups (7.9% and 6.6%), respectively, showing no significant difference between the two groups. No significant difference was noted when the cases were divided into surgical site infections and remote infections. The positive rate of SIRS was significantly higher in the 2 day treatment group than in the 5 day treatment group on days 2 and 3 after surgery. The risk factors in patients who developed infections were blood loss, operation time and the complication of biliary fistula. Two day administration of flomoxef sodium may be sufficient for antimicrobial prophylaxis after hepatectomy. However, when SIRS is positive on post-operative day 2, and induction of liver failure is of concern, it may be safer to continue antimicrobial drug administration until SIRS is eliminated.

  2. A prospective randomized trial of content expertise versus process expertise in small group teaching.

    Science.gov (United States)

    Peets, Adam D; Cooke, Lara; Wright, Bruce; Coderre, Sylvain; McLaughlin, Kevin

    2010-10-14

    Effective teaching requires an understanding of both what (content knowledge) and how (process knowledge) to teach. While previous studies involving medical students have compared preceptors with greater or lesser content knowledge, it is unclear whether process expertise can compensate for deficient content expertise. Therefore, the objective of our study was to compare the effect of preceptors with process expertise to those with content expertise on medical students' learning outcomes in a structured small group environment. One hundred and fifty-one first year medical students were randomized to 11 groups for the small group component of the Cardiovascular-Respiratory course at the University of Calgary. Each group was then block randomized to one of three streams for the entire course: tutoring exclusively by physicians with content expertise (n = 5), tutoring exclusively by physicians with process expertise (n = 3), and tutoring by content experts for 11 sessions and process experts for 10 sessions (n = 3). After each of the 21 small group sessions, students evaluated their preceptors' teaching with a standardized instrument. Students' knowledge acquisition was assessed by an end-of-course multiple choice (EOC-MCQ) examination. Students rated the process experts significantly higher on each of the instrument's 15 items, including the overall rating. Students' mean score (±SD) on the EOC-MCQ exam was 76.1% (8.1) for groups taught by content experts, 78.2% (7.8) for the combination group and 79.5% (9.2) for process expert groups (p = 0.11). By linear regression student performance was higher if they had been taught by process experts (regression coefficient 2.7 [0.1, 5.4], p teach first year medical students within a structured small group environment; preceptors with process expertise result in at least equivalent, if not superior, student outcomes in this setting.

  3. Evaluation of the Achieve Mapping Catheter in cryoablation for atrial fibrillation: a prospective randomized trial.

    Science.gov (United States)

    Gang, Yi; Gonna, Hanney; Domenichini, Giulia; Sampson, Michael; Aryan, Niloufar; Norman, Mark; Behr, Elijah R; Zuberi, Zia; Dhillon, Paramdeep; Gallagher, Mark M

    2016-03-01

    The purpose of this study is to establish the role of Achieve Mapping Catheter in cryoablation for paroxysmal atrial fibrillation (PAF) in a randomized trial. A total of 102 patients undergoing their first ablation for PAF were randomized at 2:1 to an Achieve- or Lasso-guided procedure. Study patients were systematically followed up for 12 months with Holter monitoring. Primary study endpoint was acute procedure success. Secondary endpoint was clinical outcomes assessed by AF free at 6 and 12 months after the procedure. Of 102 participants, 99 % of acute procedure success was achieved. Significantly shorter procedure duration with the Achieve-guided group than with the Lasso-guided group (118 ± 18 vs. 129 ± 21 min, p < 0.05) was observed as was the duration of fluoroscopy (17 ± 5 vs. 20 ± 7 min, p < 0.05) by subgroup analysis focused on procedures performed by experienced operators. In the whole study patients, procedure and fluoroscopic durations were similar in the Achieve- (n = 68) and Lasso-guided groups (n = 34). Transient phrenic nerve weakening was equally prevalent with the Achieve and Lasso. No association was found between clinical outcomes and the mapping catheter used. The use of second-generation cryoballoon (n = 68) reduced procedure time significantly compared to the first-generation balloon (n = 34); more patients were free of AF in the former than the latter group during follow-up. The use of the Achieve Mapping Catheter can reduce procedure and fluoroscopic durations compared with Lasso catheters in cryoablation for PAF after operators gained sufficient experience. The type of mapping catheter used does not affect procedure efficiency and safety by models of cryoballoon.

  4. Transcriptome modulation by hydrocortisone in severe burn shock: ancillary analysis of a prospective randomized trial.

    Science.gov (United States)

    Plassais, Jonathan; Venet, Fabienne; Cazalis, Marie-Angélique; Le Quang, Diane; Pachot, Alexandre; Monneret, Guillaume; Tissot, Sylvie; Textoris, Julien

    2017-06-16

    Despite shortening vasopressor use in shock, hydrocortisone administration remains controversial, with potential harm to the immune system. Few studies have assessed the impact of hydrocortisone on the transcriptional response in shock, and we are lacking data on burn shock. Our objective was to assess the hydrocortisone-induced transcriptional modulation in severe burn shock, particularly modulation of the immune response. We collected whole blood samples during a randomized controlled trial assessing the efficacy of hydrocortisone administration in burn shock. Using whole genome microarrays, we first compared burn patients (n = 32) from the placebo group to healthy volunteers to describe the transcriptional modulation induced by burn shock over the first week. Then we compared burn patients randomized for either hydrocortisone administration or placebo, to assess hydrocortisone-induced modulation. Study groups were similar in terms of severity and major outcomes, but shock duration was significantly reduced in the hydrocortisone group. Many genes (n = 1687) were differentially expressed between burn patients and healthy volunteers, with 85% of them exhibiting a profound and persistent modulation over seven days. Interestingly, we showed that hydrocortisone enhanced the shock-associated repression of adaptive, but also innate immunity. We found that the initial host response to burn shock encompasses wide and persistent modulation of gene expression, with profound modulation of pathways associated with metabolism and immunity. Importantly, hydrocortisone administration may worsen the immunosuppression associated with severe injury. These data should be taken into account in the risk ratio of hydrocortisone administration in patients with inflammatory shock. ClinicalTrials.gov, NCT00149123 . Registered on 6 September 2005.

  5. Hyoscine butylbromide for colorectal polyp detection: prospective, randomized, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Carlos Eduardo Oliveira dos Santos

    Full Text Available OBJECTIVES: The removal of pre-malignant colorectal lesions prevents cancer. Hyoscine has been proposed as a means of improving diagnosis by reducing colonic movements. The aim of this study was to analyze whether this anti-spasmodic enhances the detection of pre-malignant colorectal lesions. METHODS: In a randomized, double-blinded fashion patients received hyoscine or a saline solution in all consecutive colonoscopies in which the cecum was reached. Lesions were analysed with respect to number, size, location, histology and capillary pattern. RESULTS: A total of 440 colonoscopies were randomized. The overall polyp detection rate (PDR and the adenoma detection rate (ADR were 65.2% and 49.3%, respectively. In the hyoscine group, non-polypoid lesions were detected significantly more often (p=0.01. In the placebo group 281 lesions were diagnosed (202 adenomas and in the hyoscine group 282 lesions were detected (189 adenomas (p=0.23. The PDR and ADR were similar between the placebo and hyoscine groups (64% vs 66% and 50% vs 47%, respectively. No differences were observed between the two groups in the advanced-ADR or advanced neoplasia detection rate, as well the mean numbers of polyps, adenomas, advanced adenomas and advanced neoplasias detected per patient. The administration of hyoscine also did not improve the diagnostic accuracy of digital chromoendoscopy. The presence of adenomatous polyps in the right colon was detected significantly more frequently in the hyoscine group (OR 5.41 95% CI 2.7 - 11; p<0.01 vs OR 2.3 95% CI 1.1 - 4.6; p=0.02. CONCLUSION: The use of hyoscine before beginning the withdrawal of the colonoscope does not seem to enhance the PDR and the ADR.

  6. Early Parenteral Nutrition in Patients with Biliopancreatic Mass Lesions, a Prospective, Randomized Intervention Trial.

    Directory of Open Access Journals (Sweden)

    Janine Krüger

    Full Text Available Patients with biliopancreatic tumors frequently suffer from weight loss and cachexia. The in-hospital work-up to differentiate between benign and malignant biliopancreatic lesions requires repeated pre-interventional fasting periods that can aggravate this problem. We conducted a randomized intervention study to test whether routine in-hospital peripheral intravenous nutrition on fasting days (1000 ml/24 h, 700 kcal has a beneficial effect on body weight and body composition.168 patients were screened and 100 enrolled in the trial, all undergoing in-hospital work-up for biliopancreatic mass lesions and randomized to either intravenous nutrition or control. Primary endpoint was weight loss at time of hospital discharge; secondary endpoints were parameters determined by bioelectric impedance analysis and quality of life recorded by the EORTC questionnaire.Within three months prior to hospital admission patients had a median self-reported loss of 4.0 kg (25*th: -10.0 kg and 75*th* percentile: 0.0kg of body weight. On a multivariate analysis nutritional intervention increased body weight by 1.7 kg (95% CI: 0.204; 3.210, p = 0.027, particularly in patients with malignant lesions (2.7 kg (95% CI: 0.71; 4.76, p < 0.01.In a hospital setting, patients with suspected biliopancreatic mass lesions stabilized their body weight when receiving parenteral nutrition in fasting periods even when no total parenteral nutrition was required. Analysis showed that this effect was greatest in patients with malignant tumors. Further studies will be necessary to see whether patient outcome is affected as well.ClinicalTrials.gov NCT02670265.

  7. Combined impact of negative lifestyle factors on cardiovascular risk in children: a randomized prospective study.

    Science.gov (United States)

    Meyer, Ursina; Schindler, Christian; Bloesch, Tamara; Schmocker, Eliane; Zahner, Lukas; Puder, Jardena J; Kriemler, Susi

    2014-12-01

    Negative lifestyle factors are known to be associated with increased cardiovascular risk (CVR) in children, but research on their combined impact on a general population of children is sparse. Therefore, we aimed to quantify the combined impact of easily assessable negative lifestyle factors on the CVR scores of randomly selected children after 4 years. Of the 540 randomly selected 6- to 13-year-old children, 502 children participated in a baseline health assessment, and 64% were assessed again after 4 years. Measures included anthropometry, fasting blood samples, and a health assessment questionnaire. Participants scored one point for each negative lifestyle factor at baseline: overweight; physical inactivity; high media consumption; little outdoor time; skipping breakfast; and having a parent who has ever smoked, is inactive, or overweight. A CVR score at follow-up was constructed by averaging sex- and age-related z-scores of waist circumference, blood pressure, glucose, inverted high-density lipoprotein, and triglycerides. The age-, sex-, pubertal stage-, and social class-adjusted probabilities (95% confidence interval) for being in the highest CVR score tertile at follow-up for children who had at most one (n = 48), two (n = 64), three (n = 56), four (n = 41), or five or more (n = 14) risky lifestyle factors were 15.4% (8.9-25.3), 24.3% (17.4-32.8), 36.0% (28.6-44.2), 49.8% (38.6-61.0), and 63.5% (47.2-77.2), respectively. Even in childhood, an accumulation of negative lifestyle factors is associated with higher CVR scores after 4 years. These negative lifestyle factors are easy to assess in clinical practice and allow early detection and prevention of CVR in childhood. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  8. A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial).

    Science.gov (United States)

    Paajanen, Hannu; Grönroos, Juha M; Rautio, Tero; Nordström, Pia; Aarnio, Markku; Rantanen, Tuomo; Hurme, Saija; Dean, Kirsti; Jartti, Airi; Mecklin, Jukka-Pekka; Sand, Juhani; Salminen, Paulina

    2013-02-08

    Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18-60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75-85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting

  9. Periarticular Injection of Liposomal Bupivacaine Offers No Benefit Over Standard Bupivacaine in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial.

    Science.gov (United States)

    Alijanipour, Pouya; Tan, Timothy L; Matthews, Christopher N; Viola, Jessica R; Purtill, James J; Rothman, Richard H; Parvizi, Javad; Austin, Matthew S

    2017-02-01

    Periarticular injection of liposomal bupivacaine has been adopted as part of multimodal pain management after total knee arthroplasty (TKA). In this prospective, randomized clinical trial, we enrolled 162 patients undergoing primary TKA in a single institution between January 2014 and May 2015. Eighty-seven patients were randomized to liposomal bupivacaine (experimental group), and 75 patients were randomized to free bupivacaine (control group). All patients received spinal anesthesia and otherwise identical surgical approaches, pain management, and rehabilitation protocols. Outcomes evaluated include the patient-reported visual analog pain scores, narcotic consumption, and narcotic-related side effects (Brief Pain Inventory) within 96 hours after surgery as well as functional outcomes using the Knee Society Score and the Short-Form 12 measured preoperatively and at 4-6 weeks after surgery. There were no statistically significant differences between the groups in terms of postoperative daily pain scores, narcotic consumption (by-day and overall), or narcotic-related side effects. There were no statistically significant differences between the groups in terms of surgical (P = .76) and medical complications or length of hospital stay (P = .35). There were no statistically significant differences in satisfaction between the groups (P = .56) or between the groups in postoperative Knee Society Score (P = .53) and the Short-Form 12 at 4-6 weeks (P = .82, P = .66). As part of multimodal pain management protocol, periarticular injection of liposomal bupivacaine compared with bupivacaine HCl did not result in any clinically or statistically significant improvement of the measured outcomes following TKA. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. A prospective randomized controlled trial comparing early postoperative complications in patients undergoing loop colostomy with and without a stoma rod.

    Science.gov (United States)

    Franklyn, J; Varghese, G; Mittal, R; Rebekah, G; Jesudason, M R; Perakath, B

    2017-07-01

    A stoma rod or bridge has been traditionally placed under the bowel loop while constructing a loop colostomy. This is believed to prevent stomal retraction and provide better faecal diversion. However, the rod can cause complications such as mucosal congestion, oedema and necrosis. This single-centre prospective randomized controlled trial compared outcomes after creation of loop colostomy with and without a supporting stoma rod. The primary outcome studied was stoma retraction rate; other stoma-related complications were studied as secondary outcomes. One hundred and fifty-one patients were randomly allotted to one of two arms, colostomy with or without a supporting rod. Postoperative complications such as retraction, mucocutaneous separation, congestion and re-exploration for stoma-related complications were recorded. There was no difference in the stoma retraction rate between the two arms (8.1% in the rod arm and 6.6% in the no-rod arm; P = 0.719). Stomal necrosis (10.7% vs 1.3%; P = 0.018), oedema (23% vs 3.9%; P = 0.001), congestion (20.3% vs 2.6%; P = 0.001) and re-admission rates (8.5% vs 0%; P = 0.027) were significantly increased in the arm randomized to the rod. The stoma rod does not prevent stomal retraction. However, complication rates are significantly higher when a stoma rod is used. Routine use of a stoma rod for construction of loop colostomy can be avoided. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

  11. Role of modified ultrfiltration in adult cardic surgery: a prospective randomized control trial

    International Nuclear Information System (INIS)

    Naveed, D.; Khan, R.A.; Malik, A.; Shah, S.Z.A.; Ullah, I.; Hussain, A.

    2016-01-01

    Background: Cardiopulmonary bypass (CPB) is associated with morbidity and mortality. To reduce its adverse effect modified ultrafiltration is being increasingly employed. This study is planned to evaluate the benefits of modified ultrafiltration (MUF) in adult cardiac surgery. Methods: Eighty consecutive patients presenting to adult cardiac surgery as elective case were enrolled. These patients were randomly divided in to two groups. MUF group which received modified ultrafiltration after separation from CPB and control group which did not receive modified ultrafiltration. Postoperative mediastinal and chest drainage in 24 hrs, blood products requirement, reopening, ICU stay, and mortality in 30 days were recorded. These variables were compared between MUF group and control group. Results: Forty patients were randomized to control group and 40 in MUF group. Mean age was 51.15±8.90 in control group as compared to 46.95±13.24 MUF group (p=0.1). Out of 40 patients in control group 7 (17.5 percentage) were female while 11 (27.5 percentage) out of total 40 were female in MUF group. (p=.284). Mean CBP time was 120.62±20.97 in control group versus 117.37±38.78 in MUF group (p=0.64). Post-operative drain output ranged from 330 ml to 1300 ml in control group and 300 ml to 780 ml in MUF group. Mean postoperative drain output 554.25±192.57 in control group versus 439.22±89.59 in MUF group (p=.001). Three (7.5 percentage) out of 40 patients required re-exploration in control group versus 1 (2.5 percentage) in MUF group. (p=.305). Mean ICU stay was 52.80±22.37 hours in control group versus 45.30±21.82 hours in MUF group (p=0.133). Three (7.5 percentage) out of 40 patients died in control group versus 1 (2.5 percentage) in MUF group. (p=0.305). Conclusion: Use of modified ultrafiltration is associated with low postoperative bleeding less requirements of blood and blood products. (author)

  12. Effect of branched chain amino acid enrichment of total parenteral nutrition on nitrogen sparing and clinical outcome of sepsis and trauma: a prospective randomized double blind trial

    NARCIS (Netherlands)

    von Meyenfeldt, M. F.; Soeters, P. B.; Vente, J. P.; van Berlo, C. L.; Rouflart, M. M.; de Jong, K. P.; van der Linden, C. J.; Gouma, D. J.

    1990-01-01

    Administration of extra branched chain amino acids (BCAA) has been associated with a nitrogen sparing effect in septic and traumatized patients. Whether nitrogen sparing is associated with decreased morbidity and mortality rates is unknown. We therefore undertook a prospective, randomized, double

  13. Comparison of a trifocal intraocular lens with a+3.0 D bifocal IOL: results of a prospective randomized clinical trial

    NARCIS (Netherlands)

    Jonker, S.M.R.; Bauer, N.J.C.; Makhotkina, N.Y.; Berendschot, T.T.J.M.; van den Biggelaar, F.J.H.M.; Nuijts, R.M.M.A.

    Purpose To compare visual outcomes in patients with cataract surgery and bilateral implantation of a trifocal or bifocal intraocular lens (IOL). Setting University Eye Clinic Maastricht, the Netherlands. Design Prospective randomized clinical trial. Methods Eyes with cataract and less than 1.0

  14. Does interscalene catheter placement with stimulating catheters improve postoperative pain or functional outcome after shoulder surgery? A prospective, randomized and double-blinded trial

    NARCIS (Netherlands)

    Stevens, Markus F.; Werdehausen, Robert; Golla, Elisabeth; Braun, Sebastian; Hermanns, Henning; Ilg, Ansgar; Willers, Reinhardt; Lipfert, Peter

    2007-01-01

    BACKGROUND: In this prospective, randomized, double-blind trial we investigated the use of stimulating catheters in patients during and after shoulder surgery; functional improvement being the primary outcome measurement. METHODS: After eliciting an adequate muscular twitch at

  15. A six-year prospective randomized study of a nano-hybrid and a conventional hybrid resin composite in Class II restorations

    DEFF Research Database (Denmark)

    van Dijken, Jan W V; Pallesen, Ulla

    2013-01-01

    The objective of this 6 year prospective randomized equivalence trial was to evaluate the long-term clinical performance of a new nano-hybrid resin composite (RC) in Class II restorations in an intraindividual comparison with its well-established conventional hybrid RC predecessor....

  16. Effects of daikenchuto, a Japanese herb, on intestinal motility after total gastrectomy: a prospective randomized trial.

    Science.gov (United States)

    Akamaru, Yusuke; Takahashi, Tsuyoshi; Nishida, Toshirou; Omori, Takeshi; Nishikawa, Kazuhiro; Mikata, Shoki; Yamamura, Noriyuki; Miyazaki, Satoru; Noro, Hiroshi; Takiguchi, Shuji; Mori, Masaki; Doki, Yuichiro

    2015-03-01

    This study aimed to assess the efficacy of daikenchuto (DKT), a commonly prescribed, traditional Japanese herbal medicine, on postoperative intestinal dysfunction after gastric cancer surgery. Patients with gastric cancer scheduled for a total gastrectomy were randomly assigned before surgery to receive either no treatment (n = 40; control group) or DKT (7.5 g/day, t.i.d.) for 3 months (n = 41) postoperatively. We examined gastrointestinal motility, stool attributes, the quantity of bowel gas, the quality of life, and the incidence of postoperative ileus. During the hospital stay, significant differences were observed between the DKT group and controls in the number of stools per day (1.1 ± 0.6 vs 0.8 ± 0.4, respectively; P = 0.037) and stool consistencies (Bristol scale ratings were 3.7 ± 0.8 vs 3.1 ± 0.8, respectively; P = 0.041). The DKT group showed significant reductions in gas volume scores, calculated from abdominal radiographs, at 7 days, 1 month, and 3 months after surgery. The groups did not show significant differences in quality of life scores (based on the Gastrointestinal Symptom Rating Scale) or in the incidence of postoperative ileus. DKT improved bowel movements, stool properties, and bowel gas. These results suggested that DKT promoted early postoperative bowel functions after total gastrectomy.

  17. Does preparation of children before MRI reduce the need for anesthesia? Prospective randomized control trial

    International Nuclear Information System (INIS)

    Rothman, Sarah; Shelef, Ilan; Gonen, Anat; Vodonos, Alina; Novack, Victor

    2016-01-01

    Magnetic resonance imaging has been recognized for years as the safest and most precise imaging method, particularly for children. The accuracy of MRI depends on avoidance of patient movement during the study. This may be difficult for children and may require anesthesia. We evaluated an introductory instruction program as an assistive tool in performing MRI without anesthesia. In one institution, 121 children were randomized to undergo full interactive pre-MRI instruction (n=64), which included an instructional booklet, movie and simulator practice, or partial instruction (n=57), comprised of the booklet only. All researchers and health care professionals involved, except for the one who instructed the families, were masked to the group allocation. Parents' anxiety, according to the Spielberger state anxiety inventory, was measured. Median age was 7.4 years (range: 5 years-16 years). Anesthesia was required for fewer children who received full compared to partial instruction: 17 (27%) vs. 27 (47%), P≤0.02. The median anxiety level prior to instruction was higher than the median level after instruction, for both the partial and full instruction groups. Instruction including simulator practice was associated with a decreased need for anesthesia among children undergoing MRI scans. (orig.)

  18. Prospective randomized assessment of single versus double-gloving for general surgical procedures.

    Science.gov (United States)

    Na'aya, H U; Madziga, A G; Eni, U E

    2009-01-01

    There is increased tendency towards double-gloving by general surgeons in our practice, due probably to awareness of the risk of contamination with blood or other body fluids during surgery. The aim of the study was to compare the relative frequency of glove puncture in single-glove versus double glove sets in general surgical procedures, and to determine if duration of surgery affects perforation rate. Surgeons at random do single or double gloves at their discretion, for general surgical procedures. All the gloves used by the surgeons were assessed immediately after surgery for perforation. A total of 1120 gloves were tested, of which 880 were double-glove sets and 240 single-glove sets. There was no significant difference in the overall perforation rate between single and double glove sets (18.3% versus 20%). However, only 2.3% had perforations in both the outer and inner gloves in the double glove group. Therefore, there was significantly greater risk for blood-skin exposure in the single glove sets (p < 0.01). The perforation rate was also significantly greater during procedures lasting an hour or more compared to those lasting less than an hour (p < 0.01). Double-gloving reduces the risk of blood-skin contamination in all general surgical procedures, and especially so in procedures lasting an hour or more.

  19. Optimal chest compression rate in cardiopulmonary resuscitation: a prospective, randomized crossover study using a manikin model.

    Science.gov (United States)

    Lee, Seong Hwa; Ryu, Ji Ho; Min, Mun Ki; Kim, Yong In; Park, Maeng Real; Yeom, Seok Ran; Han, Sang Kyoon; Park, Seong Wook

    2016-08-01

    When performing cardiopulmonary resuscitation (CPR), the 2010 American Heart Association guidelines recommend a chest compression rate of at least 100 min, whereas the 2010 European Resuscitation Council guidelines recommend a rate of between 100 and 120 min. The aim of this study was to examine the rate of chest compression that fulfilled various quality indicators, thereby determining the optimal rate of compression. Thirty-two trainee emergency medical technicians and six paramedics were enrolled in this study. All participants had been trained in basic life support. Each participant performed 2 min of continuous compressions on a skill reporter manikin, while listening to a metronome sound at rates of 100, 120, 140, and 160 beats/min, in a random order. Mean compression depth, incomplete chest recoil, and the proportion of correctly performed chest compressions during the 2 min were measured and recorded. The rate of incomplete chest recoil was lower at compression rates of 100 and 120 min compared with that at 160 min (P=0.001). The numbers of compressions that fulfilled the criteria for high-quality CPR at a rate of 120 min were significantly higher than those at 100 min (P=0.016). The number of high-quality CPR compressions was the highest at a compression rate of 120 min, and increased incomplete recoil occurred with increasing compression rate. However, further studies are needed to confirm the results.

  20. Standard versus Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Prospective Randomized Study

    Directory of Open Access Journals (Sweden)

    Daniel Serban

    2017-01-01

    Full Text Available Symptomatic spondylolisthesis patients may benefit from surgical decompression and stabilization. The standard (S technique is a transforaminal lumbar interbody fusion (TLIF. Newer, minimally invasive (MI techniques seem to provide similar results with less morbidity. We enrolled patients with at least 6 months of symptoms and image-confirmed low-grade spondylolisthesis, at a single academic institution, between 2011 and 2015. The patients were randomized to either S or MI TLIF. The primary outcome measure was the Oswestry Disability Index (ODI improvement at 1 year. Secondary outcome measures included length of operation, estimated blood loss, length of hospitalization, and fusion rates at 1 year. Forty patients were enrolled in each group. The differences in mean operative time and estimated blood loss were not statistically significant between the two groups. The patients were discharged after surgery at 4.12 days for the S TLIF group and 1.92 days for the MI TLIF group. The ODI improvement was similar and statistically significant in both groups. The fusion was considered solid in 36 (90% of patients at 1 year in both groups. In conclusion, the two techniques provided similar clinical and radiological outcomes at 1 year. The patients undergoing MI TLIF had a shorter hospital stay. This trial is registered with NCT03155789.

  1. Effect of Sugammadex on Postoperative Bleeding and Coagulation Parameters After Septoplasty: A Randomized Prospective Study

    Science.gov (United States)

    Taş, Nilay; Korkmaz, Hakan; Yağan, Özgür; Korkmaz, Mukadder

    2015-01-01

    Backround Sugammadex is a reversal agent with well known advantages but it’s effects on haemostasis and bleeding have been a topic of interest. Septoplasty is a common surgical procedure with postoperative respiratory complications and bleeding. The aim of this study is to investigate the effects of sugammadex on postoperative coagulation parameters and bleeding after septoplasty procedure. Material/Methods In this randomized controlled study, fifty patients were grouped into two groups; neostigmine (Group N) vs. sugammadex (Group S). For the evaluation of PT, aPTT and INR, blood samples were taken for at the postoperative 120th minutes and alteration of these values with respect to preoperative values were documented. Postoperative bleeding was measured by evaluating the amount of blood absorbed on the nasal tip dressing during 3 hours postoperatively. Results Postoperative bleeding amount was significantly higher in the Group S compared to Group N (p=0.013). No significant difference was observed between two groups according to coagulation parameters (PT; p=0.953, aPTT; p=0.734, INR; p=0.612). Conclusions Sugammadex was associated with higher amount of postoperative bleeding than neostigmine in septoplasty patients. In surgical procedures having high risk of bleeding the safety of sugammadex need to be verified. PMID:26271275

  2. ABC versus CAB for cardiopulmonary resuscitation: a prospective, randomized simulator-based trial.

    Science.gov (United States)

    Marsch, Stephan; Tschan, Franziska; Semmer, Norbert K; Zobrist, Roger; Hunziker, Patrick R; Hunziker, Sabina

    2013-09-06

    After years of advocating ABC (Airway-Breathing-Circulation), current guidelines of cardiopulmonary resuscitation (CPR) recommend CAB (Circulation-Airway-Breathing). This trial compared ABC with CAB as initial approach to CPR from the arrival of rescuers until the completion of the first resuscitation cycle. 108 teams, consisting of two physicians each, were randomized to receive a graphical display of either the ABC algorithm or the CAB algorithm. Subsequently teams had to treat a simulated cardiac arrest. Data analysis was performed using video recordings obtained during simulations. The primary endpoint was the time to completion of the first resuscitation cycle of 30 compressions and two ventilations. The time to execution of the first resuscitation measure was 32 ± 12 seconds in ABC teams and 25 ± 10 seconds in CAB teams (P = 0.002). 18/53 ABC teams (34%) and none of the 55 CAB teams (P = 0.006) applied more than the recommended two initial rescue breaths which caused a longer duration of the first cycle of 30 compressions and two ventilations in ABC teams (31 ± 13 vs.23 ± 6 sec; P = 0.001). Overall, the time to completion of the first resuscitation cycle was longer in ABC teams (63 ± 17 vs. 48 ± 10 sec; P ABC with an earlier start of CPR and a shorter time to completion of the first 30:2 resuscitation cycle. These findings endorse the change from ABC to CAB in international resuscitation guidelines.

  3. Regenerative Endodontics Versus Apexification in Immature Permanent Teeth with Apical Periodontitis: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Lin, Jiacheng; Zeng, Qian; Wei, Xi; Zhao, Wei; Cui, Minyi; Gu, Jing; Lu, Jiaxuan; Yang, Maobin; Ling, Junqi

    2017-11-01

    The aim of the study was to compare the outcomes of regenerative endodontic treatment (RET) and apexification on immature permanent teeth with pulp necrosis and apical periodontitis. A total of 118 patients (118 teeth) were recruited and randomly assigned to either RET or apexification treatment. Each treatment group was divided into 2 subgroups according to the etiology: dens evaginatus or trauma. Clinical symptoms and complications were recorded, and cone-beam computed tomographic imaging with a limited field of view was used to measure the change of root length, root thickness, and apical foramen size at the 12-month follow-up. The t test/rank sum test and Fisher exact test were applied to compare the change of root morphology between RET and apexification. One hundred three of 118 cases were completed at the 12-month follow-up. The survival rate was 100% for both treatment groups. All cases were asymptomatic with apical healing. The RET group showed a significant increase in root length and root thickness compared with the apexification group (P apical healing. RET showed a better outcome than apexification regarding increased root thickness and root length. The etiology had an impact on the outcome of RET. Dens evaginatus cases showed better prognoses than trauma cases after RET. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  4. Hypofractionated radiation therapy in the treatment of epidemic Kaposi sarcoma - A prospective randomized trial

    International Nuclear Information System (INIS)

    Singh, Niveditha B.; Lakier, Roy H.; Donde, Bernard

    2008-01-01

    Purpose: To compare a conventional fractionation regimen with a hypofractionated regimen in the treatment of Epidemic Kaposi sarcoma with radiation therapy. Materials and methods: Sixty patients were randomized to receive a standard regimen of 24 Gy in 12 fractions (ARM A) or the study regimen of 20 Gy in five fractions (ARM B). Radiation technique was individualized. Treatment response, local control and toxicity were recorded. Results: Thirty five sites were treated in ARM A and 30 sites in ARM B. Treatment arms were similar for gender, ECOG performance score, treated site, antiretroviral therapy usage, T stage, I stage and S stage. The overall survival using the Kaplan Meier method was 37% at 1 year. Complete responses were recorded at 28 sites (13 Arm A, 15 Arm B), partial responses at 19 sites (8 Arm A, 11 Arm B) and stable disease at three sites (2 Arm A, 1 Arm B). The mean time to maximum objective response was 3 months (range: 1-14 months). Response rates and local control were equal in the two arms (p = 0.73 and 0.77, respectively, log rank test). Acute skin toxicity (p = 0.77) and late skin toxicity (p = 0.24) were equal in the two arms. Conclusion: The two treatment regimens produced equivalent results for treatment response, local recurrence-free survival and toxicity

  5. Does preparation of children before MRI reduce the need for anesthesia? Prospective randomized control trial

    Energy Technology Data Exchange (ETDEWEB)

    Rothman, Sarah; Shelef, Ilan [Ben Gurion University of the Negev, Department of Radiology, Soroka University Medical Center, Beersheva (Israel); Gonen, Anat [Ben Gurion University of the Negev, Division of Pediatrics, Soroka University Medical Center, Beersheva (Israel); Vodonos, Alina; Novack, Victor [Ben Gurion University of the Negev, Clinical Research Center, Soroka University Medical Center, Beersheva (Israel)

    2016-10-15

    Magnetic resonance imaging has been recognized for years as the safest and most precise imaging method, particularly for children. The accuracy of MRI depends on avoidance of patient movement during the study. This may be difficult for children and may require anesthesia. We evaluated an introductory instruction program as an assistive tool in performing MRI without anesthesia. In one institution, 121 children were randomized to undergo full interactive pre-MRI instruction (n=64), which included an instructional booklet, movie and simulator practice, or partial instruction (n=57), comprised of the booklet only. All researchers and health care professionals involved, except for the one who instructed the families, were masked to the group allocation. Parents' anxiety, according to the Spielberger state anxiety inventory, was measured. Median age was 7.4 years (range: 5 years-16 years). Anesthesia was required for fewer children who received full compared to partial instruction: 17 (27%) vs. 27 (47%), P≤0.02. The median anxiety level prior to instruction was higher than the median level after instruction, for both the partial and full instruction groups. Instruction including simulator practice was associated with a decreased need for anesthesia among children undergoing MRI scans. (orig.)

  6. A Prospective Randomized Trial of Functional Outcomes Following Rotator Cuff Repair With and Without Acromioplasty

    Science.gov (United States)

    Tetteh, Elizabeth; Hussey, Kristen Elizabeth; Abrams, Geoffrey D.; Gupta, Anil K.; Dhawan, Aman; Karas, Vasili; Cole, Brian J.; Romeo, Anthony A.; Verma, Nikhil N.

    2013-01-01

    Objectives: The purpose of this study is to report the clinical outcomes of patients undergoing an arthroscopic rotator cuff repair with and without acromioplasty at a minumul of two year follow-up. Methods: Patients undergoing arthroscopic repair of full thickness rotator cuff tears were randomized into acromioplasty or non-acromioplasty groups. Pre-operatively, validated outcome scores including the Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons score (ASES), UCLA score, and SF-12 health assessment were collected along with physical examination including range of motion and dynamometer strength testing. Pre-operative imaging was also reviewed to classify the acromial morphology, acromial angle, and lateral acromial angulation. Intra-operative data including tear size, repair configuration, and concomitant procedures were recorded. Postoperatively, data was collected at 6 weeks, 6 months, one year and at two years. Results are reported as mean ± standard deviation. Student’s t-test was utilized for statistical analysis with an alpha value of 0.05 set as significant. Results: Sixty-one patients completed surveys pre- and post-operatively at a mean 2.6 years. All patients had at least two year follow-up. Thirty-five patients with an average age of 58.4 years (range 44.4 - 74.7) were randomized to the acromioplasty group (22 male, 13 female) and 26 patients with a mean age of 58.2 years (range 42.9-77.0) to the non-acromioplasty group (17 male, 9 female). All outcome scores improved significantly (p < 0.05) in both groups from pre- to post-operatively at two year follow-up. In the acromioplasty group, improvements were observed for SST (5.6 ± 2.7 to 10.7 ± 1.7), ASES (53.5 ± 16.8 to 91.0 ± 13.5) and UCLA (10.7 ± 3.1 to 17.9 ± 30.0) scores. In the non-acromioplasty group, SST increased from 5.6 ± 3.1 to 10.5 ± 2.2; ASES from 58.9 ± 19.1 to 93.5 ± 10.8, and UCLA from 12.0 ± 2.8 to 17.4 ± 3.7. There was no statistical difference in

  7. A prospective randomized evaluation of negative-pressure wound dressings for diabetic foot wounds.

    Science.gov (United States)

    Eginton, Mark T; Brown, Kellie R; Seabrook, Gary R; Towne, Jonathan B; Cambria, Robert A

    2003-11-01

    Optimal treatment for large diabetic foot wounds is ill defined. The purpose of this study was to compare the rate of wound healing with the Vacuum Assisted Closure device trade mark (VAC) to conventional moist dressings in the treatment of large diabetic foot wounds. Diabetics with significant soft tissue defects of the foot were considered for enrollment. Patients were randomized to receive either moist gauze dressings or VAC treatments for 2 weeks, after which they were treated with the alternative dressing for an additional 2 weeks. Wounds were photographed weekly and wound dimensions calculated in a blinded fashion with spatial analysis software. Percent change in wound dimensions were calculated and compared for each weekly assessment and over 2 weeks of therapy with each dressing type. Ten patients were enrolled in the trial, but two were lost to follow-up and two were withdrawn. Complete data were available for analysis on seven wounds in six patients. Average length, width, and depth of the wounds at initiation of the trial was 7.7, 3.5, and 3.1 cm, respectively. Only the wound depth was significantly decreased over the weeks of the trial to 1.2 cm ( p VAC dressings decreased the wound volume and depth significantly more than moist gauze dressings (59% vs. 0% and 49% vs. 8%, respectively). VAC dressings were associated with a decrease in all wound dimensions while wound length and width increased with moist dressings. In summary, over the first several weeks of therapy, VAC dressings decreased wound depth and volume more effectively than moist gauze dressings. Negative-pressure wound treatment may accelerate closure of large foot wounds in the diabetic patient.

  8. Outpatient parenteral antimicrobial therapy in children with febrile urinary tract infection: a prospective randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Nasiri Kalmarzi R

    2009-01-01

    Full Text Available "nBackground: Acute pyelonephritis may lead to permanent renal scarring. The standard recommendation for treatment of febrile children with urinary tract infection (UTI is hospitalization for intravenous antibiotics. The purpose of this study was to compare the efficacy of outpatient intravenous ceftriaxone and cefixime versus inpatient of the same regimen for children with febrile UTI.   "nMethods: In a randomized clinical trial, we compared the efficacy of administration two days intravenous ceftriaxone followed by an oral cefixime for eight days (as outpatient group versus four days intravenous ceftriaxone followed by an oral cefixime for six days (as inpatient group, in 203 children (99 cases in outpatient group and 104 cases in inpatient group 3 months to 15 years of age with febrile UTI, in terms of short-term clinical outcomes (sterilization of the urine and defeverescence and long-term morbidity (incidence of reinfection and renal scarring documented by DMSA scintigraphy. "nResults: Repeat urine cultures were sterile within 48 hours in all children, mean time to defeverescence was 27.58 (SD=±12.62 and 31.44 (SD=±17.06 hours for children in outpatient and inpatient groups, respectively (P=0.067. Reinfection occurred in 9.1% of outpatient and 13.4% of inpatient group (P=0.326. Renal scarring developed in 11% of children of outpatient and 7.6% of children of inpatient group (P=0.884. There was no significant difference between the two groups in respect of renal scarring. "nConclusions: Outpatient ceftriaxone for two days followed by cefixime to complete a 10 days course can be recommended as a safe and effective treatment for children with febrile UTI.

  9. Perioperative analgesia with a buprenorphine transdermal patch for hallux valgus surgery: a prospective, randomized, controlled study

    Directory of Open Access Journals (Sweden)

    Xu C

    2018-04-01

    Full Text Available Can Xu, Mingqing Li, Chenggong Wang, Hui Li, Hua Liu Department of Orthopaedics, Xiangya Hospital, Central South University, Changsha, Hunan Province, People’s Republic of China Purpose: Hallux valgus surgery often results in significant postoperative pain. Adequate control of pain is essential for patient satisfaction and improves the outcome of the procedure. This study aimed to investigate the perioperative analgesic effect of a buprenorphine transdermal patch in patients who underwent hallux valgus surgery.Patients and methods: A total of 90 patients were randomly divided into the following three groups based on the perioperative analgesic method: flurbiprofen axetil intravenous injection (Group F, oral celecoxib (Group C, and buprenorphine transdermal delivery system (BTDS (Group BTDS. The pain status, degree of satisfaction, adverse effects, and administration of tramadol hydrochloride for uncontrolled pain were recorded on the night before surgery, postoperative day 1, postoperative day 2, and postoperative day 3.Results: The BTDS could effectively control perioperative pain for patients undergoing ­hallux valgus surgery. The analgesic effect of the BTDS was better than that of oral celecoxib. In addition, statistically significant differences were not observed in the visual analog scale (VAS scores, adverse effects, and rescue analgesia between the patients who received the BTDS and the patients who received the flurbiprofen axetil intravenous injection. However, the degree of patient satisfaction of the BTDS group was significantly higher (P<0.05 than that of the other two groups.Conclusion: The BTDS (a preemptive analgesia regimen could exert an analgesic effect during the perioperative period for patients who had received hallux valgus surgery, and this effect is beneficial for sustaining postoperative physiological and psychological states and promoting functional rehabilitation. Keywords: hallux valgus, buprenorphine transdermal

  10. Prospectively randomized clinical trial to compare in situ and reversed saphenous vein grafts for femoropopliteal bypass.

    Science.gov (United States)

    Harris, P L; How, T V; Jones, D R

    1987-04-01

    Two hundred and fifteen femoropopliteal bypass procedures using autologous saphenous vein grafts were randomly allocated to either the reversed or in situ technique. Eleven veins (5 per cent) were rejected at operation on the basis of their small size, nine in the reversed group and two in the in situ group, and there were two (2 per cent) perioperative deaths in each group, leaving 102 reversed and 98 in situ grafts for further study. The cumulative patency at 3 years of the reversed grafts was 77 per cent and that of the in situ grafts was 68 per cent (n.s.). The patency of all grafts was affected adversely by small veins (P less than 0.005), long grafts (P less than 0.05), low volume of blood flow in the grafts (P less than 0.001) and poor run-off (P less than 0.05). These factors influenced the outcome of the in situ and reversed operations to a similar degree and there was no statistically significant difference between them within any subgroup. The mean compliance of the in situ grafts measured 3 months or more after operation with an ultrasonic echo-tracking system was 0.024 +/- 0.01 per cent/mmHg (+/- s.d.) compared with 0.017 +/- 0.01 per cent/mmHg for the reversed grafts (t = 2.43, P less than 0.02). The incidence of fibrous stricture formation as shown by intravenous digital subtraction angiography was 29 per cent in both the reversed and the in situ grafts. The results of the study to date indicate that reversed and in situ vein grafts are equally effective for femoropopliteal bypass.

  11. One- vs 2-Stage Bursectomy for Septic Olecranon and Prepatellar Bursitis: A Prospective Randomized Trial.

    Science.gov (United States)

    Uçkay, Ilker; von Dach, Elodie; Perez, Cédric; Agostinho, Americo; Garnerin, Philippe; Lipsky, Benjamin A; Hoffmeyer, Pierre; Pittet, Didier

    2017-07-01

    To assess the optimal surgical approach and costs for patients hospitalized with septic bursitis. From May 1, 2011, through December 24, 2014, hospitalized patients with septic bursitis at University of Geneva Hospitals were randomized (1:1) to receive 1- vs 2-stage bursectomy. All the patients received postsurgical oral antibiotic drug therapy for 7 days. Of 164 enrolled patients, 130 had bursitis of the elbow and 34 of the patella. The surgical approach used was 1-stage in 79 patients and 2-stage in 85. Overall, there were 22 treatment failures: 8 of 79 patients (10%) in the 1-stage arm and 14 of 85 (16%) in the 2-stage arm (Pearson χ 2 test; P=.23). Recurrent infection was caused by the same pathogen in 7 patients (4%) and by a different pathogen in 5 (3%). Outcomes were better in the 1- vs 2-stage arm for wound dehiscence for elbow bursitis (1 of 66 vs 9 of 64; Fisher exact test P=.03), median length of hospital stay (4.5 vs 6.0 days), nurses' workload (605 vs 1055 points), and total costs (Sw₣6881 vs Sw₣11,178; all Pbursitis requiring hospital admission, bursectomy with primary closure, together with antibiotic drug therapy for 7 days, was safe, effective, and resource saving. Using a 2-stage approach may be associated with a higher rate of wound dehiscence for olecranon bursitis than the 1-stage approach. Clinicaltrials.gov Identifier: NCT01406652. Copyright © 2017 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

  12. Mitral valve repair or replacement in hypertrophic obstructive cardiomyopathy: a prospective randomized study.

    Science.gov (United States)

    Bogachev-Prokophiev, Alexander; Afanasyev, Alexander; Zheleznev, Sergey; Fomenko, Michael; Sharifulin, Ravil; Kretov, Eugenie; Karaskov, Alexander

    2017-09-01

    The optimal surgical strategy for concomitant mitral valve intervention during myectomy remains controversial. The purpose of this study was to compare the results of mitral valve replacement versus repair in patients with hypertrophic obstructive cardiomyopathy and severe mitral regurgitation. Between 2010 and 2013, a total of 88 patients with hypertrophic obstructive cardiomyopathy and severe mitral regurgitation were randomly assigned to undergo either mitral valve replacement or repair in addition to extended myectomy. Three patients from the repair group were switched to mitral valve replacement after repair failure. There was 1 early death (2.4%) in the replacement group. The resting left ventricular outflow tract gradient was reduced from 89.1 ± 20.4 to 18.3 ± 5.7 mmHg (P replacement and repair groups, respectively; there was no significant difference between the groups (P = 0.458). At 2-year follow-up, overall survival was 87.2 ± 4.9% and 96.7 ± 3.3% (P = 0.034); freedom from sudden cardiac death was 95.6 ± 3.1% and 96.7 ± 3.3% (P = 0.615); and freedom from thromboembolic events was 91.2 ± 4.2% and 100%, respectively (P = 0.026). Both mitral valve repair and valve replacement in addition to extended myectomy are effective methods of surgical treatment in patients with hypertrophic obstructive cardiomyopathy who have severe mitral regurgitation. The benefits of mitral valve repair are better overall survival and a lower rate of thromboembolic events. ClinicalTrials.gov: NCT02054221. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  13. The effect of posture and repetition on urodynamic parameters: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Ho Joon Jeon

    2017-01-01

    Full Text Available Purpose: To evaluate the effect of posture and repetition of filling cystometry on urodynamic parameters. Materials and Methods: Seventy-one men with benign prostatic hyperplasia participated in a urodynamic study between September 2015 and August 2016 and were randomly assigned to a supine to supine (group SS, n=16, erect to erect (group EE, n=16, supine to erect (group SE, n=19 or erect to supine (group ES, n=20 group. The patients underwent filling cystometry twice. We evaluated the effect of posture and the effect of repetition on filling cystometric parameters. We also evaluated the correlation between overactive bladder (OAB and detrusor overactivity (DO and between maximum voided volume (MVV and maximum cystometric capacity (MCC for each posture and filling cystometry time. Results: There was a decrease in bladder sensation and occurrence of DO, and an increase in bladder compliance and MCC in the supine posture group compared to that in the erect posture group. A more significant decrease in bladder sensation and occurrence of DO as well as an increase in MCC was seen during the second filling cystometry than the first one. The supine posture during first filling cystometry showed a better correlation between OAB and DO and between MVV and MCC than erect posture. Conclusions: There were clear effects of posture and filling cystometry repetition on urodynamic parameters. The supine posture and repeated filling cystometry caused the bladder to be less sensitive and less overactive. The supine posture showed a better correlation to OAB symptoms than erect posture during first filling cystometry.

  14. Advantages of Arthroscopic Rotator Cuff Repair With a Transosseous Suture Technique: A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Randelli, Pietro; Stoppani, Carlo Alberto; Zaolino, Carlo; Menon, Alessandra; Randelli, Filippo; Cabitza, Paolo

    2017-07-01

    Rotator cuff tear is a common finding in patients with painful, poorly functioning shoulders. The surgical management of this disorder has improved greatly and can now be fully arthroscopic. To evaluate clinical and radiological results of arthroscopic rotator cuff repair using 2 different techniques: single-row anchor fixation versus transosseous hardware-free suture repair. Randomized controlled trial; Level of evidence, 1. Sixty-nine patients with rotator cuff tears were enrolled: 35 patients were operated with metal anchors and 34 with standardized transosseous repair. The patients were clinically evaluated before surgery, during the 28 days after surgery, and at least 1 year after the operation by the use of validated rating scores (Constant score, QuickDASH, and numerical rating scale [NRS]). Final follow-up was obtained at more than 3 years by a QuickDASH evaluation to detect any difference from the previous follow-up. During the follow-up, rotator cuff integrity was determined through magnetic resonance imaging and was classified according to the 5 Sugaya categories. Patients operated with the transosseous technique had significantly less pain, especially from the 15th postoperative day: In the third week, the mean NRS value for the anchor group was 3.00 while that for transosseous group was 2.46 ( P = .02); in the fourth week, the values were 2.44 and 1.76, respectively ( P rotator cuff repair integrity, based on Sugaya magnetic resonance imaging classification, no significant difference was found between the 2 techniques in terms of retear rate ( P = .81). No significant differences were found between the 2 arthroscopic repair techniques in terms of functional and radiological results. However, postoperative pain decreased more quickly after the transosseous procedure, which therefore emerges as a possible improvement in the surgical repair of the rotator cuff. Registration: NCT01815177 ( ClinicalTrials.gov identifier).

  15. Comparison of 3 different methods of anesthesia before transrectal prostate biopsy: a prospective randomized trial

    International Nuclear Information System (INIS)

    Oebek, C.; Oezkan, B.; Tunc, B.; Can, G.; Yalcin, V.; Solok, V.

    2004-01-01

    Purpose: Periprostatic nerve block (PNB) is the most common anesthesia technique used before prostate biopsy. However, needle punctures for anesthetic infiltration may be painful and cause higher infectious complications. We assessed whether addition of rectal lidocaine gel would improve its efficacy. We also investigated the efficacy and safety of tramadol, a codeine derivative, as a noninvasive method. Materials and Methods: A total of 300 patients who underwent prostate biopsies were randomized into 4 groups of controls, PNB, perianal/intrarectal lidocaine gel plus PNB and tramadol. Pain was assessed with a numeric analog scale. Results: Each group consisted of 75 patients, and there was a statistically significant difference among pain scores (p = 0.001). Mean pain scores were 4.63 for controls, 2.57 for PNB, 2.03 for infiltration plus gel group and 3.11 for tramadol. Pain and discomfort were least in PNB plus gel arm. The difference of pain score between PNB alone and tramadol group did not reach statistical significance. Infectious complications were higher in the combination group, whereas there were no complications with tramadol. Conclusions: Any form of analgesia/anesthesia was superior to none. The combination of PNB plus gel provided significantly better analgesia compared to PNB alone or tramadol. If this can be duplicated in other trials, the combination may be accepted as the new gold standard of anesthesia for prostate biopsy. The efficacy of tramadol was similar to that of PNB, and was free of complications. Therefore, tramadol may have a role before prostate biopsy, which needs to be explored. (author)

  16. A prospective randomized study assessing optimal method for teaching vascular anastomoses.

    Science.gov (United States)

    Schwartz, Samuel; de Virgilio, Michael; Chisum, Patrick; Heslin, Andrew; Zein, Alyssar; McDermott, Meilu; Kaji, Amy; Yaghoubian, Arezou; de Virgilio, Christian

    2014-07-01

    Laboratory skills training is now required for general surgery residents. The optimal method of teaching vascular anastomosis (VA) is not well defined. Teaching VA skills one-on-one with a faculty instructor will result in a more rapid accumulation of skills than teaching in a large group setting. Residents were shown an instructional video on how to perform a VA using a standardized model (cadaver saphenous vein and porcine aorta). Each resident then performed a baseline VA. Sixteen first- and second-year surgical residents were then randomized to 2 VA teaching sessions that consisted of either 1) group teaching (GT, 8 residents in a room with 1 faculty instructor circulating) or 2) one-on-one teaching (1-on-1, faculty member focused on individual resident). After each of these sessions, residents performed a standardized VA. The anastomoses were video recorded. Performance was evaluated using a standardized scoring system by a separate expert who viewed the video recordings in a blinded fashion. Outcome measures included total errors, total time, global rating scale, and an anastomosis-specific end-product evaluation (leak and passage of coronary dilator). Overall, significant decreases in total errors (21 to 15, P=0.001) and time to complete anastomoses (42 to 38 min, P=0.02) and an increase in global rating scales (7 to 11, P=0.003) were noted in both groups from baseline after 2 VA teaching session. The 1-on-1 group demonstrated significantly greater improvement in terms of reduced anastomotic time (30 vs. 42 min, P=0.007) and in reduction of errors (13 vs. 19 errors, P=0.09) than the GT group. The high-fidelity VA model is a useful tool for junior general surgery residents. Both GT and 1-on-1 groups demonstrated significant improvement in total errors and time after only 2 sessions. Greater improvement was noted using the 1-on-1 model. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Use of a sealant to prevent prolonged air leaks after lung resection: a prospective randomized study.

    Science.gov (United States)

    Lequaglie, Cosimo; Giudice, Gabriella; Marasco, Rita; Morte, Aniello Della; Gallo, Massimiliano

    2012-10-08

    Pulmonary air leaks are common complications of lung resection and result in prolonged hospital stays and increased costs. The purpose of this study was to investigate whether, compared with standard care, the use of a synthetic polyethylene glycol matrix (CoSeal®) could reduce air leaks detected by means of a digital chest drain system (DigiVent™), in patients undergoing lung resection (sutures and/or staples alone). Patients who intraoperatively showed moderate or severe air leaks (evaluated by water submersion tests) were intraoperatively randomized to receive just sutures/staples (control group) or sutures/staples plus CoSeal® (sealant group). Differences among the groups in terms of air leaks, prolonged air leaks, time to chest tube removal, length of hospital stay and related costs were assessed. In total, 216 lung resection patients completed the study. Nineteen patients (18.1%) in the control group and 12 (10.8%) patients in the sealant group experienced postoperative air leaks, while a prolonged air leak was recorded in 11.4% (n=12) of patients in the control group and 2.7% (n=3) of patients in the sealant group. The difference in the incidence of air leaks and prolonged air leaks between the two groups was statistically significant (p=0.0002 and p=0.0013). The mean length of hospital stay was significantly shorter in the sealant group (4 days) than the control group (8 days) (p=0.0001). We also observed lower costs in the sealant group than the control group. The use of CoSeal® may decrease the occurrence and severity of postoperative air leaks after lung resection and is associated with shorter hospital stay. Not registered. The trial was approved by the Institutional Review Board of the IRCCS-CROB Basilicata Regional Cancer Institute, Rionero in Vulture, Italy.

  18. Prospective Randomized Study of the Effect of Music on the Efficiency of Surgical Closures.

    Science.gov (United States)

    Lies, Shelby R; Zhang, Andrew Y

    2015-09-01

    Music is commonly played in operating theaters. Some surgeons believe music reduces stress and operative time, while others think music is a distraction and should be avoided. There is limited published evidence evaluating the effects of music on surgical performance. The goal of this study is to evaluate the effect of music on simple wound closure. Plastic surgery residents were asked to perform layered closures on pigs' feet with and without their preferred music playing. Simple randomization was used to assign residents to the music playing first or music playing second group. The time to complete the repair was measured and repairs were graded by blinded faculty. Results were analyzed to determine significant differences in time to complete the task and quality of repair. Participants were retested in a second session with music played in the opposite order to evaluate consistency. Listening to preferred music decreased repair time by 8% for all plastic surgery residents (p = 0.009). Subgroup analysis demonstrated even more significant improvement in speed for senior residents (PGY 4-6), resulting in a 10% decrease in repair time (p = 0.006). The quality of repair was also better in the music group, at 3.3 versus 3.1 (p = 0.047). Retesting revealed results remained significant whether music was played first or second. Playing preferred music made plastic surgery residents faster in completing wound closure with a 10% improvement in senior residents. Music also improved quality of repair as judged by blinded faculty. Our study showed that music improves efficiency of wound closure, which may translate to healthcare cost savings. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

  19. Laparoscopic Sleeve Gastrectomy versus Laparoscopic Banded Sleeve Gastrectomy: First Prospective Pilot Randomized Study

    Directory of Open Access Journals (Sweden)

    Valeria Tognoni

    2016-01-01

    Full Text Available Introduction. The placement of ring or band around the gastric tube might prevent the dilation after Laparoscopic Sleeve Gastrectomy (LSG. We describe the first randomized study comparing LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG. Material and Method. Fifty obese patients were enrolled in the study between January 2014 and January 2015. We analysed differences in operative time, complication rate, mortality, and BMI between the two groups over a period of 12 months. Results. Twenty-five patients received LSG (group A and 25 LBSG (group B. The mean preoperative BMI was 47.3±6.58 kg/m2 and 44.95±5.85 kg/m2, respectively, in the two groups. There was no statistical relevant difference in operative time. No intraoperative complications occurred. Mean BMI registered after 3, 6, and 12 months in groups A and B, respectively, were 37.86±5.72 kg/m2 and 37.58±6.21 kg/m2 (p=0.869, 33.64±6.08 kg/m2 and 32.03±5.24 kg/m2 (p=0.325, and 29.72±4.40 kg/m2 and 27.42±4.47 kg/m2 (p=0.186; no statistical relevant difference was registered between the two groups. Conclusion. LBSG is a safe and feasible procedure. The time required for the device positioning did not influence significantly the surgical time. The results of bodyweight loss did not document any statistically significant differences among the two groups, even though LBSG group showed a mean BMI slightly lower than that of the control group.

  20. Concomitant boost radiation therapy for inoperable non-small-cell lung cancer: preliminary report of a prospective randomized study

    International Nuclear Information System (INIS)

    Sun, L.-M.; Leung, Stephen Wan; Wang, C.-J.; Chen, H.-C.; Fang, F.-M.; Huang, E.-Y.; Hsu, H.-C.; Yeh, S.-A.; Hsiung, C.-Y.; Huang, David T.

    2000-01-01

    Purpose: The radiation therapy results for patients with inoperable non-small-cell lung cancer (NSCLC) have been disappointing. Tumor dose escalation using concomitant boost technique (CBT) has been shown to improve local control in a few prospective studies. This trial was carried out to prospectively assess the radiation response and acute toxicity of CBT in comparison to the conventional treatment technique (CTT). Methods and Materials: Ninety-seven consecutive eligible patients were entered in this prospective clinical trial between November 1994 and February 1998. Patients were randomized to receive either CBT (43 patients) or CTT (54 patients) radiation therapy. These patients either refused chemotherapy or were judged as unsuitable for chemotherapy. Patients in the CBT group received 46.8 Gy in 26 fractions using large fields that encompassed the gross and occult disease. A concomitant boost of 18.2 Gy (0.7 Gy per fraction) was delivered to the gross disease using small fields with 1.5-cm margins. The small fields were treated concurrently with the large fields and the total dose to the tumor area was 65 Gy in 26 fractions. Patients in the CTT group received 70.8 Gy in 38 fractions. The acute toxicity between each group was compared. The response rate was analyzed and compared by treatment group, gender, age, stage, histology, initial Karnofsky performance score (KPS), severity of acute toxicity, and maximum body weight loss (MBWL) during treatment course. Results: The demographic parameters such as sex, age, and stage were evenly distributed in each treatment group. The majority of these patients had Stage IIIA and IIIB disease. Overall median treatment times were 39 days for the CBT group of patients and 62 days for the CTT group. No treatment-related mortality was found. There were 2 patients in the CTT group with acute RTOG Grade 3 lung toxicity, and no Grade 3 lung or esophageal toxicity was observed in CBT group. The response rates, assessed by

  1. Comparison of two picosecond lasers to a nanosecond laser for treating tattoos: a prospective randomized study on 49 patients.

    Science.gov (United States)

    Lorgeou, A; Perrillat, Y; Gral, N; Lagrange, S; Lacour, J-P; Passeron, T

    2018-02-01

    Q-switched nanosecond lasers demonstrated their efficacy in treating most types of tattoos, but complete disappearance is not always achieved even after performing numerous laser sessions. Picosecond lasers are supposed to be more efficient in clearing tattoos than nanosecond lasers, but prospective comparative data remain limited. To compare on different types of tattoos the efficacy of a nanosecond laser with two types of picosecond lasers. We conducted a prospective randomized study performed from December 2014 to June 2016 on adult patients with all types of tattoos. The tattoos were divided into two halves of equal size. After randomization, half of the tattoo was treated with a picosecond laser and the other half with a nanosecond laser. The evaluation was performed on standardized pictures performed before treatment and 2 months after the last session, by two physicians, not involved in the treatment, blinded on the type of treatments received. The main end point was a clearance above 75% of the tattoos. A total of 49 patients were included. Professional tattoos represented 85.7%, permanent make-up 8.2% and non-professional tattoo 6.1%. The majority were black or blue and 10.2% were polychromatic. No patient was lost during follow-up. A reduction of 75% or more of the colour intensity was obtained for 33% of the tattoos treated with the picosecond lasers compared to 14% with the nanosecond laser (P = 0.008). An improvement superior to 75% was obtained in 34% monochromic black or blue tattoos with the picosecond lasers compared to 9% for the nanosecond laser. Only one of the five polychromic tattoos achieved more than 75% of improvement with the two types of laser. Our results show a statistically significant superiority of the picosecond lasers compared to the nanosecond laser for tattoo clearance. However, they do not show better efficacy for polychromic tattoos and the difference in terms of side-effects was also minimal with a tendency of picosecond

  2. Ankle Block vs Single-Shot Popliteal Fossa Block as Primary Anesthesia for Forefoot Operative Procedures: Prospective, Randomized Comparison.

    Science.gov (United States)

    Schipper, Oliver N; Hunt, Kenneth J; Anderson, Robert B; Davis, W Hodges; Jones, Carroll P; Cohen, Bruce E

    2017-11-01

    Postoperative pain is often difficult to control with oral medications, requiring large doses of opioid analgesia. Regional anesthesia may be used for primary anesthesia, reducing the need for general anesthetic and postoperative pain medication requirements in the immediate postoperative period. The purpose of this study was to compare the analgesic effects of an ankle block (AB) to a single-shot popliteal fossa block (PFB) for patients undergoing orthopedic forefoot procedures. All patients having elective outpatient orthopedic forefoot procedures were invited to participate in the study. Patients were prospectively randomized to receive either an ultrasound-guided AB or PFB by a board-certified anesthesiologist prior to their procedure. Intraoperative conversion to general anesthesia and postanesthesia care unit (PACU) opioid requirements were recorded. Postoperative pain was assessed using the visual analog scale (VAS) at regular time intervals until 8 am on postoperative day (POD) 2. Patients rated the effectiveness of the block on a 1 to 5 scale, with 5 being very effective. A total of 167 patients participated in the study with 88 patients (53%) receiving an AB and 79 (47%) receiving a single-shot PFB. There was no significant difference in the rate of conversion to general anesthesia between the 2 groups (13.6% [12/88] AB vs 12.7% [10/79] PFB). PACU morphine requirements and doses were significantly reduced in the PFB group ( P = .004) when compared to the AB group. The VAS was also significantly lower for the PFB patients at 10 pm on POD 0 (4.6 vs 1.6, P block site pain and/or erythema (AB 6.9% [6/88] vs PFB 5.1% [4/79], P = .44). The analgesic effect of the PFB lasted significantly longer when compared to the ankle block (AB 14.5 hours vs PFB 20.9 hours, P block between the 2 groups, with both blocks being highly effective (AB 4.79/5 vs PFB 4.82/5, P = .68). Regional anesthesia was a safe and reliable adjunct to perioperative pain management and highly

  3. Prospective randomized study comparing coronary artery bypass grafting with the new mini-extracorporeal circulation Jostra System or with a standard cardiopulmonary bypass.

    Science.gov (United States)

    Remadi, Jean Paul; Rakotoarivelo, Zava; Marticho, Paul; Benamar, Amar

    2006-01-01

    To assess the potential benefits of a new concept of cardiopulmonary bypass (CPB), the mini-extracorporeal circulation (MECC) Jostra System, we conducted a prospective randomized study among patients who underwent coronary artery bypass grafting (CABG) with a MECC Jostra System or with a standard CPB. In a prospective randomized study, 400 patients underwent elective CABG using a standard CPB (200 patients) or a Jostra MECC System (200 patients). The patients were randomly assigned to have preoperative data similar for both groups. The operative mortality rate (system is a new concept of CPB that seems to be reliable and safe. To perform CABG, the MECC provides an excellent surgical exposure like a standard CPB and a better biologic profile like CABG without CPB.

  4. Hypospadias repair using laser tissue soldering (LTS): preliminary results of a prospective randomized study

    Science.gov (United States)

    Kirsch, Andrew J.; Cooper, Christopher S.; Canning, Douglas A.; Snyder, Howard M., III; Zderic, Stephen A.

    1998-07-01

    Purpose: The purpose of this study was to evaluate laser tissue soldering using an 808 nm diode laser and wavelength- matched human albumin solder for urethral surgery in children. Methods: Currently, 30 boys, ages 3 months to 8 years were randomized to standard suturing (n equals 22) or 'sutureless' laser hypospadias repair (n equals 18). Laser soldering was performed with a human albumin solder doped with indocyanine green dye (2.5 mg/ml) using a laser power output of 0.5 W, pulse duration of 0.5 sec, and interval of 0.1 sec. Power density was approximately 16 W/cm2. In the laser group, sutures were used for tissue alignment only. At the time of surgery, neourethral and penile lengths, operative time for urethral repair, and number of sutures/throws were measured. Postoperatively, patients were examined for complications of wound healing, stricture, or fistula formation. Results: Mean age, severity of urethral defect, type of repair, and neourethra length were equivalent between the two groups. Operative time was significantly faster for laser soldering in both simple (1.6 plus or minus 0.21 min, p less than 0.001) and complex (5.4 plus or minus 0.28 min, p less than 0.0001) hypospadias repairs compared to controls (10.6 plus or minus 1.4 min and 27.8 plus or minus 2.9 min, respectively). The mean number of sutures used in the laser group for simple and complex repairs (3.3 plus or minus 0.3 and 8.1 plus or minus 0.64, respectively) were significantly (p less than 0.0001) less than for controls (8.2 plus or minus 0.84 and 20 plus or minus 2.3, respectively). Followup was between 3 months and 14 months. The overall complication rate in the laser group (11%) was lower than the controls (23%). However, statistical significance (p less than 0.05) was achieved only for the subgroup of patients undergoing simple repairs (LTS, 100% success versus suturing, 69% success). Conclusions: These preliminary results indicate that laser tissue soldering for hypospadias repair

  5. Influence of low ambient temperature on epitympanic temperature measurement: a prospective randomized clinical study.

    Science.gov (United States)

    Strapazzon, Giacomo; Procter, Emily; Putzer, Gabriel; Avancini, Giovanni; Dal Cappello, Tomas; Überbacher, Norbert; Hofer, Georg; Rainer, Bernhard; Rammlmair, Georg; Brugger, Hermann

    2015-11-05

    Epitympanic temperature (Tty) measured with thermistor probes correlates with core body temperature (Tcore), but the reliability of measurements at low ambient temperature is unknown. The aim of this study was to determine if commercially-available thermistor-based Tty reflects Tcore in low ambient temperature and if Tty is influenced by insulation of the ear. Thirty-one participants (two females) were exposed to room (23.2 ± 0.4 °C) and low (-18.7 ± 1.0 °C) ambient temperature for 10 min using a randomized cross-over design. Tty was measured using an epitympanic probe (M1024233, GE Healthcare Finland Oy) and oesophageal temperature (Tes) with an oesophageal probe (M1024229, GE Healthcare Finland Oy) inserted into the lower third of the oesophagus. Ten participants wore ear protectors (Arton 2200, Emil Lux GmbH & Co. KG, Wermelskirchen, Switzerland) to insulate the ear from ambient air. During exposure to room temperature, mean Tty increased from 33.4 ± 1.5 to 34.2 ± 0.8 °C without insulation of the ear and from 35.0 ± 0.8 to 35.5 ± 0.7 °C with insulation. During exposure to low ambient temperature, mean Tty decreased from 32.4 ± 1.6 to 28.5 ± 2.0 °C without insulation and from 35.6 ± 0.6 to 35.2 ± 0.9 °C with insulation. The difference between Tty and Tes at low ambient temperature was reduced by 82% (from 7.2 to 1.3 °C) with insulation of the ear. Epitympanic temperature measurements are influenced by ambient temperature and deviate from Tes at room and low ambient temperature. Insulating the ear with ear protectors markedly reduced the difference between Tty and Tes and improved the stability of measurements. The use of models to correct Tty may be possible, but results should be validated in larger studies.

  6. Topical Calendula and Betamethasone Valerate in the prevention of acute radiation dermatitis: a randomized prospective trial

    Directory of Open Access Journals (Sweden)

    Fotouhi M

    2007-07-01

    Full Text Available Background: Acute radiation dermatitis is a very common side effect of radiation therapy for many cancers, including breast cancer. Despite the high prevalence of acute radiation dermatitis as well as wet desquamation, only a few trials studying the prophylaxis of this complication using topical treatment have been conducted. In spite of these studies, some controversy still exists about regarding treatments for acute radiation dermatitis, as does some concern about their long-term complications. For this reason, we conducted a clinical trial for a new treatment with the same effectiveness as corticosteroids, but fewer complications. Methods: This trial included 60 patients with pathologic diagnoses of breast cancer for whom radiotherapy had been planned. Patients were 30-73 years old. Patients with radical mastectomy received 5000 cGy over five weeks, and those with conservative surgery received 6000 cGy over six weeks divided in 200 cGy fractions. Patients were divided randomly into two groups: one group received a moderately-potent glucocorticoid steroid, 0.1% betamethasone ointment (30, and the other received the new treatment, 0.1% calendula ointment (30. All patients applied their respective drugs twice daily within the tangential field from the first day of radiation treatment until one month after treatment was completed. Starting one week after radiation therapy commenced, patients were monitored weekly for symptoms of dermatitis and the degree of severity as well as possible adverse drug effects, in addition to such monitoring on the days of their appointments. Four weeks after termination of therapy, patients were again examined, at which time they completed a questionnaire about dermatologic complications. Results: The mean time to develop dermatitis was 3.7 weeks for the betamethasone group and 3.87 weeks for the calendula group. Maximal dermatitis intensity during treatment in the betamethasone group was: 0, 6.7%; I, 73.3%; II, 16

  7. Use of a sealant to prevent prolonged air leaks after lung resection: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Lequaglie Cosimo

    2012-10-01

    Full Text Available Abstract Background Pulmonary air leaks are common complications of lung resection and result in prolonged hospital stays and increased costs. The purpose of this study was to investigate whether, compared with standard care, the use of a synthetic polyethylene glycol matrix (CoSeal® could reduce air leaks detected by means of a digital chest drain system (DigiVent™, in patients undergoing lung resection (sutures and/or staples alone. Methods Patients who intraoperatively showed moderate or severe air leaks (evaluated by water submersion tests were intraoperatively randomized to receive just sutures/staples (control group or sutures/staples plus CoSeal® (sealant group. Differences among the groups in terms of air leaks, prolonged air leaks, time to chest tube removal, length of hospital stay and related costs were assessed. Results In total, 216 lung resection patients completed the study. Nineteen patients (18.1% in the control group and 12 (10.8% patients in the sealant group experienced postoperative air leaks, while a prolonged air leak was recorded in 11.4% (n = 12 of patients in the control group and 2.7% (n = 3 of patients in the sealant group. The difference in the incidence of air leaks and prolonged air leaks between the two groups was statistically significant (p = 0.0002 and p = 0.0013. The mean length of hospital stay was significantly shorter in the sealant group (4 days than the control group (8 days (p = 0.0001. We also observed lower costs in the sealant group than the control group. Conclusion The use of CoSeal® may decrease the occurrence and severity of postoperative air leaks after lung resection and is associated with shorter hospital stay. Trial registration Not registered. The trial was approved by the Institutional Review Board of the IRCCS-CROB Basilicata Regional Cancer Institute, Rionero in Vulture, Italy.

  8. One-site versus two-site phacotrabeculectomy: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Moschos MM

    2015-08-01

    Full Text Available Marilita M Moschos,1 Irini P Chatziralli,2 Michael Tsatsos3 1First Department of Ophthalmology, University of Athens, 2Second Department of Ophthalmology, Ophthalmiatrion Athinon, Athens, Greece; 3Department of Ophthalmology, Cambridge University Hospital NHS, Cambridge, UK Purpose: The purpose of this study is to compare the efficacy and safety of one-site and two-site combined phacotrabeculectomy with foldable posterior chamber intraocular lens implantation.Methods: Thirty-four patients (41 eyes with glaucoma and cataract were randomly assigned to undergo either a one-site (22 eyes or a two-site (19 eyes combined procedure. One-site approach consisted of a standard superior phacotrabeculectomy with a limbus-based conjunctival flap, while two-site approach consisted of a clear cornea phacoemulsification and a separate superior trabeculectomy with a limbus-based conjunctival flap.Results: Mean follow-up period was 54 months (standard deviation [SD] 2.3. Mean preoperative intraocular pressure (IOP in the one-site group was 21.3 mmHg (SD 2.8 and in the two-site group was 21.8 mmHg (SD 3.0 (P>0.1. Mean postoperative IOP significantly decreased in both groups compared to the preoperative level and was 15.6 mmHg (SD 3.5 in the one-site group and 14.9 mmHg (SD 2.7 in the two-site group. Three months later, the difference between the two groups was not statistically significant (P=0.058. The one-site group required significantly more medications than the two-site group (P=0.03. Best-corrected visual acuity (BCVA improved similarly in both groups, but there was less postoperative (induced astigmatism in the two-site group in a marginal statistical level (P=0.058. Intra- and postoperative complications were comparable in the two groups.Conclusion: Both techniques yielded similar results concerning final BCVA and IOP reduction. However, the two-site group had less induced astigmatism and a better postoperative IOP control with less required

  9. Anesthesiologic Effects of Transperitoneal Versus Extraperitoneal Approach During Robot-Assisted Radical Prostatectomy: Results of a Prospective Randomized Study

    Directory of Open Access Journals (Sweden)

    Fabrizio Dal Moro

    2015-06-01

    Full Text Available ABSTRACTObjectives:To compare the effects of CO2 insufflation on hemodynamics and oxygen levels and on acid-base level during Robot-Assisted Radical Prostatectomy (RARP with transperitoneal (TP versus extra-peritoneal (EP accesses.Materials and Methods:Sixty-two patients were randomly assigned to TP (32 and EP (30 to RARP. Pre-operation data were collected for all patients. Hemodynamic, respiratory and blood acid-base parameters were measured at the moment of induction of anesthesia (T0, after starting CO2 insuffation (T1, and at 60 (T2 and 120 minutes (T3 after insufflation. In all cases, the abdominal pressure was set at 15 mmHg. Complications were reported according to the Clavien-Dindo classification. Student's two–t-test, with a significance level set at pResults:The demographic characteristics of the patients in both groups were statistically comparable. Analysis of intra-operative anesthesiologic parameters showed that partial CO2 pressure during EP was significantly higher than during TP, with a consequent decrease in arterial pH. Other parameters analysed were similar in the two groups. Postoperative complications were comparable between groups. The most important limitations of this study were the small size of the patient groups and the impossibility of maintaining standard abdominal pressure throughout the operational phases, despite attempts to regulate it.Conclusions:This prospective randomized study demonstrates that, from the anesthesiologic viewpoint, during RARP the TP approach is preferable to EP, because of lower CO2 reabsorption and risk of acidosis.

  10. The effect of raloxifene on left ventricular hypertrophy in postmenopausal women: A prospective, randomized, and controlled study

    Science.gov (United States)

    Bal, Uğur Abbas; Atar, İlyas; Öktem, Mesut; B. Zeyneloğlu, Hulusi; Yıldırır, Aylin; Kuşcu, Esra; Müderrisoğlu, Haldun

    2015-01-01

    Objective: In healthy women, there is a progressive age-related increase in myocardial mass that is not seen in their male counterparts and occurs primarily in postmenopausal women. Raloxifene is a selective estrogen receptor modulator that has estrogenic actions on bone and the cardiovascular system. The aim of this study was to investigate the effect of raloxifene on myocardial hypertrophy in postmenopausal patients. Methods: A total of 22 postmenopausal osteoporotic women were included in this open-label, randomized, prospective, controlled study. Patients were randomized into two groups: 11 of the patients (group 1) were treated with raloxifene 60 mg/day, and the other 11 patients (group 2) were defined as the control group. Quantitative 2-dimensional and M-mode echocardiographic examination was performed in all patients at the beginning and repeated at the end of the 6-month follow-up period. Left ventricle mass (LVM) and left ventricle mass index (LVMI) were calculated for all patients. Results: The mean age of the patients was 57.2±3.9 years, and baseline clinical characteristics and echocardiographic parameters were similar between the two groups. After 6 months of raloxifene treatment, there was no difference in echocardiographic parameters of LVM and LVMI compared with the control group (201.2±25.9 gr vs. 169.7±46.2 gr, p=0.14 and 120.4±25.9 gr/m2 vs. 105.5±26.3 gr/m2, p=0.195, respectively). There was also no significant difference in LVM and LVMI in the within-group analysis of both groups. Conclusion: Raloxifene therapy does not affect myocardial hypertrophy in postmenopausal women after 6 months of treatment. PMID:25430415

  11. Defining Dogma: Quantifying Crystalloid Hemodilution in a Prospective Randomized Control Trial with Blood Donation as a Model for Hemorrhage.

    Science.gov (United States)

    Ross, Samuel Wade; Christmas, A Britton; Fischer, Peter E; Holway, Haley; Seymour, Rachel; Huntington, Ciara R; Heniford, B Todd; Sing, Ronald F

    2018-06-04

    The concept of hemodilution after blood loss and crystalloid infusion is a surgical maxim that remains unproven in humans. We sought to quantify the effect of hemodilution after crystalloid administration in voluntary blood donors as a model for acute hemorrhage. A prospective, randomized control trial was conducted in conjunction with community blood drives. Donors were randomized to receive no IV fluid(noIVF), two liters normal saline(NS), or two liters lactated ringers(LR) after blood donation. Blood samples were taken before donation of 500 mL of blood, immediately after donation, and following IV fluid administration. Hemoglobin(Hgb) was measured at each time point. Hgb between time points were compared between groups using standard statistical tests and the Bonferroni correction for multiple comparisons. Statistical significance was set at p≤0.0167. Of 165 patients consented, 157 patients completed the study. Average pre-donation Hgb was 14.3 g/dL. There was no difference in the mean Hgb levels after blood donation between the three groups(p>0.05). Compared to the control group, there was a significant drop in Hgb in the crystalloid infused groups from the post-donation level to post-resuscitation(13.2 vs 12.1 vs 12.2 g/dL, pdonation Hgb - hemorrhage Hgb drop - equilibration hemoglobin drop - resuscitation Hgb drop)=MeanPre-donation Hgb - [(EBL/TBV)*l] - [(EBL/TBV)*h] - [(VR/TBV)*r], l = 5.111g/dL = blood loss coefficient, h=6.722 g/dL=equilibration coefficient, r= 2.617g/dL= resuscitation coefficient. This study proves the concept of hemodilution and derived a mathematical relationship between blood loss and resuscitation. This data may help to estimate response of hemoglobin levels to blood loss and fluid resuscitation in clinical practice. Copyright © 2018. Published by Elsevier Inc.

  12. A prospective randomized study of operative treatment for noncomminuted humeral shaft fractures: conventional open plating versus minimal invasive plate osteosynthesis.

    Science.gov (United States)

    Kim, Ji Wan; Oh, Chang-Wug; Byun, Young-Soo; Kim, Jung Jae; Park, Ki Chul

    2015-04-01

    To compare the clinical and radiologic results of conventional open plating (COP) and minimally invasive plate osteosynthesis (MIPO) in the treatment of noncomminuted humeral shaft fractures. Randomized prospective study. Five level 1 trauma centers. Sixty-eight consecutive patients were randomized into 2 study groups: those treated by COP (COP group; n = 32) and those treated by MIPO (MIPO group; n = 36). Simple humeral shaft fractures (AO/OTA classification types A and B) were reduced by open reduction or closed reduction and fixed with a narrow 4.5/5.0 locking compression plate, metaphyseal locking compression plate, or proximal humeral internal locking system plate to the anterior lateral aspect of the humerus. Fracture healing time, operative time, radiation exposure time, and intraoperative nerve injury. To assess shoulder and elbow function, we used the University of California, Los Angeles (UCLA) scoring system and the Mayo elbow performance index, including the range of motion and pain. Radiographic measurements included fracture alignment, delayed union, and nonunion. Thirty-one fractures (97%) healed in the COP group within 16 weeks, whereas 36 fractures (100%) were healed in the MIPO group by 15 weeks. No significant difference was observed in the operative time or complication rates. In both groups, all fractures achieved union without malunion and with excellent functional outcomes by definition of the Mayo elbow performance index and UCLA scoring system. This study confirmed a high overall rate of union and excellent functional outcomes in both MIPO and COP groups. MIPO is equivalent to COP as a safe and effective method for simple types of humeral shaft fractures when surgery is indicated, and the surgeon is experienced in the technique. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  13. Combination therapy with milrinone and esmolol for heart protection in patients with severe sepsis: a prospective, randomized trial.

    Science.gov (United States)

    Wang, Zenggeng; Wu, Qinghua; Nie, Xiangbi; Guo, Jinghua; Yang, Chunli

    2015-11-01

    As a β-adrenoceptor antagonist (β-blocker), esmolol can reduce cardiac output and the phosphodiesterase III inhibitor milrinone has been shown to improve heart contractility in patients with septic shock. This study was performed to assess the effects of esmolol combined with milrinone in patients with severe sepsis. This prospective randomized study was conducted in patients with severe sepsis in the intensive care unit of the Jiangxi Provincial People's Hospital (Nanchang, Jiangsu, China) between June 2013 and June 2014. Patients were randomly divided into control (C), milrinone (M), and milrinone-esmolol (ME) groups. The primary outcome was the rate of controlling the heart rate (HR) to achieve target levels. Secondary outcomes included the 28-day survival rate and changes in hemodynamic variables, organ function variables, myocardial injury markers, and the serum levels of proinflammatory factors. A total of 90 patients with severe sepsis were included in this study (30 per group). The HR in the ME group was lower than in the M and C groups after 12 h. The rate of successful HR control during the first 96 h was significantly higher in the ME group (60.0 vs. 33.3 % in the M group, vs. 26.7 % in the C group). Also, patients in the ME group had higher 28-day overall survival compared with the M (Log rank statistic = 5.452; P = 0.020) and C groups (Log rank statistic = 10.206; P = 0.001). Additionally, several variables showed significant improvement in the ME group 96 h after treatment compared with the M and C groups (P milrinone and esmolol could improve cardiac function and the 28-day survival rate in patients with severe sepsis.

  14. A prospective, randomized, single - blind study comparing intraplaque injection of thiocolchicine and verapamil in Peyronie's Disease: a pilot study

    Directory of Open Access Journals (Sweden)

    I. L. Toscano Jr.

    Full Text Available ABSTRACT Objectives: To compare the response to tiocolchicine and verapamil injection in the plaque of patients with Peyronie's disease. Materials and Methods: Prospective, single-blind, randomized study, selecting patients who have presented Peyronie's disease for less than 18 months. Thiocolchicine 4mg or verapamil 5mg were given in 7 injections (once a week. Patients who had received any treatment for Peyronie's disease in the past three months were excluded. The parameters used were the International Index of Erectile Function (IIEF-5 score, analysis of the curvature on pharmaco-induced erections and size of the plaque by ultrasonography. Results: Twenty-five patients were randomized, 13 received thiocolchicine and 12 were treated with verapamil. Both groups were statistically similar. The mean curvature was 46.7° and 36.2° before and after thiocolchicine, respectively (p=0.019 and 50.4° and 42.08° before and after verapamil, respectively (p=0.012. The curvature improved in 69% of patients treated with thiocolchicine and in 66% of those who received verapamil. Regarding sexual function, there was an increase in the IIEF-5 from 16.69 to 20.85 (p=0.23 in the thiocolchicine group. In the verapamil group the IIEF-5 score dropped from 17.50 to 16.25 (p=0.58. In the thiocolchicine group, the plaque was reduced in 61% of patients. In the verapamil group, 8% presented decreased plaque size. No adverse event was associated to thiocolchicine. Conclusion: The use of thiocolchicine in Peyronie's disease demonstrated improvement on penile curvature and reduction in plaque size. Thiocolchicine presented similar results to verapamil in curvature assessment. No significant side effects were observed with the use of tiocolchicine.

  15. Prospective randomized crossover study of a new closed-loop control system versus pressure support during weaning from mechanical ventilation.

    Science.gov (United States)

    Clavieras, Noémie; Wysocki, Marc; Coisel, Yannael; Galia, Fabrice; Conseil, Matthieu; Chanques, Gerald; Jung, Boris; Arnal, Jean-Michel; Matecki, Stefan; Molinari, Nicolas; Jaber, Samir

    2013-09-01

    Intellivent is a new full closed-loop controlled ventilation that automatically adjusts both ventilation and oxygenation parameters. The authors compared gas exchange and breathing pattern variability of Intellivent and pressure support ventilation (PSV). In a prospective, randomized, single-blind design crossover study, 14 patients were ventilated during the weaning phase, with Intellivent or PSV, for two periods of 24 h in a randomized order. Arterial blood gases were obtained after 1, 8, 16, and 24 h with each mode. Ventilatory parameters were recorded continuously in a breath-by-breath basis during the two study periods. The primary endpoint was oxygenation, estimated by the calculation of the difference between the PaO2/FIO2 ratio obtained after 24 h of ventilation and the PaO2/FIO2 ratio obtained at baseline in each mode. The variability in the ventilatory parameters was also evaluated by the coefficient of variation (SD to mean ratio). There were no adverse events or safety issues requiring premature interruption of both modes. The PaO2/FIO2 (mean ± SD) ratio improved significantly from 245 ± 75 at baseline to 294 ± 123 (P = 0.03) after 24 h of Intellivent. The coefficient of variation of inspiratory pressure and positive end-expiratory pressure (median [interquartile range]) were significantly higher with Intellivent, 16 [11-21] and 15 [7-23]%, compared with 6 [5-7] and 7 [5-10]% in PSV. Inspiratory pressure, positive end-expiratory pressure, and FIO2 changes were adjusted significantly more often with Intellivent compared with PSV. Compared with PSV, Intellivent during a 24-h period improved the PaO2/FIO2 ratio in parallel with more variability in the ventilatory support and more changes in ventilation settings.

  16. Adjuvant therapy in stage I and stage II epithelial ovarian cancer. Results of two prospective randomized trials

    International Nuclear Information System (INIS)

    Young, R.C.; Walton, L.A.; Ellenberg, S.S.; Homesley, H.D.; Wilbanks, G.D.; Decker, D.G.; Miller, A.; Park, R.; Major, F. Jr.

    1990-01-01

    About a third of patients with ovarian cancer present with localized disease; despite surgical resection, up to half the tumors recur. Since it has not been established whether adjuvant treatment can benefit such patients, we conducted two prospective, randomized national cooperative trials of adjuvant therapy in patients with localized ovarian carcinoma. All patients underwent surgical resection plus comprehensive staging and, 18 months later, surgical re-exploration. In the first trial, 81 patients with well-differentiated or moderately well differentiated cancers confined to the ovaries (Stages Iai and Ibi) were assigned to receive either no chemotherapy or melphalan (0.2 mg per kilogram of body weight per day for five days, repeated every four to six weeks for up to 12 cycles). After a median follow-up of more than six years, there were no significant differences between the patients given no chemotherapy and those treated with melphalan with respect to either five-year disease-free survival or overall survival. In the second trial, 141 patients with poorly differentiated Stage I tumors or with cancer outside the ovaries but limited to the pelvis (Stage II) were randomly assigned to treatment with either melphalan (in the same regimen as above) or a single intraperitoneal dose of 32P (15 mCi) at the time of surgery. In this trial (median follow-up, greater than 6 years) the outcomes for the two treatment groups were similar with respect to five-year disease-free survival (80 percent in both groups) and overall survival (81 percent with melphalan vs. 78 percent with 32P; P = 0.48). We conclude that in patients with localized ovarian cancer, comprehensive staging at the time of surgical resection can serve to identify those patients (as defined by the first trial) who can be followed without adjuvant chemotherapy

  17. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital.

    Science.gov (United States)

    Knudson, Rachel A; Dunlavy, Paul W; Franko, Jan; Raman, Shankar R; Kraemer, Soren R

    2016-09-01

    Prior industry conducted studies have shown that long acting liposomal bupivacaine injection improves pain control postoperatively. To evaluate whether liposomal bupivacaine reduced the use of postoperative opioid (http://links.lww.com/DCR/A253) pain medication as compared to standard bupivacaine following colorectal surgery. A double blinded, prospective, randomized controlled trial comparing liposomal bupivacaine versus standard bupivacaine in patients undergoing elective colon resection. Community hospital with general surgery residency program with all cases performed by colorectal surgeons. Fifty-seven patients were randomized and reported as intention-to-treat analysis with 6 protocol violations. Sensitivity analysis excluding these 6 patients demonstrated no change in study results or conclusion. Mean age was 67 ± 2 years and 56% were male. There were 36 patients who underwent minimally invasive surgery, and 21 patients had an open colon resection. Experimental arm received liposomal bupivacaine while control arm received standard bupivacaine. Primary outcome measure was intravenous hydromorphone equivalent used via PCA during first 48 hours after operation. There was no significant difference between the two groups in the amount of opioid used orally or intravenously in the postoperative period. The primary outcome measure was PCA hydromorphone consumption during first two postoperative days after operation (hydromorphone equivalent use in standard bupivacaine group 11.3 ± 8.9 mg versus 13.3 ± 11.9 mg in liposomal bupivacaine group, p = 0.58 Mann-Whitney test). Small pragmatic trials typically remain underpowered for secondary analyses. A larger study could help to further delineate other outcomes that are impacted by postoperative pain. Liposomal bupivacaine did not change the amount of opioid used postoperatively. Based on our study, liposomal bupivacaine does not provide any added benefit over conventional bupivacaine after colon

  18. Prospective Randomized Evaluation of Intraoperative Application of Autologous Platelet-Rich Plasma on Surgical Site Infection or Delayed Wound Healing.

    Science.gov (United States)

    SanGiovanni, Thomas P; Kiebzak, Gary M

    2016-05-01

    Prevention of surgical site infections and the reduction of wound-related complication rates have become increasingly emphasized by hospital task groups and government agencies given the degree of economic burden it places on the health care system. Platelet-rich plasma (PRP) contains growth factors and other biomolecules that promote endogenous microbicidal activity. We hypothesized that PRP would help prevent postoperative infection and delayed wound healing (DWH). We randomized patients having foot or ankle surgery to the treatment group receiving intraoperative PRP (applied to operative field) and platelet-poor plasma at closing (PPP, on the sutured skin) or the control group (no PRP/PPP). The incidence of deep surgical site infection and DWH (collectively called endpoints) was compared between groups (n = 250/group). PRP had a mean 5.3-fold platelet concentration compared to whole blood, with concentrated white blood cells. Mean age (±SD) of patients was 52 years (±15), 65% were women. Minor and major operative procedures were included. Patients were followed for 60 days. Seventy controls had PRP prepared for assay of growth factors. Procedure mix, ASA scores, mean operative times, and comorbidity mix were similar between groups. The primary result was no difference in number of endpoints between groups: 19 patients in the PRP group (7.6%) versus 18 controls (7.2%). Endpoints were deep surgical site infections in 2 PRP/PPP patients and 1 control, and DWH in 17 PRP/PPP patients and 17 controls. Analysis of PRP samples revealed a large variation in growth factor concentrations between patients. Intraoperative application of PRP/PPP did not reduce the incidence of postoperative infection or DWH. Growth factor profiles varied greatly between patients, suggesting that the potentially therapeutic treatment delivered was not consistent from patient-to-patient. Level I, prospective randomized trial. © The Author(s) 2015.

  19. Metoclopramide improves the quality of tramadol PCA indistinguishable to morphine PCA: a prospective, randomized, double blind clinical comparison.

    Science.gov (United States)

    Pang, Weiwu; Liu, Yu-Cheng; Maboudou, Edgard; Chen, Tom Xianxiu; Chois, John M; Liao, Cheng-Chun; Wu, Rick Sai-Chuen

    2013-09-01

    Multimodal analgesia has been effectively used in postoperative pain control. Tramadol can be considered "multimodal" because it has two main mechanisms of action, an opioid agonist and a reuptake inhibitor of norepinephrine and serotonin. Tramadol is not as commonly used as morphine due to the increased incidence of postoperative nausea and vomiting (PONV). As metoclopramide is an antiemetic and an analgesic, it was hypothesized that when added to reduce PONV, metoclopromide may enhance the multimodal feature of tramadol by the analgesic property of metoclopramide. Therefore, the effectiveness of postoperative patient-controlled analgesia (PCA) with morphine was compared against PCA with combination of tramadol and metoclopramide. A prospective, randomized, double blind clinical trial. Academic pain service of a university hospital. Sixty patients undergoing elective total knee arthroplasty with general anesthesia. Sixty patients were randomly divided into Group M and Group T. In a double-blinded fashion, Group M received intraoperative 0.2 mg/kg morphine and postoperative PCA with 1 mg morphine per bolus, whereas Group T received intraoperative tramadol 2.5 mg/kg and postoperative PCA with 20 mg tramadol plus 1 mg metoclopramide per bolus. Lockout interval was 5 minutes in both groups. Pain scale, satisfaction rate, analgesic consumption, PCA demand, and side effects were recorded by a blind investigator. These two groups displayed no statistically significant difference between the items and variables evaluated. This combination provides analgesia equivalent to that of morphine and can be used as an alternative to morphine PCA. Wiley Periodicals, Inc.

  20. Comparative study of intravenous Tramadol versus Ketorolac for preventing postoperative pain after third molar surgery--a prospective randomized study.

    Science.gov (United States)

    Gopalraju, Prathibha; Lalitha, Ramanujapuram Manikarnike; Prasad, Kavitha; Ranganath, Krishnappa

    2014-07-01

    The aim of this comparative, prospective, randomized, controlled study was to evaluate two different regimens of analgesics: a preoperative intravenous dose of either Tramadol or Ketorolac given 10 min prior to surgery to assess their impact on clinical recovery after third molar surgery. Forty patients requiring surgical extraction of unilateral impacted mandibular third molars similar in position were enrolled in the study. Patients were randomly divided into two groups based on permuting the numbers. Patients in Group 1 and Group 2 were administered either Tramadol 50 mg or Ketorolac 30 mg, intravenously, 10 min prior to surgery. The difference in postoperative pain was assessed by four primary points: pain intensity as measured by a 10 mm visual analogue scale hourly for 12 h, median time to rescue analgesics, number of analgesics consumed and patient's overall 5-point global assessment scale. Throughout the 12 h investigation period, patients treated with Ketorolac reported significantly lower pain intensity scores, significantly longer time to rescue analgesics (Acetaminophen 500 mg) and less intake of postoperative analgesics. In Group 2, 40% of the patient had good overall assessment as compared to Group 1 where only 25% of patients had good overall assessment. The current study shows that pre-emptive use of Inj. Ketorolac 30 mg intravenously can reduce the severity of the postoperative sequelae of asymptomatic impacted mandibular third molar surgery. Copyright © 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  1. A Prospective, Randomized Trial in The Emergency Department Of Suggestive Audio-Therapy Under Deep Sedation for Smoking Cessation

    Directory of Open Access Journals (Sweden)

    Shah, Sushma

    2007-08-01

    Full Text Available Objectives: In a sample of patients undergoing procedural deep sedation in the emergency department (ED, we conducted a prospective, randomized, single-blinded trial of audio-therapy for smoking cessation. Methods: We asked subjects about their smoking, including desire to quit (0-10 numerical scale and number of cigarettes smoked per day. Subjects were randomized to either a control tape (music alone or a tape with repeated smoking-cessation messages over music. Tapes were started with first doses of sedation and stopped with patient arousal. Telephone follow-up occurred between two weeks and three months to assess the number of cigarettes smoked per day. Study endpoints were self-reported complete cessation and decrease of half or more in total cigarettes smoked per day. Results: One hundred eleven patients were enrolled in the study, 54 to intervention and 57 to control. Mean desire to quit was 7.15 ± 2.6 and mean cigarettes per day was 17.5 ± 12.1. We successfully contacted 69 (62% patients. Twenty-seven percent of intervention and 26% of control patients quit (mean difference = 1%; 95% CI: –22.0% to 18.8%. Thirty-seven percent of intervention and 51% of control patients decreased smoking by half or more (mean difference = 14.6%; 95% CI: –8.7% to 35.6%. Conclusion: Suggestive audio-therapy delivered during deep sedation in the ED did not significantly decrease self-reported smoking behavior.

  2. A prospective, randomized, controlled study of a suspension positioning system used with elderly bedridden patients with neurogenic fecal incontinence.

    Science.gov (United States)

    Su, Mei-Yin; Lin, Shi-Quan; zhou, Ye-Wen; Zhou, Ye-Wen; Liu, Si-Ya; Lin, Ai; Lin, Xi-Rong

    2015-01-01

    Elderly patients with acute neurological impairment are prone to severe disability, fecal incontinence (FI), and resultant complications. A suspension positioning system (SPS), based on the orthopedic suspension traction system commonly used for conservative treatment of pediatric femoral fracture and uncomplicated adult pelvic fracture, was developed to facilitate FI management in patients immobilized secondary to an acute neurological condition. To evaluate the effectiveness and safety of the system, a prospective, randomized, controlled study was conducted between October 2009 and July 2012. Two hundred (200) elderly, bedridden, hospitalized patients with acute, nonchronic neurological impairment were randomly assigned to receive routine FI nursing care (ie, individualized dietary modification, psychological support, health education, and social support for caregivers and family members [control group]) or routine incontinence care plus the SPS (experimental group) during the day. Rates of perianal fecal contamination, skin breakdown, incontinence associated dermatitis, pressure ulcer development, and lower urinary tract infection (LUTI) were significantly lower in the SPS than in the control group (P <0.05). Length of hospitalization and costs of care were also lower in the SPS group (P <0.05). Patient quality-of-life (QoL) and FI QoL scores were similar at baseline but significantly higher (better) at the 6-month follow-up interview in the SPS than in the control group (P <0.05). In this study, the rate of FI-associated morbidities was lower and 6-month patient QoL scores were higher in the SPS than in the control group. No adverse events were observed, and all patients completed the study. Further clinical studies are needed to examine the long-term effects of SPS use among neurologically impaired FI patients.

  3. Hyperbaric oxygen therapy can improve post concussion syndrome years after mild traumatic brain injury - randomized prospective trial.

    Directory of Open Access Journals (Sweden)

    Rahav Boussi-Gross

    Full Text Available Traumatic brain injury (TBI is the leading cause of death and disability in the US. Approximately 70-90% of the TBI cases are classified as mild, and up to 25% of them will not recover and suffer chronic neurocognitive impairments. The main pathology in these cases involves diffuse brain injuries, which are hard to detect by anatomical imaging yet noticeable in metabolic imaging. The current study tested the effectiveness of Hyperbaric Oxygen Therapy (HBOT in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments.The trial population included 56 mTBI patients 1-5 years after injury with prolonged post-concussion syndrome (PCS. The HBOT effect was evaluated by means of prospective, randomized, crossover controlled trial: the patients were randomly assigned to treated or crossover groups. Patients in the treated group were evaluated at baseline and following 40 HBOT sessions; patients in the crossover group were evaluated three times: at baseline, following a 2-month control period of no treatment, and following subsequent 2-months of 40 HBOT sessions. The HBOT protocol included 40 treatment sessions (5 days/week, 60 minutes each, with 100% oxygen at 1.5 ATA. "Mindstreams" was used for cognitive evaluations, quality of life (QOL was evaluated by the EQ-5D, and changes in brain activity were assessed by SPECT imaging. Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period. SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements.HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage.ClinicalTrials.gov NCT00715052.

  4. Hyperbaric oxygen therapy can improve post concussion syndrome years after mild traumatic brain injury - randomized prospective trial.

    Science.gov (United States)

    Boussi-Gross, Rahav; Golan, Haim; Fishlev, Gregori; Bechor, Yair; Volkov, Olga; Bergan, Jacob; Friedman, Mony; Hoofien, Dan; Shlamkovitch, Nathan; Ben-Jacob, Eshel; Efrati, Shai

    2013-01-01

    Traumatic brain injury (TBI) is the leading cause of death and disability in the US. Approximately 70-90% of the TBI cases are classified as mild, and up to 25% of them will not recover and suffer chronic neurocognitive impairments. The main pathology in these cases involves diffuse brain injuries, which are hard to detect by anatomical imaging yet noticeable in metabolic imaging. The current study tested the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments. The trial population included 56 mTBI patients 1-5 years after injury with prolonged post-concussion syndrome (PCS). The HBOT effect was evaluated by means of prospective, randomized, crossover controlled trial: the patients were randomly assigned to treated or crossover groups. Patients in the treated group were evaluated at baseline and following 40 HBOT sessions; patients in the crossover group were evaluated three times: at baseline, following a 2-month control period of no treatment, and following subsequent 2-months of 40 HBOT sessions. The HBOT protocol included 40 treatment sessions (5 days/week), 60 minutes each, with 100% oxygen at 1.5 ATA. "Mindstreams" was used for cognitive evaluations, quality of life (QOL) was evaluated by the EQ-5D, and changes in brain activity were assessed by SPECT imaging. Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period. SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements. HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage. ClinicalTrials.gov NCT00715052.

  5. Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation.

    Science.gov (United States)

    Hsieh, Yu-Hsi; Tseng, Chih-Wei; Hu, Chi-Tan; Koo, Malcolm; Leung, Felix W

    2017-07-01

    Adenoma detection rate (ADR), defined as the proportion of patients with at least one adenoma of any size, is a quality indicator. We tested the hypothesis that water exchange (WE) improves ADR but water immersion (WI) has no adverse effect on ADR compared with air insufflation (AI). A prospective study was conducted at the Dalin Tzu Chi Hospital in southern Taiwan and the Hualien Tzu Chi Hospital in eastern Taiwan on patients randomly assigned to WE, WI, or AI with stratification by the 3 study colonoscopists. The primary outcome was ADR. From July 2013 to December 2015, 651 patients were recruited and randomized into 3 groups with a 1:1:1 ratio (217 patients per group). Overall, ADR met quality standards: WE 49.8% (95% CI, 43.2%-56.4%), AI 37.8% (95% CI, 31.6%-44.4%), and WI 40.6% (95% CI, 34.2%-47.2%). Compared with AI, WE significantly increased ADR (P = .016). There was no difference between WI and WE. ADRs of WI and AI were comparable. Compared with AI, WE confirmed a longer insertion time, higher cleanliness score, but similar adenoma per positive colonoscopy (APPC) and withdrawal time with polypectomy. Subgroup analysis found WE significantly increased ADR in propofol-sedated patients. Multivariate generalized linear mixed model analysis revealed that age ≥50 years, WE (vs AI), colonoscopy indication, no previous history of colonoscopy, and withdrawal time >8 minutes were significant predictors of increased ADR. Confirmation of prior reports showing WE, but not WI, increased ADR further strengthened the validity of our observations. WE significantly increased ADR in propofol-sedated patients. The outcome differences justify assessment of the role of WE in colorectal cancer prevention. Similar APPC and withdrawal times suggest that adequate inspection was performed on colonoscope withdrawal in each of the study arms. (Clinical trial registration number: NCT01894191.). Copyright © 2017 American Society for Gastrointestinal Endoscopy. All rights reserved.

  6. Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II.

    Science.gov (United States)

    Versyck, Barbara; van Geffen, Geert-Jan; Van Houwe, Patrick

    2017-08-01

    The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. A prospective randomized double blind placebo-controlled study. A secondary hospital. 140 breast cancer stage 1-3 patients undergoing mastectomy or tumorectomy with sentinel node or axillary node dissection. Patients were randomized to receive either a Pecs block with levobupivacaine 0.25% (n=70) or placebo block with saline (n=70). The pain levels were evaluated by Numeric Rating Scale (NRS) pain scores at 15-minute intervals during the post anesthesia care unit stay time (PACU), at 2-hour intervals for the first 24h on the ward and at 4-hour intervals for the next 24h. Intraoperative and postoperative opioid consumption were recorded during the full stay. Patient satisfaction was evaluated upon discharge using a 10-point scale. Intraoperative sufentanil requirements were comparable for the Pecs and placebo group (8.0±3.5μg and 7.8±3.0μg, P=0.730). Patients in the Pecs group experienced significantly less pain than patients in the control group (P=0.048) during their PACU stay. Furthermore, patients in the Pecs group required significant less postoperative opioids (9.16±10.15mg and 14.97±14.38mg morphine equivalent, P=0.037) and required significant fewer postsurgical opioid administration interventions than patients in the control group (P=0.045). Both patient-groups were very satisfied about their management (9.6±0.6 and 9.1±1.8 on a 10-point scale, P=0.211). The Pecs block reduces postsurgical opioid consumption during the PACU stay time for patients undergoing breast surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Air charged and microtip catheters cannot be used interchangeably for urethral pressure measurement: a prospective, single-blind, randomized trial.

    Science.gov (United States)

    Zehnder, Pascal; Roth, Beat; Burkhard, Fiona C; Kessler, Thomas M

    2008-09-01

    We determined and compared urethral pressure measurements using air charged and microtip catheters in a prospective, single-blind, randomized trial. A consecutive series of 64 women referred for urodynamic investigation underwent sequential urethral pressure measurements using an air charged and a microtip catheter in randomized order. Patients were blinded to the type and sequence of catheter used. Agreement between the 2 catheter systems was assessed using the Bland and Altman 95% limits of agreement method. Intraclass correlation coefficients of air charged and microtip catheters for maximum urethral closure pressure at rest were 0.97 and 0.93, and for functional profile length they were 0.9 and 0.78, respectively. Pearson's correlation coefficients and Lin's concordance coefficients of air charged and microtip catheters were r = 0.82 and rho = 0.79 for maximum urethral closure pressure at rest, and r = 0.73 and rho = 0.7 for functional profile length, respectively. When applying the Bland and Altman method, air charged catheters gave higher readings than microtip catheters for maximum urethral closure pressure at rest (mean difference 7.5 cm H(2)O) and functional profile length (mean difference 1.8 mm). There were wide 95% limits of agreement for differences in maximum urethral closure pressure at rest (-24.1 to 39 cm H(2)O) and functional profile length (-7.7 to 11.3 mm). For urethral pressure measurement the air charged catheter is at least as reliable as the microtip catheter and it generally gives higher readings. However, air charged and microtip catheters cannot be used interchangeably for clinical purposes because of insufficient agreement. Hence, clinicians should be aware that air charged and microtip catheters may yield completely different results, and these differences should be acknowledged during clinical decision making.

  8. Comparison of del Nido and St Thomas Cardioplegia Solutions in Pediatric Patients: A Prospective Randomized Clinical Trial.

    Science.gov (United States)

    Talwar, Sachin; Bhoje, Amolkumar; Sreenivas, Vishnubhatla; Makhija, Neeti; Aarav, Sudheer; Choudhary, Shiv Kumar; Airan, Balram

    2017-01-01

    We conducted a prospective randomized trial to compare del Nido (DN) cardioplegia with conventional cold blood cardioplegia (St Thomas [STH]) in pediatric patients. We randomized 100 pediatric patients aged ≤12 years undergoing elective repair of ventricular septal defects and tetralogy of Fallot to the DN and the STH groups. In the DN group, a 20 mL/kg single dose was administered. In the STH group, a 30 mL/kg dose was administered, followed by repeated doses at 25- to 30-minute intervals. The primary outcome was cardiac index that was measured 4 times intra- and postoperatively. Troponin-I, interleukin-6, and tissue necrosis factor-alpha were measured. Myocardial biopsy was obtained to assess electron-microscopic ultrastructural changes. Cardiac indices were significantly higher in the DN group than in the STH group 2 hours after termination of cardiopulmonary bypass (P = 0.0006), after 6 hours (P = 0.0006), and after 24 hours (P ≤ 0.0001). On repeated measure regression analysis, the cardiac index was on an average 0.50 L/min/m 2 higher in the DN group than in the STH group at any time point (P = 0.002). Duration of mechanical ventilation (P = 0.01), intensive care unit stay (P = 0.01), and hospital stay (P = 0.0007) was significantly lower in the DN group. Patients in the DN group exhibited lower troponin-I release 24 hours following cardiopulmonary bypass (P = 0.021). Electron microscopic studies showed more myofibrillar disarray in the STH group (P = 0.02). Use of long-acting DN cardioplegia solution was associated with better preservation of cardiac index, lesser troponin-I release, and decreased morbidity. Ultrastructural changes showed better preservation of myofibrillar architecture. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

    Science.gov (United States)

    Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P videogames were equally effective as traditional therapy for overall ROM gains and resulted in quicker recovery of motion with less pain experienced. Such videogames are a useful adjunct to therapy and should be considered as part of a holistic approach to rehabilitation within the hospital and at home after discharge in pediatric patients recovering from burn injury.

  10. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2013-02-01

    The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the 133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery. No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.

  11. Effect of increased exercise in school children on physical fitness and endothelial progenitor cells: a prospective randomized trial.

    Science.gov (United States)

    Walther, Claudia; Gaede, Luise; Adams, Volker; Gelbrich, Götz; Leichtle, Alexander; Erbs, Sandra; Sonnabend, Melanie; Fikenzer, Kati; Körner, Antje; Kiess, Wieland; Bruegel, Mathias; Thiery, Joachim; Schuler, Gerhard

    2009-12-01

    The aim of this prospective, randomized study was to examine whether additional school exercise lessons would result in improved peak oxygen uptake (primary end point) and body mass index-standard deviation score, motor and coordinative abilities, circulating progenitor cells, and high-density lipoprotein cholesterol (major secondary end points). Seven sixth-grade classes (182 children, aged 11.1+/-0.7 years) were randomized to an intervention group (4 classes with 109 students) with daily school exercise lessons for 1 year and a control group (3 classes with 73 students) with regular school sports twice weekly. The significant effects of intervention estimated from ANCOVA adjusted for intraclass correlation were the following: increase of peak o(2) (3.7 mL/kg per minute; 95% confidence interval, 0.3 to 7.2) and increase of circulating progenitor cells evaluated by flow cytometry (97 cells per 1 x 10(6) leukocytes; 95% confidence interval, 13 to 181). No significant difference was seen for body mass index-standard deviation score (-0.08; 95% confidence interval, -0.28 to 0.13); however, there was a trend to reduction of the prevalence of overweight and obese children in the intervention group (from 12.8% to 7.3%). No treatment effect was seen for motor and coordinative abilities (4; 95% confidence interval, -1 to 8) and high-density lipoprotein cholesterol (0.03 mmol/L; 95% confidence interval, -0.08 to 0.14). Regular physical activity by means of daily school exercise lessons has a significant positive effect on physical fitness (o(2)max). Furthermore, the number of circulating progenitor cells can be increased, and there is a positive trend in body mass index-standard deviation score reduction and motor ability improvement. Therefore, we conclude that primary prevention by means of increasing physical activity should start in childhood. URL: http://www.clinicaltrials.gov. Identifier: NCT00176371.

  12. Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site.

    Science.gov (United States)

    Hacker, Francis M; Babcock, Rebecca M; Hacker, Robert J

    2013-12-15

    Prospective, single-site, randomized, Food and Drug Administration-approved investigational device exemption clinical trials of 2 cervical arthroplasty (CA) devices. To evaluate complications with CA occurring more than 4 years after the surgical procedure in Food and Drug Administration clinical trials of the Bryan and Prestige LP arthroplasty devices. Reports of several randomized clinical studies have shown CA to be a safe and effective alternative to anterior cervical fusion in the treatment of degenerative cervical disc disorders. A majority include follow-up intervals of 4 years or less. Between 2002 and 2006, 94 patients were enrolled in Food and Drug Administration studies of the Bryan and Prestige LP cervical disc devices. Charts, imaging studies, and hospital records were reviewed for those who underwent arthroplasty and returned more than 4 years after their surgical procedure with neck-related pain or dysfunction. Excluding adjacent segment disease that occurred with a similar rate for patients who underwent fusion and arthroplasty, 5 patients, all treated with arthroplasty, returned for evaluation of neck and arm symptoms between 48 and 72 months after surgery. Four patients had peridevice vertebral body bone loss. One patient had posterior device migration and presented with myelopathy. Three required revision surgery and 2 were observed. Four patients maintained follow-up and reported stabilization or improvement in symptoms. Despite their similarities, CA and fusion are not equivalent procedures in this study in regard to very late complications. Similar to large joint arthroplasty, delayed device-related complications may occur with CA. These complications commenced well beyond the time frame for complications associated with more traditional cervical spine procedures. Both patients and surgeons should be aware of the potential for very late device-related complications occurring with CA and the need for revision surgery. 1.

  13. Ketamine as an adjunct to postoperative pain management in opioid tolerant patients after spinal fusions: a prospective randomized trial.

    Science.gov (United States)

    Urban, Michael K; Ya Deau, Jacques T; Wukovits, Barbara; Lipnitsky, Jane Y

    2008-02-01

    Management of acute postoperative pain is challenging, particularly in patients with preexisting narcotic dependency. Ketamine has been used at subanesthetic doses as a N-methyl D-aspartate (NMDA) receptor antagonist to block the processing of nociceptive input in chronic pain syndromes. This prospective randomized study was designed to assess the use of ketamine as an adjunct to acute pain management in narcotic tolerant patients after spinal fusions. Twenty-six patients for 1-2 level posterior lumbar fusions with segmental instrumentation were randomly assigned to receive ketamine or act as a control. Patients in the ketamine group received 0.2 mg/kg on induction of general anesthesia and then 2 mcg kg(-1) hour(-1) for the next 24 hours. Patients were extubated in the operating room and within 15 minutes of arriving in the Post Anesthesia Care Unit (PACU) were started on intravenous patient-controlled analgesia (PCA) hydromorphone without a basal infusion. Patients were assessed for pain (numerical rating scale [NRS]), narcotic use, level of sedation, delirium, and physical therapy milestones until discharge. The ketamine group had significantly less pain during their first postoperative hour in the PACU (NRS 4.8 vs 8.7) and continued to have less pain during the first postoperative day at rest (3.6 vs 5.5) and with physical therapy (5.6 vs 8.0). Three patients in the control group failed PCA pain management and were converted to intravenous ketamine infusions when their pain scores improved. Patients in the ketamine group required less hydromorphone than the control group, but the differences were not significant. Subanesthetic doses of ketamine reduced postoperative pain in narcotic tolerant patients undergoing posterior spine fusions.

  14. Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250).

    Science.gov (United States)

    Noguera, José F; Cuadrado, Angel; Dolz, Carlos; Olea, José M; García, Juan C

    2012-12-01

    Natural orifice transluminal endoscopic surgery (NOTES) is a technique still in experimental development whose safety and effectiveness call for assessment through clinical trials. In this paper we present a three-arm, noninferiority, prospective randomized clinical trial of 1 year duration comparing the vaginal and transumbilical approaches for transluminal endoscopic surgery with the conventional laparoscopic approach for elective cholecystectomy. Sixty female patients between the ages of 18 and 65 years who were eligible for elective cholecystectomy were randomized in a ratio of 1:1:1 to receive hybrid transvaginal NOTES (TV group), hybrid transumbilical NOTES (TU group) or conventional laparoscopy (CL group). The main study variable was parietal complications (wound infection, bleeding, and eventration). The analysis was by intention to treat, and losses were not replaced. Cholecystectomy was successfully performed on 94% of the patients. One patient in the TU group was reconverted to CL owing to difficulty in maneuvering the endoscope. After a minimum follow-up period of 1 year, no differences were noted in the rate of parietal complications. Postoperative pain, length of hospital stay, and time off from work were similar in the three groups. No patient developed dyspareunia. Surgical time was longer among cases in which a flexible endoscope was used (CL, 47.04 min; TV, 64.85 min; TU, 59.80 min). NOTES approaches using the flexible endoscope are not inferior in safety or effectiveness to conventional laparoscopy. The transumbilical approach with flexible endoscope is as effective and safe as the transvaginal approach and is a promising, single-incision approach.

  15. Prospective randomized controlled intervention trial: Comprehensive Yogic Breathing Improves Cardiac autonomic functions and Quality of life in Diabetes

    Directory of Open Access Journals (Sweden)

    V P Jyotsna

    2012-01-01

    Full Text Available Aims and Objectives: To assess the effect of Comprehensive Yogic Breathing Program on glycemic control, quality of life, and cardiac autonomic functions in diabetes. Material and Methods: This is a prospective randomized controlled intervention trial. Cardiac autonomic functions were assessed in 120 diabetics. Patients were randomized into two groups, one group receiving standard therapy for diabetes (n = 56 and the other group receiving standard therapy for diabetes and comprehensive yogic breathing program (n = 64. Standard therapy included advice on diet, walk, and oral antidiabetic drugs. Comprehensive yogic breathing program was an interactive session in which Sudarshan kriya yoga, a rhythmic cyclical breathing, preceded by Pranayam was taught under guidance of a certified teacher. Change in fasting, post prandial blood sugars, glycated hemoglobin, and quality of life were assessed. Cardiac autonomic function tests were done before and six months after intervention. Results: There was significant improvement in psychological (P = 0.006 and social domains (P = 0.04 and total quality of life (P = 0.02 in the group practicing comprehensive yogic breathing program as compared to the group following standard therapy alone. In the group following breathing program, the improvement in sympathetic cardiac autonomic functions was statistically significant (P = 0.01, while the change in the standard group was not significant (P = 0.17. When both parasympathetic and sympathetic cardiac autonomic functions were considered, there was a trend toward improvement in patients following comprehensive yogic breathing program (P = 0.07. In the standard therapy group, no change in cardiac autonomic functions was noted (P = 0.76. The parameters of glycemic control were comparable in both groups. Conclusion: There was significant improvement in quality of life and cardiac autonomic functions in the diabetes patients practicing comprehensive yogic breathing

  16. A prospective randomized evaluation of the prophylactic use of low-dose dopamine in cancer patients receiving interleukin-2.

    Science.gov (United States)

    Cormier, J N; Hurst, R; Vasselli, J; Lee, D; Kim, C J; McKee, M; Venzon, D; White, D; Marincola, F M; Rosenberg, S A

    1997-07-01

    The administration of high-dose interleukin-2 (IL-2) causes tumor regression in 17-25% of patients with metastatic melanoma or renal cell carcinoma. Renal dysfunction is a common dose-limiting toxicity of IL-2 administration, limiting 26% of treatment cycles. We have conducted a prospective randomized trial to evaluate whether the prophylactic administration of low-dose dopamine (2 mg/kg/min) can minimize renal toxicity and thus affect the amount of IL-2 administered. Forty-two patients were randomly assigned to receive systemic high-dose IL-2 with standard supportive measures (group A = 21 patients) or with the addition of prophylactic dopamine (group B = 21 patients) at 2 mg/kg/min. For patients in group B, dopamine was instituted 1 h before the initiation of IL-2 administration and was discontinued 6-12 h after the maximum number of doses of IL-2 were given. There was no difference in the amount of IL-2 administered for each course of therapy for groups A and B. Despite differences in urine flow (milliliters per kilogram per day), fluid balance (liters per day), and overall weight gain, prophylactic low-dose dopamine did not significantly alter maximum plasma urea or creatinine levels in group B when compared with the control group (group A). The overall toxicity profile considering all grade 3 and 4 toxicities for patients in groups A and B was comparable. Thus, there is no evidence to support the routine use of prophylactic low-dose dopamine in patients receiving high-dose IL-2.

  17. Clown doctors as a treatment for preoperative anxiety in children: a randomized, prospective study.

    Science.gov (United States)

    Vagnoli, Laura; Caprilli, Simona; Robiglio, Arianna; Messeri, Andrea

    2005-10-01

    The induction of anesthesia is one of the most stressful moments for a child who must undergo surgery: it is estimated that 60% of children suffer anxiety in the preoperative period. Preoperative anxiety is characterized by subjective feelings of tension, apprehension, nervousness, and worry. These reactions reflect the child's fear of separation from parents and home environment, as well as of loss of control, unfamiliar routines, surgical instruments, and hospital procedures. High levels of anxiety have been identified as predictors of postoperative troubles that can persist for 6 months after the procedure. Both behavioral and pharmacologic interventions are available to treat preoperative anxiety in children. The aim of this study was to investigate the effects of the presence of clowns on a child's preoperative anxiety during the induction of anesthesia and on the parent who accompanies him/her until he/she is asleep. The sample was composed of 40 subjects (5-12 years of age) who had to undergo minor day surgery and were assigned randomly to the clown group (N = 20), in which the children were accompanied in the preoperative room by the clowns and a parent, or the control group (N = 20), in which the children were accompanied by only 1 of his/her parents. The anxiety of the children in the preoperative period was measured through the Modified Yale Preoperative Anxiety Scale instrument (observational behavioral checklist to measure the state anxiety of young children), and the anxiety of the parents was measured with the State-Trait Anxiety Inventory (Y-1/Y-2) instrument (self-report anxiety behavioral instrument that measures trait/baseline and state/situational anxiety in adults). In addition, a questionnaire for health professionals was developed to obtain their opinion about the presence of clowns during the induction of anesthesia, and a self-evaluation form was developed to be filled out by the clowns themselves about their interactions with the child

  18. A prospective randomized trial of two solutions for intrapartum amnioinfusion: effects on fetal electrolytes, osmolality, and acid-base status.

    Science.gov (United States)

    Pressman, E K; Blakemore, K J

    1996-10-01

    Our purpose was to compare the effects of intrapartum amnioinfusion with normal saline solution versus lactated Ringer's solution plus physiologic glucose on neonatal electrolytes and acid-base balance. Patients undergoing amnioinfusion for obstetric indications were randomized to receive normal saline solution or lactated Ringer's solution plus physiologic glucose at standardized amnioinfusion rates. Data were collected prospectively on maternal demographics, course of labor, and maternal and neonatal outcome. Arterial cord blood was obtained for analysis of electrolytes, glucose, osmolality, lactic acid, and blood gases. Control subjects with normal fetal heart rate patterns, and clear amniotic fluid not receiving amnioinfusion were studied concurrently. Data were collected on 59 patients (21 normal saline solution, 18 lactated Ringer's solution plus physiologic glucose, and 20 controls). Maternal demographics, course of labor, and neonatal outcome were similar in all three groups. Cesarean sections were performed more often in the amnioinfusion groups (33.3% for normal saline solution, 38.9% for lactated Ringer's solution plus physiologic glucose) than in the control group (5.0%), p amnioinfusion with either solution. Intrapartum amnioinfusion with normal saline solution or lactated Ringer's solution plus physiologic glucose has no effect on neonatal electrolytes or acid-base balance.

  19. A randomized prospective study of oral levofloxacin vs intravenous flomoxef prophylaxis in postoperative infection after endoscopic sinus surgery.

    Science.gov (United States)

    Inoshita, Ayako; Yokoi, Hidenori; Matsumoto, Fumihiko; Yao, Toru; Kawano, Kenji; Furukawa, Masayuki; Ikeda, Katsuhisa

    2010-01-01

    The clinical efficacy and cost effectiveness of oral antimicrobial prophylaxis with levofloxacin (LVFX) on endoscopic sinus surgery (ESS) was evaluated. Ninety-three patients undergoing ESS were prospectively enrolled in the present study. The patients were randomly divided into 2 groups, LVFX and flomoxef (FMOX). Two hundred milligrams of LVFX was orally given 2 hours before the start of surgery and 6 hours after the end of surgery, which was followed by the administration of 200 mg every 12 hours for 2 days. One gram of FMOX was dissolved in 100 ml of physiological saline and given intravenously at the induction of anesthesia and 6 hours after the end of surgery, followed by infusion twice daily for 2 days. There were no statistically significant differences between 2 groups in terms of age, sex, systemic complications, surgical procedures, the duration of the operation, the length of hospitalization, the amount of blood loss, body temperature, or the number of white blood cells or C-reactive protein. Although no statistical significance was observed in the bacterial resistance between the two antibiotics, LVFX seems to show a low rate of resistance pattern change as compared to FMOX. The present study demonstrated that no patients treated with LVFX or FMOX were afflicted with postsurgical infection. Oral administration of LVFX is a simple, cost-effective and safe alternative to intravenous prophylaxis in ESS based on clinical efficacy and bacteriological study. Copyright 2010 Elsevier Inc. All rights reserved.

  20. The infiltration of the AC joint performed by one specialist: Ultrasound versus palpation a prospective randomized pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Sabeti-Aschraf, M., E-mail: manuel.sabeti-aschraf@meduniwien.ac.a [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Ochsner, A. [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Schueller-Weidekamm, C. [Vienna Medical School, Department for Radiology, AKH-Wien, Waehringer Guertel 18-20, 1090 Vienna (Austria); Schmidt, M. [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Funovics, Ph.T. [Vienna Medical School, Department for Radiology, AKH-Wien, Waehringer Guertel 18-20, 1090 Vienna (Austria); Skrbensky, G. von [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Goll, A. [Vienna Medical School, Core Unit for Medical Statistics and Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Schatz, K.D. [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria)

    2010-07-15

    Introduction: The acromio-clavicular (AC) joint is very susceptible to degenerative processes that result in pain and functional impairment. One common modality of treatment has been local infiltration of the joint space. Although this procedure has produced notable positive results, needle misplacement occurs frequently. The aim of this investigation is to evaluate the effects of an intra articular infiltration by comparing precise needle placement into the joint space using high-resolution-ultrasound with the conventional palpation technique. Methods: This prospective and randomized pilot study analysed 20 patients who were assigned either to the 'ultrasound' or the 'palpation' group. Clinical examinations were performed before treatment and at 1 h, 1 week and 3 weeks after a single infiltration of local anaesthetic and corticoid carried out by one specialist. Results: In both groups significant improvement in pain and function was obtained up to one-week post injection. Function remained significantly improved until the last follow-up and did not differ between the two groups. The agent was administered in all patients into the joint space in the ultrasound group. Conclusion: Ultrasound guided infiltration of the AC joint is an easily achieved procedure without any complications. However, clinical follow-up did not differ between free-hand and ultrasound-guided AC joint space infiltration.

  1. Gut barrier function and systemic endotoxemia after laparotomy or laparoscopic resection for colon cancer: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Mario Schietroma

    2016-01-01

    Full Text Available Purpose: The gut barrier is altered in certain pathologic conditions (shock, trauma, or surgical stress, resulting in bacterial and/or endotoxin translocation from the gut lumen into the systemic circulation. In this prospective randomized study, we investigated the effect of surgery on intestinal permeability (IP and endotoxemia in patients undergoing elective colectomy for colon cancer by comparing the laparoscopic with the open approach. Patients and Methods: A hundred twenty-three consecutive patients underwent colectomy for colon cancer: 61 cases were open resection (OR and 62 cases were laparoscopic resection (LR. IP was measured preoperatively and at days 1 and 3 after surgery. Serial venous blood sample were taken at 0, 30, 60, 90, 120, and 180 min, and at 12, 24, and 48 h after surgery for endotoxin measurement. Results: IP was significantly increased in the open and closed group at day 1 compared with the preoperative level (P < 0.05, but no difference was found between laparoscopic and open surgery group. The concentration endotoxin systemic increased significantly in the both groups during the course of surgery and returned to baseline levels at the second day. No difference was found between laparoscopic and open surgery. A significant correlation was observed between the maximum systemic endotoxin concentration and IP measured at day 1 in the open group and in the laparoscopic group. Conclusion: An increase in IP, and systemic endotoxemia were observed during the open and laparoscopic resection for colon cancer, without significant statistically difference between the two groups.

  2. Hemodiafiltration Improves Plasma 25-Hepcidin Levels: A Prospective, Randomized, Blinded, Cross-Over Study Comparing Hemodialysis and Hemodiafiltration

    Directory of Open Access Journals (Sweden)

    Bergur V. Stefánsson

    2012-03-01

    Full Text Available Background/Aims: Data from studies comparing the effect of hemodiafiltration (HDF and conventional hemodialysis (HD on clinically important outcomes are insufficient to support superiority of HDF. None of these studies has been participant-blinded. Methods: We performed a prospective, randomized, and patient-blinded cross-over study. Twenty patients on chronic HD received either HD for 2 months followed by post-dilution HDF for 2 months or in opposite order. A range of clinical parameters, as well as markers of inflammation, oxidative stress and iron metabolism was measured. Results: The two treatments were similar with respect to dialysis-related complications, quality of life, and the biomarkers of oxidative stress and inflammation. Compared to HD, 25-hepcidin and β2-microglobulin were 38 and 32%, respectively, lower after 60 days of HDF (p Conclusion: In short term, HDF is not superior to HD regarding dialysis-related complications. The higher ESA consumption observed with HDF can be explained by blood clotting in tubing and dialyzers, as more anticoagulation was needed with post-dilution HDF. In a longer perspective, lowering serum hepcidin levels may improve pathological iron homeostasis.

  3. Effect of warming bupivacaine 0.5% on ultrasound-guided axillary plexus block. Randomized prospective double-blind study.

    Science.gov (United States)

    Trabelsi, W; Ben Gabsia, A; Lebbi, A; Sammoud, W; Labbène, I; Kchelfi, S; Ferjani, M

    2017-02-01

    To evaluate the effect of warming bupivacaine 0.5% on ultrasound-guided axillary brachial plexus block. Prospective, randomized, double-blind. Eighty patients undergoing elective or emergency surgery beyond the distal third of the upper limb were divided into two groups of 40 patients: the warm group received 15mL bupivacaine 0.5% heated to 37°C; the cold group received 15mL 0.5% bupivacaine stored for at least 24hours in the lower compartment of a refrigerator at 13-15°C. Onset and duration of sensory and motor blocks were evaluated every 5minutes for 40minutes. Postoperative pain was evaluated at 1, 3, 6, 12 and 24hours. Effective analgesia time was recorded as the interval between anesthetic injection and the first analgesia requirement (VAS>30mm). Time to onset of sensory and motor block was significantly shorter in the warm group, and mean duration of sensory and motor block and of postoperative analgesia significantly longer. Warming bupivacaine 0.5% to 37°C accelerated onset of sensory and motor block and extended action duration. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  4. Transfer of training in the development of intracorporeal suturing skill in medical student novices: a prospective randomized trial.

    Science.gov (United States)

    Muresan, Claude; Lee, Tommy H; Seagull, Jacob; Park, Adrian E

    2010-10-01

    To help optimize the use of limited resources in trainee education, we developed a prospective randomized trial to determine the most effective means of teaching laparoscopic suturing to novices. Forty-one medical students received rudimentary instruction in intracorporeal suturing, then were pretested on a pig enterotomy model. They then were posttested after completion of 1 of 4 training arms: laparoscopic suturing, laparoscopic drills, open suturing, and virtual reality (VR) drills. Tests were scored for speed, accuracy, knot quality, and mental workload (National Aeronautics and Space Administration [NASA] Task Load Index). Paired t tests were used. Task time was improved in all groups except the VR group. Knot quality improved only in the open or laparoscopic suturing groups. Mental workload improved only for those practicing on a physical laparoscopic trainer. For novice trainees, the efficacy of VR training is questionable. In contrast, the other training methods had benefits in terms of time, quality, and perceived workload. Copyright © 2010 Elsevier Inc. All rights reserved.

  5. Use of ready-made insoles in the treatment of lesser metatarsalgia: a prospective randomized controlled trial.

    Science.gov (United States)

    Kelly, A; Winson, I

    1998-04-01

    Two insoles designed to treat primary lesser metatarsalgia were compared in terms of their effect on plantar pressures and the subjective symptom relief. A prospective single blind randomized trial of 8 weeks' treatment in 46 feet in 33 patients was performed. Subjective outcome measures were visual analogue pain scores and estimated compliance. Objective outcome measures were dynamic plantar pressures using the Musgrave Footprint System. In group 1 (Viscoped), 6 of 18 patients rated themselves much improved or somewhat improved, and in group 2 (Langer) the proportion was 12 of 15 (P = 0.02). Reported mean compliance was 16% higher in the Langer group. Plantar forefoot pressure was lowered by the insoles in all cases. The reduction was significantly greater (P < 0.001) in group 2, both in absolute pressure and as a percentage of initial pressure. Group 2 (Langer) was significantly better in terms of reduction of peak metatarsal pressure. All the subjective outcome measures were better for the group 2 (Langer).

  6. Randomized Prospective Study of Endoscopic Rubber Band Ligation Compared With Bipolar Coagulation for Chronically Bleeding Internal Hemorrhoids

    Science.gov (United States)

    Jutabha, Rome; Jensen, Dennis M.; Chavalitdhamrong, Disaya

    2013-01-01

    OBJECTIVES: Our purpose was to compare the efficacy, complications, success rate, recurrence rate at 1 year, and crossovers of rubber band ligation (RBL) with those of bipolar electrocoagulation (BPEC) treatment for chronically bleeding internal hemorrhoids. METHODS: A total of 45 patients of mean age 51.5 years, who had rectal bleeding from grade II or III hemorrhoids and in whom intensive medical therapy failed, were randomized in a prospective study comparing RBL with BPEC. Treatment failure was predefined as continued bleeding, occurrence of a major complication, or failure to reduce the size of all internal hemorrhoidal segments to grade I in ≤ 3 treatments. Patients were followed up for 1 year. RESULTS: With similar patients, rectal bleeding and other symptoms were controlled with significantly fewer treatments of RBL than of BPEC (2.3±0.2 vs. 3.8±0.4, P 0.05), but significantly fewer failures and crossovers (8% vs. 38%). Symptomatic recurrence at 1 year was 10% RBL and 15% BPEC. CONCLUSIONS: For patients with chronically bleeding grade II or III internal hemorrhoids that are unresponsive to medical therapy, safety and complication rates of banding and BPEC were similar. The success rate was significantly higher with RBL than with BPEC. Symptom recurrence rates at 1 year were similar. PMID:19513028

  7. Individual finger synchronized robot-assisted hand rehabilitation in subacute to chronic stroke: a prospective randomized clinical trial of efficacy.

    Science.gov (United States)

    Hwang, Chang Ho; Seong, Jin Wan; Son, Dae-Sik

    2012-08-01

    To evaluate individual finger synchronized robot-assisted hand rehabilitation in stroke patients. Prospective parallel group randomized controlled clinical trial. The study recruited patients who were ≥18 years old, more than three months post stroke, showed limited index finger movement and had weakened and impaired hand function. Patients with severe sensory loss, spasticity, apraxia, aphasia, disabling hand disease, impaired consciousness or depression were excluded. Patients received either four weeks (20 sessions) of active robot-assisted intervention (the FTI (full-term intervention) group, 9 patients) or two weeks (10 sessions) of early passive therapy followed by two weeks (10 sessions) of active robot-assisted intervention (the HTI (half-term intervention) group, 8 patients). Patients underwent arm function assessments prior to therapy (baseline), and at 2, 4 and 8 weeks after starting therapy. Compared to baseline, both the FTI and HTI groups showed improved results for the Jebsen Taylor test, the wrist and hand subportion of the Fugl-Meyer arm motor scale, active movement of the 2nd metacarpophalangeal joint, grasping, and pinching power (P vs. 46.4 ± 37.4) and wrist and hand subportion of the Fugl-Meyer arm motor scale (4.3 ± 1.9 vs. 3.4 ± 2.5) after eight weeks. A four-week rehabilitation using a novel robot that provides individual finger synchronization resulted in a dose-dependent improvement in hand function in subacute to chronic stroke patients.

  8. The infiltration of the AC joint performed by one specialist: Ultrasound versus palpation a prospective randomized pilot study

    International Nuclear Information System (INIS)

    Sabeti-Aschraf, M.; Ochsner, A.; Schueller-Weidekamm, C.; Schmidt, M.; Funovics, Ph.T.; Skrbensky, G. von; Goll, A.; Schatz, K.D.

    2010-01-01

    Introduction: The acromio-clavicular (AC) joint is very susceptible to degenerative processes that result in pain and functional impairment. One common modality of treatment has been local infiltration of the joint space. Although this procedure has produced notable positive results, needle misplacement occurs frequently. The aim of this investigation is to evaluate the effects of an intra articular infiltration by comparing precise needle placement into the joint space using high-resolution-ultrasound with the conventional palpation technique. Methods: This prospective and randomized pilot study analysed 20 patients who were assigned either to the 'ultrasound' or the 'palpation' group. Clinical examinations were performed before treatment and at 1 h, 1 week and 3 weeks after a single infiltration of local anaesthetic and corticoid carried out by one specialist. Results: In both groups significant improvement in pain and function was obtained up to one-week post injection. Function remained significantly improved until the last follow-up and did not differ between the two groups. The agent was administered in all patients into the joint space in the ultrasound group. Conclusion: Ultrasound guided infiltration of the AC joint is an easily achieved procedure without any complications. However, clinical follow-up did not differ between free-hand and ultrasound-guided AC joint space infiltration.

  9. Radiation-induced proctosigmoiditis. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate

    Energy Technology Data Exchange (ETDEWEB)

    Kochhar, R.; Patel, F.; Dhar, A.; Sharma, S.C.; Ayyagari, S.; Aggarwal, R.; Goenka, M.K.; Gupta, B.D.; Mehta, S.K. (Postgraduate Institute of Medical Education and Research, Chandigarh (India))

    1991-01-01

    In a prospective study, 37 consecutive patients with radiation-induced proctosigmoiditis were randomized to receive a four-week course of either 3.0 g oral sulfasalazine plus 20 mg twice daily rectal prednisolone enemas (group I, N = 18) or 2.0 g twice daily rectal sucralfate enemas plus oral placebo (group II, N = 19). The two groups were comparable with respect to demographic features, duration of symptoms, and clinical and endoscopic staging of the disease. Fifteen patients in group I and 17 in group II completed the trial. At four weeks, both groups showed significant clinical improvement (P less than 0.01 for group I and P less than 0.001 for group II) and endoscopic healing (P less than 0.01 for group I and P less than 0.001 for group II). When the two groups were compared, sucralfate enemas showed a significantly better response as assessed clinically (P less than 0.05), although endoscopically the response was not statistically different (P greater than 0.05). We conclude that both treatment regimens are effective in the management of radiation proctitis. Sucralfate enemas give a better clinical response, are tolerated better, and because of the lower cost should be the preferred mode of short-term treatment.

  10. Radiation-induced proctosigmoiditis. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate

    International Nuclear Information System (INIS)

    Kochhar, R.; Patel, F.; Dhar, A.; Sharma, S.C.; Ayyagari, S.; Aggarwal, R.; Goenka, M.K.; Gupta, B.D.; Mehta, S.K.

    1991-01-01

    In a prospective study, 37 consecutive patients with radiation-induced proctosigmoiditis were randomized to receive a four-week course of either 3.0 g oral sulfasalazine plus 20 mg twice daily rectal prednisolone enemas (group I, N = 18) or 2.0 g twice daily rectal sucralfate enemas plus oral placebo (group II, N = 19). The two groups were comparable with respect to demographic features, duration of symptoms, and clinical and endoscopic staging of the disease. Fifteen patients in group I and 17 in group II completed the trial. At four weeks, both groups showed significant clinical improvement (P less than 0.01 for group I and P less than 0.001 for group II) and endoscopic healing (P less than 0.01 for group I and P less than 0.001 for group II). When the two groups were compared, sucralfate enemas showed a significantly better response as assessed clinically (P less than 0.05), although endoscopically the response was not statistically different (P greater than 0.05). We conclude that both treatment regimens are effective in the management of radiation proctitis. Sucralfate enemas give a better clinical response, are tolerated better, and because of the lower cost should be the preferred mode of short-term treatment

  11. A prospective randomized comparison of continuous hemihepatic with intermittent total hepatic inflow occlusion in hepatectomy for liver tumors.

    Science.gov (United States)

    Liang, Guanlin; Wen, Tianfu; Yan, Lunan; Li, B O; Wu, Guochang; Yang, Jian; Lu, Bo; Chen, Zheyu; Liao, Zhixue; Ran, Shun; Yu, Zhang

    2009-01-01

    To evaluate whether continuous hemihepatic inflow occlusion (HHO) during hepatectomy can be safer than and be as effective as intermittent total hepatic inflow occlusion (THO) in reducing blood loss. Eighty patients undergoing liver resections were included in a prospective randomized study comparing the intra- and postoperative course under THO (n=40) or HHO (n=40). THO was performed with periods of 20 minutes of occlusion and 5 minutes of releasing, while HHO was performed with continuous occlusion. The surface area of liver transection, amount of blood loss, measurements of alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and postoperative evolution were recorded. The two groups were similar at entry in terms of preoperative liver function and in the proportion of patients experiencing major hepatectomy. The total ischemic time of the two groups was similar (p=0.37), but the operative time in the THO group was longer than in the HHO group (p=0.02). No significant difference was found between the HHO and THO group in blood loss during liver parenchyma transection (p=0.14), the elevations of ALT and AST on the first postoperative day (ALT: p=0.12; AST: p=0.66) and postoperative morbidity (p=0.35). On the basis of our findings, if it is feasible, continuous HHO is recommended for complex liver resection.

  12. Conformable covered versus uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction: a randomized prospective study.

    Science.gov (United States)

    Lim, Sun Gyo; Kim, Jin Hong; Lee, Kee Myung; Shin, Sung Jae; Kim, Chan Gyoo; Kim, Kyung Ho; Kim, Ho Gak; Yang, Chang Heon

    2014-07-01

    A conformable self-expandable metallic stent was developed to overcome the limitation of previous self-expandable metallic stents. The aim of this study was to evaluate outcomes after placement of conformable covered and uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction. A single-blind, randomized, parallel-group, prospective study were conducted in 4 medical centres between March 2009 and July 2012. 134 patients with unresectable malignant gastroduodenal obstruction were assigned to a covered double-layered (n=66) or uncovered unfixed-cell braided (n=68) stent placement group. Primary analysis was performed to compare re-intervention rates between two groups. 120 patients were analysed (59 in the covered group and 61 in the uncovered group). Overall rates of re-intervention were not significantly different between the two groups: 13/59 (22.0%) in the covered group vs. 13/61 (21.3%) in the uncovered group, p=0.999. Stent migration was more frequent in the covered group than in the uncovered group (p=0.003). The tumour ingrowth rate was higher in the uncovered group than in the covered group (p=0.016). The rates of re-intervention did not significantly differ between the two stents. Conformable covered double-layered and uncovered unfixed-cell braided stents were associated with different patterns of stent malfunction. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  13. Efficacy of Clopidogrel and Clinical Outcome When Clopidogrel Is Coadministered With Atorvastatin and Lansoprazole: A Prospective, Randomized, Controlled Trial.

    Science.gov (United States)

    Zhang, Jian-rong; Wang, Di-qing; Du, Jun; Qu, Guang-su; Du, Jian-lin; Deng, Song-bai; Liu, Ya-jie; Cai, Jin-xi; She, Qiang

    2015-12-01

    This prospective, randomized, nonblind, controlled trial evaluated the effects of clopidogrel on platelet function upon coadministration with atorvastatin and lansoprazole. One hundred four adult patients with non-ST-segment elevated acute coronary syndrome (NSTE-ACS) who underwent percutaneous coronary intervention (PCI) with drug-eluting stent implantation were included. All patients were treated with standard dual antiplatelet therapy (DAPT) plus rosuvastatin 10  mg daily after the operation. On the sixth day after PCI, patients were randomly divided into 4 groups, Group A: DAPT + atorvastatin 20  mg daily (a change from rosuvastatin to atorvastatin) + lansoprazole 30  mg daily, Group B: DAPT + atorvastatin 20  mg daily (a change from rosuvastatin to atorvastatin), Group C: DAPT + lansoprazole 30  mg daily (continuing to take rosuvastatin), Group D is the control group. Additional drugs were used according to the situation of patients. Platelet function and concentrations of platelet activation markers (granular membrane protein 140 (P-selectin), thromboxane B2 (TXB2), and human soluble cluster of differentiation 40 ligand (sCD40L)) were assessed before randomization and at 15- and 30-day follow-up visits. All patients were maintained on treatment for 6 months and observed for bleeding and ischemic events. A total of 104 patients were enrolled, 27 patients in group A, 26 patients in Group B/C, 25 patients in Group D separately, and all the patients were analyzed. There were no differences in platelet function and the levels of platelet activation markers (P-selectin, TXB2, and sCD40L) among or within the 4 groups at the 3 time points of interest (P > 0.05). In the subsequent 6 months, no significant bleeding events occurred, and 12 patients experienced ischemic events, these results were also not significantly different among the groups (P > 0.05). In patients diagnosed with NSTE-ACS who have had drug-eluting stent implantation

  14. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial.

    Science.gov (United States)

    Hannemann, Pascal; Göttgens, Kevin W A; van Wely, Bob J; Kolkman, Karel A; Werre, Andries J; Poeze, Martijn; Brink, Peter R G

    2011-05-06

    The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences.Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning).Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory.Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional

  15. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

    Directory of Open Access Journals (Sweden)

    Poeze Martijn

    2011-05-01

    Full Text Available Abstract Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%, non-union (5-21% and early osteo-arthritis (up to 32% which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning. Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation

  16. Risk reduction of brain infarction during carotid endarterectomy or stenting using sonolysis - Prospective randomized study pilot data

    Science.gov (United States)

    Kuliha, Martin; Školoudík, David; Martin Roubec, Martin; Herzig, Roman; Procházka, Václav; Jonszta, Tomáš; Krajča, Jan; Czerný, Dan; Hrbáč, Tomáš; Otáhal, David; Langová, Kateřina

    2012-11-01

    Sonolysis is a new therapeutic option for the acceleration of arterial recanalization. The aim of this study was to confirm risk reduction of brain infarction during endarterectomy (CEA) and stenting (CAS) of the internal carotid artery (ICA) using sonolysis with continuous transcranial Doppler (TCD) monitoring by diagnostic 2 MHz probe, additional interest was to assess impact of new brain ischemic lesions on cognitive functions. Methods: All consecutive patients 1/ with ICA stenosis >70%, 2/ indicated to CEA or CAS, 3/ with signed informed consent, were enrolled to the prospective study during 17 months. Patients were randomized into 2 groups: Group 1 with sonolysis during intervention and Group 2 without sonolysis. Neurological examination, assessment of cognitive functions and brain magnetic resonance imaging (MRI) were performed before and 24 hours after intervention in all patients. Occurrence of new brain infarctions (including infarctions >0.5 cm3), and the results of Mini-Mental State Examination, Clock Drawing and Verbal Fluency tests were statistically evaluated using T-test. Results: 97 patients were included into the study. Out of the 47 patients randomized to sonolysis group (Group 1) 25 underwent CEA (Group 1a) and 22 CAS (Group 1b). Out of the 50 patients randomized to control group (Group 2), 22 underwent CEA (Group 2a) and 28 CAS (Group 2b). New ischemic brain infarctions on follow up MRI were found in 14 (29.8%) patients in Group 1-4 (16.0%) in Group 1a and 10 (45.5%) in Group 1b. In Group 2, new ischemic brain infarctions were found in 18 (36.0%) patients-6 (27.3%) in Group 2a and 12 (42.9%) in Group 2b (p>0.05 in all cases). New ischemic brain infarctions >0.5 cm3 were found in 4 (8.5 %) patients in Group 1 and in 11 (22.0 %) patients in Group 2 (p= 0.017). No significant differences were found in cognitive tests results between subgroups (p>0.05 in all tests). Conclusion: Sonolysis seems to be effective in the prevention of large ischemic

  17. Analysis of complications in a prospective randomized trial comparing two brachytherapy low dose rates in cervical carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1994-07-30

    The analysis of complications in a prospective randomized trial comparing two preoperative brachytherapy low-dose rates in early stage cervical cancer is presented. The objective of this trial was to determine the benefits, if any, of the higher-dose rate within the therapeutic aresenal for this patient population, in terms of survival, local control, and complications. Overall survival, 85% at 2 years and local control, 93% at 2 years, were similarly distributed between the two groups. Regardless of their nature and severity, 139 and 175 complications were observed among 63% and 75% of patients, in the 0.4 and 0.8 Gy/h dose rate groups respectively. Gynecologic and urinary complications were the most frequent (38% and 28% of all complications), followed by vascular (15%), digestive (10%), nervous (5%), and cutaneous (5%). A total of 14 and 17 severe complications (Grade 3) were observed in 7% and 13% of patients, respectively in the 0.4 and 0.8 Gy/h dose rate groups (p = 0.12) Nonparametric survival methods used to compare the time to the first complication did not show a significant difference between the two groups: 62% and 72% at 2 years (p = 0.27). When the first complication and its evolution were considered (early complications), the prevalence of complications was not significantly different between the two groups: 28% vs. 34% at 2 years (p = 0.31). In this prospective trial, patients were regularly followed-up and complications of varying nature and severity were observed in succession during follow-up. When successive complications and their evolution were taken into account, the prevalence of complications was significantly greater in the higher-dose rate group: 30% vs 45% at 2 years (p = 0.03). The results of this trial showed that long-term effects of treatment, when represented by prevalence of complications over time, were more frequent in the higher dose rate group. 33 refs., 3 figs., 5 tabs.

  18. Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: protocol for a feasibility randomized pilot trial.

    Science.gov (United States)

    Johnstone, Jennie; Meade, Maureen; Marshall, John; Heyland, Daren K; Surette, Michael G; Bowdish, Dawn Me; Lauzier, Francois; Thebane, Lehana; Cook, Deborah J

    2015-01-01

    Probiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate. Patients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 10 10 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded. The primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and

  19. Efficacy and safety of fosfomycin-trometamol in the prophylaxis for transrectal prostate biopsy. Prospective randomized comparison with ciprofloxacin.

    Science.gov (United States)

    Lista, F; Redondo, C; Meilán, E; García-Tello, A; Ramón de Fata, F; Angulo, J C

    2014-01-01

    Prostate biopsy is the standardized diagnostic method for prostate cancer. However, although there is not a standardized protocol, there are recommendations in order to reduce the incidence of complications. The objective of the present work is to assess the efficacy and safety of antibiotic prophylaxis in the prostate biopsy by comparing two antibiotic regimes: two doses of fosfomycin-trometamol 3g (FMT) every 48 hours with 10 doses of oral ciprofloxacin 500 mg every 12 hours during 5 days. Randomized prospective study was performed with 671 patients who had undergone to walking transrectal ultrasound guided prostate biopsy. Patients of group A (n=312) were treated with ciprofloxacin, and patients of group B (n=359) with FMT. Efficacy and tolerability of two prophylactic regimes were compared. Urine culture was carried out at 2 weeks after biopsy. Initially, patients with asymptomatic bacteriuria were not treated with antibiotics; urine culture was repeated after 1 month, persistent bacteriuria was treated according to antibiogram. No differences between groups were found in age (P=.78), cancer presence (P=.9) or number of biopsy cylinders (P=.93). The mean number of cores obtained was 11.3 ± 3.25 (range 6-20). Digestive intolerance was observed for 9 patients (2.9%) of group A and 10 patients (2.8%) in group B. One patient (.3%) of group A showed severe allergic reaction. In total, 167 patients (24.6%) had complications: 16 (2.4%) fever, 47 (6.9%) hemospermia, 81 (11.9%) hematuria, 7 (1%) rectal bleeding and 16 (2.4%) urinary retention. No statistically differences between groups were observed (27.6% vs. 22.6%; P=.17). However, hemospermia was more frequent in group A (9.9% vs. 4.5%; P=.006). Bacteriuria after biopsy was detected in 44 patients (6.6%), being more frequent in group B patients (4.2% vs. 8.6%; P=.02) although a higher number of second treatment cycles were not needed (53.9% vs. 29%; P=.17). The likelihood of resistance to ciprofloxacin in patients

  20. Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety.

    Science.gov (United States)

    Shimonovich, Shachar; Gigi, Roy; Shapira, Amir; Sarig-Meth, Tal; Nadav, Danielle; Rozenek, Mattan; West, Debra; Halpern, Pinchas

    2016-11-09

    Ketamine has been well studied for its efficacy as an analgesic agent. However, intranasal (IN) administration of ketamine has only recently been studied in the emergency setting. The objective of this study was to elucidate the efficacy and adverse effects of a sub-dissociative dose of IN Ketamine compared to IV and IM morphine. A single-center, randomized, prospective, parallel clinical trial of efficacy and safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency department (ED). A convenience sample of 90 patients aged 18-70 experiencing moderate-severe acute traumatic pain (≥80 mm on 100 mm Visual Analog Scale [VAS]) were randomized to receive either 1.0 mg/kg IN ketamine, 0.1 mg/kg IV MO or 0.15 mg/kg IM MO. Pain relief and adverse effects were recorded for 1 h post-administration. The primary outcome was efficacy of IN ketamine compared to IV and IM MO, measured by "time-to-onset" (defined as a ≥15 mm pain decrease on VAS), as well as time to and degree of maximal pain reduction. The 3 study groups showed a highly significant, similar maximal pain reduction of 56 ± 26 mm for IN Ketamine, and 59 ± 22 and 48 ± 30 for IV MO and IM MO, respectively. IN Ketamine provided clinically-comparable results to those of IV MO with regards to time to onset (14.3 ± 11.2 v. 8.9 ± 5.6 min, respectively) as well as in time to maximal pain reduction (40.4 ± 16.3) versus (33.4 ± 18), respectively. IN ketamine shows efficacy and safety comparable to IV and IM MO. Given the benefits of this mode of analgesia in emergencies, it should be further studied for potential clinical applications. Retrospectively registered on 27 June 2016. ClinicalTrials.gov ID: NCT02817477.

  1. Impact of outpatient clinic ultrasound imaging in the diagnosis and treatment for shoulder impingement: a randomized prospective study.

    LENUS (Irish Health Repository)

    Saeed, Aamir

    2013-11-05

    The use of musculoskeletal ultrasonography (MSUS) in guiding subdeltoid injection has been shown to improve outcome up to 6 weeks in a few small studies. A recent meta-analysis identified the need for further studies with longer-term outcome and larger sample size. This randomized prospective study assessed whether clinic-based MSUS can significantly improve diagnostic accuracy in shoulder pain and whether MSUS-guided shoulder injection results in improved long-term outcomes. One hundred consecutive patients with 125 painful shoulders were recruited. Patients were randomized to receive either sonographic assessment with consequent palpation-guided injection (Group 1, n = 66) or sonographic assessment with a MSUS-guided injection of 40 mg of methylprednisolone acetate (Group 2, n = 59). A blinded rheumatologist (ADF) performed clinical assessments at baseline, 6 and 12 weeks including shoulder function tests (SFTs) (Hawkins-Kennedy test, supraspinatus tendon tenderness), physician global assessment (PGA) and patient visual analogue scores (VAS) for pain (0-10). Eighty patients with 90 symptomatic shoulders completed 12-week follow-up. Twenty patients, 11 (20 shoulders) from the palpation-guided group and 9 (15 shoulders) from the MSUS-guided group, were excluded at 6 weeks either due to requirement for repeat injection or due to surgical referral. Mean age for patients was 57.7 years, and 65 % patients were female; mean shoulder pain duration was 18 weeks (range 14-22 weeks). SFTs, patient VAS and PGA scores for pain improved significantly from baseline in both groups with significantly greater improvements in the MSUS-guided group (44 shoulders) compared to the palpation-guided group (46 shoulders) in all parameters at 6 (p < 0.01) and 12 weeks (p < 0.05). The use of MSUS in guiding subdeltoid injection has been shown to improve outcome up to 6 weeks in a few small studies. A recent meta-analysis identified the need for further studies with longer

  2. Accuracy of VarioGuide Frameless Stereotactic System Against Frame-Based Stereotaxy: Prospective, Randomized, Single-Center Study.

    Science.gov (United States)

    Bradac, Ondrej; Steklacova, Anna; Nebrenska, Katerina; Vrana, Jiri; de Lacy, Patricia; Benes, Vladimir

    2017-08-01

    Frameless stereotactic brain biopsy systems are widely used today. VarioGuide (VG) is a relatively novel frameless system. Its accuracy was studied in a laboratory setting but has not yet been studied in the clinical setting. The purpose of this study was to determine its accuracy and diagnostic yield and to compare this with frame-based (FB) stereotaxy. Overall, 53 patients (33 males and 20 females, 60 ± 15 years old) were enrolled into this prospective, randomized, single-center study. Twenty-six patients were randomized into the FB group and 27 patients into the VG group. Real trajectory was pointed on intraoperative magnetic resonance. The distance of the targets and angle deviation between the planned and real trajectories were computed. The overall discomfort of the patient was subjectively assessed by the visual analog scale score. The median lesion volume was 5 mL (interquartile range [IQR]: 2-16 mL) (FB) and 16 mL (IQR: 2-27 mL) (VG), P = 0.133. The mean distance of the targets was 2.7 ± 1.1 mm (FB) and 2.9 ± 1.3 mm (VG), P = 0.456. Mean angle deviation was 2.6 ± 1.3 deg (FB) and 3.5 ± 2.1 deg (VG), P = 0.074. Diagnostic yield was 93% (25/27) in VG and 96% (25/26) in FB, P = 1.000. Mean operating time was 47 ± 26 minutes (FB) and 59 ± 31 minutes (VG), P = 0.140. One minor bleeding was encountered in the VG group. Overall patient discomfort was significantly higher in the FB group (visual analog scale score 2.5 ± 2.1 vs. 1.2 ± 0.6, P = 0,004). The VG system proved to be comparable in terms of the trajectory accuracy, rate of complications and diagnostic yield compared with the "gold standard" represented by the traditional FB stereotaxy for patients undergoing brain biopsy. VG is also better accepted by patients. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. A prospective, randomized controlled trial of conscious sedation using propofol combined with inhaled nitrous oxide for dental treatment.

    Science.gov (United States)

    Yokoe, Chizuko; Hanamoto, Hiroshi; Sugimura, Mitsutaka; Morimoto, Yoshinari; Kudo, Chiho; Niwa, Hitoshi

    2015-03-01

    Adverse reactions during propofol sedation include a decrease in arterial blood pressure, propofol-induced pain on injection, and airway complications. The purpose of this study was to investigate whether combined use of intravenous propofol and inhaled nitrous oxide could decrease the hypotensive and other adverse effects of propofol. We designed and implemented a prospective, randomized controlled trial. Patients undergoing dental procedures requiring intravenous sedation were randomly allocated to 2 groups: group P comprised those receiving sedation with propofol alone, and group N+P comprised those receiving sedation with 40% nitrous oxide inhalation and propofol. During the dental procedures, the sedation level was maintained at an Observer's Assessment of Alertness/Sedation scale score of 4 by adjusting propofol's target plasma concentration. Nitrous oxide inhalation was the predictor variable, whereas the hemodynamic changes, amount and concentration of propofol, and adverse events were the outcome variables. Eighty-eight patients were successfully analyzed without any complications. The total amount of propofol was significantly less in group N+P (249.8 ± 121.7 mg) than in group P (310.3 ± 122.4 mg) (P = .022), and the mean concentration of propofol was significantly less in group N+P (1.81 ± 0.34 μg/mL) than in group P (2.05 ± 0.44 μg/mL) (P = .006). The mean blood pressure reduction in group N+P (11.0 ± 8.0 mm Hg) was significantly smaller than that in group P (15.8 ± 10.2 mm Hg) (P = .034). Pain associated with the propofol injection and memory of the procedure were less in group N+P (P = .011 and P = .048, respectively). Nitrous oxide did not affect respiratory conditions or recovery characteristics. The results of this study suggest that nitrous oxide inhalation combined with propofol sedation attenuates the hypotensive effect and pain associated with propofol injections, along with potentiating the amnesic effect. Copyright © 2015 American

  4. A Prospective Randomized Study of the Radiotherapy Volume for Limited-stage Small Cell Lung Cancer: A Preliminary Report

    Directory of Open Access Journals (Sweden)

    Xiao HU

    2010-07-01

    Full Text Available Background and objective Controversies exists with regard to target volumes as far as thoracic radiotherapy (TRT is concerned in the multimodality treatment for limited-stage small cell lung cancer (LSCLC. The aim of this study is to prospectively compare the local control rate, toxicity profiles, and overall survival (OS between patients received different target volumes irradiation after induction chemotherapy. Methods LSCLC patients received 2 cycles of etoposide and cisplatin (EP induction chemotherapy and were randomly assigned to receive TRT to either the post- or pre-chemotherapy tumor extent (GTV-T as study arm and control arm, CTV-N included the positive nodal drainage area for both arms. One to 2 weeks after induction chemotherapy, 45 Gy/30 Fx/19 d TRT was administered concurrently with the third cycle of EP regimen. After that, additional 3 cycles of EP consolidation were administered. Prophylactic cranial irradiation (PCI was administered to patients with a complete response. Results Thirty-seven and 40 patients were randomly assigned to study arm and control arm. The local recurrence rates were 32.4% and 28.2% respectively (P=0.80; the isolated nodal failure (INF rate were 3.0% and 2.6% respectively (P=0.91; all INF sites were in the ipsilateral supraclavicular fossa. Medastinal N3 disease was the risk factor for INF (P=0.02, OR=14.13, 95%CI: 1.47-136.13. During radiotherapy, grade I, II weight loss was observed in 29.4%, 5.9% and 56.4%, 7.7% patients respectively (P=0.04. Grade 0-I and II-III late pulmonary injury was developed in 97.1%, 2.9% and 86.4%, 15.4% patients respectively (P=0.07. Median survival time was 22.1 months and 26.9 months respectively. The 1 to 3-year OS were 77.9%, 44.4%, 37.3% and 75.8%, 56.3%, 41.7% respectively (P=0.79. Conclusion The preliminary results of this study indicate that irradiant the post-chemotherapy tumor extent (GTV-T and positive nodal drainage area did not decrease local control and overall

  5. Benign painful shoulder syndrome. Initial results of a single-center prospective randomized radiotherapy dose-optimization trial

    International Nuclear Information System (INIS)

    Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R.

    2012-01-01

    Background and purpose: To compare the efficacy of two different dose-fractionation schedules for radiotherapy of patients with benign painful shoulder syndrome. Patients and methods: Between February 2006 and February 2010, 312 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy with an orthovoltage technique. One radiotherapy course consisted of 6 single fractions in 3 weeks. In case of insufficient remission of pain after 6 weeks, a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 83% directly after and 85% 6 weeks after radiotherapy. The mean VAS values before, directly after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 56.8 ± 23.7 and 53.2 ± 21.8 (p = 0.158), 38.2 ± 26.1 and 34.0 ± 24.5 (p = 0.189), and 33.0 ± 27.2 and 23.7 ± 22.7 (p = 0.044), respectively. The mean CPS before, directly after, and 6 weeks after treatment was 9.7 ± 3.0 and 9.5 ± 2.7 (p = 0.309), 6.1 ± 3.6 and 5.4 ± 3.6 (p = 0.096), 5.3 ± 3.7 and 4.1 ± 3.7 (p = 0.052), respectively. Despite a slight advantage in the VAS analysis for the 1.0 Gy group for delayed response, the CPS analysis revealed no statistically significant differences between the two single-dose trial arms for early (p = 0.652) and delayed response quality (p = 0.380). Conclusion: Radiotherapy is an effective treatment option for the management of benign painful shoulder syndrome. Concerning radiation protection, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  6. Use of a surgical rehearsal platform and improvement in aneurysm clipping measures: results of a prospective, randomized trial.

    Science.gov (United States)

    Chugh, A Jessey; Pace, Jonathan R; Singer, Justin; Tatsuoka, Curtis; Hoffer, Alan; Selman, Warren R; Bambakidis, Nicholas C

    2017-03-01

    OBJECTIVE The field of neurosurgery is constantly undergoing improvements and advances, both in technique and technology. Cerebrovascular neurosurgery is no exception, with endovascular treatments changing the treatment paradigm. Clipping of aneurysms is still necessary, however, and advances are still being made to improve patient outcomes within the microsurgical treatment of aneurysms. Surgical rehearsal platforms are surgical simulators that offer the opportunity to rehearse a procedure prior to entering the operative suite. This study is designed to determine whether use of a surgical rehearsal platform in aneurysm surgery is helpful in decreasing aneurysm dissection time and clip manipulation of the aneurysm. METHODS The authors conducted a blinded, prospective, randomized study comparing key effort and time variables in aneurysm clip ligation surgery with and without preoperative use of the SuRgical Planner (SRP) surgical rehearsal platform. Initially, 40 patients were randomly assigned to either of two groups: one in which surgery was performed after use of the SRP (SRP group) and one in which surgery was performed without use of the SRP (control group). All operations were videotaped. After exclusion of 6 patients from the SRP group and 9 from the control group, a total of 25 surgical cases were analyzed by a reviewer blinded to group assignment. The videos were analyzed for total microsurgical time, number of clips used, and number of clip placement attempts. Means and standard deviations (SDs) were calculated and compared between groups. RESULTS The mean (± SD) amount of operative time per clip used was 920 ± 770 seconds in the SRP group and 1294 ± 678 seconds in the control group (p = 0.05). In addition, the mean values for the number of clip attempts, total operative time, ratio of clip attempts to clips used, and time per clip attempt were all lower in the SRP group, although the between-group differences were not statistically significant

  7. Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus in Adults: A Prospective Randomized Controlled Trial in China.

    Science.gov (United States)

    Su, Yingying; Liu, Gang; Tian, Fei; Ren, Guoping; Jiang, Mengdi; Chun, Brian; Zhang, Yunzhou; Zhang, Yan; Ye, Hong; Gao, Daiquan; Chen, Weibi

    2016-12-01

    Although generalized convulsive status epilepticus (GCSE) is a life-threatening emergency, evidence-based data to guide initial drug treatment choices are lacking in the Chinese population. We conducted this prospective, randomized, controlled trial to evaluate the relative efficacy and safety of intravenous phenobarbital and valproate in patients with GCSE. After the failure of first-line diazepam treatment, Chinese adult patients with GCSE were randomized to receive either intravenous phenobarbital (standard doses, low rate) or valproate (standard). Successful treatment was considered when clinical and electroencephalographic seizure activity ceased. Adverse events following treatment, as well as the neurological outcomes at discharge and 3 months later, were also evaluated. Overall, 73 cases were enrolled in the study. Intravenous phenobarbital was successful in 81.1% of patients, and intravenous valproate was successful in 44.4% of patients (p phenobarbital (6.7%) was significantly lower than that in patients receiving valproate (31.3%), and the total number of adverse events did not differ significantly between the two groups (p > 0.05). In the phenobarbital group, two patients (5.4%) required ventilation and two patients (5.4%) developed serious hypotension. The neurological outcomes of the phenobarbital group were generally better than those of the valproate group; however, no significant differences were observed between phenobarbital and valproate with respect to mortality (8.1 vs. 16.6%) at discharge, or mortality (16.2 vs. 30.5%) and post-symptomatic epilepsy (26.3 vs. 42.8%) at 3-month follow-up. Intravenous phenobarbital appears to be more effective than intravenous valproate for Chinese adult patients with GCSE. The occurrence of serious respiratory depression and hypotension caused by phenobarbital was reduced by decreasing the intravenous infusion rate; however, even at a lower infusion rate than typically used in other institutions, intravenous

  8. Dextran-related complications in head and neck microsurgery: do the benefits outweigh the risks? A prospective randomized analysis.

    Science.gov (United States)

    Disa, Joseph J; Polvora, Virginia P; Pusic, Andrea L; Singh, Bhuvinesh; Cordeiro, Peter G

    2003-11-01

    Increased experience with free-tissue transfer has minimized flap loss secondary to microvascular thrombosis, yet pharmacologic antithrombotic prophylaxis continues to be used routinely. Currently there is no consensus on the ideal pharmacologic agent, dosing, or efficacy. Low-molecular-weight dextran has been widely used for prophylaxis due to its properties of volume expansion and enhanced microrheology. Significant systemic morbidity (pulmonary morbidity, cardiac morbidity, anaphylaxis) is known to occur with use of low-molecular-weight dextran. The purpose of this study was to evaluate morbidity associated with postoperative low-molecular-weight dextran and aspirin prophylaxis in head and neck microsurgery patients. This study was a randomized prospective analysis of 100 consecutive patients undergoing microvascular reconstruction for head and neck malignancy during a 2-year period. Patients were randomized into one of three postoperative antithrombotic prophylaxis treatment groups: low-molecular-weight dextran 20 cc/hour for 48 hours (n = 35), low-molecular-weight dextran 20 cc/hour for 120 hours (n = 32), or aspirin 325 mg/day for 120 hours (n = 27). Six patients were excluded intraoperatively due to the need for systemic heparin therapy. Treatment groups were compared for age, sex, prior medical problems, duration of anesthesia, and intraoperative fluid intake. Flap outcome and the incidence of local and systemic complications were evaluated in the treatment groups. Patient ages ranged from 12 to 84 years (mean age, 58 years). No significant difference was found among the treatment groups with respect to age, sex, prior medical problems, duration of anesthesia, intraoperative fluid intake, and the distribution of donor and recipient sites. There were no total flap losses and two partial flap losses in this series. Three flaps were reexplored and all were salvaged. The incidence of systemic complications (congestive heart failure, myocardial infarction

  9. Does Stepwise Voltage Ramping Protect the Kidney from Injury During Extracorporeal Shockwave Lithotripsy? Results of a Prospective Randomized Trial.

    Science.gov (United States)

    Skuginna, Veronika; Nguyen, Daniel P; Seiler, Roland; Kiss, Bernhard; Thalmann, George N; Roth, Beat

    2016-02-01

    Renal damage is more frequent with new-generation lithotripters. However, animal studies suggest that voltage ramping minimizes the risk of complications following extracorporeal shock wave lithotripsy (SWL). In the clinical setting, the optimal voltage strategy remains unclear. To evaluate whether stepwise voltage ramping can protect the kidney from damage during SWL. A total of 418 patients with solitary or multiple unilateral kidney stones were randomized to receive SWL using a Modulith SLX-F2 lithotripter with either stepwise voltage ramping (n=213) or a fixed maximal voltage (n=205). SWL. The primary outcome was sonographic evidence of renal hematomas. Secondary outcomes included levels of urinary markers of renal damage, stone disintegration, stone-free rate, and rates of secondary interventions within 3 mo of SWL. Descriptive statistics were used to compare clinical outcomes between the two groups. A logistic regression model was generated to assess predictors of hematomas. Significantly fewer hematomas occurred in the ramping group(12/213, 5.6%) than in the fixed group (27/205, 13%; p=0.008). There was some evidence that the fixed group had higher urinary β2-microglobulin levels after SWL compared to the ramping group (p=0.06). Urinary microalbumin levels, stone disintegration, stone-free rate, and rates of secondary interventions did not significantly differ between the groups. The logistic regression model showed a significantly higher risk of renal hematomas in older patients (odds ratio [OR] 1.03, 95% confidence interval [CI] 1.00-1.05; p=0.04). Stepwise voltage ramping was associated with a lower risk of hematomas (OR 0.39, 95% CI 0.19-0.80; p=0.01). The study was limited by the use of ultrasound to detect hematomas. In this prospective randomized study, stepwise voltage ramping during SWL was associated with a lower risk of renal damage compared to a fixed maximal voltage without compromising treatment effectiveness. Lithotripsy is a noninvasive

  10. Prospective, double blind, randomized, controlled trial comparing vapocoolant spray versus placebo spray in adults undergoing intravenous cannulation.

    Science.gov (United States)

    Mace, Sharon E

    2017-10-01

    Painful diagnostic and therapeutic procedures are common in the health care setting. Eliminating, or at least, minimizing the pain associated with various procedures should be a priority. Although there are many benefits of providing local/topical anesthesia prior to performing painful procedures, ranging from greater patient/family satisfaction to increased procedural success rates; local/topical anesthetics are frequently not used. Reasons include the need for a needlestick to administer local anesthetics such as lidocaine and the long onset for topical anesthetics. Vapocoolants eliminate the risks associated with needlesticks, avoids the tissue distortion with intradermal local anesthetics, eliminates needlestick pain, have a quick almost instantaneous onset, are easy to apply, require no skills or devices to apply, are convenient, and inexpensive. The aims of this study were to ascertain if peripheral intravenous (PIV) cannulation pain would be significantly decreased by using a vapocoolant (V) versus sterile water placebo (S) spray, as determined by a reduction of at least ≥1.8 points on numerical rating scale (NRS) after vapocoolant versus placebo spray, the side effects and incidence of side effects from a vapocoolant spray; and whether there were any long term visible skin abnormalities associated with the use of a vapocoolant spray. Prospective, randomized, double-blind controlled trial of 300 adults (ages 18-80) requiring PIV placement in a hospital ED, randomized to S (N=150) or V (N=150) prior to PIV. Efficacy outcome was the difference in PIV pain: NRS from 0 (none) to worst (10). Safety outcomes included a skin checklist for local adverse effects (i.e., redness, blanching, edema, ecchymosis, itching, changes in skin pigmentation), vital sign (VS) changes, and before/after photographs of the PIV site. Patient demographics (age, gender, race), comorbidity, medications, and vital signs; and PIV procedure variables (e.g., IV needle size, location

  11. Comparison of F(ab')2 versus Fab antivenom for pit viper envenomation: a prospective, blinded, multicenter, randomized clinical trial.

    Science.gov (United States)

    Bush, Sean P; Ruha, Anne-Michelle; Seifert, Steven A; Morgan, David L; Lewis, Brandon J; Arnold, Thomas C; Clark, Richard F; Meggs, William J; Toschlog, Eric A; Borron, Stephen W; Figge, Gary R; Sollee, Dawn R; Shirazi, Farshad M; Wolk, Robert; de Chazal, Ives; Quan, Dan; García-Ubbelohde, Walter; Alagón, Alejandro; Gerkin, Richard D; Boyer, Leslie V

    2015-01-01

    Crotalidae Polyvalent Immune Fab (Ovine) has been the only antivenom commercially available in the US since 2007 for treatment of Crotalinae envenomation. Late coagulopathy can occur or recur after clearance of Fab antivenom, often after hospital discharge, lasting in some cases more than 2 weeks. There have been serious, even fatal, bleeding complications associated with recurrence phenomena. Frequent follow-up is required, and additional intervention or hospitalization is often necessary. F(ab')2 immunoglobulin derivatives have longer plasma half life than do Fab. We hypothesized that F(ab')2 antivenom would be superior to Fab in the prevention of late coagulopathy following treatment of patients with Crotalinae envenomation. We conducted a prospective, double-blind, randomized clinical trial, comparing late coagulopathy in snakebitten patients treated with F(ab')2 with maintenance doses [F(ab')2/F(ab')2], or F(ab')2 with placebo maintenance doses [F(ab')2/placebo], versus Fab with maintenance doses [Fab/Fab]. The primary efficacy endpoint was coagulopathy (platelet count Fab/Fab cohort experienced late coagulopathy versus 4/39 (10.3%, p < 0.05) in the F(ab')2/F(ab')2 cohort and 2/38 (5.3%, p < 0.05) in the F(ab')2/placebo cohort. The lowest heterologous protein exposure was with F(ab')2/placebo. No serious adverse events were related to study drug. In each study arm, one patient experienced an acute serum reaction and one experienced serum sickness. In this study, management of coagulopathic Crotalinae envenomation with longer-half-life F(ab')2 antivenom, with or without maintenance dosing, reduced the risk of subacute coagulopathy and bleeding following treatment of envenomation.

  12. [Alcohol versus bath and natural drying for term newborns' umbilical cord care: a prospective randomized clinical trial].

    Science.gov (United States)

    Covas, María del Carmen; Alda, Ernesto; Medina, María Sol; Ventura, Silvia; Pezutti, Ornella; Paris de Baeza, Ana; Sillero, Josefna; Esandi, María Eugenia

    2011-08-01

    Umbilical cord (UC) care is a cause of concern for parents right from birth until its separation. Standard practice in Argentina includes frequent cleansing of the UC with alcohol and body bath only two days after its separation. The effect of different methods of UC care on its separation time and on colonization with microorganisms has been insufficiently explored. Main: To compare the effect on time of UC separation when using body bath with neutral soap followed by natural drying of the UC vs. standard care. Secondary: a) colonization rates during hospitalization; b) incidence of skin infection and conjunctivitis and c) parental comfort with both types of care. Normal term newborns (≥37 weeks), born at the HPS, and whose parents provided informed consent. Open prospective controlled clinical trial, with random allocation to two groups: study group -natural drying of the UC and body bath with neutral soap- and control group -UC hygiene with alcohol 70% at each diaper change until its separation and bath two days later-. UC separation time; UC colonization during hospital stay and skin and conjunctive infections in the first 30 days of life were monitored. Analysis was by intention-to-treat. 362 newborns were included, 181 in each group. The groups were well balanced in baseline characteristics. Being in the study group was associated with a shorter time to UC separation (median [interquartile range]= 6.00 [3] vs. 7.00 [4] days; p natural drying of the UC reduced the time to cord separation. This practice increased the colonization rate, but the risk of skin and conjunctive infections was apparently not modified by it. However, the study has insufficient power for secondary outcomes. Health care providers should continue to develop evidence to support or eliminate historical practices.

  13. A Prospective Randomized Study Comparing Mini-surgical Percutaneous Dilatational Tracheostomy With Surgical and Classical Percutaneous Tracheostomy

    Science.gov (United States)

    Hashemian, Seyed Mohammad-Reza; Digaleh, Hadi

    2015-01-01

    Abstract Although percutaneous dilatational tracheostomy (PDT) is more accessible and less time-demanding compared with surgical tracheostomy (ST), it has its own limitations. We introduced a modified PDT technique and brought some surgical knowledge to the bedside to overcome some standard percutaneous dilatational tracheostomy relative contraindications. PDT uses a blind route of tracheal access that usually requires perioperational imaging guidance to protect accidental injuries. Moreover, there are contraindications in certain cases, limiting widespread PDT application. Different PDT modifications and devices have been represented to address the problem; however, these approaches are not generally popular among professionals due to limited accessibility and/or other reasons. We prospectively analyzed the double-blinded trial, patient and nurse head evaluating the complications, and collected data from 360 patients who underwent PDT, ST, or our modified mini-surgical PDT (msPDT, Hashemian method). These patients were divided into 2 groups—contraindicated to PDT—and randomization was done for msPDT or PDT in PDT-indicated group and msPDT or ST for PDT-contraindicated patients. The cases were compared in terms of pre and postoperational complications. Data analysis demonstrated that the mean value of procedural time was significantly lower in the msPDT group, either compared with the standard PDT or the ST group. Paratracheal insertion, intraprocedural hypoxemia, and bleeding were also significantly lower in the msPDT group compared with the standard PDT group. Other complications were not significantly different between msPDT and ST patients. The introduced msPDT represented a semiopen incision, other than blinded PDT route of tracheal access that allowed proceduralist to withdraw bronchoscopy and reduced the total time of procedure. Interestingly, the most important improvement was performing msPDT on PDT-contraindicated patients with the complication rate

  14. Effect of vonoprazan on the treatment of artificial gastric ulcers after endoscopic submucosal dissection: Prospective randomized controlled trial.

    Science.gov (United States)

    Tsuchiya, Izumi; Kato, Yuri; Tanida, Emiko; Masui, Yoshifumi; Kato, Shingo; Nakajima, Atsushi; Izumi, Motoyoshi

    2017-07-01

    Proton pump inhibitors are effective for the treatment of gastric ulcers after endoscopic submucosal dissection (ESD). However, the most excellent therapy is controversial. Vonoprazan, an active potassium-competitive acid blocker, has a strong gastric acid secretion inhibitory effect, but its efficacy for the treatment of post-ESD gastric ulcers is unclear. Herein, we aimed to determine the healing effect of vonoprazan on post-ESD gastric ulcers. We carried out a prospective randomized controlled trial examining 92 patients who had undergone ESD for the treatment of gastric neoplasms between April 2015 and June 2016 at Machida Municipal Hospital. Patients were treated with 20 mg/day vonoprazan (V group) or 20 mg/day esomeprazole (E group) for 8 weeks. We evaluated the 8-week cure rate for artificial ulcers and any complications after ESD. A total of 80 patients (median age, 73.5 years; 71.3% male) were analyzed. Cure rate for the V group was significantly higher than that for the E group (94.9% [37/39] vs 78.0% [32/41], respectively; P = 0.049). In a multivariate analysis, only vonoprazan was correlated with ulcer healing (odds ratio = 6.33; 95% CI = 1.21-33.20; P = 0.029). Delayed bleeding was experienced only in the E group (7.3% [3/41]), but no significant difference compared with the V group was observed (P = 0.241). Vonoprazan was significantly superior to esomeprazole for the healing of post-ESD gastric ulcers and should be considered as a treatment of first choice. © 2017 Japan Gastroenterological Endoscopy Society.

  15. Quality of recovery from anesthesia of patients undergoing balanced or total intravenous general anesthesia. Prospective randomized clinical trial.

    Science.gov (United States)

    Moro, Eduardo Toshiyuki; Leme, Fábio Caetano Oliveira; Noronha, Bernardo Roveda; Saraiva, Gustavo Farinha Pinto; de Matos Leite, Nathália Vianna; Navarro, Laís Helena Camacho

    2016-12-01

    The aim of the present study was to assess the quality of recovery from anesthesia of patients subjected to otorhinolaryngological (ORL) surgery under balanced or total intravenous general anesthesia by means of Quality of Recovery-40 (QoR-40) questionnaire. Prospective randomized clinical trial. The setting is at an operating room, a postoperative recovery area, and a hospital ward. One-hundred thirty American Society of Anesthesiologists physical status I or II patients scheduled to undergo general anesthesia for ORL interventions under remifentanil, in combination with sevoflurane (balanced technique) or propofol (total intravenous anesthesia). Occurrence of nausea, vomiting, body temperature less than 36°C, and length of stay in the postanesthesia care unit were recorded. The QoR-40 was administered by an investigator blind to group allocation 24 hours after surgery. The quality of recovery, as assessed by the score on the QoR-40, was compared between the groups. There is no difference regarding the QoR-40 score among intravenous and inhalation anesthesia groups (190.5 vs 189.5, respectively; P=.33). Similarly, among the 5 dimensions of the QoR-40, the scores were comparable between the groups. Incidence of hypothermia (P=.58), nauseas or vomits (P=.39), and length of surgery (P=.16) were similar among groups. The evaluation of pain intensity (P=.80) and dose of morphine use in the postanesthesia care unit (P=.4) was also comparable between groups. The quality of recovery from anesthesia assessed based on the patients' perception did not differ between the ones subjected to either inhalation or intravenous general anesthesia for ORL surgery based on QoR-40 questionnaire assessment. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. A prospective randomized trial comparing the efficacy of Letrozole and Clomiphene citrate in induction of ovulation in polycystic ovarian syndrome

    Directory of Open Access Journals (Sweden)

    Kallol Kumar Roy

    2012-01-01

    Full Text Available Objectives: To compare the efficacy of letrozole and clomiphene citrate (CC in patients of anovulatory polycystic ovarian syndrome (PCOS with infertility. Materials and Methods: This prospective randomized clinical trial included 204 patients of PCOS. 98 patients (294 cycles received 2.5-5 mg of letrozole; 106 patients (318 cycles received 50-100 mg of CC (both orally from Days 3-7 of menstrual cycle. The treatment continued for three cycles in both the groups. Main outcome measures: ovulation rate, endometrial thickness, and pregnancy rate. Statistical analysis was done using SPSS 13 software. P value less than 0.05 was considered significant. Results: The mean number of dominant follicles in letrozole groups and CC groups was 1.86±0.26 and 1.92±0.17, respectively (P=0.126. Number of ovulatory cycle in letrozole group was 196 (66.6% versus 216 (67.9% in CC group (P=0.712. The mean mid-cycle endometrial thickness was 9.1±0.3 mm in letrozole group and 6.3±1.1 in CC group, which was statistically significant (P=0.014. The mean Estradiol [E2] level in clomiphene citrate group was significantly higher in CC group (364.2±71.4 pg/mL than letrozole group (248.2± 42.2 pg/mL. 43 patients from the letrozole group (43.8% and 28 patients from the CC group (26.4% became pregnant. Conclusion: Letrozole and CC have comparable ovulation rate. The effect of letrozole showed a better endometrial response and pregnancy rate compared with CC.

  17. Alveolar ridge preservation using autogenous tooth graft versus beta-tricalcium phosphate alloplast: A randomized, controlled, prospective, clinical pilot study

    Directory of Open Access Journals (Sweden)

    Chaitanya Pradeep Joshi

    2016-01-01

    Full Text Available Background: A randomized, prospective clinical, radiographical, and histological study was conducted to evaluate healing after alveolar ridge preservation technique using two different graft materials, namely, a novel autogenous graft material i. e., autogenous tooth graft (ATG and beta-tricalcium phosphate (β-TCP alloplast. Materials and Methods: Fifteen patients undergoing extraction of at least three teeth were selected. Atraumatic extractions were performed. Of the three extraction sockets, one was grafted with ATG, other with β-TCP, and the third was left ungrafted. Cone-beam computed tomography scans were taken immediately after grafting and 4 months postoperatively to check the changes in alveolar crest height and width at all the sites. Three patients in whom implant placement was done after complete healing; bone samples were harvested using a 3 mm diameter trephine during osteotomy preparation from both the ridge preserved sites and studied histologically. Results: There was a statistically significant difference when the changes in width and height of alveolar crest were compared within all the three groups (P < 0.05. Among three sites, ATG-grafted sites showed the most superior results with a minimal reduction in alveolar crest height and width. Histological analysis also showed the same trend with more new bone formation at ATG-grafted sites as compared to β-TCP-grafted sites. Conclusion: Postextraction, ridge preservation leads to more predictable maintenance of alveolar ridge height and width. ATG as compared to β-TCP provided superior results. Based on this, we conclude that ATG material can serve as a better alternative to conventional bone graft materials.

  18. Dexmedetomidine in a surgically inserted catheter for transversus abdominis plane block in donor hepatectomy: A prospective randomized controlled study.

    Science.gov (United States)

    Aboelela, Mohamed Adel; Kandeel, Al-Refaey; Elsayed, Usama; Elmorshedi, Mohamed; Elsarraf, Waleed; Elsayed, Eman; Elgawalby, Ahmed; Sultan, Ahmed Mohamed; Wahab, Mohamed Abdel; Yassen, Amr

    2018-01-01

    Transversus abdominis plane (TAP) block is a promising technique for analgesia after abdominal surgery. This prospective, randomized controlled trial assessed the effect of adding dexmedetomidine to bupivacaine in TAP block for donor hepatectomy. We hypothesized that this would improve postoperative morphine consumption and reduce analgesia related complication and inflammation. A total of 50 donor hepatectomy were enrolled in this study. Patients divided into two equal groups according to drugs used for TAP block. Group (B) received 20 ml of bupivacaine hydrochloride 0.25%, Group (BD) received 20 ml of bupivacaine hydrochloride 0.25% and 0.3 μg/kg dexmedetomidine, on both sides at the end of surgery and every 8 h for 48 h at right side only through inserted catheter. Primary outcome objective was morphine consumption at first 72 h. Secondary outcome objectives were morphine requirement, numbers of intake, time to first intake, pain score numerical analog scale (NAS), postoperative analgesia related complications, recovery of intestinal motility, and inflammatory markers. Data were analyzed, rescue morphine analgesia was significantly lower in (BD) group compared with (B) groups as considering total morphine consumption (B 4 ± 1.9, BD 1.5 ± 0.5, P = 0.03), numbers of morphine intake ( P = 0.04), morphine requirement ( P = 0.03), and first time of analgesia intake ( P = 0.04). NAS was significantly lower in group (BD) compared with group (B) group in the first 12 h (NAS 0 - P = 0.001, NAS 1 - P = 0.03). Adding dexmedetomidine improved gut motility, first oral intake without detectable anti-inflammatory effect. Adding dexmedetomidine to bupivacine in a surgically inserted catheter for TAP block in donor hepatectomy reduced morphine consumption without detectable anti-inflammatory effect.

  19. The role of topical vitamin A in promoting healing in surface refractive procedures: a prospective randomized controlled study

    Directory of Open Access Journals (Sweden)

    Chelala E

    2013-09-01

    Full Text Available Elias Chelala,1 Ali Dirani,1 Ali Fadlallah,1 Sharbel Fahd21Saint Joseph University, Faculty of Medicine, Beirut, Lebanon; 2Ophthalmic Consultant of Beirut, Chairman Ophthalmology, Lebanese American University, Beirut, LebanonAim: To evaluate the effect of topical vitamin A supplementation on corneal re-epithelialization time, postoperative pain, visual acuity, and haze following photorefractive keratectomy (PRK.Patients and methods: This prospective study included 32 patients. For each patient, one eye was randomized to the vitamin A group and the fellow eye to the non-vitamin A group (control group. Eyes in the vitamin A group received perioperative topical vitamin A (retinol palmitate, 250 IU/g VitAPOS eye ointment [AFT Pharmaceuticals Pty, Ltd, Sydney, NSW, Australia] in addition to the classic treatment for PRK. Clinical outcomes were evaluated up to 3 months after PRK.Results: There was no difference in the mean time to complete healing between the vitamin A group and the control group (3.36 ± 0.6 days in the control group; 3.42 ± 0.7 days in the vitamin A group; P = 0.854. Mean postoperative pain at the 48-hour visit was 4.35 ± 1.42 over 10 in the control group, and 4.42 ± 1.37 over 10 in the vitamin A group, with no difference between the two groups (P = 0.589. Subepithelial haze evaluated at 3 months postoperatively did not differ between the two groups (P = 0.960. Also, visual and refractive outcomes were not different between the two groups 3 months postoperatively.Conclusion: Topical vitamin A supplementation did not affect re-epithelialization time, postoperative pain, corneal haze formation, or visual outcomes after PRK.Keywords: photorefractive keratectomy, topical vitamin A, corneal re-epithelialization

  20. Beneficial role of green plantain [Musa paradisiaca] in the management of persistent diarrhea: a prospective randomized trial.

    Science.gov (United States)

    Alvarez-Acosta, Thais; León, Cira; Acosta-González, Salvador; Parra-Soto, Haydeé; Cluet-Rodriguez, Isabel; Rossell, Maria Rosario; Colina-Chourio, José A

    2009-04-01

    To evaluate the beneficial effects of green plantain-based diet on stool volume, frequency and weight gain as compared with a traditional yogurt-based diet in children with persistent diarrhea. In a prospective, in-hospital controlled trial, two different treatments were administered to a sample of 80 children of both sexes, with ages ranging from 1 to 28 months, who had experienced >or= 14 days of persistent diarrhea. The sample was divided into two groups of isocaloric (100 kcal/kg/d) diets: experimental and control, of 40 patients each. The experimental group was randomly given a-week treatment consisting of a 50 g/L of cooked green plantain-based diet. The control group was fed on a yogurt-based diet. Both groups were not statistically different at admission. Pathogens were isolated from stools in 21.2% and 25% of patients in the experimental and control groups respectively; Aeromonas hydrophilia and Shigela flexneri were the most frequently found bacteria. The experimental group fed on a green plantain diet had a significantly better response in: diminishing stool output and consistency (p < 0.002), stool weight, diarrhea duration (p < 0.001), and increasing daily body weight gain (p < 0.001) than the yogurt-based diet group. The average duration of diarrhea in the plantain-based diet group was 18 hours shorter (p < 0.005) and it also had lower cost (p < 0.005). Our results support the benefits of green plantain in the dietary management of persistent diarrhea in hospitalized children, in relation to diarrheal duration, weight gain and costs.

  1. Adjuvant chemotherapy and radiotherapy in triple-negative breast carcinoma: A prospective randomized controlled multi-center trial

    International Nuclear Information System (INIS)

    Wang, Jianhua; Shi, Mei; Ling, Rui; Xia Yuesheng; Luo Shanquan; Fu Xuehai; Xiao Feng; Li Jianping; Long Xiaoli; Wang Jianguo; Hou Zengxia; Chen Yunxia; Zhou Bin; Xu, Man

    2011-01-01

    Background and purpose: Triple-negative breast cancer (TNBC) presents a high risk breast cancer that lacks the benefit from hormone treatment, chemotherapy is the main strategy even though it exists in poor prognosis. Use of adjuvant radiation therapy, which significantly decreases breast cancer mortality, has not been well described among poor TNBC women. The aim of this study was to evaluate whether the combination of chemotherapy and radiotherapy could significantly increase survival outcomes in TNBC women after mastectomy. Patients and methods: A prospective randomized controlled multi-center study was performed between February 2001 and February 2006 and comprised 681 women with triple-negative stage I-II breast cancer received mastectomy, of them, 315 cases received systemic chemotherapy alone, 366 patients received radiation after the course of chemotherapy. Recurrence-free survival (RFS) and overall survival (OS) were estimated. Simultaneously local and systemic toxicity were observed. Results: After a median follow-up of 86.5 months, five-year RFS rates were 88.3% and 74.6% for adjuvant chemotherapy plus radiation and adjuvant chemotherapy alone, respectively, with significant difference between the two groups (HR 0.77 [95% CI 0.72, 0.98]; P = 0.02). Five-year OS significantly improved in adjuvant chemotherapy plus radiation group compared with chemotherapy alone (90.4% and 78.7%) (HR 0.79 [95% CI 0.74, 0.97]; P = 0.03). No severe toxicity was reported. Conclusions: Patients received standard adjuvant chemotherapy plus radiation therapy was more effective than chemotherapy alone in women with triple-negative early-stage breast cancer after mastectomy.

  2. Shoulder Magnetic Resonance Arthrography: A Prospective Randomized Study of Anterior and Posterior Ultrasonography-Guided Contrast Injections

    Energy Technology Data Exchange (ETDEWEB)

    Koivikko, M.P.; Mustonen, A.O.T. (Dept. of Radiology, Helsinki Univ. Central Hospital, Helsinki (Finland))

    2008-10-15

    Background: Magnetic resonance (MR) arthrography is an accurate imaging method for internal shoulder derangements and rotator cuff pathologies. Both anterior and posterior contrast injection techniques, under palpatory, fluoroscopic, or ultrasonographic guidance have been described in the literature. However, clinical comparisons of the injection techniques remain few. Purpose: To compare the performance of anterior and posterior ultrasonography (US)-guided arthrography injections of the shoulder regarding patient discomfort and influence on diagnostic MR reading, and to illustrate the typical artifacts resulting from contrast leakage in the respective techniques. Material and Methods: 43 MR arthrographies were prospectively randomized into anterior and posterior US-guided contrast injections and performed by two radiologists, with the study of artifacts from contrast leakage. Pain from the injections was assessed by a survey utilizing a 100-mm visual analogue scale (VAS). Results: Of the 23 anterior injections, nine caused contrast artifacts in the subscapular tendon, and in three the leakage extended further anteriorly. Of the 20 posterior injections, 12 showed injection artifacts of the rotator cuff, extending outside the cuff in seven. Two of the anterior and none of the posterior artifacts compromised diagnostic quality. In posterior injections, the leakage regularly occurred at the caudal edge of the infraspinatus muscle and was easily distinguishable from rotator cuff tears. All patients completed the pain survey. Mean VAS scores were 25.0 (median 18, SD 22) for anterior, and 25.4 (median 16, SD 25) for posterior injections. The two radiologists achieved different mean VAS scores but closely agreed as to anterior and posterior VAS scores. Conclusion: Arthrography injections were fairly simple to perform under US guidance. Patient discomfort for anterior and posterior injections was equally minor. A tailored approach utilizing anterior or posterior injections

  3. Patient-specific guides do not improve accuracy in total knee arthroplasty: a prospective randomized controlled trial.

    Science.gov (United States)

    Victor, Jan; Dujardin, Jan; Vandenneucker, Hilde; Arnout, Nele; Bellemans, Johan

    2014-01-01

    Recently, patient-specific guides (PSGs) have been introduced, claiming a significant improvement in accuracy and reproducibility of component positioning in TKA. Despite intensive marketing by the manufacturers, this claim has not yet been confirmed in a controlled prospective trial. We (1) compared three-planar component alignment and overall coronal mechanical alignment between PSG and conventional instrumentation and (2) logged the need for applying changes in the suggested position of the PSG. In this randomized controlled trial, we enrolled 128 patients. In the PSG cohort, surgical navigation was used as an intraoperative control. When the suggested cut deviated more than 3° from target, the use of PSG was abandoned and marked as an outlier. When cranial-caudal position or size was adapted, the PSG was marked as modified. All patients underwent long-leg standing radiography and CT scan. Deviation of more than 3° from the target in any plane was defined as an outlier. The PSG and conventional cohorts showed similar numbers of outliers in overall coronal alignment (25% versus 28%; p = 0.69), femoral coronal alignment (7% versus 14%) (p = 0.24), and femoral axial alignment (23% versus 17%; p = 0.50). There were more outliers in tibial coronal (15% versus 3%; p = 0.03) and sagittal 21% versus 3%; p = 0.002) alignment in the PSG group than in the conventional group. PSGs were abandoned in 14 patients (22%) and modified in 18 (28%). PSGs do not improve accuracy in TKA and, in our experience, were somewhat impractical in that the procedure needed to be either modified or abandoned with some frequency.

  4. [Prevention of intrauterine adhesion with auto-crosslinked hyaluronic acid gel: a prospective, randomized, controlled clinical study].

    Science.gov (United States)

    Xiao, Songshu; Wan, Yajun; Zou, Fangjun; Ye, Mingzhu; Deng, Henan; Ma, Jiezhi; Wei, Yingying; Tan, Chen; Xue, Min

    2015-01-01

    To evaluate the efficacy and safety of auto-crosslinked hyaluronic acid (HA) gel for preventing intrauterine adhesion (IUA) after hysteroscopic adhesiolysis. A prospective, randomized, double blinded and controlled clinical trial (level I) was performed. According to American Fertility Society (AFS) scoring system, 120 patients (treatment group: 60 cases, control group: 60 cases) with moderate to severe IUA were enrolled. Upon completion of adhesiolysis, a Foley balloon catheter was first introduced into the uterine cavity and then 3 ml of auto-crosslinked HA gel for patients in the treatment group; patients in the control group, however, only received Foley balloon catheter. Second-look hysteroscopic examination was performed to all patients at 3 months postoperatively for evaluation of IUA. Primary endpoint was the reduction rate of IUA at 3 months after surgery. The secondary endpoints include total AFS score, score of each individual AFS category. At 3 months after surgery, auto-crosslinked HA gel resulted in significantly higher effective rate for reduction of adhesion, the effective rate were 76% (42/55) and 48% (27/56) respectively (P = 0.000 9); the total AFS score of treatment group was 2.1 ± 1.1, and significantly lower than that of control group (3.7 ± 2.5, P = 0.000 8). Application of auto-crosslinked HA gel after surgery significantly enhanced the improvement for each individual patient with regard to their adhesive type and menstrual pattern (P = 0.037 8, P = 0.000 4). The treatment group had significantly lower proportion of patients with moderate to severe adhesive stages than that of control group [13% (7/55) versus 38% (21/56), P = 0.000 6]. No adverse events and complications were observed. Auto-crosslinked HA gel coule be able to reduce IUA, decrease adhesion severity, and improve menopause postoperatively. This absorbable auto-crosslinked HA gel is proposed as a barrier for preventing IUA after intrauterine procedures.

  5. Pars Plana-Modified versus Conventional Ahmed Glaucoma Valve in Patients Undergoing Penetrating Keratoplasty: A Prospective Comparative Randomized Study.

    Science.gov (United States)

    Parihar, Jitendra Kumar Singh; Jain, Vaibhav Kumar; Kaushik, Jaya; Mishra, Avinash

    2017-03-01

    To compare the outcome of pars-plana-modified Ahmed glaucoma valve (AGV) versus limbal-based conventional AGV into the anterior chamber, in patients undergoing penetrating keratoplasty (PK) for glaucoma with coexisting corneal diseases. In this prospective randomized clinical trial, 58 eyes of 58 patients with glaucoma and coexisting corneal disease were divided into two groups. Group 1 (29 eyes of 29 patients) included patients undergoing limbal-based conventional AGV into the anterior chamber (AC) along-with PK and group 2 (29 eyes of 29 patients) included those undergoing pars-plana-modified AGV along-with PK. Outcome measures included corneal graft clarity, intraocular pressure (IOP), number of antiglaucoma medications, and postoperative complications. Patients were followed up for a minimum period of 2 years. Out of 58 eyes (58 patients), 50 eyes (50 patients: 25 eyes of 25 patients each in group 1 and group 2) completed the study and were analyzed. Complete success rate for AGV (group 1: 76%; group 2: 72%; p = 0.842) and corneal graft clarity (group 1: 68%; group 2: 76%; p = 0.081) were comparable between the two groups at 2 years. Graft failure was more in conventional AGV (32%) as compared to pars plana-modified AGV (24%) but not statistically significant (p = 0.078) at 2 years. Though both procedures were comparable in various outcome measures, pars-plana-modified AGV is a viable option for patients undergoing PK, as it provides a relatively better corneal graft survival rate and lesser complications that were associated with conventional AGV.

  6. Opening the Internal Hematoma Membrane Does Not Alter the Recurrence Rate of Chronic Subdural Hematomas: A Prospective Randomized Trial.

    Science.gov (United States)

    Unterhofer, Claudia; Freyschlag, Christian F; Thomé, Claudius; Ortler, Martin

    2016-08-01

    Factors determining the recurrence of chronic subdural hematomas (CSDHs) are not clear. Whether opening the so-called internal hematoma membrane is useful has not been investigated. To investigate whether splitting the inner hematoma membrane influences the recurrence rate in patients undergoing burr-hole craniotomy for CSDH. Fifty-two awake patients undergoing surgery for 57 CSDHs were prospectively randomized to either partial opening of the inner hematoma membrane (group A) or not (group B) after enlarged burr-hole craniotomy and hematoma evacuation. Drainage was left in situ for several days postoperatively. Groups were comparable with regard to demographic, clinical, and imaging variables. Outcome was assessed after 3-6 weeks for the combined outcome variable of reoperation or residual hematoma of one third or more of the original hematoma thickness. Fourteen patients underwent reoperation for clinical deterioration or residual hematoma during follow-up (n = 6 in group A, 21%; n = 8 in group B, 28 %) (P = 0.537). Residual hematoma of ≥ one third not requiring surgery was present in 7 patients in group A (25%) and 10 patients in group B (36%) (P = 0.383). The overall cumulative failure rate (reoperation or hematoma thickness ≥ one third) was 13/28 (46%) in group A and 18/28 in group B (P = 0.178; relative risk, 0.722 [95% confidence interval, 0.445-1.172]; absolute risk reduction -16% [95% confidence interval, -38% to 8%]). Opening the internal hematoma membrane does not alter the rate of patients requiring revision surgery and the number of patients showing a marked residual hematoma 6 weeks after evacuation of a CSDH. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Prospective randomized comparison of standard didactic lecture versus high-fidelity simulation for radiology resident contrast reaction management training.

    Science.gov (United States)

    Wang, Carolyn L; Schopp, Jennifer G; Petscavage, Jonelle M; Paladin, Angelisa M; Richardson, Michael L; Bush, William H

    2011-06-01

    The objective of our study was to assess whether high-fidelity simulation-based training is more effective than traditional didactic lecture to train radiology residents in the management of contrast reactions. This was a prospective study of 44 radiology residents randomized into a simulation group versus a lecture group. All residents attended a contrast reaction didactic lecture. Four months later, baseline knowledge was assessed with a written test, which we refer to as the "pretest." After the pretest, the 21 residents in the lecture group attended a repeat didactic lecture and the 23 residents in the simulation group underwent high-fidelity simulation-based training with five contrast reaction scenarios. Next, all residents took a second written test, which we refer to as the "posttest." Two months after the posttest, both groups took a third written test, which we refer to as the "delayed posttest," and underwent performance testing with a high-fidelity severe contrast reaction scenario graded on predefined critical actions. There was no statistically significant difference between the simulation and lecture group pretest, immediate posttest, or delayed posttest scores. The simulation group performed better than the lecture group on the severe contrast reaction simulation scenario (p = 0.001). The simulation group reported improved comfort in identifying and managing contrast reactions and administering medications after the simulation training (p ≤ 0.04) and was more comfortable than the control group (p = 0.03), which reported no change in comfort level after the repeat didactic lecture. When compared with didactic lecture, high-fidelity simulation-based training of contrast reaction management shows equal results on written test scores but improved performance during a high-fidelity severe contrast reaction simulation scenario.

  8. A Prospective Randomized Peri- and Post-Operative Comparison of the Minimally Invasive Anterolateral Approach Versus the Lateral Approach

    Science.gov (United States)

    Landgraeber, Stefan; Quitmann, Henning; Güth, Sebastian; Haversath, Marcel; Kowalczyk, Wojciech; Kecskeméthy, Andrés; Heep, Hansjörg; Jäger, Marcus

    2013-01-01

    There is still controversy as to whether minimally invasive total hip arthroplasty enhances the postoperative outcome. The aim of this study was to compare the outcome of patients who underwent total hip replacement through an anterolateral minimally invasive (MIS) or a conventional lateral approach (CON). We performed a randomized, prospective study of 75 patients with primary hip arthritis, who underwent hip replacement through the MIS (n=36) or CON (n=39) approach. The Western Ontario and McMaster Universities Osteoarthritis Index and Harris Hip score (HHS) were evaluated at frequent intervals during the early postoperative follow-up period and then after 3.5 years. Pain sensations were recorded. Serological and radiological analyses were performed. In the MIS group the patients had smaller skin incisions and there was a significantly lower rate of patients with a positive Trendelenburg sign after six weeks postoperatively. After six weeks the HHS was 6.85 points higher in the MIS group (P=0.045). But calculating the mean difference between the baseline and the six weeks HHS we evaluated no significant differences. Blood loss was greater and the duration of surgery was longer in the MIS group. The other parameters, especially after the twelfth week, did not differ significantly. Radiographs showed the inclination of the acetabular component to be significantly higher in the MIS group, but on average it was within the same permitted tolerance range as in the CON group. Both approaches are adequate for hip replacement. Given the data, there appears to be no significant long term advantage to the MIS approach, as described in this study. PMID:24191179

  9. A prospective randomized peri- and post-operative comparison of the minimally invasive anterolateral approach versus the lateral approach

    Directory of Open Access Journals (Sweden)

    Stefan Landgraeber

    2013-07-01

    Full Text Available There is still controversy as to whether minimally invasive total hip arthroplasty enhances the postoperative outcome. The aim of this study was to compare the outcome of patients who underwent total hip replacement through an anterolateral minimally invasive (MIS or a conventional lateral approach (CON. We performed a randomized, prospective study of 75 patients with primary hip arthritis, who underwent hip replacement through the MIS (n=36 or CON (n=39 approach. The Western Ontario\tand\tMcMaster\tUniversities Osteoarthritis Index and Harris Hip score (HHS were evaluated at frequent intervals during the early postoperative follow-up period and then after 3.5 years. Pain sensations were recorded. Serological and radiological analyses were performed. In the MIS group the patients had smaller skin incisions and there was a significantly lower rate of patients with a positive Trendelenburg sign after six weeks postoperatively. After six weeks the HHS was 6.85 points higher in the MIS group (P=0.045. But calculating the mean difference between the baseline and the six weeks HHS we evaluated no significant differences. Blood loss was greater and the duration of surgery was longer in the MIS group. The other parameters, especially after the twelfth week, did not differ significantly. Radiographs showed the inclination of the acetabular component to be significantly higher in the MIS group, but on average it was within the same permitted tolerance range as in the CON group. Both approaches are adequate for hip replacement. Given the data, there appears to be no significant long term advantage to the MIS approach, as described in this study.

  10. Effect of Continuous Motion Parameter Feedback on Laparoscopic Simulation Training: A Prospective Randomized Controlled Trial on Skill Acquisition and Retention.

    Science.gov (United States)

    Buescher, Julian Frederik; Mehdorn, Anne-Sophie; Neumann, Philipp-Alexander; Becker, Felix; Eichelmann, Ann-Kathrin; Pankratius, Ulrich; Bahde, Ralf; Foell, Daniel; Senninger, Norbert; Rijcken, Emile

    To investigate the effect of motion parameter feedback on laparoscopic basic skill acquisition and retention during a standardized box training curriculum. A Lap-X Hybrid laparoscopic simulator was designed to provide individual and continuous motion parameter feedback in a dry box trainer setting. In a prospective controlled trial, surgical novices were randomized into 2 groups (regular box group, n = 18, and Hybrid group, n = 18) to undergo an identical 5-day training program. In each group, 7 standardized tasks on laparoscopic basic skills were completed twice a day on 4 consecutive days in fixed pairs. Additionally, each participant performed a simulated standard laparoscopic cholecystectomy before (day 1) and after training (day 5) on a LAP Mentor II virtual reality (VR) trainer, allowing an independent control of skill progress in both groups. A follow-up assessment of skill retention was performed after 6 weeks with repetition of both the box tasks and VR cholecystectomy. Muenster University Hospital Training Center, Muenster, Germany. Medical students without previous surgical experience. Laparoscopic skills in both groups improved significantly during the training period, measured by the overall task performance time. The 6 week follow-up showed comparable skill retention in both groups. Evaluation of the VR cholecystectomies demonstrated significant decrease of operation time (p Simulation training on both trainers enables reliable acquisition of laparoscopic basic skills. Furthermore, individual and continuous motion feedback improves laparoscopic skill enhancement significantly in several aspects. Thus, training systems with feedback of motion parameters should be considered to achieve long-term improvement of motion economy among surgical trainees. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  11. Questioning the wisdom of tubeless percutaneous nephrolithotomy (PCNL): a prospective randomized controlled study of early tube removal vs tubeless PCNL.

    Science.gov (United States)

    Mishra, Shashikant; Sabnis, Ravindra B; Kurien, Abraham; Ganpule, Arvind; Muthu, Veeramani; Desai, Mahesh

    2010-10-01

    To establish the efficacy of early removal of a nephrostomy tube after percutaneous nephrolithotomy (PCNL), to challenge the wisdom of tubeless PCNL, as we hypothesized that it would result in a shorter hospital stay, comparable benefit and safety, while maintaining the option of check nephroscopy ensuring far superior stone clearance. In all, 22 patients were prospectively randomized equally into two groups, group 1 (early nephrostomy removal) or group 2 (tubeless) during a 1-month study period. Inclusion criteria for the study were: a simple stone of Foley catheter were used, while in group 2 only a 6 F retrograde ureteric catheter and Foley catheter were placed at the end of the procedure. Computed tomography (CT) with no contrast medium was done on the first morning after surgery before removing all catheters/tubes, and patients discharged subsequently. The variables assessed were stone clearance, hospital stay, analgesic requirement, postoperative complications and auxiliary procedures. The mean (SD) stone bulk was similar between the groups, at 2737 (946.9) and 2934.2 (2090.7) µL, respectively. Despite an on-table complete clearance, clearance assessed by CT was nine of 11 vs eight of 11 in groups 1 and 2, respectively. CT showed a 6 mm stone in one patient in group 1, while the remaining patients had stones of haematuria in none vs three (P= 0.21), urinoma none vs one, and fever in two vs one, respectively; one patient in group 1 required a check nephroscopy for a residual fragment. Overall clearance including re-treatment was 10/11 vs eight of 11 (P= 0.009), respectively. Early tube removal after PCNL results in an equivalent analgesic requirement, decrease in haemoglobin and hospital stay as tubeless PCNL. It has a significantly lower incidence of early haematuria, better clearance rates and preserves the option of check nephroscopy. It can be considered as an accepted standard of care, with the preserved advantages of tubeless PCNL. © 2010 THE AUTHORS

  12. Validation of orthopedic postoperative pain assessment methods for dogs: a prospective, blinded, randomized, placebo-controlled study.

    Directory of Open Access Journals (Sweden)

    Pascale Rialland

    Full Text Available In the context of translational research, there is growing interest in studying surgical orthopedic pain management approaches that are common to humans and dogs. The validity of postoperative pain assessment methods is uncertain with regards to responsiveness and the potential interference of analgesia. The hypothesis was that video analysis (as a reference, electrodermal activity, and two subjective pain scales (VAS and 4A-VET would detect different levels of pain intensity in dogs after a standardized trochleoplasty procedure. In this prospective, blinded, randomized study, postoperative pain was assessed in 25 healthy dogs during a 48-hour time frame (T. Pain was managed with placebo (Group 1, n = 10, preemptive and multimodal analgesia (Group 2, n = 5, or preemptive analgesia consisting in oral tramadol (Group 3, n = 10. Changes over time among groups were analyzed using generalized estimating equations. Multivariate regression tested the significance of relationships between pain scales and video analysis. Video analysis identified that one orthopedic behavior, namely 'Walking with full weight bearing' of the operated leg, decreased more in Group 1 at T24 (indicative of pain, whereas three behaviors indicative of sedation decreased in Group 2 at T24 (all p<0.004. Electrodermal activity was higher in Group 1 than in Groups 2 and 3 until T1 (p<0.0003. The VAS was not responsive. 4A-VET showed divergent results as its orthopedic component (4A-VETleg detected lower pain in Group 2 until T12 (p<0.0009, but its interactive component (4A-VETbeh was increased in Group 2 from T12 to T48 (p<0.001. Concurrent validity established that 4A-VETleg scores the painful orthopedic condition accurately and that pain assessment through 4A-VETbeh and VAS was severely biased by the sedative side-effect of the analgesics. Finally, the video analysis offered a concise template for assessment in dogs with acute orthopedic pain. However, subjective pain

  13. Training With Curved Laparoscopic Instruments in Single-Port Setting Improves Performance Using Straight Instruments: A Prospective Randomized Simulation Study.

    Science.gov (United States)

    Lukovich, Peter; Sionov, Valery Ben; Kakucs, Timea

    2016-01-01

    Lately single-port surgery is becoming a widespread procedure, but it is more difficult than conventional laparoscopy owing to the lack of triangulation. Although, these operations are also possible with standard laparoscopic instruments, curved instruments are being developed. The aims of the study were to identify the effect of training on a box trainer in single-port setting on the quality of acquired skills, and transferred with the straight and curved instruments for the basic laparoscopic tasks, and highlight the importance of a special laparoscopic training curriculum. A prospective study on a box trainer in single-port setting was conducted using 2 groups. Each group performed 2 tasks on the box trainer in single-port setting. Group-S used conventional straight laparoscopic instruments, and Group-C used curved laparoscopic instruments. Learning curves were obtained by daily measurements recorded in 7-day sessions. On the last day, the 2 groups changed instruments between each other. 1st Department of Surgery, Semmelweis University of Medicine from Budapest, Hungary, a university teaching hospital. In all, 20 fifth-year medical students were randomized into 2 groups. None of them had any laparoscopic or endoscopic experience. Participation was voluntary. Although Group-S performed all tasks significantly faster than Group-C on the first day, the difference proved to be nonsignificant on the last day. All participants achieved significantly shorter task completion time on the last day than on the first day, regardless of the instrument they used. Group-S showed improvement of 63.5%, and Group-C 69.0% improvement by the end of the session. After swapping the instruments, Group-S reached significantly higher task completion time with curved instruments, whereas Group-C showed further progression of 8.9% with straight instruments. Training with curved instruments in a single-port setting allows for a better acquisition of skills in a shorter period. For this

  14. Autologous platelet-rich plasma reduces transfusions during ascending aortic arch repair: a prospective, randomized, controlled trial.

    Science.gov (United States)

    Zhou, Shao Feng; Estrera, Anthony L; Loubser, Paul; Ignacio, Craig; Panthayi, Sreelatha; Miller, Charles; Sheinbaum, Roy; Safi, Hazim J

    2015-04-01

    Blood conservation using autologous platelet-rich plasma (aPRP), a technique of whole blood harvest that separates red blood cells from plasma and platelets before cardiopulmonary bypass with retransfusion of the preserved platelets after completion of cardiopulmonary bypass, has not been studied extensively. We sought to prospectively determine whether aPRP reduces blood transfusions during ascending and transverse aortic arch repair. We randomly assigned 80 patients undergoing elective ascending and transverse aortic arch repair using deep hypothermic circulatory arrest to receive either aPRP (n = 38) or no aPRP (n = 42). Volume of aPRP retransfused was 726 ± 124 mL. The primary end point was transfusion amount. Secondary end points were death, stroke, renal failure, pulmonary failure, and transfusion costs. Perioperative transfusion rate was defined as blood transfusions given during surgery and up to 72 hours afterward. The surgeon and intensivist were blinded to the treatment arm. Because an anesthesiologist initiated the protocol, the surgeon was not aware of aPRP collection, as this occurred only after the sterile drape was in place. In addition, because cell salvage was performed on all cases, differentiation in perfusionist activities (during spinning of aPRP) was not evident. Platelet, fresh frozen plasma, and cryoprecipitate intraoperative transfusions were performed only after heparin was reversed and the patient was judged as coagulopathic on the basis of associated criteria: cryoprecipitate transfusion for fibrinogen level less than 150 μg/dL, platelet transfusion for platelet count less than 80,000, and fresh frozen plasma when thromboelastogram test was suggestive or a partial thromboplastin time was greater than 55 seconds, and prothrombin time was greater than 1.6 seconds. Early mortality, stroke, and respiratory complications were similar between groups. Only acute renal failure was reduced in the aPRP group, 7% versus 0% (p platelets by 56

  15. Prospective randomized trial of enoxaparin, pentoxifylline and ursodeoxycholic acid for prevention of radiation-induced liver toxicity.

    Directory of Open Access Journals (Sweden)

    Max Seidensticker

    Full Text Available Targeted radiotherapy of liver malignancies has found to be effective in selected patients. A key limiting factor of these therapies is the relatively low tolerance of the liver parenchyma to radiation. We sought to assess the preventive effects of a combined regimen of pentoxifylline (PTX, ursodeoxycholic acid (UDCA and low-dose low molecular weight heparin (LMWH on focal radiation-induced liver injury (fRILI.Patients with liver metastases from colorectal carcinoma who were scheduled for local ablation by radiotherapy (image-guided high-dose-rate interstitial brachytherapy were prospectively randomized to receive PTX, UDCA and LMWH for 8 weeks (treatment or no medication (control. Focal RILI at follow-up was assessed using functional hepatobiliary magnetic resonance imaging (MRI. A minimal threshold dose, i.e. the dose to which the outer rim of the fRILI was formerly exposed to, was quantified by merging MRI and dosimetry data.Results from an intended interim-analysis made a premature termination necessary. Twenty-two patients were included in the per-protocol analysis. Minimal mean hepatic threshold dose 6 weeks after radiotherapy (primary endpoint was significantly higher in the study treatment-group compared with the control (19.1 Gy versus 14.6 Gy, p = 0.011. Qualitative evidence of fRILI by MRI at 6 weeks was observed in 45.5% of patients in the treatment versus 90.9% of the control group. No significant differences between the groups were observed at the 12-week follow-up.The post-therapeutic application of PTX, UDCA and low-dose LMWH significantly reduced the extent and incidence fRILI at 6 weeks after radiotherapy. The development of subsequent fRILI at 12 weeks (4 weeks after cessation of PTX, UDCA and LMWH during weeks 1-8 in the treatment group was comparable to the control group thus supporting the observation that the agents mitigated fRILI.EU clinical trials register 2008-002985-70 ClinicalTrials.gov NCT01149304.

  16. Corneal power, thickness, and stiffness: results of a prospective randomized controlled trial of PRK and LASIK for myopia.

    Science.gov (United States)

    Hjortdal, Jesper Ø; Møller-Pedersen, Torben; Ivarsen, Anders; Ehlers, Niels

    2005-01-01

    To compare the short-, medium-, and long-term changes in corneal optical power and corneal aberrations, central corneal thickness, and corneal "stiffness" assessed by pneumotonometry readings in patients having laser in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) for myopia. Department of Ophthalmology, Arhus University Hospital, Arhus, Denmark. One eye of each of 45 patients with myopia ranging from -6.00 to -8.00 diopters (D) (spherical equivalent spectacle refraction [SER]) was randomized to LASIK (n=25; mean SER -7.12 D +/- 0.57 [SD]) or PRK (n=20; mean SER -6.91 +/- 0.57 D). Data were collected prospectively before and 1, 3, 6, 12, and 36 months after surgery. Measurements included corneal topography (TMS-1, Tomey), corneal thickness (ultrasound pachymetry), and apparent intraocular pressure (IOP) (pneumotonometry). Retreatments were not performed during the first year, and retreated eyes were excluded from the 3-year follow-up. Changes in corneal power and aberrations, thickness, and apparent IOP were calculated in a pair-wise manner for 3 time periods: short term (preoperative to 1 month after surgery), medium term (1 to 12 months after surgery), and long term (1 to 3 years after surgery). In the short term, corneal power decreased equally in LASIK and PRK eyes. Spherical aberrations and coma-like aberrations increased equally, while corneal thickness decreased significantly less in LASIK eyes than in PRK eyes. The apparent IOP decreased more in LASIK eyes than in PRK eyes. In the medium term, corneal power increased significantly in both groups. Spherical aberrations decreased significantly in PRK eyes but not in LASIK eyes. From 1 to 12 months, corneal thickness increased more in PRK eyes than in LASIK eyes. During this period, the apparent IOP increased significantly in LASIK eyes. In the long term, corneal power and corneal aberrations did not change significantly in either group. Corneal thickness increased slightly but

  17. Portable Video Media Versus Standard Verbal Communication in Surgical Information Delivery to Nurses: A Prospective Multicenter, Randomized Controlled Crossover Trial.

    Science.gov (United States)

    Kam, Jonathan; Ainsworth, Hannah; Handmer, Marcus; Louie-Johnsun, Mark; Winter, Matthew

    2016-10-01

    Continuing education of health professionals is important for delivery of quality health care. Surgical nurses are often required to understand surgical procedures. Nurses need to be aware of the expected outcomes and recognize potential complications of such procedures during their daily work. Traditional educational methods, such as conferences and tutorials or informal education at the bedside, have many drawbacks for delivery of this information in a universal, standardized, and timely manner. The rapid uptake of portable media devices makes portable video media (PVM) a potential alternative to current educational methods. To compare PVM to standard verbal communication (SVC) for surgical information delivery and educational training for nurses and evaluate its impact on knowledge acquisition and participant satisfaction. Prospective, multicenter, randomized controlled crossover trial. Two hospitals: Gosford District Hospital and Wyong Hospital. Seventy-two nursing staff (36 at each site). Information delivery via PVM--7-minute video compared to information delivered via SVC. Knowledge acquisition was measured by a 32-point questionnaire, and satisfaction with the method of education delivery was measured using the validated Client Satisfaction Questionnaire (CSQ-8). Knowledge acquisition was higher via PVM compared to SVC 25.9 (95% confidence interval [CI] 25.2-26.6) versus 24.3 (95% CI 23.5-25.1), p = .004. Participant satisfaction was higher with PVM 29.5 (95% CI 28.3-30.7) versus 26.5 (95% CI 25.1-27.9), p = .003. Following information delivery via SVC, participants had a 6% increase in knowledge scores, 24.3 (95% CI 23.5-25.1) versus 25.7 (95% CI 24.9-26.5) p = .001, and a 13% increase in satisfaction scores, 26.5 (95% CI 25.1-27.9) versus 29.9 (95% CI 28.8-31.0) p < .001, when they crossed-over to information delivery via PVM. PVM provides a novel method for providing education to nurses that improves knowledge retention and satisfaction with the

  18. Prospective, Randomized Study on the Use of a Prosthetic Mesh for Prevention of Parastomal Hernia of Permanent Colostomy.

    Science.gov (United States)

    Vierimaa, Mika; Klintrup, Kai; Biancari, Fausto; Victorzon, Mikael; Carpelan-Holmström, Monika; Kössi, Jyrki; Kellokumpu, Ilmo; Rauvala, Erkki; Ohtonen, Pasi; Mäkelä, Jyrki; Rautio, Tero

    2015-10-01

    Prophylactic placement of a mesh has been suggested to prevent parastomal hernia, but evidence to support this approach is scarce. The aim of this study was to evaluate whether laparoscopic placement of a prophylactic, dual-component, intraperitoneal onlay mesh around a colostomy is safe and prevents parastomal hernia formation after laparoscopic abdominoperineal resection. This is a prospective, multicenter, randomized controlled clinical trial. This study was conducted at 2 university and 3 central Finnish hospitals. From 2010 to 2013, 83 patients undergoing laparoscopic abdominoperineal resection for rectal cancer were recruited. After withdrawals and exclusions, the outcome of 70 patients, 35 patients in each study group, could be examined. In the intervention group, an end colostomy was created with placement of a intraperitoneal, dual-component onlay mesh and compared with a group with a traditional stoma. The main outcome measures were the incidence of clinically and radiologically detected parastomal hernias and their extent 12 months after surgery. Stoma-related morbidity and the need for surgical repair of parastomal hernia were secondary outcome measures. Parastomal hernia was observed by clinical inspection in 5 intervention patients (14.3%) and in 12 control patients (32.3%; p = 0.049). Surgical repair of parastomal hernia was performed in 1 control patient (3.2%) and in none of the patients in the intervention group. CT detected parastomal hernia in 18 intervention patients (51.4%) and in 17 control patients (53.1%; p = 1.00). The extent of hernias was similar according to European Hernia Society classification (p = 0.41). Colostomy-related morbidity (32.3% vs 14.3%; p = 0.140) did not differ between the study groups. The study was limited by its small size and short follow-up time. Prophylactic laparoscopic placement of intraperitoneal onlay mesh does not significantly reduce the overall risk of radiologically detected parastomal hernia after

  19. Treatment of patients with severe sepsis using Ulinastatin and Thymosin α1: a prospective, randomized, controlled pilot study

    Institute of Scientific and Technical Information of China (English)

    CHEN Hao; HE Ming-yan; LI Yu-min

    2009-01-01

    Background Tradition treatment of sepsis and new therapies, including high dose corticosteroids and non-steroidal anti-inflammatory drugs, have proven unsuccessful in improving survival. This study aimed to evaluate the potential efficacy of immunomodulating therapy using Ulinastatin (UTI) plus Thymosin α1 (Tα1) for improving organ function and reducing mortality in patients with severe sepsis.Methods A prospective study was carried out with randomized and controlled clinical analysis of 114 patients conforming to the enrollment standard. All patients had severe sepsis and received standard supportive care and antimicrobial therapy. Fifty-nine patients were also administered UTI plus Tα1 (defined as Group A), 55 patients were given a placebo (defined as Group B). Clinical parameters were determined by evaluation with the Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ), multiple organ failure (MOF) and the Glasgow Coma Scores (GCS) on entry and after therapy on the 3rd, 8th, and 28th day. By flow cytometery and ELISA lymphocyte subsets and cytokines were analyzed. Survival analysis was determined by the Kaplan-Meier method at 28, 60, and 90 days. Results Based on comparison of the two groups, patients in Group A exhibited a better performance in organ failure scores which was noticeable soon after initiation of treatment. Patients in Group A also demonstrated a better resolution of pre-existing organ failures during the observation period. After initiation of treatment, significant improvements in the CD4+/CD8+ ratio, a quicker balance between proinflammatory mediators such as tumor necrosis factor a, interleukin 6 and anti-inflammatory cytokines including interleukin 4 and interleukin 10 were found. This was followed by cumulative survival increases of 17.3% at 28 days, 28.9% at 60 days, and 31.4% at 90 days in Group A. The reduction in mortality was accompanied by a considerably shorter stay in the ICU and a shorter length of supportive

  20. Can probiotics improve efficiency and safety profile of triple Helicobacter pylori eradication therapy? A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Grgov Saša

    2016-01-01

    Full Text Available Background/Aim. Some studies suggest the benefit of applying different probiotic strains in combination with antibiotics in the eradication of Helicobacter pylori (H. pylori infection. The aim of this study was to evaluate the effect of co-administration of multiple probiotic strains with triple H. pylori eradication therapy. Methods. This prospective study included 167 patients with dyspeptic symptoms and chronic gastritis who were diagnosed with H. pylori infection and randomized into two groups. The group I of 77 patients underwent triple eradication therapy, for 7 days, with lansoprazole, 2 × 30 mg half an hour before the meal, amoxicillin 2 × 1.000 mg per 12 hours and clarithromycin 2 × 500 mg per 12 hours. After the 7th day of the therapy, lansoprazole continued at a dose of 30 mg for half an hour before breakfast for 4 weeks. The group II of 90 patients received the same treatment as the patients of the group I, with the addition of the probiotic cultures in the form of a capsule comprising Lactobacillus Rosell-52, Lactobacillus Rosell-11, Bifidobacterium Rosell-1755 and Saccharomyces boulardii, since the beginning of eradication for 4 weeks. Eradication of H. pylori infection control was performed 8 weeks after the therapy by rapid urease test and histopathologic evaluation of endoscopic biopsies or by stool antigen test for H. pylori. Results. Eradication of H. pylori infection was achieved in 93.3% of the patients who received probiotics with eradication therapy and in 81.8% of patients who were only on eradication therapy without probiotics. The difference in eradication success was statistically significant, (p < 0.05. The incidence of adverse effects of eradication therapy was higher in the group of patients who were not on probiotic (28.6% than in the group that received probiotic (17.7%, but the difference was not statistically significant. Conclusion. Multiple probiotic strains addition to triple eradication therapy of H

  1. Advanced colorectal carcinoma. A prospective randomized trial of sequential methotrexate, 5-fluorouracil, and leucovorin versus 5-fluorouracil alone.

    Science.gov (United States)

    Machiavelli, M; Leone, B A; Romero, A; Rabinovich, M G; Vallejo, C T; Bianco, A; Pérez, J E; Rodríguez, R; Cuevas, M A; Alvarez, L A

    1991-06-01

    One hundred and twenty-five previously untreated patients bearing metastatic or advanced recurrent (inoperable) colorectal carcinoma and measurable disease were prospectively randomized. Those in arm A received 5-fluorouracil (5-FU), 1,200 mg/m2 i.v. infusion over 2 h, while those in arm B received methotrexate (MTX), 200 mg/m2 i.v. (push injection), followed 20 h later by 5-FU, 1,200 mg/m2 i.v. infusion over 2 h, plus calcium leucovorin (LV), 25 mg i.m. every 6 h for eight doses beginning 24 h after MTX administration. Cycles were repeated every 15 days. All patients receiving treatment were evaluable for toxicity and survival, and 118 patients were evaluable for response. The objective regression rate (complete plus partial response) was 12% (7 of 58) in arm A and 28% (17 of 60) in arm B (p = 0.049). No change was observed in 24% (14 of 58) in arm A and in 35% (21 of 60) in arm B (p = 0.28), while progressive disease was registered in 64% (37 of 58) and 37% (22 of 60) in arms A and B, respectively (p = 0.006). Median duration of response was 3 months in arm A and 5 months in arm B (p = 0.39). The median survival was 8.3 months in arm A and 11.2 months in arm B (p = 0.25). No statistically significant differences were found when objective regression and survival were related to site of primary tumor, performance status, and number of involved organs. There were two drug-related deaths in arm B due to severe myelosuppression followed by mucositis and sepsis. Of nonhematologic toxicities, diarrhea was more frequently observed in arm B, as were mucositis and infectious complications. Our results indicate that the sequential schedule MTX-5-FU-LV with 20-h intervals between MTX and 5-FU is superior in terms of objective regression to 5-FU alone given at the dose and schedule used in the present study. However, MTX-5-FU-LV did not have a significant impact on survival.

  2. PROSPECTIVE RANDOMIZED DOUBLE BLINDED PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECTS OF INTRAVENOUS DEXMEDETOMIDINE ON SPINAL BUPIVACAINE ANAESTHESIA

    Directory of Open Access Journals (Sweden)

    Janaki Babu

    2016-02-01

    Full Text Available BACKGROUND AND AIMS There is a dearth of studies on the effect of intravenously administered Dexmedetomidine in Sub Arachnoid Block hence, this study was conducted to compare the effects of intravenously administered Dexmedetomidine prior to the administration of subarachnoid block with bupivacaine 0.5% heavy, on hemodynamic variables and the level and onset and duration of sensory and motor blockade. MATERIAL AND METHODS After obtaining ethical Committee approval, a double-blind, randomized prospective clinical study was conducted on 90 American Society of Anesthesiologist Grade I and II patients in the age group of 18-55 years, divided randomly into two groups: Group D received 50 ml solution containing Inj. Dexmedetomidine infusion at 0.5 mcg/kg for 10 minutes, and Group P received 50 ml of solution 0.9% Normal Saline as infusion at 10 minutes time. Subsequently Spinal Anaesthesia is carried out with Bupivacaine heavy 0.5%, and carried out recordings as per protocol. Besides Hemodynamic parameters other parameters observed were effectiveness, Sedation score; highest level of sensory block achieved; Motor and Sensory block; Time for first rescue analgesic requirement were recorded. RESULTS Group D (n=45 (Mean±SD Sedation Score 3.42±0.621 and Group P (n=45 (Mean±SD Sedation Score 1.80±0.405. Better sedation was seen in Group – D with a p value of less than 0.0001.The highest level of sensory blockade achieved was significantly higher in Group D when compared to the control group, and mean duration (in minutes to achieve the highest sensory blockade in both the groups: Group D (n=45 (Mean±SD 7.91±2.42 and Group P (n=45 (Mean±SD 9.82±3.973 p Value< 0.0001. The highest level of sensory blockade achieved was significantly higher in Group D when compared to the control group, and mean duration (in minutes to achieve the highest sensory blockade in both the groups. Group D (n=45 (Mean±SD 7.91±2.42 and Group P(n=45 (Mean±SD 9.82±3.973 p

  3. Oral versus intramuscular cobalamin treatment in megaloblastic anemia: a single-center, prospective, randomized, open-label study.

    Science.gov (United States)

    Bolaman, Zahit; Kadikoylu, Gurhan; Yukselen, Vahit; Yavasoglu, Irfan; Barutca, Sabri; Senturk, Taskin

    2003-12-01

    Cobalamin (vitamin B12) deficiency, the most common cause of megaloblastic anemia, is treated with intramuscular (IM) cobalamin. It has been suggested by some investigators that oral (p.o.) cobalamin treatment may be as effective in the treatment of this condition, with the advantages of ease of administration and lower cost. This study assessed the effects and cost of p.o. versus i.m. cobalamin treatment in patients with megaloblastic anemia due to cobalamin deficiency. This was a 90-day, prospective, randomized, open-label study conducted at the Division of Hematology, Department of Internal Medicine, Adnan Menderes University Research and Practice Hospital (Aydin, Turkey). Patients aged > or =16 years with megaloblastic anemia due to cobalamin deficiency were randomized to receive 1000-microg cobalamin p.o. once daily for 10 days (p.o. group) or 1000-microg cobalamin i.m. once daily for 10 days (i.m. group). After 10 days, both treatments were administered once a week for 4 weeks, and after that, once a month for life. Patients were assessed for the presence of reticulocytosis between treatment days 5 and 10 until it was detected. Therapeutic effectiveness was assessed by measuring hematologic parameters on days 0, 10, 30, and 90 and serum vitamin B12 concentration on days 0 and 90. The Mini-Mental State Examination was used before and after the B12 therapy for cognitive function assessment and 125-Hz diapozone was used for vibration threshold testing. Neurologic sensory assessment, including soft-touch and pinprick examinations, was used to identify neuropathy at baseline and study end. Tolerability was assessed using laboratory tests and patient interview. Cost was assessed using the cost of the study drug and of the injection. Sixty patients completed the study 26 in the p.o. group (16 men, 10 women; mean [SD] age, 60 [15] years) and 34 in the i.m. group (17 men, 17 women; mean [SD] age, 64 [10] years). Reticulocytosis was observed in all patients. In the p

  4. A Comparison of Radiofrequency-Based Microtenotomy and Arthroscopic Release of the Extensor Carpi Radialis Brevis Tendon in Recalcitrant Lateral Epicondylitis: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Lee, Jae-Hoo; Park, In; Hyun, Hwan-Sub; Shin, Sang-Jin

    2018-01-20

    To compare the clinical effects of radiofrequency (RF)-based microtenotomy and arthroscopic release of the extensor carpi radialis brevis (ECRB) tendon in patients with recalcitrant lateral epicondylitis through a prospective randomized controlled study. A total of 46 patients were randomly assigned to receive arthroscopic release (group A, 24 patients) or RF-based microtenotomy (group B, 22 patients). The visual analog scale (VAS) score for pain, flexion-extension arc, operation time, Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH), Mayo Elbow Performance Score (MEPS), and grip power of groups A and B were compared during the recovery phases for up to 2 postoperative years. Both groups showed statistically significant functional improvement compared with their preoperative grip strength and DASH, VAS, and MEPS scores at 2 years after surgery (P lateral epicondylitis provided clinical outcomes comparable with those from arthroscopic release of ECRB tendon during the recovery phase. RF-based microtenotomy is considered as one of the surgical procedures for treating recalcitrant lateral epicondylitis, with the advantages of reliable elbow functional restoration and significantly shorter operation time. Level I, prospective randomized trial. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  5. Regional hyperthermia combined with radiotherapy for locally advanced non-small cell lung cancers. A multi-institutional prospective randomized trial of the International Atomic Energy Agency

    International Nuclear Information System (INIS)

    Mitsumori, Michihide; Hiraoka, Masahiro; Zeng Zhifan; Oliynychenko, P.; Park, Jeong-Ho; Choi, Ihl-Bohng; Tatsuzaki, Hideo; Tanaka, Yoshiaki

    2007-01-01

    An International Atomic Energy Agency (IAEA)-sponsored, multi-institutional prospective randomized trial was conducted to clarify whether the combination of hyperthermia and radiotherapy improves the local response rate of locally advanced non-small cell lung cancer (NSCLC) compared with that obtained by radiotherapy alone. Between October 1998 and April 2002, 80 patients with locally advanced NSCLC were randomized to receive either standard radiation therapy alone (RT) or radiation therapy combined with hyperthermia (RT+HT). The primary endpoint was the local response rate. The secondary endpoints were local progression-free survival and overall survival. The median follow-up period was 204 days for all patients and 450 days for surviving patients. There were no significant differences between the two arms with regard to local response rate (P=0.49) or overall survival rate (P=0.868). However, local progression-free survival was significantly better in the RT+HT arm (P=0.036). Toxicity was generally mild and no grade 3 late toxicity was observed in either arm. Although improvement of local progression-free survival was observed in the RT+HT arm, this prospective randomized study failed to show any substantial benefit from the addition of hyperthermia to radiotherapy in the treatment of locally advanced NSCLC. (author)

  6. Involved-Field Radiotherapy versus Elective Nodal Irradiation in Combination with Concurrent Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Prospective Randomized Study

    Science.gov (United States)

    Chen, Ming; Bao, Yong; Ma, Hong-Lian; Wang, Jin; Wang, Yan; Peng, Fang; Zhou, Qi-Chao; Xie, Cong-Hua

    2013-01-01

    This prospective randomized study is to evaluate the locoregional failure and its impact on survival by comparing involved field radiotherapy (IFRT) with elective nodal irradiation (ENI) in combination with concurrent chemotherapy for locally advanced non-small cell lung cancer. It appears that higher dose could be delivered in IFRT arm than that in ENI arm, and IFRT did not increase the risk of initially uninvolved or isolated nodal failures. Both a tendency of improved locoregional progression-free survival and a significant increased overall survival rate are in favor of IFRT arm in this study. PMID:23762840

  7. Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients

    DEFF Research Database (Denmark)

    Husted, Henrik; Blønd, Lars; Sonne-Holm, Stig

    2003-01-01

    INTRODUCTION: We performed a prospective, randomized, double-blind study on 40 patients scheduled for primary total hip arthroplasty due to arthrosis or osteonecrosis to determine the effect of tranexamic acid on per- and postoperative blood losses and on the number of blood transfusions needed....... PATIENTS AND METHODS: 40 patients were randomized to tranexamic acid (10 mg/kg given as a bolus intravenous injection, followed by a continuous infusion of 1 mg/kg/hour for 10 hours) or placebo (20 mL saline given intravenously) 15 minutes before the incision. We recorded the peroperative and postoperative...... blood losses at removal of the drain 24 hours after the operation and the number of blood transfusions. RESULTS: Patients receiving tranexamic acid had a mean peroperative blood loss of 480 mL versus 622 mL in patients receiving placebo (p = 0.3), a postoperative blood loss of 334 mL versus 609 mL (p...

  8. Evaluation of the Efficacy of Tranexamic Acid on the Surgical Field in Primary Cleft Palate Surgery on Children-A Prospective, Randomized Clinical Study.

    Science.gov (United States)

    Durga, Padmaja; Raavula, Parvathi; Gurajala, Indira; Gunnam, Poojita; Veerabathula, Prardhana; Reddy, Mukund; Upputuri, Omkar; Ramachandran, Gopinath

    2015-09-01

    To assess the effect of tranexamic acid on the quality of the surgical field. Prospective, randomized, double-blind study. Institutional, tertiary referral hospital. American Society of Anesthesiologists physical status class I patients, aged 8 to 60 months with Group II or III (Balakrishnan's classification) clefts scheduled for cleft palate repair. Children were randomized into two groups. The control group received saline, and the tranexamic acid group received tranexamic acid 10 mg/kg as a bolus, 15 minutes before incision. Grade of surgical field on a 10-point scale, surgeon satisfaction, and primary hemorrhage. Significant improvements were noted in surgeon satisfaction and median grade of assessment of the surgical field (4 [interquartile range, 4 to 6] in the control group vs. 3 [interquartile range, 2 to 4] in the test group; P = .003) in the tranexamic acid group compared to the control group. Preincision administration of 10 mg/kg of tranexamic acid significantly improved the surgical field during cleft palate repair.

  9. Thymoglobulin induction in liver transplant recipients with a tacrolimus, mycophenolate mofetil, and steroid immunosuppressive regimen: a five-year randomized prospective study.

    Science.gov (United States)

    Boillot, Olivier; Seket, Belhassen; Dumortier, Jérôme; Pittau, Gabriella; Boucaud, Catherine; Bouffard, Yves; Scoazec, Jean-Yves

    2009-11-01

    This randomized, comparative study assessed the long-term efficacy and tolerability of thymoglobulin (TMG) induction in 93 liver transplant patients with an initial regimen of tacrolimus (Tac), mycophenolate mofetil (MMF), and steroids. Forty-four patients were randomly allocated to the TMG+ group, and 49 patients were randomly allocated to the TMG- group. In both groups, Tac was given orally at the initial daily dose of 0.075 mg/kg twice daily, and MMF was given at the initial daily dose of 2 g/day. Steroid withdrawal was planned at 3 months after liver transplantation. The results were evaluated with respect to acute rejection incidence, patient and graft survival, graft function, and medical complications until 5 years or death for all patients. No significant differences were found between groups for the incidence of acute rejection at 5 years (11.4% versus 14.3%), 5-year patient survival (77.3% versus 87.8%), graft function, or postoperative renal function. One patient in the TMG- group underwent retransplantation. There was no difference between groups with respect to the incidence of medical complications, excepted for a higher rate of leukopenia in the TMG+ group, during the 5-year follow-up. In conclusion, the results of this prospective randomized study suggest that the addition of TMG to a triple immunosuppressive regimen (Tac, MMF, and steroids) did not modify the incidence of acute rejection episodes or long-term survival and was responsible for increased leukopenia rates.

  10. Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.

    Science.gov (United States)

    Götberg, Matthias; Christiansen, Evald H; Gudmundsdottir, Ingibjörg; Sandhall, Lennart; Omerovic, Elmir; James, Stefan K; Erlinge, David; Fröbert, Ole

    2015-11-01

    Instantaneous wave-free ratio (iFR) is a new hemodynamic resting index for assessment of coronary artery stenosis severity. iFR uses high frequency sampling to calculate a gradient across a coronary lesion during a period of diastole. The index has been tested against fractional flow reserve (FFR) and found to have an overall classification agreement of 80% to 85%. Whether the level of disagreement is clinically relevant is unknown. Clinical outcome data on iFR are scarce. This study is a registry-based randomized clinical trial, which is a novel strategy using health quality registries as on-line platforms for randomization, case record forms, and follow-up. iFR-SWEDEHEART is a multicenter, prospective, randomized, controlled, clinical open-label clinical trial. Two thousand patients with stable angina or acute coronary syndrome and an indication for physiology-guided assessment of one or more coronary stenoses will be randomized 1:1 to either iFR- or FFR-guided intervention. The randomization will be conducted online in the Swedish web-based system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART) registry. The trial has a non-inferiority design, with a primary combined end point of all-cause death, non-fatal myocardial infarction, and unplanned revascularization at 12 months. End points will be identified through national registries and undergo central blind adjudication to ensure data quality. The iFR-SWEDEHEART trial is an registry-based randomized clinical trial evaluating the safety and efficacy of the diagnostic method iFR compared to FFR. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. Randomized controlled trial evaluating the temporal effects of high-intensity exercise on learning, short-term and long-term memory, and prospective memory.

    Science.gov (United States)

    Frith, Emily; Sng, Eveleen; Loprinzi, Paul D

    2017-11-01

    The broader purpose of this study was to examine the temporal effects of high-intensity exercise on learning, short-term and long-term retrospective memory and prospective memory. Among a sample of 88 young adult participants, 22 were randomized into one of four different groups: exercise before learning, control group, exercise during learning, and exercise after learning. The retrospective assessments (learning, short-term and long-term memory) were assessed using the Rey Auditory Verbal Learning Test. Long-term memory including a 20-min and 24-hr follow-up assessment. Prospective memory was assessed using a time-based procedure by having participants contact (via phone) the researchers at a follow-up time period. The exercise stimulus included a 15-min bout of progressive maximal exertion treadmill exercise. High-intensity exercise prior to memory encoding (vs. exercise during memory encoding or consolidation) was effective in enhancing long-term memory (for both 20-min and 24-h follow-up assessments). We did not observe a differential temporal effect of high-intensity exercise on short-term memory (immediate post-memory encoding), learning or prospective memory. The timing of high-intensity exercise may play an important role in facilitating long-term memory. © 2017 Federation of European Neuroscience Societies and John Wiley & Sons Ltd.

  12. Efficacy of fluoride varnish for preventing white spot lesions and gingivitis during orthodontic treatment with fixed appliances-a prospective randomized controlled trial.

    Science.gov (United States)

    Kirschneck, Christian; Christl, Jan-Joachim; Reicheneder, Claudia; Proff, Peter

    2016-12-01

    The development of white spot lesions around orthodontic brackets and gingivitis is a common problem during orthodontic treatment with fixed appliances. This prospective randomized double-blind controlled clinical trial investigated the preventive efficacy of a one-time application of two commonly used fluoride varnishes in patients with low to moderate caries risk. Ninety adolescent orthodontic patients with a low to moderate caries risk were prospectively randomized to three groups of 30 patients each: (1) standardized dental hygiene with fluoride toothpaste and one-time application of placebo varnish (control) or (2) of elmex® fluid or (3) of Fluor Protector S on all dental surfaces at the start of fixed therapy. The extent of enamel demineralization and gingivitis was determined with the ICDAS and the gingivitis index (GI) at baseline and after 4, 12, and 20 weeks. Each treatment group showed a significant increase of the ICDAS index, but not of the GI over the course of time with no significant intergroup differences detectable. A one-time application of fluoride varnish at the start of orthodontic treatment did not provide any additional preventive advantage over sufficient dental hygiene with fluoride toothpaste with regard to formation of white spots and gingivitis in patients with a low to moderate caries risk. In dental practice, patients often receive an application of fluoride varnish at the start of orthodontic treatment with fixed appliances. However, the efficacy of this procedure is still unclear.

  13. Intravenous paracetamol for relief of pain during transrectal-ultrasound-guided biopsy of the prostate: A prospective, randomized, double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Ozcan Kilic

    2015-11-01

    Full Text Available Transrectal-ultrasound-guided prostate biopsy (TRUS-PBx is the standard procedure for diagnosing prostate cancer. The procedure does cause some pain and discomfort; therefore, an adequate analgesia is necessary to ensure patient comfort, which can also facilitate good-quality results. This prospective, randomized, double-blinded, placebo-controlled study aimed to determine if intravenous (IV paracetamol can reduce the severity of pain associated with TRUS-PBx. The study included 104 patients, scheduled to undergo TRUS-PBx with a suspicion of prostate cancer, that were prospectively randomized to receive either IV paracetamol (paracetamol group or placebo (placebo group 30 minutes prior to TRUS-PBx. All patients had 12 standardized biopsy samples taken. Pain was measured using a 10-point visual analog pain scale during probe insertion, during the biopsy procedure, and 1 hour postbiopsy. All biopsies were performed by the same urologist, whereas a different urologist administered the visual analog pain scale. There were not any significant differences in age, prostate-specific antigen level, or prostate volume between the two groups. The pain scores were significantly lower during probe insertion, biopsy procedure, and 1 hour postbiopsy in the paracetamol group than in the placebo group. In conclusion, the IV administration of paracetamol significantly reduced the severity of pain associated with TRUS-PBx.

  14. Fractionated bipolar radiofrequency and bipolar radiofrequency potentiated by infrared light for treating striae: A prospective randomized, comparative trial with objective evaluation.

    Science.gov (United States)

    Harmelin, Yona; Boineau, Dominique; Cardot-Leccia, Nathalie; Fontas, Eric; Bahadoran, Philippe; Becker, Anne-Lise; Montaudié, Henri; Castela, Emeline; Perrin, Christophe; Lacour, Jean-Philippe; Passeron, Thierry

    2016-03-01

    Very few treatments for striae are based on prospective randomized trials. The objective of this study was to assess the efficacy of bipolar fractional radiofrequency and bipolar radiofrequency potentiated with infrared light, alone or combined, for treating abdominal stretch marks. Bicentric prospective interventional randomized controlled trial in the department of Dermatology of University Hospital of Nice and Aesthetics Laser Center of Bordeaux, France. Men and women of age 18 years or above, who presented for the treatment of mature or immature abdominal striae were included. The patients' abdomens were divided into four equal quadrants. Bipolar radiofrequency potentiated with infrared light and fractional bipolar radiofrequency were applied, alone or combined, and compared to the remaining untreated quadrant. The main criterion of evaluation was the measurement of depth of striae, using 3D photography at 6 months follow-up. A global assessment was also rated by the physician performing the treatment and by the patients. Histological analysis and confocal laser microscopy were additionally performed. A total of 22 patients were enrolled, and 384 striae were measured. In per protocol analysis mean striae depth was decreased by 21.64%, observed at 6 months follow-up with the combined approach, compared to an increase of 1.73% in the control group (P radiofrequency, combined with bipolar radiofrequency potentiated by infrared light, is an effective treatment of both immature and mature striae of the abdomen. © 2016 Wiley Periodicals, Inc.

  15. Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer: Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses

    Science.gov (United States)

    Khankari, Nikhil K.; Shu, Xiao-Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I.; Easton, Douglas; Gruber, Stephen B.; Haiman, Christopher A.; Hunter, David J.; Chanock, Stephen J.; Pierce, Brandon L.; Zheng, Wei

    2016-01-01

    Background Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using height-associated genetic variants identified in a genome-wide association study (GWAS), to evaluate the association of adult height with these cancers. Methods and Findings A systematic review of prospective studies was conducted using the PubMed, Embase, and Web of Science databases. Using meta-analyses, results obtained from 62 studies were summarized for the association of a 10-cm increase in height with cancer risk. Mendelian randomization analyses were conducted using summary statistics obtained for 423 genetic variants identified from a recent GWAS of adult height and from a cancer genetics consortium study of multiple cancers that included 47,800 cases and 81,353 controls. For a 10-cm increase in height, the summary relative risks derived from the meta-analyses of prospective studies were 1.12 (95% CI 1.10, 1.15), 1.07 (95% CI 1.05, 1.10), and 1.06 (95% CI 1.02, 1.11) for colorectal, prostate, and lung cancers, respectively. Mendelian randomization analyses showed increased risks of colorectal (odds ratio [OR] = 1.58, 95% CI 1.14, 2.18) and lung cancer (OR = 1.10, 95% CI 1.00, 1.22) associated with each 10-cm increase in genetically predicted height. No association was observed for prostate cancer (OR = 1.03, 95% CI 0.92, 1.15). Our meta-analysis was limited to published studies. The sample size for the Mendelian randomization analysis of colorectal cancer was relatively small, thus affecting the precision of the point estimate. Conclusions Our study provides evidence for a potential causal association of adult height with the risk of colorectal and lung cancers and suggests that certain genetic factors and biological pathways affecting adult height may also affect the

  16. Lightweight bilayer barium sulfate-bismuth oxide composite thyroid collars for superior radiation protection in fluoroscopy-guided interventions: a prospective randomized controlled trial.

    Science.gov (United States)

    Uthoff, Heiko; Benenati, Matthew J; Katzen, Barry T; Peña, Constantino; Gandhi, Ripal; Staub, Daniel; Schernthaner, Melanie

    2014-02-01

    To test whether newer bilayer barium sulfate-bismuth oxide composite (XPF) thyroid collars (TCs) provide superior radiation protection and comfort during fluoroscopy-guided interventions compared with standard 0.5-mm lead-equivalent TCs. Institutional review board approval and written informed consent were obtained for this HIPAA-compliant study, and 144 fluoroscopy-guided vascular interventions were included at one center between October 2011 and July 2012, with up to two operators randomly assigned to wear XPF (n = 135) or standard 0.5-mm lead-equivalent (n = 121) TCs. Radiation doses were measured by using dosimeters placed outside and underneath the TCs. Wearing comfort was assessed at the end of each procedure on a visual analog scale (0-100, with 100 indicating optimal comfort). Adjusted differences in comfort and radiation dose reductions were calculated by using a mixed logistic regression model and the common method of inverse variance weighting, respectively. Patient (height, weight, and body mass index) and procedure (type and duration of intervention, operator, fluoroscopy time, dose-area product, and air kerma) data did not differ between the XPF and standard groups. Comfort was assessed in all 256 measurements. On average, the XPF TCs were 47.6% lighter than the standard TCs (mean weight ± standard deviation, 133 g ± 14 vs 254 g ± 44; P 90; odds ratio, 7.6; 95% confidence interval: 3.0, 19.2; P standard group). The mean radiation dose reductions (ie, radiation protection) provided by XPF and standard TCs were 90.7% and 72.4%, with an adjusted mean difference of 17.9% (95% confidence interval: 7.7%, 28.1%; P standard 0.5-mm lead-equivalent TCs and provide superior radiation protection during fluoroscopy-guided interventions. © RSNA, 2013.

  17. Physical function outcome in cervical radiculopathy patients after physiotherapy alone compared with anterior surgery followed by physiotherapy: a prospective randomized study with a 2-year follow-up.

    Science.gov (United States)

    Peolsson, Anneli; Söderlund, Anne; Engquist, Markus; Lind, Bengt; Löfgren, Håkan; Vavruch, Ludek; Holtz, Anders; Winström-Christersson, Annelie; Isaksson, Ingrid; Öberg, Birgitta

    2013-02-15

    Prospective randomized study. To investigate differences in physical functional outcome in patients with radiculopathy due to cervical disc disease, after structured physiotherapy alone (consisting of neck-specific exercises with a cognitive-behavioral approach) versus after anterior cervical decompression and fusion (ACDF) followed by the same structured physiotherapy program. No earlier studies have evaluated the effectiveness of a structured physiotherapy program or postoperative physical rehabilitation after ACDF for patients with magnetic resonance imaging-verified nerve compression due to cervical disc disease. Our prospective randomized study included 63 patients with radiculopathy and magnetic resonance imaging-verified nerve root compression, who were randomized to receive either ACDF in combination with physiotherapy or physiotherapy alone. For 49 of these patients, an independent examiner measured functional outcomes, including active range of neck motion, neck muscle endurance, and hand-related functioning before treatment and at 3-, 6-, 12-, and 24-month follow-ups. There were no significant differences between the 2 treatment alternatives in any of the measurements performed (P = 0.17-0.91). Both groups showed improvements over time in neck muscle endurance (P ≤ 0.01), manual dexterity (P ≤ 0.03), and right-handgrip strength (P = 0.01). Compared with a structured physiotherapy program alone, ACDF followed by physiotherapy did not result in additional improvements in neck active range of motion, neck muscle endurance, or hand-related function in patients with radiculopathy. We suggest that a structured physiotherapy program should precede a decision for ACDF intervention in patients with radiculopathy, to reduce the need for surgery. 2.

  18. Comparison of the effects of sodium hyaluronate-chondroitin sulphate and corticosteroid in the treatment of lateral epicondylitis: a prospective randomized trial.

    Science.gov (United States)

    Tosun, Haci Bayram; Gumustas, Seyitali; Agir, Ismail; Uludag, Abuzer; Serbest, Sancar; Pepele, Demet; Ertem, Kadir

    2015-09-01

    Hyaluronic acid and glycosaminoglycans have shown positive effects in improving lateral epicondylitis and other tendinosis conditions. Therefore, we designed a prospective, randomized study to compare the effects of a combined sodium hyaluronate and chondroitin sulfate (HA + CS) injection versus a triamcinolone injection in the treatment of lateral epicondylitis. In total, 57 consecutive patients with clinically diagnosed lateral epicondylitis were divided randomly into two groups. In the HA + CS group, 25 patients received a single injection of a solution containing an HA + CS combination and prilocaine HCl, while the 32 patients in the triamcinolone group received a single injection of a solution of triamcinolone and prilocaine HCl. We evaluated the pain and function outcome measures using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire at the beginning of the study, and 3 and 6 months after the injection. Additionally, the Minimum Clinically Important Difference values and percentage changes in the PRTEE subscale scores between the assessments were calculated. No serious adverse events were reported throughout the study. The mean pain and function scores for the HA + CS and triamcinolone groups had significantly improved at 3 months, but the mean function scores in the HA + CS group were statistically significantly better when compared to the triamcinolone group. At 6 months, both groups had significantly improved mean pain and function scores, compared to the baseline scores; however, the mean pain and function scores in the 6-month HA + CS treatment group were better than in the 6-month triamcinolone group. The relative change for the mean total score in the HA + CS group was much better when compared with the triamcinolone group, and the HA + CS treatment group showed clinically significant improvement when compared with triamcinolone group at 3 and 6 months. This study supports the idea that for a single injection treatment of patients with

  19. MicroSaw and Piezosurgery in Harvesting Mandibular Bone Blocks from the Retromolar Region: A Randomized Split-Mouth Prospective Clinical Trial.

    Science.gov (United States)

    Hanser, Thomas; Doliveux, Romain

    The aim of this randomized prospective split-mouth clinical trial was to evaluate the outcome of bone block harvesting from the retromolar region using the MicroSaw and Piezosurgery. Fifty-three patients for extensive bilateral bone grafting procedures with or without concomitant implant placement in the maxilla and/or mandible were scheduled. In each patient, bone blocks were harvested in the retromolar area within the external oblique ridge of the mandible. Using a randomized protocol, bone blocks were harvested with the MicroSaw and Piezosurgery either from the right or the left side. Clinical outcome parameters were the comparison of osteotomy time; volume of block graft; and clinical determination of intraoperative complications such as hemorrhage, nerve injury, pain, swelling, and healing of the donor site. The mean osteotomy time for harvesting including luxating a bone block was 5.63 (± 1.37) minutes using the MicroSaw and 16.47 (± 2.74) minutes using Piezosurgery (P .05). Swelling did not appear significantly different either (P > .05), and none of the donor sites showed primary healing complications. The data described in this randomized prospective split-mouth clinical trial indicate that the MicroSaw and Piezosurgery allowed efficient and safe bone block harvesting from the external oblique ridge. Clinically, concerning harvesting time and volume of the grafts, the MicroSaw performed significantly better, whereas pain, swelling, and healing did not appear to be considerably different. Given the improved visibility, precise cut geometries, and the margin of safety afforded by the MicroSaw and Piezosurgery, they are both instruments of choice when harvesting bone from the retromolar area.

  20. Moist wound healing compared with standard care of treatment of primary closed vascular surgical wounds: a prospective randomized controlled study

    DEFF Research Database (Denmark)

    Vogt, Katja C; Uhlyarik, M; Schroeder, Torben V

    2007-01-01

    This study was a randomized-controlled trial comparing the standard type of dry dressing, Mepore, with moist wound healing, using a hydrofiber dressing, Aquacel, in primary closed wounds after vascular surgery. The endpoints were patient comfort, cost-effectiveness, infections, wound complications......, and length of hospital stay. One hundred and sixty patients were randomized to receive either Mepore or Aquacel dressing. There was no significant difference in patient comfort between the two groups, but a higher cost in the Aquacel group despite significantly fewer changes of dressings in these patients...

  1. Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc.

    Science.gov (United States)

    Coric, Domagoj; Guyer, Richard D; Nunley, Pierce D; Musante, David; Carmody, Cameron; Gordon, Charles; Lauryssen, Carl; Boltes, Margaret O; Ohnmeiss, Donna D

    2018-03-01

    OBJECTIVE Seven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. In this prospective, randomized multicenter study, the authors evaluate the safety and efficacy of a metal-on-metal (MoM) TDR (Kineflex|C) versus anterior cervical discectomy and fusion (ACDF) in the treatment of single-level spondylosis with radiculopathy through a long-term (5-year) follow-up. METHODS An FDA-regulated investigational device exemption (IDE) pivotal trial was conducted at 21 centers across the United States. Standard validated outcome measures including the Neck Disability Index (NDI) and visual analog scale (VAS) for assessing pain were used. Patients were randomized to undergo TDR using the Kineflex|C cervical artificial disc or anterior cervical fusion using structural allograft and an anterior plate. Patients were evaluated preoperatively and at 6 weeks and 3, 6, 12, 24, 36, 48, and 60 months after surgery. Serum ion analysis was performed on a subset of patients randomized to receive the MoM TDR. RESULTS A total of 269 patients were enrolled and randomly assigned to undergo either TDR (136 patients) or ACDF (133 patients). There were no significant differences between the TDR and ACDF groups in terms of operative time, blood loss, or length of hospital stay. In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 60-month follow-up (both p < 0.01). Similarly, VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 60-month follow-up (both p < 0.01). There were no significant changes in outcomes between the 24- and 60-month follow-ups in either group. Range of motion in the TDR group decreased at 3 months but

  2. Unexpected difficulties in randomizing patients in a surgical trial: A prospective study comparing extracorporeal shock wave lithotripsy with open cholecystectomy

    NARCIS (Netherlands)

    P.W. Plaisier; M.Y. Berger (Marjolein); R.L. van der Hul (René); H.G. Nijs (Huub); R. den Toom (Rene); O.T. Terpstra (Onno); H.A. Bruining (Hajo); S.M. Strasberg (S.)

    1994-01-01

    textabstractShortly after extracorporeal shock wave lithotripsy (ESWL) was introduced as a promising new treatment modality for gallstone disease, a randomized controlled study was performed to assess the cost-effectiveness of ESWL compared to open cholecystectomy, the gold standard. During the

  3. The beneficial effects of Kampo medicine Dai-ken-chu-to after hepatic resection: a prospective randomized control study.

    Science.gov (United States)

    Nishi, Masaki; Shimada, Mitsuo; Uchiyama, Hideaki; Ikegami, Toru; Arakawa, Yusuke; Hanaoka, Jun; Kanemura, Hirofumi; Morine, Yuji; Imura, Satoru; Miyake, Hidenori; Utsunomiya, Toru

    2012-10-01

    After hepatic resection, delayed flatus and impaired bowel movement often cause problematic postoperative ileus. Kampo medicine, Dai-kenchu-to (DKT), is reported to have a various beneficial effects on bowel systems. The aim of this study was to prospectively evaluate effects of DKT after hepatic resection. Thirty-two patients who underwent hepatic resection between July 2007 and August 2008 in Tokushima University Hospital were prospectively divided into DKT group (n=16) and control group (n=16). In DKT group, 2.5 g of DKT was administered orally three times a day from postoperative day (POD) 1. Blood was examined on POD 1, 3, 5 and 7. Postoperative first flatus, bowel movement and full recovery of oral intake, hospital stays and complications were checked. In DKT group, levels of c-reactive protein and beta-(1-3)-D-glucan on POD 3 were significantly decreased (pDKT group (pDKT suppressed inflammatory reaction, stimulated bowel movement and improved oral intake after hepatic resection, which may decrease serious morbidity after hepatic resection.

  4. A Randomized 10-year Prospective Follow-up of Class II Nanohybrid and Conventional Hybrid Resin Composite Restorations

    DEFF Research Database (Denmark)

    van Dijken, Jan Wv; Pallesen, Ulla

    2014-01-01

    Purpose: To evaluate the 10-year durability of a nanohybrid resin composite in Class II restorations in a randomized controlled intraindividual comparison with its conventional hybrid resin composite predecessor. Materials and Methods: Each of 52 participants received at least two Class II...... restorations that were as similar as possible. The cavities were chosen at random to be restored with a nanohybrid resin composite (Excite/Tetric EvoCeram (TEC); n = 61) and a conventional hybrid (Excite/Tetric Ceram (TC); n = 61). The restorations were evaluated with slightly modified USPHS criteria...... investigated resin composites. Conclusion: The nanohybrid and the conventional hybrid resin composite showed good clinical effectiveness in extensive Class II restorations during the 10-year study....

  5. Ultrasound-Guided Out-of-Plane vs. In-Plane Interscalene Catheters: A Randomized, Prospective Study

    OpenAIRE

    Schwenk, Eric S.; Gandhi, Kishor; Baratta, Jaime L.; Torjman, Marc; Epstein, Richard H.; Chung, Jaeyoon; Vaghari, Benjamin A.; Beausang, David; Bojaxhi, Elird; Grady, Bernadette

    2015-01-01

    Background: Continuous interscalene blocks provide excellent analgesia after shoulder surgery. Although the safety of the ultrasound-guided in-plane approach has been touted, technical and patient factors can limit this approach. We developed a caudad-to-cephalad out-of-plane approach and hypothesized that it would decrease pain ratings due to better catheter alignment with the brachial plexus compared to the in-plane technique in a randomized, controlled study. Objectives: To compare an out-...

  6. A Prospective, Randomized Investigation of Plasma First Resuscitation for Traumatic Hemorrhage and Attenuation of Acute Coagulopathy of Trauma

    Science.gov (United States)

    2016-05-01

    COMBAT study staff was made aware of a code 10 trauma return of a male patient who sustained an anterior left- chest stab wound. Paramedics enrolled the...Attenuation of Acute Coagulopathy of Trauma . PRINCIPAL INVESTIGATOR: Ernest E. Moore, MD CONTRACTING ORGANIZATION: University of Colorado Denver...Randomized Investigation of “Plasma First Resuscitation” for Traumatic Hemorrhage and Attenuation of Acute Coagulopathy of Trauma . 5b. GRANT NUMBER

  7. Moderate alcohol consumption, adiponectin, inflammation and type 2 diabetes risk : prospective cohort studies and randomized crossover trials

    OpenAIRE

    Joosten, M.M.

    2011-01-01

    Background: Moderate alcohol consumption has been associated with a lower risk of type 2 diabetes in various populations. However, the underlying mechanisms are not entirely clear. The aims of this thesis were 1) to substantiate the evidence of the association between alcohol consumption and type 2 diabetes in observational research and 2) to examine physiological mechanisms in randomized trials with specific attention to adiponectin, inflammation and insulin sensitivity which may mediate the...

  8. Washed cell salvage in surgical patients: A review and meta-analysis of prospective randomized trials under PRISMA.

    Science.gov (United States)

    Meybohm, Patrick; Choorapoikayil, Suma; Wessels, Anke; Herrmann, Eva; Zacharowski, Kai; Spahn, Donat R

    2016-08-01

    Cell salvage is commonly used as part of a blood conservation strategy. However concerns among clinicians exist about the efficacy of transfusion of washed cell salvage. We performed a meta-analysis of randomized controlled trials in which patients, scheduled for all types of surgery, were randomized to washed cell salvage or to a control group with no cell salvage. Data were independently extracted, risk ratio (RR), and weighted mean differences (WMD) with 95% confidence intervals (CIs) were calculated. Data were pooled using a random effects model. The primary endpoint was the number of patients exposed to allogeneic red blood cell (RBC) transfusion. Out of 1140 search results, a total of 47 trials were included. Overall, the use of washed cell salvage reduced the rate of exposure to allogeneic RBC transfusion by a relative 39% (RR = 0.61; 95% CI 0.57 to 0.65; P platelets, or rate of myocardial infarction and stroke. Washed cell salvage is efficacious in reducing the need for allogeneic RBC transfusion and risk of infection in surgery.

  9. Effect of the pringle maneuver on tumor recurrence of hepatocellular carcinoma after curative resection (EPTRH): a randomized, prospective, controlled multicenter trial

    International Nuclear Information System (INIS)

    Xiaobin, Feng; Shuguang, Wang; Ping, Bie; Jiahong, Dong; Shuguo, Zheng; Jian, Zhou; Yudong, Qiu; Lijian, Liang; Kuansheng, Ma; Xiaowu, Li; Feng, Xia; Dong, Yi

    2012-01-01

    Hepatic resection is currently still the best choice of therapeutic strategies for liver cancer, but the long-term survival rate after surgery is unsatisfactory. Most patients develop intra- and/or extrahepatic recurrence. The reasons for this high recurrence rate are not entirely clear. Recent studies have indicated that ischemia-reperfusion injury to the liver may be a significant factor promoting tumor recurrence and metastasis in animal models. If this is also true in humans, the effects of the Pringle maneuver, which has been widely used in hepatectomy for the past century, should be examined. To date, there are no reported data or randomized controlled studies examining the relationship between use of the Pringle maneuver and local tumor recurrence. We hypothesize that the long-term prognosis of patients with liver cancer could be worsened by use of the Pringle maneuver due to an increase in the rate of tumor recurrence in the liver remnant. We designed a multicenter, prospective, randomized surgical trial to test this hypothesis. At least 498 eligible patients from five participating centers will be enrolled and randomized into either the Pringle group or the non-Pringle group in a ratio of 1:1 using a permuted-blocks randomization protocol. After the completion of surgical intervention, patients will be included in a 3-year follow-up program. This multicenter surgical trial will examine whether the Pringle maneuver has a negative effect on the long-term outcome of hepatocellular carcinoma patients. The trial will also provide information about prognostic differences, safety, advantages and disadvantages between Pringle and non-Pringle surgical procedures. Ultimately, the results will increase the available information about the effects of ischemia-reperfusion injury on tumor recurrence, which will be of immense benefit to general surgery.

  10. Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus.

    Science.gov (United States)

    Baumhauer, Judith F; Singh, Dishan; Glazebrook, Mark; Blundell, Chris; De Vries, Gwyneth; Le, Ian L D; Nielsen, Dominic; Pedersen, M Elizabeth; Sakellariou, Anthony; Solan, Matthew; Wansbrough, Guy; Younger, Alastair S E; Daniels, Timothy

    2016-05-01

    Although a variety of great toe implants have been tried in an attempt to maintain toe motion, the majority have failed with loosening, malalignment/dislocation, implant fragmentation and bone loss. In these cases, salvage to arthrodesis is more complicated and results in shortening of the ray or requires structural bone graft to reestablish length. This prospective study compared the efficacy and safety of this small (8/10 mm) hydrogel implant to the gold standard of a great toe arthrodesis for advanced-stage hallux rigidus. In this prospective, randomized non-inferiority study, patients from 12 centers in Canada and the United Kingdom were randomized (2:1) to a synthetic cartilage implant or first metatarsophalangeal (MTP) joint arthrodesis. VAS pain scale, validated outcome measures (Foot and Ankle Ability Measure [FAAM] sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment, and safety parameters were evaluated. Analysis was performed using intent-to-treat (ITT) and modified ITT (mITT) methodology. The primary endpoint for the study consisted of a single composite endpoint using the 3 primary study outcomes (pain, function, and safety). The individual subject's outcome was considered a success if all of the following criteria were met: (1) improvement (decrease) from baseline in VAS pain of ≥30% at 12 months; (2) maintenance of function from baseline in FAAM sports subscore at 12 months; and (3) absence of major safety events at 2 years. The proportion of successes in each group was determined and 1-sided 95% confidence interval for the difference between treatment groups was calculated. Noninferiority of the implant to arthrodesis was considered statistically significant if the 1-sided 95% lower confidence interval was greater than the equivalence limit (sports and activity of daily living subscores improved significantly at 12 and 24 months in both groups. First MTP active dorsiflexion motion improvement was 6

  11. A randomized phase III prospective trial of bethanechol to prevent mucositis, candidiasis, and taste loss in patients with head and neck cancer undergoing radiotherapy. A secondary analysis

    International Nuclear Information System (INIS)

    Jham, B.C.; Chen, H.; Carvalho, A.L.; Freire, A.R.

    2009-01-01

    The aim of this study was to determine the impact of bethanechol administration concomitant to radiotherapy (RT) on oral mucositis, candidiasis and taste loss. We performed a secondary analysis of a previously conducted prospective randomized trial which evaluated the effect of bethanechol on salivary gland dysfunction before, during, and after RT for head and neck cancer (HNC), in comparison to artificial saliva. Mucositis, candidiasis and taste loss were analyzed in 36 patients. Mucositis was scored using the World Health Organization (WHO) method; candidiasis was diagnosed by means of clinical examination, whereas taste loss was assessed by the patients' subjective report of absence of taste. No significant differences were observed between groups in relation to frequency and severity of mucositis or frequency of candidiasis and taste loss. In conclusion, bethanechol does not appear to reduce the incidence of mucositis, candidiasis, and taste loss when administered during RT. (author)

  12. Perioperative Alanyl-Glutamine-Supplemented Parenteral Nutrition in Chronic Radiation Enteritis Patients With Surgical Intestinal Obstruction: A Prospective, Randomized, Controlled Study.

    Science.gov (United States)

    Yao, Danhua; Zheng, Lei; Wang, Jian; Guo, Mingxiao; Yin, Jianyi; Li, Yousheng

    2016-04-01

    A prospective, randomized, controlled study was performed to evaluate the effects of perioperative alanyl-glutamine-supplemented parenteral nutrition (PN) support on the immunologic function, intestinal permeability, and nutrition status of surgical patients with chronic radiation enteritis (CRE)-induced intestinal obstruction. Patients who received 0.4 g/kg/d alanyl-glutamine and isonitrogenous PN were assigned to an alanyl-glutamine-supplemented PN (Gln-PN) group and a control group, respectively. Serum levels of alanine aminotransferase and glutamine, body fat mass (FM), immunologic function, and intestinal permeability were measured before and after surgery. Serum glutamine levels of the Gln-PN group significantly exceeded that of the control group (P nutrition state and intestinal motility of surgical patients with CRE-induced intestinal obstruction. © 2015 American Society for Parenteral and Enteral Nutrition.

  13. Effects of Na-sucrose Octasulfate on skin and mucosa reactions during radiotherapy of head and neck cancers - A randomized prospective study

    Energy Technology Data Exchange (ETDEWEB)

    Evensen, Jan F.; Bjordal, K.; Jacobsen, Anne-Birgitte; Loekkevik, E.; Tausjoe, J.E. [Norwegian Radium Hospital, Oslo (Norway). Dept. of Medical Oncology and Radiotherapy

    2001-11-01

    Na sucrose octasulfate (Na SOS) was tested for ability to relieve radiation-induced acute skin and mucosal reactions in patients with head and neck cancer. Sixty patients were included in this prospective, double-blind, randomized study. Skin and mucosal reactions were scored using several variables. No statistically significant difference was found between the results with Na SOS and those with placebo for any of the variables, with the exception of skin desquamation, which showed a significant difference in the placebo group. The most likely explanation for this is that the Na SOS gel itself left behind a flaky layer that was difficult to distinguish from radiation-induced flaking. In conclusion, we cannot recommend Na SOS in the routine management of radiation-induced skin and mucosal reactions.

  14. Preventive effect of feeding high-risk infants a casein hydrolysate formula or an ultrafiltrated whey hydrolysate formula. A prospective, randomized, comparative clinical study

    DEFF Research Database (Denmark)

    Halken, S; Høst, A; Hansen, L G

    1993-01-01

    In a prospective study of a 1-year birth cohort of 158 high-risk infants the effect of feeding breastmilk, a casein hydrolysate (Nutramigen) or a new ultrafiltrated whey hydrolysate (Profylac) on the development of cow milk protein allergy/intolerance (CMPA/CMPI) was assessed and compared. All...... the infants had biparental or severe single atopic predisposition, the latter combined with cord blood IgE > or = 0.5 kU/L. At birth all infants were randomized to Nutramigen or Profylac, which was used when breastfeeding was insufficient or not possible during the first 6 months of life. During the same...... period this regimen was combined with avoidance of solid foods and cow milk protein. All mothers had unrestricted diets and were encouraged to do breastfeeding only. Moreover, avoidance of daily exposure to tobacco smoking, furred pets and dust-collecting materials in the bedroom was advised. The infants...

  15. The effects of metformin or orlistat on obese women with polycystic ovary syndrome: a prospective randomized open-label study.

    Science.gov (United States)

    Ghandi, Sedigheh; Aflatoonian, Abbas; Tabibnejad, Nasim; Moghaddam, Mohammad Hossein Sojoodi

    2011-07-01

    Comparing the effects of metformin or orlistat on hormone, lipid profile and ovulation status in obese women with polycystic ovary syndrome. A total of 80 women were prospectively recruited to receive either metformin (n = 40) or orlistat (n = 40). Weight, BMI, waist, serum LH, total serum testosterone and lipid profile were assessed at baseline and after 3 months. The subjects' ovulatory status was assessed after 3 months. There was no significant difference in ovulation between the two treatment groups (30% vs 15%). Treatment with either drug showed a significant decline in body weight, BMI (Body Mass Index), and waist circumference, but the degree of decline in both groups was the same. Patients who were treated with orlistat, showed a significant reduction in total testosterone and serum lipid. Women in metformin group showed a significant reduction in serum LH. Both metformin and orlistat showed a similar effect on weight loss and ovulation rates.

  16. Efficacy and safety of two different n-butyl-2-cyanoacrylates for the embolization of varicoceles: a prospective, randomized, blinded study.

    Science.gov (United States)

    Vanlangenhove, Peter; De Keukeleire, Katrien; Everaert, Karel; Van Maele, Georges; Defreyne, Luc

    2012-06-01

    This was a prospective, randomized, blinded comparative study of the efficacy and safety of two different n-butyl-2-cyanoacrylates (NBCAs) for embolization of varicoceles. A total of 112 insufficient spermatic veins (left-sided, n=84; right-sided, n=28) that were diagnosed in 83 adult males were prospectively randomized for blinded embolization with NBCA (n=54; Histoacryl, Braun, Germany) or NBCA-MS (n=58; Glubran2, General Enterprise Marketing, Viareggio, Lucca, Italy). Handling, embolic efficacy, and safety of both NBCAs were compared according the fulfillment of a standardized embolization plan, the occlusive effect on the spermatic vein, and the sticking to the microcatheter. Statistical analysis was performed with the Mann-Whitney U test and the Fisher's exact test. Patients of both study arms were comparable for age and clinical indication. Spermatic vein characteristics were comparable for varicocele classification and embolization side. Both NBCAs were equally efficient in occluding the spermatic vein and blocking reflux (NBCA, n=54/54, 100% vs. NBCA-MS, n=54/57, 94.7%; P=0.244). The embolization plan could be accomplished in an equal number of veins for both groups (NBCA, n=45/54, 83.3% vs. NBCA-MS, n=41/58, 70.7%; P=0.124). Adhesiveness of the glue to the microcatheter was the same in both NBCA groups (NBCA, n=25/54, 46.3% vs. NBCA-MS, n=29/58, 50%; P=0.71). No glue-related complications were noted. NBCA and NBCA-MS are equally efficient and safe glues for embolization of varicoceles.

  17. Synergistic effects of intravenous and intra-articular tranexamic acid on reducing hemoglobin loss in revision total knee arthroplasty: a prospective, randomized, controlled study.

    Science.gov (United States)

    Yuan, Xiangwei; Wang, Jiaxing; Wang, Qiaojie; Zhang, Xianlong

    2018-04-01

    Tranexamic acid decreases blood loss in primary total knee arthroplasty, and no related prospective randomized clinical trials have been conducted to evaluate the effectiveness and safety of tranexamic acid in revision total knee arthroplasty. Thus, we conducted this work to evaluate the synergistic effects of intravenous plus intra-articular tranexamic acid on reducing hemoglobin loss compared with intra-articular tranexamic acid alone in revision total knee arthroplasty. This prospective, controlled study randomized 96 patients undergoing revision total knee arthroplasty into two groups: an intravenous plus intra-articular tranexamic acid group (48 patients who received 20 mg/kg intravenous tranexamic acid and 3.0 g intra-articular tranexamic acid); and an intra-articular tranexamic acid alone group (48 patients who received the same intravenous volume of normal saline and 3.0 g intra-articular tranexamic acid). The primary outcome was hemoglobin loss. Secondary outcomes included the volume of drain output, the percentage of patients who received transfusions, the number of units transfused, and thromboembolic events. The baseline data, preoperative hemoglobin, and tourniquet time were similar in both groups. There was significantly less hemoglobin loss in the intravenous plus intra-articular tranexamic acid group compared with the intra-articular tranexamic acid alone group (2.7 ± 0.6 g/dL and 3.7 ± 0.7 g/dL; p tranexamic acid alone group, the intravenous plus intra-articular tranexamic acid group also had significantly less drain output, fewer patients who received transfusions, and fewer units transfused (all p tranexamic acid alone, combined intravenous plus intra-articular tranexamic acid significantly reduced hemoglobin loss and the need for transfusion without an apparent increase in thromboembolic events in patients who underwent revision total knee arthroplasty. © 2018 AABB.

  18. The Effect of Botulinum Toxin A Injections in the Spine Muscles for Cerebral Palsy Scoliosis, Examined in a Prospective, Randomized Triple-blinded Study.

    Science.gov (United States)

    Wong, Christian; Pedersen, Søren Anker; Kristensen, Billy B; Gosvig, Kasper; Sonne-Holm, Stig

    2015-12-01

    A prospective, randomized triple-blinded cross-over design treating with either botulinum toxin A (BXT) or saline (NaCl). To examine the efficacy of BTX treatment in cerebral palsy scoliosis (CPS). Intramuscular injections with BTX have been used off label in treating CPS. 1 prospective study has been conducted, demonstrating in both radiological and clinical improvement, whereas showing no side effects or complications. Subjects (brace-treated CPS between 2 and 18 yr) were injected using ultrasonic-guidance with either NaCl or BTX in selected spine muscles with 6 mo intervals (block randomization, sealed envelope). Radiographs of the spine and clinical follow-up were captured before and 6 weeks after each injection. Primary outcome parameter was radiological change in Cobb angle, where a 7° change was regarded as an effect (1 SD). Radiological parameters were measured before and 6 weeks after treatment by 3 experienced doctors separately. Moreover, clinical results were evaluated by the pediatric quality of life score and systematic open questioning of the parents about the child's wellbeing. Subjects, researchers, and monitors were blinded during the trial. Appropriate permissions (2008-004584-19) and no funding were obtained. 16 cerebral palsy patients (GFMCS III-V) with CPS were consecutively included, whereas 6 patients were excluded. There were no drop-outs to follow-up, but 1 possible serious adverse event of pneumonia resulting in death was recorded and the study was terminated. No significant radiological or clinical changes were detected when compared with NaCl injections using Wilcoxon matched pair signed-rank test. No positive radiological or clinical effects were demonstrated by this treatment, except for the parent's initial subjective but positive appraisal of the effect. However, the study was terminated due to 1 possible severe adverse event and scheduled numbers needed to treat (hence power) were not reached. 1.

  19. Do Clinical and Radiological Assessments Contribute to the Understanding of Biomaterials? Results From a Prospective Randomized Sinus Augmentation Split-Mouth Trial.

    Science.gov (United States)

    Lorenz, Jonas; Korzinskas, Tadas; Chia, Poju; Maawi, Sarah Al; Eichler, Katrin; Sader, Robert A; Ghanaati, Shahram

    2018-02-01

    The present prospective randomized split-mouth trial reports on the 3-year clinical and radiological follow-up investigation of implants placed 7 months after sinus augmentation with 2 different bone substitute materials. The aim of the study was to complete the histologic observation of cellular reactions by analyses of the implants and the volumetric changes of the augmented bone substitute materials. A sinus augmentation split-mouth trial was performed in 14 patients with the synthetic bone substitute material Nanobone (NB) and the xenogeneic Bio-Oss (BO). Changes in volume and density of the augmented biomaterials were investigated by analysis of computed tomography scans, taken immediately after augmentation and after 7 months. Clinical implant parameters were assessed after 3 years of loading. Both bone substitute materials underwent nonsignificant volume reduction and significant increase in bone density over an integration period of 7 months. No significant differences concerning volume and bone density were observed between the groups. Three years after loading, 51 of 53 implants were in situ with no peri-implant infections, and only a few soft-tissue variations were present. The present prospective randomized study showed that no differences could be observed clinically and radiologically. Accordingly, it seems that both biomaterials, independent of their physicochemical composition, enable clinical success and long-time stability for dental implants. Interestingly, the histological results showed distinct differences in cellular reactions: While the xenogeneic BO induced a mild tissue reaction with only few multinucleated giant cells and comparably low vascularization, the synthetic NB induced a multinucleated giant cell-triggered tissue reaction with an increase of vascularization. Thus, the present study showed that a combination analysis-histological, clinical, and radiological-is necessary for a detailed assessment of a biomaterial's quality for

  20. Comparison of palonosetron, granisetron, and ramosetron for the prevention of postoperative nausea and vomiting after laparoscopic gynecologic surgery: a prospective randomized trial.

    Science.gov (United States)

    Lee, Won-Suk; Lee, Kwang-Beom; Lim, Soyi; Chang, Young Gin

    2015-09-03

    Selective 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists are reported to have potent antiemetic effects for postoperative nausea and vomiting (PONV). The purpose of this study was to prospectively evaluate the efficacy of palonosetron, granisetron, and ramosetron for the prevention of PONV in patients undergoing laparoscopic gynecologic surgery. In this prospective, randomized observational study, 105 healthy female patients who were undergoing laparocopic hystectomy under general anaesthesia were enrolled (clinical trial number: NCT01752374, www.clinicaltrials.gov ). Patients were divided into three groups: the palonostron (0.075 mg i.v.; n = 35), the granisetron group (3 mg i.v.; n = 35), and the ramosetron group (0.3 mg i.v.; n = 35). The treatments were given before the end of surgery. The incidence of PONV, severity of nausea/vomiting, and the use of rescue antiemetic requirements during the first 48 h after surgery were evaluated. The overall incidence of PONV was 33.3 % for this series. The number of complete responders at 48 h after the surgery was 21 (60.0 %) for palonosetron, 24 (68.6 %) for granisetron, and 26 (71.4 %) for ramosetron, representing no statistical difference (P = 0.086). There were no significant differences in the overall incidence of postoperative nausea and vomiting and complete responders for palonosetron, granisetron and ramosetron group. NCT01752374 , www.clinicaltrials.gov .

  1. Laparoscopic Complete Mesocolic Excision versus Open Complete Mesocolic Excision for Transverse Colon Cancer: Long-Term Survival Results of a Prospective Single Centre Non-Randomized Study.

    Science.gov (United States)

    Storli, Kristian Eeg; Eide, Geir Egil

    2016-01-01

    Laparoscopic complete mesocolic excision (CME) used in the treatment of transverse colon cancer has been questioned on the basis of the technical challenges. The aim of this study was to evaluate the medium- and long-term clinical and survival outcomes after laparoscopic and open CME for transverse colon cancer and to compare the 2 approaches. This study was a retrospective non-randomized study of patients with prospectively registered data on open and laparoscopic CME for transverse colon cancer tumour-node-metastasis stages I-III operated on between 2007 and 2014. This was a single-centre study in a community teaching hospital. A total of 56 patients with transverse colon cancer were included, excluding those with tumours in the colonic flexures. The outcome aims were 4-year time to recurrence (TTR) and cancer-specific survival (CSS). Morbidity was also measured. The 4-year TTR was 93.9% in the laparoscopic group and 91.3% in the open group (p = 0.71). The 4-year CSS was 97.0% in the laparoscopic group and 91.3% in the open group (p = 0.42). This was a prospective single-institution study with a small sample size. Results of the study suggest that the laparoscopic CME approach might be the preferred approach for transverse colon cancer, especially regarding its benefits in terms of short-term morbidity, length of stay and oncological outcome. © 2016 S. Karger AG, Basel.

  2. The Effect of Listening to Music During Percutaneous Nephrostomy Tube Placement on Pain, Anxiety, and Success Rate of Procedure: A Randomized Prospective Study.

    Science.gov (United States)

    Hamidi, Nurullah; Ozturk, Erdem

    2017-05-01

    To evaluate the effect of listening to music on pain, anxiety, and success of procedure during office-based percutaneous nephrostomy tube placement (PNTP). One hundred consecutive patients (age >18 years) with hydronephrosis were prospectively enrolled in this study. All patients were prospectively randomized to undergo office-based PNTP with (Group I, n = 50) or without music (Group II, n = 50). Anxiety levels were evaluated with State Trait Anxiety Inventory. A visual analog scale was used to evaluate pain levels, patient's satisfaction, and willingness to undergo the procedure. We also compared success rates of procedures. The mean age, duration of procedure, and gender distribution were statistically similar between the two groups. The mean postprocedural heart rates and systolic blood pressures in Group I patients were significantly lower than Group II patients (p = 0.01 and p = 0.028, respectively), whereas preprocedural pulse rate and systolic blood pressure were similar. The mean anxiety level and mean pain score of Group I were significantly lower than those of Group II (p = 0.008 and p music during office-based PNTP decreases anxiety or pain and increases success rate of procedure. As an alternative to sedation or general anesthesia, music is easily accessible without side effect and cost.

  3. Hemodialysis without Systemic Anticoagulation: A Prospective Randomized Trial to Evaluate 3 Strategies in Patients at Risk of Bleeding

    Science.gov (United States)

    Guéry, Bruno; Alberti, Corinne; Servais, Aude; Harrami, Elarbi; Bererhi, Lynda; Zins, Brigitte; Touam, Malik; Joly, Dominique

    2014-01-01

    Objective In this clinical trial, we aimed to compare three means of performing chronic hemodialysis in patients with contra-indication to systemic heparinization. Methods This open-label monocentric randomized « n-of-one » trial, conducted in a single tertiary care center, recruited chronic hemodialysis patients with a contra-indication to systemic heparinization for at least 3 consecutive sessions. All patients underwent hemodialysis with an AN69ST dialyzer, and were administered three alternative dialysis procedures in a random sequence: intermittent saline flushes, constant saline infusion, or pre-dialysis heparin coating of the membrane. The primary outcome was the need to interrupt the dialysis session because of clotting events due to either (i) a complete coagulation of the circuit; (ii) a partial coagulation of the circuit; (iii) a>50% rise over baseline in the venous pressure. Results At the end of the inclusion period (May, 2007 to December, 2008), the number of patients to include (n = 75) was not reached: only 46 patients were included and underwent randomization. The study was terminated, and statistical analysis took into account 224 hemodialysis sessions performed in 44 patients with analyzable data. Heparin adsorption was associated with a significant reduction of the need to interrupt the dialysis session because of clotting events: odds ratio 0.3 (CI 95% 0.2 to 0.6; p3 h dialysis sessions and for having complete blood restitution. There were no significant effects of the dialysis procedure on weight loss, online ionic dialysance, and adverse events. Conclusion Heparin-coated AN69ST dialysis membrane is a safe and effective method to avoid or delay per-dialytic clotting events in patients with contra-indication to systemic anticoagulation. However, results are not generalizable safely to patients with active bleeding, since weak heparinemia, not assessed in this study, may occur. Trial Registration ClinicalTrials.gov NCT00473109. PMID

  4. Hartmann's Procedure or Primary Anastomosis for Generalized Peritonitis due to Perforated Diverticulitis: A Prospective Multicenter Randomized Trial (DIVERTI).

    Science.gov (United States)

    Bridoux, Valerie; Regimbeau, Jean Marc; Ouaissi, Mehdi; Mathonnet, Muriel; Mauvais, Francois; Houivet, Estelle; Schwarz, Lilian; Mege, Diane; Sielezneff, Igor; Sabbagh, Charles; Tuech, Jean-Jacques

    2017-12-01

    About 25% of patients with acute diverticulitis require emergency intervention. Currently, most patients with diverticular peritonitis undergo a Hartmann's procedure. Our objective was to assess whether primary anastomosis (PA) with a diverting stoma results in lower mortality rates than Hartmann's procedure (HP) in patients with diverticular peritonitis. We conducted a multicenter randomized controlled trial conducted between June 2008 and May 2012: the DIVERTI (Primary vs Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis) trial. Follow-up duration was up to 18 months. A random sample of 102 eligible participants with purulent or fecal diverticular peritonitis from tertiary care referral centers and associated centers in France were equally randomized to either a PA arm or to an HP arm. Data were analyzed on an intention-to-treat basis. The primary end point was mortality rate at 18 months. Secondary outcomes were postoperative complications, operative time, length of hospital stay, rate of definitive stoma, and morbidity. All 102 patients enrolled were comparable for age (p = 0.4453), sex (p = 0.2347), Hinchey stage III vs IV (p = 0.2347), and Mannheim Peritonitis Index (p = 0.0606). Overall mortality did not differ significantly between HP (7.7%) and PA (4%) (p = 0.4233). Morbidity for both resection and stoma reversal operations were comparable (39% in the HP arm vs 44% in the PA arm; p = 0.4233). At 18 months, 96% of PA patients and 65% of HP patients had a stoma reversal (p = 0.0001). Although mortality was similar in both arms, the rate of stoma reversal was significantly higher in the PA arm. This trial provides additional evidence in favor of PA with diverting ileostomy over HP in patients with diverticular peritonitis. ClinicalTrials.gov Identifier: NCT 00692393. Copyright © 2017. Published by Elsevier Inc.

  5. Comparison of escalating, constant, and reduction energy output in ESWL for renal stones: multi-arm prospective randomized study.

    Science.gov (United States)

    Rabah, Danny M; Mabrouki, Mohamed S; Farhat, Karim H; Seida, Mohamed A; Arafa, Mostafa A; Talic, Riyadh F

    2017-06-01

    This study was designed to find out the optimized energy delivery strategy in Shock Wave Lithotripsy (SWL) that yield to the best stone-free rate (SFR). In this clinical trial, 150 consecutive patients were randomized into three groups: (a) Dose escalation, 1500 SW at 18 kV, followed by 1500 SW at 20 kV then 1500 SW at 22 kV. (b) Constant dose, 4500 SW at 20 kV. All patients undergo plain X-ray film of the urinary tract at day 1, 14, and 90 to assess stone-free rate (SFR) which was defined as no stones or painless fragments less than 4 mm. (c) Dose reduction, 1500 SW at 22 kV, followed by 1500 SW at 20 kV and then 1500 SW at 18 kV. The three treatment groups were comparable in terms of age, sex, stone size and distribution of the kidneys, and the need for Double J stent use. On day 90, the SFR achieved was 82, 90, and 84 % in the escalating, constant, and reduction energy groups, respectively. However, this rate was not statistically significant (x 2  = 1.38, p level = 0.28). At a slow rate of 60 shocks, there was no difference in stone-free rate between different voltages at 1, 14, and 90 days. Our randomized clinical trial showed no statistically significant difference in SFR between the three groups while using the slow SWL rate. Our trial is the first randomized trial comparing the three strategies. As such, a dose adjustment strategy while delivering SWL in slow rate was not recommended.

  6. Web-Based Education Prior to Outpatient Orthopaedic Surgery Enhances Early Patient Satisfaction Scores: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    van Eck, Carola F; Toor, Aneet; Banffy, Michael B; Gambardella, Ralph A

    2018-01-01

    A good patient-surgeon relationship relies on adequate preoperative education and counseling. Several multimedia resources, such as web-based education tools, have become available to enhance aspects of perioperative care. The purpose of this study was to evaluate the effect of an interactive web-based education tool on perioperative patient satisfaction scores after outpatient orthopaedic surgery. It was hypothesized that web-based education prior to outpatient orthopaedic surgery enhances patient satisfaction scores. Randomized controlled trial; Level of evidence, 1. All patients undergoing knee arthroscopy with meniscectomy, chondroplasty, or anterior cruciate ligament reconstruction or shoulder arthroscopy with rotator cuff repair were eligible for inclusion and were randomized to the study or control group. The control group received routine education by the surgeon, whereas the study group received additional web-based education. At the first postoperative visit, all patients completed the OAS CAHPS (Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems) survey. Differences in patient satisfaction scores between the study and control groups were determined with an independent t test. A total of 177 patients were included (104 [59%] males; mean age, 42 ± 14 years); 87 (49%) patients were randomized to receive additional web-based education. Total patient satisfaction score was significantly higher in the study group (97 ± 5) as compared with the control group (94 ± 8; P = .019), specifically for the OAS CAHPS core measure "recovery" (92 ± 13 vs 82 ± 23; P = .001). Age, sex, race, workers' compensation status, education level, overall health, emotional health, procedure type and complexity, and addition of a video did not influence patient satisfaction scores. Supplemental web-based patient education prior to outpatient orthopaedic surgery enhances patient satisfaction scores.

  7. Football as a treatment for hypertension in untrained 30-55-year-old men: a prospective randomized study

    DEFF Research Database (Denmark)

    Andersen, Lars Juel; Randers, Morten Bredsgaard; Westh, K.

    2010-01-01

    The present study investigated whether football has favorable effects in the treatment of mild-to-moderate arterial hypertension in untrained middle-aged men. Twenty-five untrained males aged 31-54 year with mild-to-moderate hypertension were randomized to a football training group (FTG, two 1-h.......p.m.), whereas no change was observed for DAG. After 3 months, FTG had higher (Pattractive non-pharmacological supplement...... to the treatment of mild-to-moderate arterial hypertension in untrained middle-aged men....

  8. A prospective randomized study of conservative versus surgical treatment of unstable palmar plate disruption in the proximal interphalangeal finger joint

    DEFF Research Database (Denmark)

    Werlinrud, Jens Christian; Petersen, Kirstin; Lauritsen, Jens

    2013-01-01

    study in which 83 patients were randomly assigned into 2 groups: (1) conservative treatment with a rigid splint for 2 weeks, (2) surgical reattachment of the palmar plate in local anesthesia followed by 2 weeks of immobilization in a plaster cast. Both groups were thereafter treated by taping...... to the neighboring finger for 3 weeks. With regard to hyperextension instability, stiffness, and pain, there is no significant difference in outcome between patients with traumatic palmar plate lesions and hyperextension instability treated with surgical repair and patients treated conservatively with a splint. We...

  9. Does moderate-to-high intensity Nordic walking improve functional capacity and pain in fibromyalgia? A prospective randomized controlled trial

    OpenAIRE

    Mannerkorpi, Kaisa; Nordeman, Lena; Cider, ?sa; Jonsson, Gunilla

    2010-01-01

    Introduction The objective of this study was to investigate the effects of moderate-to-high intensity Nordic walking (NW) on functional capacity and pain in fibromyalgia (FM). Methods A total of 67 women with FM were recruited to the study and randomized either to moderate-to-high intensity Nordic Walking (n = 34, age 48 ? 7.8 years) or to a control group engaging in supervised low-intensity walking (LIW, n = 33, age 50 ? 7.6 years). Primary outcomes were the six-minute walk test (6MWT) and t...

  10. A prospective randomized controlled study of VAX-D and TENS for the treatment of chronic low back pain.

    Science.gov (United States)

    Sherry, E; Kitchener, P; Smart, R

    2001-10-01

    Low back pain is one of the most significant medical and socioeconomic problems in modern society. International guidelines call for evidence-based management for the pain and disability associated with musculoskeletal disorders. The purpose of this randomized controlled trial is to address the question of efficacy and appropriateness of vertebral axial decompression (VAX-D) therapy, a new technology that has been shown in clinical research to create negative intradiscal pressures, and has been shown to be effective in treating patients presenting with chronic low back pain (> 3 months duration) with associated leg pain. Successful outcome was defined as a 50% reduction in pain utilizing a 10 cm Visual Analog Pain Scale and an improvement in the level of functioning as measured by patient-nominated disability ratings. Patients were randomly assigned to VAX-D or to TENS which was used as a control treatment or placebo. The TENS treatment demonstrated a success rate of 0%, while VAX-D demonstrated a success rate of 68.4% (p pain and improvement in functional outcome was obtained in patients with chronic low back pain treated with VAX-D.

  11. A Prospective Randomized Controlled Trial of Nonpharmacological Pain Management During Intravenous Cannulation in a Pediatric Emergency Department.

    Science.gov (United States)

    Miller, Kate; Tan, Xianghong; Hobson, Andrew Dillon; Khan, Asaduzzaman; Ziviani, Jenny; OʼBrien, Eavan; Barua, Kim; McBride, Craig A; Kimble, Roy M

    2016-07-01

    Intravenous (IV) cannulation is commonly performed in pediatric emergency departments (EDs). The busy ED environment is often not conducive to conventional nonpharmacological pain management. This study assessed the use of Ditto (Diversionary Therapy Technologies, Brisbane, Australia), a handheld electronic device which provides procedural preparation and distraction, as a means of managing pain and distress during IV cannulation performed in the pediatric ED. A randomized controlled trial with 98 participants, aged 3 to 12 years, was conducted in a pediatric ED. Participants were recruited and randomized into 5 intervention groups as follows: (1) Standard Distraction, (2) PlayStation Portable Distraction, (3) Ditto Distraction, (4) Ditto Procedural Preparation, and (5) Ditto Preparation and Distraction. Children's pain and distress levels were assessed via self-reports and observational reports by caregivers and nursing staff across the following 3 time points: (1) before, (2) during, and (3) after IV cannulation. Caregivers and nursing staff reported significantly reduced pain and distress levels in children accessing the combined preparation and distraction Ditto protocol, as compared to standard distraction (P ≤ 0.01). This intervention also saw the greatest reduction in pain and distress as reported by the child. Caregiver reports indicate that using the combined Ditto protocol was most effective in reducing children's pain experiences while undergoing IV cannulation in the ED. The use of Ditto offers a promising opportunity to negotiate barriers to the provision of nonpharmacological approaches encountered in the busy ED environment, and provide nonpharmacological pain-management interventions in pediatric EDs.

  12. Effect of preemptive intra-articular morphine and ketamine on pain after arthroscopic rotator cuff repair: a prospective, double-blind, randomized controlled study.

    Science.gov (United States)

    Khashan, M; Dolkart, O; Amar, E; Chechik, O; Sharfman, Z; Mozes, G; Maman, E; Weinbroum, A A

    2016-02-01

    Rotator cuff tear is a leading etiology of shoulder pain and disability. Surgical treatment is indicated in patients with persistent pain who fail a trial of non-surgical treatment. Pain reduction following rotator cuff repair, particularly within the first 24-48 h, is a major concern to both doctors and patients. This study aimed to compare the postoperative antinociceptive additive effects of pre-incisional intra-articular (IA) ketamine when combined with morphine with two times the dose of morphine or saline. In this prospective, randomized, double blind, controlled trial patients undergoing arthroscopic rotator cuff tear repair (ARCR) under general anesthesia were enrolled. Patients were randomly assigned to one of the three intervention groups. Twenty minutes prior to incision, morphine (20 mg/10 ml), ketamine (50 mg + morphine 10 mg/10 ml), or saline (0.9 % 10 ml) (n = 15/group), were administered to all patients. First 24 h postoperative analgesia consisted of intravenous patient controlled analgesia (IV-PCA) morphine and oral rescue paracetamol 1000 mg or oxycodone 5 mg. 24-h, 2-week and 3-month patient rated pain numeric rating scale (NRS) and analgesics consumption were documented. Patients' demographic and perioperative data were similar among all groups. The 24-h and the 2-week NRSs were significantly (p pain in the first 2 weeks after arthroscopic rotator cuff repair. Further research is warranted to elucidate the optimal timing and dosing of IA ketamine and morphine for postoperative analgesic effects.

  13. Staple Line Reinforcement During Laparoscopic Sleeve Gastrectomy: Absorbable Monofilament, Barbed Suture, Fibrin Glue, or Nothing? Results of a Prospective Randomized Study.

    Science.gov (United States)

    Carandina, S; Tabbara, M; Bossi, M; Valenti, A; Polliand, C; Genser, L; Barrat, Christophe

    2016-02-01

    Laparoscopic sleeve gastrectomy (LSG) is associated with serious complications, such as staple line (SL) leaks and bleeding. In order to prevent the occurrence of these complications, surgeons have advocated the need to strengthen the staple line. The aim of this randomized controlled study was to compare the efficacy of three different ways of strengthening of the SL in LSG in preventing surgical post-operative complications. Between April 2012 and December 2014, 600 patients (pts) scheduled for LSG were prospectively randomized into groups without SL reinforcement (group A) or with SL reinforcement including fibrin glue coverage (group B), or oversewn SL with imbricating absorbable (Monocryl™; group C) or barbed (V lock®) running suture (group D). Primary endpoints were post-operative leaks, bleeding, and stenosis, while secondary outcomes consisted of the time to perform the staple line reinforcement (SLR) and total operative time. Mean SLR operative time was lower for group B (3.4 ± 1.3 min) compared with that for groups C (26.8 ± 8.5 min) and D (21.1 ± 8.4 min) (p running suture or with fibrin glue, is an unrewarding surgical act with the sole effect of prolonging the operative time.

  14. Nutritional support of bone marrow transplant recipients: a prospective, randomized clinical trial comparing total parental nutrition to an enteral feeding program

    International Nuclear Information System (INIS)

    Szeluga, D.J.

    1985-01-01

    Allogeneic and autologous bone marrow transplantation (BMT) have been associated with nutritionally-depleting side effects. Total parental nutrition (TPN) has become the standard, but it has not been demonstrated that TPN is the appropriate method of nutritional support. Therefore, in a prospective, randomized clinical trial TPN and enteral feeding were compared for their effectiveness in maintaining the nutritional status of patients through the first 29 post-transplant days. Nutritional assessment included measurement of serum proteins, body weight, anthropometry and isotope dilution analysis of body composition. Total body water (TBW) and extracellular fluid (ECF) were quantified by standard radioisotope dilution techniques using tritiated water and 169 ytterbium-diethylenetriaminepentaacetate, respectively as the tracers. Consenting patients 10-58 years of age were stratified by type of BMT (autologous or allogeneic) and randomized to either TPN plus ad libitum oral feeding or the individualized enteral feeding program (EFP), which included one-on-one counseling, meal-by-meal menu selection, special snacks and tube feeding. There were no differences in the rate of hematologic recovery, incidence of graft-versus-host disease, organ toxicity, length of hospitalization or survival. Therefore, the observed changes in body composition were not clinically significant. Even allowing for increased dietary service, the EFP was only half as expensive as TPN. It was concluded that TPN is not superior to the EFP and therefore, TPN should be reserved for patients who demonstrate intolerance to enteral feeding

  15. Effects of Neck-Specific Exercises Compared to Waiting List for Individuals With Chronic Whiplash-Associated Disorders: A Prospective, Randomized Controlled Study.

    Science.gov (United States)

    Peolsson, Anneli; Landén Ludvigsson, Maria; Tigerfors, Ann-Marie; Peterson, Gunnel

    2016-02-01

    To determine whether 3 months of neck-specific exercises (NSEs) could benefit individuals with chronic whiplash-associated disorder (WAD) who were on a waiting list (WL) for treatment. A prospective, randomized controlled study. Primary health care. Individuals (N=41; 31 women, 10 men; mean age ± SD, 38±11.2y) with chronic (6-36mo) WAD, grades 2 and 3, were analyzed. Patients were randomly assigned to NSEs or no treatment for 3 months. Neck-specific disability (Neck Disability Index [NDI]), neck pain (visual analog scale), general pain-related disability (Pain Disability Index [PDI]), self-perceived performance ability (Self-Efficacy Scale [SES]), and health-related quality of life (EuroQol 5 dimensions [EQ-5D]) were measured. NSEs significantly improved the NDI, SES, and EQ-5D compared with WL (P<.01). There was significant improvement (P<.0001) over time in all outcomes for NSEs, and apart from the PDI, significant worsening (P=.002-.0002) over time for the untreated group. NSEs were more beneficial than no intervention while on a WL for individuals with chronic WAD. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  16. Local anesthesia with epinephrine is safe and effective for oral surgery in patients with type 2 diabetes mellitus and coronary disease: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Marcela Alves dos Santos-Paul

    2015-03-01

    Full Text Available OBJECTIVE: To investigate the variations in blood glucose levels, hemodynamic effects and patient anxiety scores during tooth extraction in patients with type 2 diabetes mellitus T2DM and coronary disease under local anesthesia with 2% lidocaine with or without epinephrine. STUDY DESIGN: This is a prospective randomized study of 70 patients with T2DM with coronary disease who underwent oral surgery. The study was double blind with respect to the glycemia measurements. Blood glucose levels were continuously monitored for 24 hours using the MiniMed Continuous Glucose Monitoring System. Patients were randomized into two groups: 35 patients received 5.4 mL of 2% lidocaine, and 35 patients received 5.4 mL of 2% lidocaine with 1:100,000 epinephrine. Hemodynamic parameters (blood pressure and heart rate and anxiety levels were also evaluated. RESULTS: There was no difference in blood glucose levels between the groups at each time point evaluated. Surprisingly, both groups demonstrated a significant decrease in blood glucose levels over time. The groups showed no significant differences in hemodynamic and anxiety status parameters. CONCLUSION: The administration of 5.4 mL of 2% lidocaine with epinephrine neither caused hyperglycemia nor had any significant impact on hemodynamic or anxiety parameters. However, lower blood glucose levels were observed. This is the first report using continuous blood glucose monitoring to show the benefits and lack of side effects of local anesthesia with epinephrine in patients with type 2 diabetes mellitus and coronary disease.

  17. Single dose systemic acetaminophen to improve patient reported quality of recovery after ambulatory segmental mastectomy: A prospective, randomized, double-blinded, placebo controlled, clinical trial.

    Science.gov (United States)

    De Oliveira, Gildasio S; Rodes, Meghan E; Bialek, Jane; Kendall, Mark C; McCarthy, Robert J

    2017-11-15

    Few systemic drug interventions are efficacious to improve patient reported quality of recovery after ambulatory surgery. We aimed to evaluate whether a single dose systemic acetaminophen improve quality of recovery in female patients undergoing ambulatory breast surgery. We hypothesized that patients receiving a single dose systemic acetaminophen at the end of the surgical procedure would have a better global quality of postsurgical recovery compared to the ones receiving saline. The study was a prospective randomized double blinded, placebo controlled, clinical trial. Healthy female subjects were randomized to receive 1 g single dose systemic acetaminophen at the end of the surgery or the same volume of saline. The primary outcome was the Quality of Recovery 40 (QOR-40) questionnaire at 24 hours after surgery. Other data collected included opioid consumption and pain scores. Data were analyzed using group t tests and the Wilcoxon exact test. The association between opioid consumption and quality of recovery was evaluated using Spearman rho. P quality of recovery, P = .007. A single dose of systemic acetaminophen improves patient reported quality of recovery after ambulatory breast surgery. The use of systemic acetaminophen is an efficacious strategy to improve patient perceived quality of postsurgical recovery and analgesic outcomes after hospital discharge for ambulatory breast surgery. © 2017 Wiley Periodicals, Inc.

  18. Prospective Preference Assessment of Patients' Willingness to Participate in a Randomized Controlled Trial of Intensity-Modulated Radiotherapy Versus Proton Therapy for Localized Prostate Cancer

    International Nuclear Information System (INIS)

    Shah, Anand; Efstathiou, Jason A.; Paly, Jonathan J.; Halpern, Scott D.; Bruner, Deborah W.; Christodouleas, John P.; Coen, John J.; Deville, Curtiland; Vapiwala, Neha; Shipley, William U.; Zietman, Anthony L.; Hahn, Stephen M.; Bekelman, Justin E.

    2012-01-01

    Purpose: To investigate patients’ willingness to participate (WTP) in a randomized controlled trial (RCT) comparing intensity-modulated radiotherapy (IMRT) with proton beam therapy (PBT) for prostate cancer (PCa). Methods and Materials: We undertook a qualitative research study in which we prospectively enrolled patients with clinically localized PCa. We used purposive sampling to ensure a diverse sample based on age, race, travel distance, and physician. Patients participated in a semi-structured interview in which they reviewed a description of a hypothetical RCT, were asked open-ended and focused follow-up questions regarding their motivations for and concerns about enrollment, and completed a questionnaire assessing characteristics such as demographics and prior knowledge of IMRT or PBT. Patients’ stated WTP was assessed using a 6-point Likert scale. Results: Forty-six eligible patients (33 white, 13 black) were enrolled from the practices of eight physicians. We identified 21 factors that impacted patients’ WTP, which largely centered on five major themes: altruism/desire to compare treatments, randomization, deference to physician opinion, financial incentives, and time demands/scheduling. Most patients (27 of 46, 59%) stated they would either “definitely” or “probably” participate. Seventeen percent (8 of 46) stated they would “definitely not” or “probably not” enroll, most of whom (6 of 8) preferred PBT before their physician visit. Conclusions: A substantial proportion of patients indicated high WTP in a RCT comparing IMRT and PBT for PCa.

  19. Autologous fibrin sealant reduces the incidence of prolonged air leak and duration of chest tube drainage after lung volume reduction surgery: a prospective randomized blinded study.

    Science.gov (United States)

    Moser, C; Opitz, I; Zhai, W; Rousson, V; Russi, E W; Weder, W; Lardinois, D

    2008-10-01

    Prolonged air leak is reported in up to 50% of patients after lung volume reduction surgery. The effect of an autologous fibrin sealant on the intensity and duration of air leak and on the time to chest drain removal after lung volume reduction surgery was investigated in a randomized prospective clinical trial. Twenty-five patients underwent bilateral thoracoscopic lung volume reduction surgery. In each patient, an autologous fibrin sealant was applied along the staple lines on one side, whereas no additional measure was taken on the other side. Randomization of treatment was performed at the end of the resection on the first side. Air leak was assessed semiquantitatively by use of a severity score (0 = no leak; 4 = continuous severe leak) by two investigators blinded to the treatment. Mean value of the total severity scores for the first 48 hours postoperative was significantly lower in the treated group (4.7 +/- 7.7) than in the control group (16.0 +/- 10.1) (P drainage were also significantly reduced after application of the sealant (4.5% and 2.8 +/- 1.9 days versus 31.8% and 5.9 +/- 2.9 days) (P = .03 and P drainage.

  20. Impact of selected magnetic fields on the therapeutic effect in patients with lumbar discopathy: A prospective, randomized, single-blinded, and placebo-controlled clinical trial.

    Science.gov (United States)

    Taradaj, Jakub; Ozon, Marcin; Dymarek, Robert; Bolach, Bartosz; Walewicz, Karolina; Rosińczuk, Joanna

    2018-03-23

    Interdisciplinary physical therapy together with pharmacological treatment constitute conservative treatment strategies related to low back pain (LBP). There is still a lack of high quality studies aimed at an objective evaluation of physiotherapeutic procedures according to their effectiveness in LBP. The aim of this study is to carry out a prospective, randomized, single-blinded, and placebocontrolled clinical trial to evaluate the effectiveness of magnetic fields in discopathy-related LBP. A group of 177 patients was assessed for eligibility based on inclusion and exclusion criteria. In the end, 106 patients were randomly assigned into 5 comparative groups: A (n = 23; magnetic therapy: 10 mT, 50 Hz); B (n = 23; magnetic therapy: 5 mT, 50 Hz); C (n = 20; placebo magnetic therapy); D (n = 20; magnetic stimulation: 49.2 μT, 195 Hz); and E (n = 20; placebo magnetic stimulation). All patients were assessed using tests for pain intensity, degree of disability and range of motion. Also, postural stability was assessed using a stabilographic platform. In this study, positive changes in all clinical outcomes were demonstrated in group A (p 0.05). It was determined that the application of magnetic therapy (10 mT, 50 Hz, 20 min) significantly reduces pain symptoms and leads to an improvement of functional ability in patients with LBP.

  1. Does transfusion of residual cardiopulmonary bypass circuit blood increase postoperative bleeding? A prospective randomized study in patients undergoing on pump cardiopulmonary bypass

    Science.gov (United States)

    Duara, Rajnish; Misra, Manoranjan; Bhuyan, Ritwick Raj; Sarma, P. Sankara; Jayakumar, Karunakaran

    2008-01-01

    Objective: Homologous blood transfusion after open heart surgery puts a tremendous load on the blood banks. This prospective randomized study evaluates the efficacy of infusing back residual cardiopulmonary bypass (CPB) circuit i.e., pump blood as a means to reduce homologous transfusion after coronary artery bypass surgery (CABG) and whether its use increases postoperative drainage. Materials and Methods: Sixty-seven consecutive patients who underwent elective CABGs under CPB were randomized into 2 groups: (1) cases where residual pump blood was used and (2) controls where residual pump blood was not used. Patients were monitored for hourly drainage on the day of surgery and the 1st postoperative day and the requirements of homologous blood and its products. Data were matched regarding change in Hemoglobin, Packed Cell Volume and coagulation parameters till 1st postoperative day. All cases were followed up for three years. Results: There was a marginal reduction in bleeding pattern in the early postoperative period in the cases compared to controls. The requirement of homologous blood and its products were also reduced in the cases. Conclusions: The use of CPB circuit blood is safe in the immediate postoperative period. The requirement of homologous blood transfusion can come down if strict transfusion criteria are maintained. PMID:20041077

  2. Does transfusion of residual cardiopulmonary bypass circuit blood increase postoperative bleeding? A prospective randomized study in patients undergoing on pump cardiopulmonary bypass

    Directory of Open Access Journals (Sweden)

    Duara Rajnish

    2008-01-01

    Full Text Available Objective: Homologous blood transfusion after open heart surgery puts a tremendous load on the blood banks. This prospective randomized study evaluates the efficacy of infusing back residual cardiopulmonary bypass (CPB circuit i.e., pump blood as a means to reduce homologous transfusion after coronary artery bypass surgery (CABG and whether its use increases postoperative drainage. Materials and Methods: Sixty-seven consecutive patients who underwent elective CABGs under CPB were randomized into 2 groups: (1 cases where residual pump blood was used and (2 controls where residual pump blood was not used. Patients were monitored for hourly drainage on the day of surgery and the 1 st postoperative day and the requirements of homologous blood and its products. Data were matched regarding change in Hemoglobin, Packed Cell Volume and coagulation parameters till 1st postoperative day. All cases were followed up for three years. Results: There was a marginal reduction in bleeding pattern in the early postoperative period in the cases compared to controls. The requirement of homologous blood and its products were also reduced in the cases. Conclusions: The use of CPB circuit blood is safe in the immediate postoperative period. The requirement of homologous blood transfusion can come down if strict transfusion criteria are maintained.

  3. A clinical examination of antibiotics in continuous regional arterial infusion (CRAI) therapy for severe acute pancreatitis (SAP). A prospective randomized controlled trial of BIPM and IPM/CS

    International Nuclear Information System (INIS)

    Yamasaki, Shigemichi; Ishikura, Hiroyasu; Kamitani, Takanori

    2011-01-01

    Continuous regional arterial infusion (CRAI) therapy using both protease inhibitors and antibiotics are one of the specific therapeutic methods for severe acute pancreatitis (SAP). As for the administered antibiotics, imipenem/cilastatin sodium (IPM/CS) is generally chosen as a first step, but there are only a few reports comparing IPM/CS with other antibiotics. Therefore, we performed a prospective randomized controlled trial between biapenem (BIPM) and IPM/CS as CRAI antibiotics. Twelve patients with SAP were admitted to our institution during April, 2009 since August, 2006, and were randomized into two groups. They were treated with 120 mg/day of nafamostat mesilate and either 1.2 g/day of BIPM (n=6) or 2.0 g/day of IPM/CS (n=6) for CRAI therapy within 48 hours after the administration. The clinical data, inflammatory markers (WBC, CRP), serum pancreatic enzymes (lipase, tripsin, phospholipase A2, elastase 1 and pancreatic secretory trypsin inhibitor (PSTI) and contrast-enhanced abdominal Computed Tomography findings were compared between the two groups and the adverse effects were monitored. CRAI therapy was performed for seven days. The curative effect of this therapy was evaluated at the beginning of the treatment, the day 7 and the day 14. Our results suggested that BIPM was a non-recessive antibiotic which had an equal effect in CRAI therapy in comparison with IPM/CS. (author)

  4. Acquisition and retention of laparoscopic skills is different comparing conventional laparoscopic and single-incision laparoscopic surgery: a single-centre, prospective randomized study.

    Science.gov (United States)

    Ellis, Scott Michael; Varley, Martin; Howell, Stuart; Trochsler, Markus; Maddern, Guy; Hewett, Peter; Runge, Tina; Mees, Soeren Torge

    2016-08-01

    Training in laparoscopic surgery is important not only to acquire and improve skills but also avoid the loss of acquired abilities. The aim of this single-centre, prospective randomized study was to assess skill acquisition of different laparoscopic techniques and identify the point in time when acquired skills deteriorate and training is needed to maintain these skills. Sixty surgical novices underwent laparoscopic surgery (LS) and single-incision laparoscopic surgery (SILS) baseline training (BT) performing two validated tasks (peg transfer, precision cutting). The novices were randomized into three groups and skills retention testing (RT) followed after 8 (group A), 10 (group B) or 12 (group C) weeks accordingly. Task performance was measured in time with time penalties for insufficient task completion. 92 % of the participants completed the BT and managed to complete the task in the required time frame of proficiency. Univariate and multivariate analyses revealed that SILS (P skills (comparison of BT vs RT) was not identified; however, for SILS a significant deterioration of skills (adjustment of BT and RT values) was demonstrated for all groups (A-C) (P skills more difficult to maintain. Acquired LS skills were maintained for the whole observation period of 12 weeks but SILS skills had begun to deteriorate at 8 weeks. These data show that maintenance of LS and SILS skills is divergent and training curricula need to take these specifics into account.

  5. Comparison of tamsulosin and silodosin in the management of acute urinary retention secondary to benign prostatic hyperplasia in patients planned for trial without catheter. A prospective randomized study.

    Science.gov (United States)

    Patil, Siddangouda B; Ranka, Kshitiz; Kundargi, Vinay S; Guru, Nilesh

    2017-01-01

    We present a prospective randomized study to compare the efficacy of tamsulosin and silodosin in patients suffering from acute urinary retention caused by benign prostatic hyperplasia, planned for trial without catheter. Patients with acute urinary retention secondary to benign prostatic hyperplasia (total 160) were catheterized and randomized into two groups: Group A: tamsulosin 0.4 mg (80 patients) and Group B: silodosin 8 mg (80 patients). After three days, the catheter was removed, and patients were put on trial without catheter. Patients with a successful trial without catheter were followed up after two weeks and one month, taking into account the international prostate symptom score (IPSS), post void residual volume (PVR), and peak flow rate (PFR). Statistical analysis of the data was performed. Both group A (tamsulosin) and group B (silodosin) had similar results of trial without catheter (group A: 67.50%, group: B 60%). In follow up, three patients in group A and four patients in group B had retention of urine, requiring recatheterization. These patients were withdrawn from the study. No significant differences were present between group A and group B patients in regard with IPSS, PVR and PFR measured at the time of successful trial without catheter and during follow up at two weeks and one month. Efficacy for trial without catheter of tamsulosin was slightly higher than silodosin, but comparable. No statistical difference between tamsulosin & silodosin treated groups were found in regard with IPSS, PVR and PFR.

  6. Influence of Ventilation Strategies and Anesthetic Techniques on Regional Cerebral Oximetry in the Beach Chair Position: A Prospective Interventional Study with a Randomized Comparison of Two Anesthetics.

    Science.gov (United States)

    Picton, Paul; Dering, Andrew; Alexander, Amir; Neff, Mary; Miller, Bruce S; Shanks, Amy; Housey, Michelle; Mashour, George A

    2015-10-01

    Beach chair positioning during general anesthesia is associated with cerebral oxygen desaturation. Changes in cerebral oxygenation resulting from the interaction of inspired oxygen fraction (FIO2), end-tidal carbon dioxide (PETCO2), and anesthetic choice have not been fully evaluated in anesthetized patients in the beach chair position. This is a prospective interventional within-group study of patients undergoing shoulder surgery in the beach chair position that incorporated a randomized comparison between two anesthetics. Fifty-six patients were randomized to receive desflurane or total intravenous anesthesia with propofol. Following induction of anesthesia and positioning, FIO2 and minute ventilation were sequentially adjusted for all patients. Regional cerebral oxygenation (rSO2) was the primary outcome and was recorded at each of five set points. While maintaining FIO2 at 0.3 and PETCO2 at 30 mmHg, there was a decrease in rSO2 from 68% (SD, 12) to 61% (SD, 12) (P positioning. The combined interventions of increasing FIO2 to 1.0 and increasing PETCO2 to 45 mmHg resulted in a 14% point improvement in rSO2 to 75% (SD, 12) (P position. There was no significant interaction effect of the anesthetic at the study intervention points. Increasing FIO2 and PETCO2 resulted in a significant increase in rSO2 that overcomes desaturation in patients anesthetized in the beach chair position and that appears independent of anesthetic choice.

  7. Efficacy of 10% sucralfate ointment in the reduction of acute postoperative pain after open hemorrhoidectomy: a prospective, double-blind, randomized, placebo-controlled trial.

    Science.gov (United States)

    Ala, Shahram; Saeedi, Majid; Eshghi, Fariborz; Rafati, Mohamadreza; Hejazi, Vahid; Hadianamrei, Roja

    2013-01-01

    The aim of the present study was to evaluate the efficacy of 10 % sucralfate ointment in the reduction of acute postoperative pain after open hemorrhoidectomy. A total of 48 patients (24 men and 24 women) between 20 and 70 years of age who underwent open hemorrhoidectomy were included in this prospective, double-blind, randomized, controlled trial and were randomly divided into two groups (24 in each group), receiving either sucralfate ointment or placebo immediately after surgery and then every 12 h for 14 days. The primary outcome measure was pain intensity measured by a visual analogue scale at different time points after hemorrhoidectomy. The sucralfate group had significantly less pain than the placebo group at 24th h and the 48th h after hemorrhoidectomy (4 ± 1.14 vs 5.08 ± 0.97; P = 0.001 and 3 ± 0.72 vs 4.41 ± 0.8; P < 0.001, respectively), and they consumed lower amounts of analgesics at the same time intervals (12.50 ± 16.48 vs 21.87 ± 15.30 mg of pethidine; P = 0.047 and 152 ± 23 vs 172 ± 29 mg of diclofenac; P = 0.009, respectively). The same trend continued until the end of the trial. Sucralfate ointment reduced the acute postoperative pain after hemorrhoidectomy.

  8. Patient-Specific CT-Based Instrumentation versus Conventional Instrumentation in Total Knee Arthroplasty: A Prospective Randomized Controlled Study on Clinical Outcomes and In-Hospital Data

    Directory of Open Access Journals (Sweden)

    Andrzej Kotela

    2015-01-01

    Full Text Available Total knee arthroplasty (TKA is a frequently performed procedure in orthopaedic surgery. Recently, patient-specific instrumentation was introduced to facilitate correct positioning of implants. The aim of this study was to compare the early clinical results of TKA performed with patient-specific CT-based instrumentation and conventional technique. A prospective, randomized controlled trial on 112 patients was performed between January 2011 and December 2011. A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group. The experimental group comprised 52 patients who received the Signature CT-based implant positioning system, and the control group consisted of 60 patients with conventional instrumentation. Clinical outcomes were evaluated with the KSS scale, WOMAC scale, and VAS scales to assess knee pain severity and patient satisfaction with the surgery. Specified in-hospital data were recorded. Patients were followed up for 12 months. At one year after surgery, there were no statistically significant differences between groups with respect to clinical outcomes and in-hospital data, including operative time, blood loss, hospital length of stay, intraoperative observations, and postoperative complications. Further high-quality investigations of various patient-specific systems and longer follow-up may be helpful in assessing their utility for TKA.

  9. Efficacy of clonidine versus phenobarbital in reducing neonatal morphine sulfate therapy days for neonatal abstinence syndrome. A prospective randomized clinical trial.

    Science.gov (United States)

    Surran, B; Visintainer, P; Chamberlain, S; Kopcza, K; Shah, B; Singh, R

    2013-12-01

    To compare the efficacy of clonidine versus phenobarbital in reducing morphine sulfate treatment days for neonatal abstinence syndrome (NAS). Prospective, non-blinded, block randomized trial at a single level III NICU (Neonatal Intensive Care Unit). Eligible infants were treated with a combination of medications as per protocol. Primary outcome was treatment days with morphine sulfate. Secondary outcomes were the mean total morphine sulfate dose, outpatient phenobarbital days, adverse events and treatment failures. A total of 82 infants were eligible, of which 68 were randomized with 34 infants in each study group. Adjusting for covariates phenobarbital as compared with clonidine had shorter morphine sulfate treatment days (-4.6, 95% confidence interval (CI): -0.3, -8.9; P=0.037) with no difference in average morphine sulfate total dose (1.1 mg kg(-1), 95% CI: -0.1, 2.4; P=0.069). Post-discharge phenobarbital was continued for an average of 3.8 months (range 1 to 8 months). No other significant differences were noted. Phenobarbital as adjunct had clinically nonsignificant shorter inpatient but significant overall longer therapy time as compared with clonidine.

  10. Prospective randomized controlled study on the validity and safety of an absorbable adhesion barrier (Interceed®) made of oxidized regenerated cellulose for laparoscopic colorectal surgery.

    Science.gov (United States)

    Naito, Masanori; Ogura, Naoto; Yamanashi, Takahiro; Sato, Takeo; Nakamura, Takatoshi; Miura, Hirohisa; Tsutsui, Atsuko; Sakamoto, Yasutoshi; Tanaka, Rieko; Kumagai, Yuji; Watanabe, Masahiko

    2017-02-01

    Clinical use of an adhesion barrier made of oxidized, regenerated cellulose, Interceed®, has been reported in the field of obstetrics and gynecology to help prevent adhesions between the peritoneum and the bowel in various types of operations. In gastrointestinal surgery, sodium hyaluronate/carboxymethylcellulose has been reported as an absorbable membrane to reduce postoperative adhesions. The present study was a prospective randomized controlled study to investigate the safety and usefulness of Interceed in laparoscopic colorectal surgery. We analyzed 99 patients who underwent laparoscopic colorectal surgery from 2013 to 2014. The patients were randomly allocated to the group that used Interceed (Interceed group) or the group that did not (Non-Interceed group). Fifty cases used Interceed, and 49 cases did not. The incidence of adverse events was 12.0% in the Interceed group and 16.3% in the Non-Interceed group (P = 0.58). There were no significant differences, and no adhesive bowel obstructions were observed in the Interceed group. We have shown that using Interceed in laparoscopic colorectal surgery is valid and technically safe. © 2016 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and John Wiley & Sons Australia, Ltd.

  11. A prospective and randomized study of radiotherapy, sequential chemotherapy radiotherapy and concomitant chemo therapy-radiotherapy in unresectable non small cell carcinoma of the lung

    Directory of Open Access Journals (Sweden)

    Dasgupta Anirban

    2006-01-01

    Full Text Available Purpose: Treatment of advanced Non small cell lung cancer (NSCLC often produces dismal results. Combination of available treatment modalities has reportedly improved the outcome. A prospectively randomized trial was conducted, comparing combined treatment modalities versus radiotherapy alone, in treatment of unresectable NSCLC. Materials and Methods: A total of 103 patients were randomized to three groups. In group ′A′, 32 patients received radiotherapy alone (6500 cGy/30 fraction. In group ′B′, 35 patients received neoadjuvant chemotherapy (Cisplatin 80 mg/m2 on day 1 and Etoposide 100 mg/m day 1-3 intravenously q3 weeks for 3 cycles, followed by radiotherapy (6000 cGy/30 fractions and 3 more cycles of Chemotherapy, with the same regimen. In group ′C′, 36 patients received radiotherapy (5000 cGy/25 fractions with concurrent chemotherapy (ciplatin 20 mg/m2 + Etoposide 75 mg/m2 intravenously on day 1-5 and day 22-26, followed by 2 more cycles of chemotherapy,q3 weeks with the same regimen. Results: Initial treatment responses were significantly higher in group ′B′ ( P P Conclusion: Addition of chemotherapy with radiation in unresectable NSCLC improves response rates, time to tumour progression and disease free survival, though the same effect is not translated in overall survival.

  12. Effect of heat- and steam-generating sheet on daily activities of living in patients with osteoarthritis of the knee: randomized prospective study.

    Science.gov (United States)

    Seto, Hiroaki; Ikeda, Hiroshi; Hisaoka, Hidehiko; Kurosawa, Hisashi

    2008-05-01

    Thermotherapy is widely known to be effective for osteoarthritis of the knee (knee OA), but most treatment methods make use of dry heat. We developed a sheet that generates heat and steam simultaneously. In this prospective randomized study, we evaluated the effectiveness of this sheet. Of 41 female patients with knee OA randomized to use the heat/steam-generating sheet or the dry heat-generating sheet, 37 patients (20 using the heat/steam-generating sheet and 17 using the dry heat-generating sheet) who used the sheets continuously for 4 weeks were studied. Outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Japan Orthopaedic Association (JOA) scores, which were applied at baseline and after 2 and 4 weeks of use. Significant improvement of the total WOMAC score was observed at 2 and 4 weeks (compared to baseline) in the heat/steam-generating sheet group, but no significant change was observed in the dry heat-generating sheet group. Among the JOA scores, the gait ability score was also improved significantly only in the heat/steam-generating sheet group. The effects were still seen 6 weeks after completion of treatment. The present study provided evidence that the heat/steam-generating sheet that we developed is effective for alleviating pain and is especially superior in regard to improving stiffness and gait impairment in patients with knee OA. Furthermore, the effect persists for at least 6 weeks after application.

  13. Natalizumab stabilizes physical, cognitive, MRI, and OCT markers of disease activity: A prospective, non-randomized pilot study.

    Directory of Open Access Journals (Sweden)

    Garrick D Talmage

    Full Text Available Natalizumab is an effective therapy for multiple sclerosis (MS. Its effectiveness has been demonstrated in several clinical and imaging studies. The objective of this study was to further demonstrate the efficacy of natalizumab using a comprehensive battery of clinical and imaging markers in the same cohort of patients followed longitudinally, hence capturing the multi-faceted nature of the MS disease process. A prospective, open-label, pilot study of 20 MS patients treated with natalizumab was conducted. High resolution MRI, Symbol-Digit Modalities Test (SDMT, and Optical Coherence Tomography (OCT scans were obtained at baseline, 48, and 96 weeks. 15 patients completed the study. Natalizumab treatment decreased Expanded Disability Status Scale score (EDSS and no change in SDMT, Brain Parenchymal Fraction (BPF, or any of the OCT markers of retinal degeneration was observed. Thalamic and whole brain volume as assessed by Percentage Brain Volume Change (PBVC showed continuous deterioration. Higher baseline T2 lesion load correlated with increased rate of PBVC at 96-weeks (r = 0.566, R2 = 0.320, p = 0.035 and thalamic volume loss (r = -0.586, R2 = 0.344, p = 0.027. Most patients, 93%, achieved no evidence of disease activity (NEDA at 2 years, likely due to early disease duration and lower initial baseline lesion load. This study further demonstrates stabilization of clinical and imaging markers of disease activity during natalizumab treatment.

  14. Shorter maintenance therapy in childhood Acute Lymphoblastic Leukemia. The experience of the prospective, randomized Brazilian GBTLI ALL-93 protocol.

    Directory of Open Access Journals (Sweden)

    Silvia Regina Brandalise

    2016-10-01

    Full Text Available Maintenance therapy is an important phase of the childhood ALL treatment, requiring 2-year long therapy adherence of the patients and families. Weekly methotrexate (MTX with daily 6-mercaptopurine (6MP constitutes the backbone of maintenance therapy. Reduction in the maintenance therapy could overweight problems related with poverty of children with ALL living in Limited-Income countries (LIC. Objective: To compare, prospectively, the EFS rates of children with ALL treated according to two maintenance regimens: 18 vs 24 months duration. Materials and Methods: From October 1993 to September 1999, 867 consecutive untreated ALL patients 10 years and high WBC at diagnosis. Overall death in remission rate was 6.85% (56 patients. Deaths during maintenance were 13 in group 1 and 12 in group 2, all due to infection. Over 15 years of follow-up, two patients both from Group 2 presented a second malignancy (Hodgkin’s disease and thyroid carcinoma after 8.3 and 11 years off therapy, respectively. Conclusion: Six-month reduction of maintenance therapy in ALL children treated according to the GBTLI ALL-93 protocol, provided the same overall outcome as 2-year duration regimen.

  15. Ultrasound-Guided Out-of-Plane vs. In-Plane Interscalene Catheters: A Randomized, Prospective Study.

    Science.gov (United States)

    Schwenk, Eric S; Gandhi, Kishor; Baratta, Jaime L; Torjman, Marc; Epstein, Richard H; Chung, Jaeyoon; Vaghari, Benjamin A; Beausang, David; Bojaxhi, Elird; Grady, Bernadette

    2015-12-01

    Continuous interscalene blocks provide excellent analgesia after shoulder surgery. Although the safety of the ultrasound-guided in-plane approach has been touted, technical and patient factors can limit this approach. We developed a caudad-to-cephalad out-of-plane approach and hypothesized that it would decrease pain ratings due to better catheter alignment with the brachial plexus compared to the in-plane technique in a randomized, controlled study. To compare an out-of-plane interscalene catheter technique to the in-plane technique in a randomized clinical trial. Eighty-four patients undergoing open shoulder surgery were randomized to either the in-plane or out-of-plane ultrasound-guided continuous interscalene technique. The primary outcome was VAS pain rating at 24 hours. Secondary outcomes included pain ratings in the recovery room and at 48 hours, morphine consumption, the incidence of catheter dislodgments, procedure time, and block difficulty. Procedural data and all pain ratings were collected by blinded observers. There were no differences in the primary outcome of median VAS pain rating at 24 hours between the out-of-plane and in-plane groups (1.50; IQR, [0 - 4.38] vs. 1.25; IQR, [0 - 3.75]; P = 0.57). There were also no differences, respectively, between out-of-plane and in-plane median PACU pain ratings (1.0; IQR, [0 - 3.5] vs. 0.25; IQR, [0 - 2.5]; P = 0.08) and median 48-hour pain ratings (1.25; IQR, [1.25 - 2.63] vs. 0.50; IQR, [0 - 1.88]; P = 0.30). There were no differences in any other secondary endpoint. Our out-of-plane technique did not provide superior analgesia to the in-plane technique. It did not increase the number of complications. Our technique is an acceptable alternative in situations where the in-plane technique is difficult to perform.

  16. Blastocyst utilization rates after continuous culture in two commercial single-step media: a prospective randomized study with sibling oocytes.

    Science.gov (United States)

    Sfontouris, Ioannis A; Kolibianakis, Efstratios M; Lainas, George T; Venetis, Christos A; Petsas, George K; Tarlatzis, Basil C; Lainas, Tryfon G

    2017-10-01

    The aim of this study is to determine whether blastocyst utilization rates are different after continuous culture in two different commercial single-step media. This is a paired randomized controlled trial with sibling oocytes conducted in infertility patients, aged ≤40 years with ≥10 oocytes retrieved assigned to blastocyst culture and transfer. Retrieved oocytes were randomly allocated to continuous culture in either Sage one-step medium (Origio) or Continuous Single Culture (CSC) medium (Irvine Scientific) without medium renewal up to day 5 post oocyte retrieval. Main outcome measure was the proportion of embryos suitable for clinical use (utilization rate). A total of 502 oocytes from 33 women were randomly allocated to continuous culture in either Sage one-step medium (n = 250) or CSC medium (n = 252). Fertilization was performed by either in vitro fertilization or intracytoplasmic sperm injection, and embryo transfers were performed on day 5. Two patients had all blastocysts frozen due to the occurrence of severe ovarian hyperstimulation syndrome. Fertilization and cleavage rates, as well as embryo quality on day 3, were similar in the two media. Blastocyst utilization rates (%, 95% CI) [55.4% (46.4-64.1) vs 54.7% (44.9-64.6), p = 0.717], blastocyst formation rates [53.6% (44.6-62.5) vs 51.9 (42.2-61.6), p = 0.755], and proportion of good quality blastocysts [36.8% (28.1-45.4) vs 36.1% (27.2-45.0), p = 0.850] were similar in Sage one-step and CSC media, respectively. Continuous culture of embryos in Sage one-step and CSC media is associated with similar blastocyst development and utilization rates. Both single-step media appear to provide adequate support during in vitro preimplantation embryo development. Whether these observations are also valid for other continuous single medium protocols remains to be determined. NCT02302638.

  17. Evaluation of intralesional injection of hyaluronic acid compared with verapamil in Peyronie's disease: preliminary results from a prospective, double-blinded, randomized study.

    Science.gov (United States)

    Favilla, V; Russo, G I; Zucchi, A; Siracusa, G; Privitera, S; Cimino, S; Madonia, M; Cai, T; Cavallini, G; Liguori, G; D'Achille, G; Silvani, M; Franco, G; Verze, P; Palmieri, A; Torrisi, B; Mirone, V; Morgia, G

    2017-07-01

    Several intralesional therapeutic protocols have been proposed for the treatment of Peyronie's disease. Among all, hyaluronic acid (HA) and verapamil have been differently tested. We aimed to evaluate the efficacy of intralesional verapamil (ILVI) compared with intralesional HA in patients with early onset of Peyronie's disease (PD). This is a multi-centre prospective double-arm, randomized, double-blinded study comparing ILVI vs. intralesional HA after 12-weeks. Sexually active men, older than 18 years and affected by the acute phase of PD were eligible for this study. Patients have been double-blinded randomly divided into two groups (1 : 1 ratio): Group A received intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks, while group B received intralesional treatment with HA (0.8% highly purified sodium salt HA 16 mg/2 mL) weekly for 12 weeks. The primary efficacy outcome was the change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree). The secondary outcome was the change in the plaque size and in the International Index of erectile Function (IIEF-5) score. The difference between post- and pre-treatment plaque size was -1.36 mm (SD ± 1.27) for Group A and -1.80 mm (SD ± 2.47) for Group B (p-value = NS). IIEF-5 increased of 1.46 points (SD ± 2.18) in Group A and 1.78 (SD ± 2.48) in Group B (p-value ± NS). No difference in penile curvature was observed in Group A, while in Group B the penile curvature decreased of 4.60° (SD ± 5.63) from the baseline (p < 0.001) and vs. Group A. According to PGI-I results, we found significant difference as concerning patient global impression of improvement (PGI-I) (4.0 vs. 2.0; p < 0.05). This prospective, double-arm, randomized, double-blinded study comparing ILVI vs. HA as intralesional therapy showed greater efficacy of HA in terms of penile curvature and PGI-I. © 2017 American Society of Andrology and

  18. Acute Adverse Reactions to Nonionic Iodinated Contrast Media for CT: Prospective Randomized Evaluation of the Effects of Dehydration, Oral Rehydration, and Patient Risk Factors.

    Science.gov (United States)

    Motosugi, Utaroh; Ichikawa, Tomoaki; Sano, Katsuhiro; Onishi, Hiroshi

    2016-11-01

    The objective of our study was to determine the effects of dehydration and oral rehydration on the incidence of acute adverse reactions to iodinated contrast media administered during abdominal and pelvic CT in outpatients. For our prospective randomized study performed at a single institution, adult outpatients undergoing contrast-enhanced abdominal CT were randomly divided into a rehydration group (n = 2244 patients [1379 men and 865 women]; mean age, 65.2 years; age range, 18-90 years) and a control group (n = 3715 [2112 male patients and 1603 female patients]; mean age, 65.8 years; age range, 17-96 years), which included an age- and sex-matched subgroup (adjusted control group, n = 2244). The rehydration group received an oral rehydration solution (500 mL of liquid in which osmotic pressure is adjusted to enhance gastrointestinal absorption) before abdominal and pelvic CT. Patients were also divided into subclinically dehydrated (n = 997) and hydrated (n = 4962) groups according to their answers to a questionnaire that they completed before the CT examination. The patients were interviewed about contrast-induced adverse reactions before they left the CT room, and the reactions were categorized as allergiclike or physiologic. The incidence of reactions was compared between the rehydration and control groups and between the subclinical dehydration and hydrated groups. The rehydration and control groups were compared with an unpaired t test or a chi-square or Fisher test. The overall incidence of an acute adverse reaction was 4.3% (254/5959); the acute adverse reactions included 136 allergiclike and 118 physiologic reactions. Fourteen allergiclike and nine physiologic reactions were moderate grade, and none was severe. There was no significant difference between the rehydration group and adjusted control group in the overall incidence of adverse reactions (99/2244 [4.4%] vs 100/2244 [4.5%], respectively; p = 0.9422) or between the subclinically dehydrated group

  19. Changes in bone mineral density of the proximal tibia after uncemented total knee arthroplasty. A prospective randomized study

    DEFF Research Database (Denmark)

    Winther, Nikolaj; Jensen, Claus Lindkær; Petersen, Morten Bøje

    2016-01-01

    arthroplasty (TKA) using a tibial tray with this novel coating compared to a well-proven standard porous coated (PPS) tibial tray. MATERIALS: Sixty patients scheduled for TKA were randomized to receive either a Regenerex (n = 31) or a PPS tibial component (n = 29). Changes in bone mineral density (BMD......) of the proximal tibia were measured at three, six, 12 and 24 months by dual-energy X-ray absorptiometry (DEXA). RESULTS: In the lateral region (ROI 3), a significant increase in BMD was seen in both groups at three, six, and 12 months after surgery. The relative increase at 12 months was 8.1 % (P = 0...

  20. Evaluating the efficacy of lavender aromatherapy on peripheral venous cannulation pain and anxiety: A prospective, randomized study.

    Science.gov (United States)

    Karaman, Tugba; Karaman, Serkan; Dogru, Serkan; Tapar, Hakan; Sahin, Aynur; Suren, Mustafa; Arici, Semih; Kaya, Ziya

    2016-05-01

    This study was designed to evaluate the effectiveness of lavender aromatherapy on pain, anxiety, and level of satisfaction associated with the peripheral venous cannulation (PVC) in patients undergoing surgery. One hundred and six patients undergoing surgery were randomized to receive aromatherapy with lavender essential oil (the lavender group) or a placebo (the control group) during PVC. The patients' pain, anxiety, and satisfaction scores were measured. There was no statistically significantly difference between the groups in terms of demographic data. After cannulation, the pain and anxiety scores (anxiety 2) of the patients in the lavender group were significantly lower than the control group (for p = 0.01 for pain scores; p aromatherapy had beneficial effects on PVC pain, anxiety, and satisfaction level of patients undergoing surgery. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Findings From a Prospective Randomized Controlled Trial of an Individualized Music Listening Program for Persons With Dementia.

    Science.gov (United States)

    Kwak, Jung; Anderson, Keith; O'Connell Valuch, Katharine

    2018-06-01

    Music & Memory (M&M) is a passive music intervention that uses personalized music playlists delivered on digital music players. This program has been increasingly adopted in nursing homes across the United States to facilitate communication, engagement, and socialization among persons with dementia (PWDs); however, few studies have evaluated the program's effect on PWDs' outcomes. In the present study, a randomized controlled crossover design was used to examine the impact of the M&M program on 59 PWDs in 10 nursing homes over a 14-week period. Residents' evaluated outcomes included agitation, behavioral symptoms, and use of psychotropic medications. Although trends supported the positive effects of M&M, no statistically significant differences were found in any of the outcomes measured over time. Methodological limitations withstanding, these findings call into question the effectiveness of the M&M program and the ability of facility staff to implement this intervention with fidelity.

  2. No effect of Osteoset, a bone graft substitute, on bone healing in humans: a prospective randomized double-blind study

    DEFF Research Database (Denmark)

    Petruskevicius, Juozas; Nielsen, Mette Strange; Kaalund, Søren

    2002-01-01

    We studied the effects of a newly marketed bone substitute, Osteoset, on bone healing in a tibial defect in humans. 20 patients undergoing an ACL (anterior cruciate ligament) reconstruction with bone-patella tendon-bone graft were block-randomized into 2 groups of 10 each. In the treatment group......, the tibial defect was filled manually with Osteoset pellets, in the control group the defect was left empty. CTs of the defect were taken on the first day after the operation, 6 weeks, 3 and 6 months postoperatively. We found about the same amount of bone in the defect in the Osteoset and control groups...... after 6 weeks, 3, and 6 months. In the control group, but not in the Osteoset group, the bone volume increased from 6 weeks to 3 months. The Osteoset pellets were almost resorbed after 6 weeks....

  3. The use of low output laser therapy to accelerate healing of diabetic foot ulcers: a randomized prospective controlled trial

    Science.gov (United States)

    Naidu, S. V. L. G.; Subapriya, S.; Yeoh, C. N.; Soosai, S.; Shalini, V.; Harwant, S.

    2005-11-01

    The aim of this study was to assess the effects of low output laser therapy as an adjuvant treatment in grade 1 diabetic foot ulcers. Methods: Sixteen patients were randomly divided equally into two groups. Group A had daily dressing only, while group B had low output laser therapy instituted five days a week in addition to daily dressing. Serial measurement of the ulcer was done weekly using digital photography and analyzed. Results: The rate of healing in group A was 10.42 mm2/week, and in group B was 66.14mm2/week. The difference in the rate of healing was statistically significant, pdiabetic ulcer healing by six times in a six week period.

  4. Acute and Short-Term Toxicities of Conventionally Fractionated Versus Hypofractionated Whole Breast Irradiation in a Prospective, Randomized Trial

    Science.gov (United States)

    Shaitelman, Simona F.; Schlembach, Pamela J.; Arzu, Isidora; Ballo, Matthew; Bloom, Elizabeth S.; Buchholz, Daniel; Chronowski, Gregory M.; Dvorak, Tomas; Grade, Emily; Hoffman, Karen E.; Kelly, Patrick; Ludwig, Michelle; Perkins, George H.; Reed, Valerie; Shah, Shalin; Stauder, Michael C.; Strom, Eric A.; Tereffe, Welela; Woodward, Wendy A.; Ensor, Joe; Baumann, Donald; Thompson, Alastair M.; Amaya, Diana; Davis, Tanisha; Guerra, William; Hamblin, Lois; Hortobagyi, Gabriel; Hunt, Kelly K.; Buchholz, Thomas A.; Smith, Benjamin D.

    2015-01-01

    IMPORTANCE The most appropriate dose-fractionation for whole breast irradiation (WBI) remains uncertain. OBJECTIVE To assess acute and six-month toxicity and quality of life (QoL) with conventionally fractionated WBI (CF-WBI) versus hypofractionated WBI (HF-WBI). DESIGN Unblinded randomized trial of CF-WBI (n=149; 50 Gy/25 fractions + boost [10–14 Gy/5–7 fractions]) versus HF-WBI (n=138; 42.56 Gy/16 fractions + boost [10–12.5 Gy/4–5 fractions]). SETTING Community-based and academic cancer centers. PARTICIPANTS 287 women age ≥ 40 years with stage 0–II breast cancer treated with breast-conserving surgery for whom whole breast irradiation without addition of a third field was recommended. 76% (n=217) were overweight or obese. Patients were enrolled from February 2011 through February 2014. INTERVENTION(S) FOR CLINICAL TRIALS CF-WBI versus HF-WBI. MAIN OUTCOME MEASURES Physician-reported acute and six-month toxicities using NCICTCv4.0 and patient-reported QoL using the FACT-B version 4. All analyses were intention-to-treat, with outcomes compared using chi-square, Cochran-Armitage test, and ordinal logistic regression. Patients were followed for a minimum of 6 months. RESULTS Treatment arms were well-matched for baseline characteristics including FACT-B total score (P=0.46) and individual QoL items such as lack of energy (P=0.86) and trouble meeting family needs (P=0.54). Maximal physician-reported acute dermatitis (P<0.001), pruritus (P<0.001), breast pain (P=0.001), hyperpigmentation (P=0.002), and fatigue (P=0.02) during radiation were lower in patients randomized to HF-WBI. Overall grade ≥2 acute toxicity was less with HF-WBI vs. CF-WBI (47% vs. 78%; P<0.001). Six months after radiation, physicians reported less fatigue in patients randomized to HF-WBI (P=0.01), and patients randomized to HF-WBI reported less lack of energy (P<0.001) and less trouble meeting family needs (P=0.01). Multivariable regression confirmed the superiority of HF-WBI in terms

  5. Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective multicenter randomized controlled trial.

    Science.gov (United States)

    Levkovitz, Yechiel; Isserles, Moshe; Padberg, Frank; Lisanby, Sarah H; Bystritsky, Alexander; Xia, Guohua; Tendler, Aron; Daskalakis, Zafiris J; Winston, Jaron L; Dannon, Pinhas; Hafez, Hisham M; Reti, Irving M; Morales, Oscar G; Schlaepfer, Thomas E; Hollander, Eric; Berman, Joshua A; Husain, Mustafa M; Sofer, Uzi; Stein, Ahava; Adler, Shmulik; Deutsch, Lisa; Deutsch, Frederic; Roth, Yiftach; George, Mark S; Zangen, Abraham

    2015-02-01

    Major depressive disorder (MDD) is a prevalent and disabling condition, and many patients do not respond to available treatments. Deep transcranial magnetic stimulation (dTMS) is a new technology allowing non-surgical stimulation of relatively deep brain areas. This is the first double-blind randomized controlled multicenter study evaluating the efficacy and safety of dTMS in MDD. We recruited 212 MDD outpatients, aged 22-68 years, who had either failed one to four antidepressant trials or not tolerated at least two antidepressant treatments during the current episode. They were randomly assigned to monotherapy with active or sham dTMS. Twenty sessions of dTMS (18 Hz over the prefrontal cortex) were applied during 4 weeks acutely, and then biweekly for 12 weeks. Primary and secondary efficacy endpoints were the change in the Hamilton Depression Rating Scale (HDRS-21) score and response/remission rates at week 5, respectively. dTMS induced a 6.39 point improvement in HDRS-21 scores, while a 3.28 point improvement was observed in the sham group (p=0.008), resulting in a 0.76 effect size. Response and remission rates were higher in the dTMS than in the sham group (response: 38.4 vs. 21.4%, p=0.013; remission: 32.6 vs. 14.6%, p=0.005). These differences between active and sham treatment were stable during the 12-week maintenance phase. dTMS was associated with few and minor side effects apart from one seizure in a patient where a protocol violation occurred. These results suggest that dTMS constitutes a novel intervention in MDD, which is efficacious and safe in patients not responding to antidepressant medications, and whose effect remains stable over 3 months of maintenance treatment. © 2015 World Psychiatric Association.

  6. Comparison between oral antibiotics and probiotics as bowel preparation for elective colon cancer surgery to prevent infection: prospective randomized trial.

    Science.gov (United States)

    Sadahiro, Sotaro; Suzuki, Toshiyuki; Tanaka, Akira; Okada, Kazutake; Kamata, Hiroko; Ozaki, Toru; Koga, Yasuhiro

    2014-03-01

    We have already reported that, for patients undergoing elective colon cancer operations, perioperative infection can be prevented by a single intravenous dose of an antibiotic given immediately beforehand if mechanical bowel preparation and the administration of oral antibiotics are implemented. Synbiotics has been reported to reduce the rate of infection in patients after pancreatic cancer operations. The effectiveness of oral antibiotics and probiotics in preventing postoperative infection in elective colon cancer procedures was examined in a randomized controlled trial. Three hundred ten patients with colon cancer randomly were assigned to one of three groups. All patients underwent mechanical bowel preparation and received a single intravenous dose of flomoxef immediately before operation. Probiotics were administered in Group A; oral antibiotics were administered in Group B; and neither probiotics nor oral antibiotics were administered in Group C. Stool samples were collected 9 and 2 days before and 7 and 14 days after the procedure. Clostridium difficile toxin and the number of bacteria in the intestine were determined. The rates of incisional surgical-site infection were 18.0%, 6.1%, and 17.9% in Groups A, B, and C, and the rates of leakage were 12.0%, 1.0%, and 7.4% in Groups A, B, and C, respectively, indicating that both rates were lesser in Group B than in Groups A and C (P = .014 and P = .004, respectively). The detection rates of C. difficile toxin were not changed among the three groups. We recommend oral antibiotics, rather than probiotics, as bowel preparation for elective colon cancer procedures to prevent surgical-site infections. Copyright © 2014 Mosby, Inc. All rights reserved.

  7. Prospective Randomized Comparison of the Effectiveness of Radiation Therapy and Local Steroid Injection for the Treatment of Plantar Fasciitis

    International Nuclear Information System (INIS)

    Canyilmaz, Emine; Canyilmaz, Fatih; Aynaci, Ozlem; Colak, Fatma; Serdar, Lasif; Uslu, Gonca Hanedan; Aynaci, Osman; Yoney, Adnan

    2015-01-01

    Purpose: The purpose of this study was to conduct a randomized trial of radiation therapy for plantar fasciitis and to compare radiation therapy with local steroid injections. Methods and Materials: Between March 2013 and April 2014, 128 patients with plantar fasciitis were randomized to receive radiation therapy (total dose of 6.0 Gy applied in 6 fractions of 1.0 Gy three times a week) or local corticosteroid injections a 1 ml injection of 40 mg methylprednisolone and 0.5 ml 1% lidocaine under the guidance of palpation. The results were measured using a visual analog scale, a modified von Pannewitz scale, and a 5-level function score. The fundamental phase of the study was 3 months, with a follow-up period of up to 6 months. Results: The median follow-up period for all patients was 12.5 months (range, 6.5-18.6 months). For the radiation therapy patients, the median follow-up period was 13 months (range, 6.5-18.5 months), whereas in the palpation-guided (PG) steroid injection arm, it was 12.1 months (range, 6.5-18.6 months). After 3 months, results in the radiation therapy arm were significantly superior to those in the PG steroid injection arm (visual analog scale, P<.001; modified von Pannewitz scale, P<.001; 5-level function score, P<.001). Requirements for a second treatment did not significantly differ between the 2 groups, but the time interval for the second treatment was significantly shorter in the PG steroid injection group (P=.045). Conclusion: This study confirms the superior analgesic effect of radiation therapy compared to mean PG steroid injection on plantar fasciitis for at least 6 months after treatment

  8. Performance of zirconia ceramic cantilever fixed dental prostheses: 3-year results from a prospective, randomized, controlled pilot study.

    Science.gov (United States)

    Zenthöfer, Andreas; Ohlmann, Brigitte; Rammelsberg, Peter; Bömicke, Wolfgang

    2015-07-01

    Little is known about the clinical performance of ceramic cantilever fixed dental prostheses on natural teeth. The purpose of this randomized controlled pilot study was to evaluate the clinical performance of ceramic and metal ceramic cantilever fixed dental prostheses (CFDPs) after 3 years of service. Twenty-one participants were randomly allocated to 2 treatment groups. Participants in the ceramic (ZC) group (n=11) each received 1 CFDP made of yttria-stabilized, tetragonal zirconia polycrystal; the others (n=10) were fitted with a metal ceramic (MC) CFDP. All CFDPs were retained by 2 complete crown abutments and replaced 1 tooth. The clinical target variables were survival, incidence of complications, probing pocket depth (PPD), probing attachment level (PAL), plaque index (PI), gingival index (GI), and esthetic performance as rated by the participants. The United States Public Health Service (USPHS) criteria were used to evaluate chipping, retention, color, marginal integrity, and secondary caries. Descriptive statistics and nonparametric analyses were applied to the target variables in the 2 groups. The esthetic performance of the CFDPs was also visualized by using a pyramid comparison. The overall survival of the CFDPs was 100% in both groups. During the 3-year study, 6 clinically relevant complications requiring aftercare were observed among 5 participants (4 in the ZC group and 2 in the MC group). Changes in the PI, GI, PPD, and PAL of the abutment teeth were similar for both groups (P>.05). The participants regarded the esthetic performance of ZC-CFDPs and MC-CFDPs as satisfactory. Within the 3-year observation period, the clinical performance of MC-FDPs and ZC-FDPs was acceptable. More extensive research with larger sample sizes is encouraged, however, to confirm the evaluation of the survival of Y-TZP hand-veneered cantilever FPDs. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  9. Renoprotective effects of topiroxostat for hyperuremic patients with overt diabetic nephropathy study (ETUDE Study): A prospective, randomized, multicenter clinical trial.

    Science.gov (United States)

    Mizukoshi, Toshihiro; Kato, Sawako; Ando, Masahiko; Sobajima, Hiroshi; Ohashi, Norimi; Naruse, Tomohiko; Saka, Yosuke; Shimizu, Hideaki; Nagata, Takanobu; Maruyama, Shoichi

    2017-10-09

    We aimed to evaluate the anti-albuminuric effects of topiroxostat in Japanese hyperuricemic patients with diabetic nephropathy. In this 24-week, multicenter, open-label, randomized (1:1) trial, we assigned hyperuricemic patients with diabetic nephropathy (estimated glomerular filtration rate ≥ 20 mL/min/1.73m 2 ) and overt proteinuria (0.3 ≤ urine protein to creatinine ratio (UPCR) <3.5 g/g Cr) to either high dose (160 mg daily) or low dose (40 mg daily) topiroxostat. The primary endpoint was the change in albuminuria indicated by urine albumin-to-creatinine ratio (UACR) from the baseline at the final time point. A total of 80 patients underwent randomization. The changes in UACR after 24 weeks of treatment (or at the final time point if patients failed to reach 24 weeks) relative to the baseline were -122 mg/gCr (95% CI: -5.1 to -240.1, P = 0.041) in patients treated with high dose, while treatment with low dose topiroxostat could not show significant reduction (P = 0.067). In the linear mixed model including baseline albuminuria, eGFR, age, and sex as covariates, the decreases in UACR were still significant from baseline to 12 weeks by 228.7 ± 83.2 mg/gCr (P = 0.0075) in the high dose group. The adverse-event profile during this study was not different between the groups. Topiroxostat 160 mg daily reduced albuminuria in patients with diabetic nephropathy. (Funded by Sanwa Kagaku Kenkyusho; Trial registration, UMIN000015403). This article is protected by copyright. All rights reserved.

  10. Efficacy of 10% sucralfate ointment after anal fistulotomy: A prospective, double-blind, randomized, placebo-controlled trial.

    Science.gov (United States)

    Alvandipour, Mina; Ala, Shahram; Tavakoli, Hasan; Yazdani Charati, Jamshid; Shiva, Afshin

    2016-12-01

    The most frequent problems after anal fistulotomy are pain, bleeding, and delayed or impaired wound healing. Topical Sucralfate preparation has been used to treat a wide variety of wounds. In this study, we investigate effects of 10% sucralfate ointment on wound healing and postoperative pain after fistulotomy. A total of 41 patients undergoing anorectal fistulotomy were included in this randomized, blinded, controlled trial and were randomly allocated to either sucralfate ointment (every 12 h) or placebo. The patients were visited weekly for up to 5 weeks. The intensity of pain and the wound healing were assessed. The sucralfate group had significantly less pain at rest (1.92 ± 0.88 vs 2.96 ± 0.98; P = 0.002) and on defecation (1.68 ± 0.92 vs 3.08 ± 1.12; p < 0.001) than the placebo group from 1st to 5th post-operative visits. Complete wound healing was achieved after 8.15 ± 1 weeks in placebo group versus 5.9 ± 0.8 weeks in sucralfate group (p < 0.001). There were no significant differences in the frequencies of postoperative complications between the two groups. Compared with placebo, sucralfate ointment reduced postoperative pain at rest and on defecation and improves wound healing in patients undergoing fistulotomy. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  11. Effect of intravenous metoclopramide on intraocular pressure: A prospective, randomized, double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Sudheera K

    2008-01-01

    Full Text Available Background: Prevention of rise in intraocular pressure (IOP is essential in patients undergoing surgery for perforated eye injuries. Metoclopramide, a prokinetic agent, is commonly used to hasten gastric emptying in emergency surgeries. Aim: To study the change in IOP after intravenous metoclopramide and to study the influence of metoclopramide on change in IOP after succinylcholine and tracheal intubation. Settings and Design: A randomized, double-blind, placebo-controlled study of 60 patients undergoing non-ophthalmic elective surgery. Materials and Methods: Sixty American Society of Anesthesiologists (ASA I adult patients were randomly assigned to receive normal saline (Group C or metoclopramide 10 mg (Group M 30 min before the induction of anesthesia. Thiopentone was used for induction and succinylcholine for tracheal intubation. Intraocular pressure was measured in both the eyes pre and post drug treatment and succinylcholine and tracheal intubation using Perkins applanation tonometer. Statistical Analysis: Student′s t-test and repeated measures ANOVA were used. A P value < 0.05 was considered as significant. Results: Intraocular pressure was consistently lower in Group M than in Group C after the test drug, though the difference was not statistically significant. Intraocular pressure decreased significantly after administration of thiopentone and increased significantly in Groups C and M after tracheal intubation ( P < 0.01. Intraocular pressure was comparable between the groups at all the times. Conclusions: Metoclopramide does not cause a clinically significant change in IOP nor does it influence the changes in IOP during anesthesia and tracheal intubation. Metoclopramide shows a trend towards decrease in IOP, though clinically insignificant. Therefore metoclopramide can be used to promote gastric emptying in patients with perforated eye injury.

  12. Prospective Randomized Evaluation of Implantable Cardioverter-Defibrillator Programming in Patients With a Left Ventricular Assist Device.

    Science.gov (United States)

    Richardson, Travis D; Hale, Leslie; Arteaga, Christopher; Xu, Meng; Keebler, Mary; Schlendorf, Kelly; Danter, Matthew; Shah, Ashish; Lindenfeld, JoAnn; Ellis, Christopher R

    2018-02-23

    Ventricular arrhythmias are common in patients with left ventricular assist devices (LVADs) but are often hemodynamically tolerated. Optimal implantable cardioverter defibrillator (ICD) tachy-programming strategies in patients with LVAD have not been determined. We sought to determine if an ultra-conservative ICD programming strategy in patients with LVAD affects ICD shocks. Adult patients with an existing ICD undergoing continuous flow LVAD implantation were randomized to standard ICD programming by their treating physician or an ultra-conservative ICD programming strategy utilizing maximal allowable intervals to detection in the ventricular fibrillation and ventricular tachycardia zones with use of ATP. Patients with cardiac resynchronization therapy (CRT) devices were also randomized to CRT ON or OFF. Patients were followed a minimum of 6 months. The primary outcome was time to first ICD shock. Among the 83 patients studied, we found no statistically significant difference in time to first ICD shock or total ICD shocks between groups. In the ultra-conservative group 16% of patients experienced at least one shock compared with 21% in the control group ( P =0.66). There was no difference in mortality, arrhythmic hospitalization, or hospitalization for heart failure. In the 41 patients with CRT ICDs fewer shocks were observed with CRT-ON but this was not statistically significant: 10% of patients with CRT-ON (n=21) versus 38% with CRT-OFF (n=20) received shocks ( P =0.08). An ultra-conservative programming strategy did not reduce ICD shocks. Programming restrictions on ventricular tachycardia and ventricular fibrillation zone therapy should be reconsidered for the LVAD population. The role of CRT in patients with LVAD warrants further investigation. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01977703. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  13. Endoscopic outcomes of resorbable nasal packing after functional endoscopic sinus surgery: a multicenter prospective randomized controlled study.

    Science.gov (United States)

    Berlucchi, Marco; Castelnuovo, Paolo; Vincenzi, Andrea; Morra, Bruno; Pasquini, Ernesto

    2009-06-01

    Nasal packings can aid in control of postoperative bleeding and healing following functional endoscopic sinus surgery (FESS), but traditional non-resorbable stents have several inherent drawbacks. We performed a randomized, controlled, multicenter clinical trial to assess efficacy of resorbable nasal packing in patients undergoing FESS for chronic rhinosinusitis. A total of 66 patients for 88 nasal cavities were randomized to receive either hyaluronan resorbable packing (MeroGel) or standard non-resorbable nasal dressing after FESS. All underwent preoperative rhinoscopy, CT of sinuses, and, after surgery, were reassessed by rhinoscopy at 2, 4, and 12 weeks in blinded fashion. A total of 44 nasal cavities (MeroGel-group) received resorbable packing, whereas the remaining 44 were packed with non-resorbable nasal dressing. At follow-up endoscopic visit, the presence of nasal synechia was evaluated as primary outcome. Moreover, the tolerability and surgical handling properties of MeroGel and its comfort were assessed by surgeons and patients. Preoperative severity of rhinosinusitis was similar in both groups. No significant adverse events were observed in all patients. Follow-up endoscopy showed a lower proportion of nasal adhesions in MeroGel-group at both 4 (P = 0.041) and 12 weeks (P appearance of nasal mucosa of nasal cavities after FESS was observed in the MeroGel-group. Tolerability and surgical handling properties of MeroGel were positively rated by clinicians and the overall patient judged comfort of MeroGel was favorable. In conclusion, MeroGel can be considered a valid alternative to standard non-resorbable nasal dressings. It is safe, well-accepted, well-tolerated, and has significant advantage of being resorbable. Moreover, it may favor improved healing in patients undergoing FESS and reduce formation of adhesions.

  14. Gait analysis following treadmill training with body weight support versus conventional physical therapy: a prospective randomized controlled single blind study.

    Science.gov (United States)

    Lucareli, P R; Lima, M O; Lima, F P S; de Almeida, J G; Brech, G C; D'Andréa Greve, J M

    2011-09-01

    Single-blind randomized, controlled clinical study. To evaluate, using kinematic gait analysis, the results obtained from gait training on a treadmill with body weight support versus those obtained with conventional gait training and physiotherapy. Thirty patients with sequelae from traumatic incomplete spinal cord injuries at least 12 months earlier; patients were able to walk and were classified according to motor function as ASIA (American Spinal Injury Association) impairment scale C or D. Patients were divided randomly into two groups of 15 patients by the drawing of opaque envelopes: group A (weight support) and group B (conventional). After an initial assessment, both groups underwent 30 sessions of gait training. Sessions occurred twice a week, lasted for 30 min each and continued for four months. All of the patients were evaluated by a single blinded examiner using movement analysis to measure angular and linear kinematic gait parameters. Six patients (three from group A and three from group B) were excluded because they attended fewer than 85% of the training sessions. There were no statistically significant differences in intra-group comparisons among the spatial-temporal variables in group B. In group A, the following significant differences in the studied spatial-temporal variables were observed: increases in velocity, distance, cadence, step length, swing phase and gait cycle duration, in addition to a reduction in stance phase. There were also no significant differences in intra-group comparisons among the angular variables in group B. However, group A achieved significant improvements in maximum hip extension and plantar flexion during stance. Gait training with body weight support was more effective than conventional physiotherapy for improving the spatial-temporal and kinematic gait parameters among patients with incomplete spinal cord injuries.

  15. Prospective Randomized Comparison of the Effectiveness of Radiation Therapy and Local Steroid Injection for the Treatment of Plantar Fasciitis

    Energy Technology Data Exchange (ETDEWEB)

    Canyilmaz, Emine, E-mail: dremocan@ktu.edu.tr [Department of Radiation Oncology, Faculty of Medicine, Karadeniz Technical University, Trabzon (Turkey); Canyilmaz, Fatih [Department of Orthopaedics and Traumatology, Yavuz Selim Bone Disease and Rehabilitation Hospital, Trabzon (Turkey); Aynaci, Ozlem; Colak, Fatma; Serdar, Lasif [Department of Radiation Oncology, Faculty of Medicine, Karadeniz Technical University, Trabzon (Turkey); Uslu, Gonca Hanedan [Department of Radiation Oncology, Kanuni Research and Education Hospital, Trabzon (Turkey); Aynaci, Osman [Department of Orthopaedics and Traumatology, Faculty of Medicine, Karadeniz Technical University, Trabzon (Turkey); Yoney, Adnan [Department of Radiation Oncology, Faculty of Medicine, Karadeniz Technical University, Trabzon (Turkey)

    2015-07-01

    Purpose: The purpose of this study was to conduct a randomized trial of radiation therapy for plantar fasciitis and to compare radiation therapy with local steroid injections. Methods and Materials: Between March 2013 and April 2014, 128 patients with plantar fasciitis were randomized to receive radiation therapy (total dose of 6.0 Gy applied in 6 fractions of 1.0 Gy three times a week) or local corticosteroid injections a 1 ml injection of 40 mg methylprednisolone and 0.5 ml 1% lidocaine under the guidance of palpation. The results were measured using a visual analog scale, a modified von Pannewitz scale, and a 5-level function score. The fundamental phase of the study was 3 months, with a follow-up period of up to 6 months. Results: The median follow-up period for all patients was 12.5 months (range, 6.5-18.6 months). For the radiation therapy patients, the median follow-up period was 13 months (range, 6.5-18.5 months), whereas in the palpation-guided (PG) steroid injection arm, it was 12.1 months (range, 6.5-18.6 months). After 3 months, results in the radiation therapy arm were significantly superior to those in the PG steroid injection arm (visual analog scale, P<.001; modified von Pannewitz scale, P<.001; 5-level function score, P<.001). Requirements for a second treatment did not significantly differ between the 2 groups, but the time interval for the second treatment was significantly shorter in the PG steroid injection group (P=.045). Conclusion: This study confirms the superior analgesic effect of radiation therapy compared to mean PG steroid injection on plantar fasciitis for at least 6 months after treatment.

  16. Prophylactic Acetaminophen or Ibuprofen Results in Equivalent Acute Mountain Sickness Incidence at High Altitude: A Prospective Randomized Trial.

    Science.gov (United States)

    Kanaan, Nicholas C; Peterson, Alicia L; Pun, Matiram; Holck, Peter S; Starling, Jennifer; Basyal, Bikash; Freeman, Thomas F; Gehner, Jessica R; Keyes, Linda; Levin, Dana R; O'Leary, Catherine J; Stuart, Katherine E; Thapa, Ghan B; Tiwari, Aditya; Velgersdyk, Jared L; Zafren, Ken; Basnyat, Buddha

    2017-06-01

    Recent trials have demonstrated the usefulness of ibuprofen in the prevention of acute mountain sickness (AMS), yet the proposed anti-inflammatory mechanism remains unconfirmed. Acetaminophen and ibuprofen were tested for AMS prevention. We hypothesized that a greater clinical effect would be seen from ibuprofen due to its anti-inflammatory effects compared with acetaminophen's mechanism of possible symptom reduction by predominantly mediating nociception in the brain. A double-blind, randomized trial was conducted testing acetaminophen vs ibuprofen for the prevention of AMS. A total of 332 non-Nepali participants were recruited at Pheriche (4371 m) and Dingboche (4410 m) on the Everest Base Camp trek. The participants were randomized to either acetaminophen 1000 mg or ibuprofen 600 mg 3 times a day until they reached Lobuche (4940 m), where they were reassessed. The primary outcome was AMS incidence measured by the Lake Louise Questionnaire score. Data from 225 participants who met inclusion criteria were analyzed. Twenty-five participants (22.1%) in the acetaminophen group and 18 (16.1%) in the ibuprofen group developed AMS (P = .235). The combined AMS incidence was 19.1% (43 participants), 14 percentage points lower than the expected AMS incidence of untreated trekkers in prior studies at this location, suggesting that both interventions reduced the incidence of AMS. We found little evidence of any difference between acetaminophen and ibuprofen groups in AMS incidence. This suggests that AMS prevention may be multifactorial, affected by anti-inflammatory inhibition of the arachidonic-acid pathway as well as other analgesic mechanisms that mediate nociception. Additional study is needed. Copyright © 2017 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

  17. Reduction of exit-site infections of tunnelled intravascular catheters among neutropenic patients by sustained-release chlorhexidine dressings: results from a prospective randomized controlled trial.

    Science.gov (United States)

    Chambers, S T; Sanders, J; Patton, W N; Ganly, P; Birch, M; Crump, J A; Spearing, R L

    2005-09-01

    Exit-site and tunnel infections of tunnelled central intravascular catheters are a frequent source of morbidity among neutropenic patients and may necessitate catheter removal. They require antimicrobial therapy that increases healthcare costs and is associated with adverse drug reactions. A prospective randomized clinical trial was conducted among adult patients undergoing chemotherapy in a haematology unit. Tunnelled intravascular catheters were randomized to receive the control of a standard dressing regimen as recommended by the British Committee for Standards in Haematology, or to receive the intervention of a sustained-release chlorhexidine dressing. Follow-up data were available in 112 of 114 tunnelled intravascular catheters which were randomized. Exit-site or combined exit-site/tunnel infections occurred in 23 (43%) of 54 catheters in the control group, and five (9%) of 58 catheters in the intervention group [odds ratio (OR) for intervention group compared with control group =0.13, 95% confidence intervals (CI) 0.04-0.37, P<0.001]. More tunnelled intravascular catheters were prematurely removed from the control group than the intervention group for documented infections [20/54 (37%) vs 6/58 (10%), OR=0.20, 95%CI 0.53-0.07]. However, there was no difference in the numbers of tunnelled intravascular catheters removed for all proven and suspected intravascular catheter-related infections [21/54 (39%) vs 19/58 (33%)], or in the time to removal of catheters for any reason other than death or end of treatment for underlying disease. Thus chlorhexidine dressings reduced the incidence of exit-site/tunnel infections of indwelling tunnelled intravascular catheters without prolonging catheter survival in neutropenic patients, and could be considered as part of the routine management of indwelling tunnelled intravascular catheters among neutropenic patients.

  18. Influence on ocular surface after cataract surgery and effect of topical diquafosol on postoperative dry eye: a multicenter prospective randomized study

    Science.gov (United States)

    Miyake, Kensaku; Yokoi, Norihiko

    2017-01-01

    Purpose To investigate influences of 3% diquafosol sodium ophthalmic solution (DQS) on ocular surface after cataract surgery and effects on postoperative dry eye. Design This study had two consecutive prospective study phases. The former was an observational study from before cataract surgery to 4 weeks after surgery and the latter was a randomized open-label study from 4 to 8 weeks after surgery. Methods Subjects were 433 eyes of 433 patients undergoing cataract surgery with intraocular lens implantation. Dry eye examination of tear breakup time (BUT), corneal and conjunctival fluorescein staining scores, total subjective symptom score (12 symptoms), and Schirmer I test were conducted before surgery and 4 weeks after surgery. Patient demographics and these examination results were used to analyze risk factors to predict postoperative dry eye. In a randomized study, 154 eyes diagnosed with dry eye postoperatively were applied either DQS or artificial tears (AT) six times daily for 4 weeks. The data of the examinations were compared. Results At 4 weeks after surgery, BUT was shortened significantly (P=0.036), fluorescein staining score increased significantly (P=0.012), but total subjective symptom score was significantly improved (Pdry eye was shortened BUT type (53.1%). The dry eye prevalence after surgery decreased (55.7%) compared with before surgery (69.7%). Females and the patient with dry eye symptoms before surgery had significant risk factors for postoperative dry eye. In a randomized study, BUT was significantly prolonged in the DQS group (P=0.015), but not in the AT group. Fluorescein staining score was significantly improved in both groups (P<0.001). Total subjective symptom score was significantly decreased in the AT group (P<0.001), but not in the DQS group. Conclusion Our study suggests that cataract surgery has harmful effects on tear film stability and ocular surface, and DQS has a capability to improve them. PMID:28360509

  19. Prevention of lymphocele by using gelatin-thrombin matrix as a tissue sealant after pelvic lymphadenectomy in patients with gynecologic cancers: a prospective randomized controlled study.

    Science.gov (United States)

    Kim, Yun Hwan; Shin, Hyun Joo; Ju, Woong; Kim, Seung Cheol

    2017-05-01

    This prospective randomized controlled pilot study aimed to find whether gelatin-thrombin matrix used as a tissue sealant (FloSeal) can prevent the occurrence of pelvic lymphocele in patients with gynecologic cancer who has undergone pelvic lymphadenectomy. Each patient, who undergo a laparotomic pelvic lymph node dissection on both sides, was randomly assigned for FloSeal application on 1 side of the pelvis. The other side of the pelvis without any product application being the control side. The amount of lymph drainage at each side of the pelvis was measured for 3 days, and computed tomography scans were obtained 7 days and 6 months after surgery for detection of pelvic lymphocele. Among 37 cases, the median amount of lymph drainage was significantly decreased in the hemi-pelvis treated with FloSeal compared to the control hemi-pelvis (p=0.025). The occurrence of lymphocele was considerably reduced in treated hemi-pelvis (8/37, 21.6%) compared with control hemi-pelvis (12/37, 32.4%) after 7 post-operative days (p=0.219), and more decreased in the treated hemi-pelvis (5/37, 13.5%) compared with control hemi-pelvis (9/37, 24.3%) after postoperative 6 months (p=0.344). The application of FloSeal as a tissue sealant in lymph nodes resected tissues can reduce the incidence of pelvic lymphocele in gynecologic cancer patients. A large randomized controlled study could confirm these preliminary results. Copyright © 2017. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology

  20. A multicenter, randomized, prospective study of 14-day ranitidine bismuth citrate- vs. lansoprazole-based triple therapy for the eradication of Helicobacter pylori in dyspeptic patients.

    Science.gov (United States)

    Avşar, Erol; Tiftikçi, Arzu; Poturoğlu, Sule; Erzin, Yusuf; Kocakaya, Ozan; Dinçer, Dinç; Yıldırım, Bulut; Güliter, Sefa; Türkay, Cansel; Yılmaz, Uğur; Onuk, Mehmet Derya; Bölükbaş, Cengiz; Ellidokuz, Ender; Bektaş, Ahmet; Taşan, Güralp; Aytuğ, Necip; Ateş, Yüksel; Kaymakoğlu, Sabahattin

    2013-01-01

    Proton-pump inhibitor and ranitidine bismuth citrate-based triple regimens are the two recommended first line treatments for the eradication of Helicobacter pylori. We aimed to compare the effectiveness and tolerability of these two treatments in a prospective, multicentric, randomized study. Patients with dyspeptic complaints were recruited from 15 study centers. Presence of Helicobacter pylori was investigated by both histology and rapid urease test. The patients were randomized to either ranitidine bismuth citrate 400 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid (n=149) or lansoprazole 30 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid (n=130) treatment arm for 14 days. Adverse events have been recorded during the treatment phase. A 13 C urea breath test was performed 6 weeks after termination of treatment to assess the efficacy of the therapy. Eradication rate was calculated by intention-to-treat and per-protocol analysis. Two hundred seventy-nine patients (123 male, 156 female) were eligible for randomization. In per-protocol analysis (n=247), Helicobacter pylori was eradicated with ranitidine bismuth citrate- and lansoprazole-based regimens in 74,6% and 69,2% of cases, respectively (p>0,05). Intention-to-treat analysis (n=279) revealed that eradication rates were 65,1% and 63,6% in ranitidine bismuth citrate and in lansoprazole-based regimens, respectively (p>0,05). Both regimes were well-tolerated, and no serious adverse event was observed during the study. Ranitidine bismuth citrate-based regimen is at least as effective and tolerable as the classical proton-pump inhibitor-based regimen, but none of the therapies could achieve the recommendable eradication rate.

  1. Evaluation of clinical safety and beneficial effects of a fish oil containing lipid emulsion (Lipoplus, MLF541): data from a prospective, randomized, multicenter trial.

    Science.gov (United States)

    Wichmann, Matthias W; Thul, Paul; Czarnetzki, Hans-Dieter; Morlion, Bart J; Kemen, Matthias; Jauch, Karl-Walter

    2007-03-01

    To prove safety and effectiveness of a lipid emulsion enriched with n-3 fatty acids from fish oil (Lipoplus) within the setting of parenteral nutrition of patients after major abdominal surgery and to determine whether there are effects on outcome parameters. Prospective, randomized, double-blind, multicenter trial. University and surgical teaching hospitals. After obtaining informed consent, 256 patients undergoing major abdominal surgery were randomized. Parameters of safety, effectiveness, and outcome were routine laboratory parameters, complication rates, length of stay in the intensive care unit, and length of hospital stay. In addition we determined in patient subgroups of 30 patients each, the changes of the content of selected long-chain polyunsaturated fatty acids, the leukotriene synthetic capacity and the antioxidant alpha-tocopherol. Participating patients were randomized to receive either Lipoplus (group I; n = 127 patients) or Intralipid (group II; n = 129 patients). Parenteral nutrition was initiated immediately after surgery and ended on day 5 after surgery. No significant differences between groups I and II were observed when comparing routine laboratory parameters during the perioperative period. Plasma levels of eicosapentaenoic acid, leukotriene B5, and antioxidant content were significantly increased in group I. Furthermore, there was a significantly shorter length of hospital stay of approximately 21% (17.2 vs. 21.9 days; p = .0061) in group I. Our findings indicate that the administration of Lipoplus in the postoperative period after major abdominal surgery is safe and results in a significantly shorter length of hospital stay. Administration of n-3 polyunsaturated fatty acids in the postoperative period can be considered a valuable choice for patients requiring parenteral nutrition after major abdominal surgery.

  2. Evaluation of the efficacy and safety of Tribulus terrestris in male sexual dysfunction-A prospective, randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Kamenov, Zdravko; Fileva, Svetlana; Kalinov, Krassimir; Jannini, Emmanuele A

    2017-05-01

    The primary objectives were to compare the efficacy of extracts of the plant Tribulus terrestris (TT; marketed as Tribestan), in comparison with placebo, for the treatment of men with erectile dysfunction (ED) and with or without hypoactive sexual desire disorder (HSDD), as well as to monitor the safety profile of the drug. The secondary objective was to evaluate the level of lipids in blood during treatment. Phase IV, prospective, randomized, double-blind, placebo-controlled clinical trial in parallel groups. This study included 180 males aged between 18 and 65 years with mild or moderate ED and with or without HSDD: 90 were randomized to TT and 90 to placebo. Patients with ED and hypertension, diabetes mellitus, and metabolic syndrome were included in the study. In the trial, an herbal medicine intervention of Bulgarian origin was used (Tribestan ® , Sopharma AD). Each Tribestan film-coated tablet contains the active substance Tribulus terrestris, herba extractum siccum (35-45:1) 250mg which is standardized to furostanol saponins (not less than 112.5mg). Each patient received orally 3×2 film-coated tablets daily after meals, during the 12-week treatment period. At the end of each month, participants' sexual function, including ED, was assessed by International Index of Erectile Function (IIEF) Questionnaire and Global Efficacy Question (GEQ). Several biochemical parameters were also determined. The primary outcome measure was the change in IIEF score after 12 weeks of treatment. Complete randomization (random sorting using maximum allowable% deviation) with an equal number of patients in each sequence was used. This randomization algorithm has the restriction that unequal treatment allocation is not allowed; that is, all groups must have the same target sample size. Patients, investigational staff, and data collectors were blinded to treatment. All outcome assessors were also blinded to group allocation. 86 patients in each group completed the study. The IIEF

  3. Self-taught axillary vein access without venography for pacemaker implantation: prospective randomized comparison with the cephalic vein access.

    Science.gov (United States)

    Squara, Fabien; Tomi, Julien; Scarlatti, Didier; Theodore, Guillaume; Moceri, Pamela; Ferrari, Emile

    2017-12-01

    Axillary vein access for pacemaker implantation is uncommon in many centres because of the lack of training in this technique. We assessed whether the introduction of the axillary vein technique was safe and efficient as compared with cephalic vein access, in a centre where no operators had any previous experience in axillary vein puncture. Patients undergoing pacemaker implantation were randomized to axillary or cephalic vein access. All three operators had no experience nor training in axillary vein puncture, and self-learned the technique by reading a published review. Axillary vein puncture was fluoroscopy-guided without contrast venography. Cephalic access was performed by dissection of delto-pectoral groove. Venous access success, venous access duration (from skin incision to guidewire or lead in superior vena cava), procedure duration, X-ray exposure, and peri-procedural (1 month) complications were recorded. results We randomized 74 consecutive patients to axillary (n = 37) or cephalic vein access (n = 37). Axillary vein was successfully accessed in 30/37 (81.1%) patients vs. 28/37 (75.7%) of cephalic veins (P = 0.57). Venous access time was shorter in axillary group than in cephalic group [5.7 (4.4-8.3) vs. 12.2 (10.5-14.8) min, P < 0.001], as well as procedure duration [34.8 (30.6-38.4) vs. 42.0 (39.1-46.6) min, P = 0.043]. X-ray exposure and peri-procedural overall complications were comparable in both groups. Axillary puncture was safe and faster than cephalic access even for the five first procedures performed by each operator. Self-taught axillary vein puncture for pacemaker implantation seems immediately safe and faster than cephalic vein access, when performed by electrophysiologists trained to pacemaker implantation but not to axillary vein puncture. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For Permissions, please email: journals.permissions@oup.com.

  4. Virtual Reality Robotic Surgery Warm-Up Improves Task Performance in a Dry Lab Environment: A Prospective Randomized Controlled Study

    Science.gov (United States)

    Lendvay, Thomas S.; Brand, Timothy C.; White, Lee; Kowalewski, Timothy; Jonnadula, Saikiran; Mercer, Laina; Khorsand, Derek; Andros, Justin; Hannaford, Blake; Satava, Richard M.

    2014-01-01

    Background Pre-operative simulation “warm-up” has been shown to improve performance and reduce errors in novice and experienced surgeons, yet existing studies have only investigated conventional laparoscopy. We hypothesized a brief virtual reality (VR) robotic warm-up would enhance robotic task performance and reduce errors. Study Design In a two-center randomized trial, fifty-one residents and experienced minimally invasive surgery faculty in General Surgery, Urology, and Gynecology underwent a validated robotic surgery proficiency curriculum on a VR robotic simulator and on the da Vinci surgical robot. Once successfully achieving performance benchmarks, surgeons were randomized to either receive a 3-5 minute VR simulator warm-up or read a leisure book for 10 minutes prior to performing similar and dissimilar (intracorporeal suturing) robotic surgery tasks. The primary outcomes compared were task time, tool path length, economy of motion, technical and cognitive errors. Results Task time (-29.29sec, p=0.001, 95%CI-47.03,-11.56), path length (-79.87mm, p=0.014, 95%CI -144.48,-15.25), and cognitive errors were reduced in the warm-up group compared to the control group for similar tasks. Global technical errors in intracorporeal suturing (0.32, p=0.020, 95%CI 0.06,0.59) were reduced after the dissimilar VR task. When surgeons were stratified by prior robotic and laparoscopic clinical experience, the more experienced surgeons(n=17) demonstrated significant improvements from warm-up in task time (-53.5sec, p=0.001, 95%CI -83.9,-23.0) and economy of motion (0.63mm/sec, p=0.007, 95%CI 0.18,1.09), whereas improvement in these metrics was not statistically significantly appreciated in the less experienced cohort(n=34). Conclusions We observed a significant performance improvement and error reduction rate among surgeons of varying experience after VR warm-up for basic robotic surgery tasks. In addition, the VR warm-up reduced errors on a more complex task (robotic

  5. Effect of Shenzhu Guanxin Recipe () on patients with angina pectoris after percutaneous coronary intervention: A prospective, randomized controlled trial.

    Science.gov (United States)

    Xu, Dan-Ping; Wu, Huan-Lin; Lan, Tao-Hua; Wang, Xia; Sheng, Xiao-Gang; Lin, Yu; Li, Song; Zheng, Chao-Yang

    2015-06-01

    To evaluate the efficacy and safety of a combination therapy using Chinese medicine (CM) Shenzhu Guanxin Recipe (, SGR) and standard Western medicine treatment (SWMT) in patients with angina pectoris after percutaneous coronary intervention (PCI). Double-blind randomized controlled trial was used in this experimental procedure. One hundred and eighty-seven patients with coronary heart disease receiving SWMT after PCI were randomly assigned to the treatment (SGR) and control (placebo) groups. Outcome measures including angina pectoris score (APS), CM symptom score, and Seattle Angina Questionnaire (SAQ) score were evaluated in 1, 2, 3 and 12 months, and the death rate, restenosis and other emergency treatments were observed. The mixed-effects models were employed for the data analysis. In the treatment group, a larger within-treatment effect size (d=1.74) was found, with a 76.7% reduction in APS from pretreatment to 12-month follow-up assessment compared with the control group (d=0.83, 53.8% symptom reduction); betweentreatment (BT) effect size was d=0.66. CM symptom scores included an 18.3% reduction in the treatment group (d=0.46), and a 16.1% decrease in the control group (d=0.31); d=0.62 for BT effect size. In regard to scores of SAQ, the BT effect size of cognition level of disease was larger in the treatment group (d=0.63), followed by the level of body limitation of activity (d=0.62), condition of angina pectoris attacks (d=0.55), satisfaction level of treatments (d=0.31), and steady state of angina pectoris (d=0.30). Two cardiovascular related deaths and one incidental death were recorded in the control and treatment groups, respectively. No significant difference in any cardiovascular event (including death toll, frequency of cardiovascular hospitalization or emergency room visits) was found between the two groups. The combination therapy of SGR and SWMT is effective and safe in patients with angina pectoris after PCI when compared with SWMT alone.

  6. Efficacy of the natural antioxidant astaxanthin in the treatment of functional dyspepsia in patients with or without Helicobacter pylori infection: a prospective, randomized, double blind, and placebo-controlled study5

    DEFF Research Database (Denmark)

    Kupcinskas, L.; Lafolie, P.; Lignell, A.

    2008-01-01

    OBJECTIVES: The aim of this study was to evaluate the efficacy of the natural antioxidant astaxanthin in functional dyspepsia in different doses and compared with placebo. DESIGN: The study was a controlled, prospective, randomized, and double blind trial. PARTICIPANTS: Patients with functional d...

  7. Posterior lumbar interbody fusion usin