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Sample records for one-center randomized prospective

  1. 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

    OBJECTIVE: The goals for maintenance dialysis treatment are to improve patient survival, reduce patient morbidity, and improve patient quality of life. This is the first randomized prospective study comparing automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD)...

  2. The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial.

    Science.gov (United States)

    Eichhorn, Eric J; Bristow, Michael R

    2001-01-01

    Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II) have demonstrated a mortality benefit of beta-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of beta-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction.

  3. The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS trial

    Directory of Open Access Journals (Sweden)

    Bristow Michael R

    2001-02-01

    Full Text Available Abstract Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II have demonstrated a mortality benefit of β-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of β-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction.

  4. The starting dose of Levothyroxine in primary hypothyroidism treatment - A prospective, randomized, double-blind trial

    NARCIS (Netherlands)

    Roos, A; Linn-Rasker, SP; van Domburg, RT; Tijssen, JP; Berghout, A

    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, double-bl

  5. Treatment of occult bacteremia: a prospective randomized clinical trial.

    Science.gov (United States)

    Carroll, W L; Farrell, M K; Singer, J I; Jackson, M A; Lobel, J S; Lewis, E D

    1983-11-01

    Antibiotic therapy for children without foci of infection and at risk for bacteremia is controversial. A prospective randomized clinical trial was conducted using expectant antibiotic therapy in children at risk for bacteremia. A total of 96 children (aged 6 to 24 months) with temperature of more than 40 degrees C, no identifiable source of infection, and a leukocyte count greater than or equal to 15,000/microL and/or sedimentation rate greater than or equal to 30 were enrolled. The following tests were performed on all children: blood culture, chest roentgenogram, urinalysis, and urine culture. A lumbar puncture was performed if a child was 12 months or less. Patients were randomized to receive either no antibiotic therapy or Bicillin C-R, 50,000 U/kg intramuscularly, followed by penicillin V, 100 mg/kg/d, orally four times a day for three days. Patients were examined at 24 and 72 hours. Fifty patients were treated expectantly and 46 received no antimicrobial therapy. Ten of the 96 patients were bacteremic (nine had Streptococcus pneumoniae, one had Haemophilus influenzae). Four of the five children treated for bacteremia showed improvement at the first follow-up visit (afebrile and no obvious focus of infection). The five untreated patients showed no improvement; four patients developed focal infections (two had meningitis, two had otitis media) (P less than or equal to .05, Fisher exact test). No complications of expectant therapy were detected. Thus, expectant antibiotic therapy for children who have no obvious source of infection and who meet these criteria associated with occult bacteremia is warranted.

  6. Reducing mucus production after urinary reconstruction: a prospective randomized trial.

    Science.gov (United States)

    N'Dow, J; Robson, C N; Matthews, J N; Neal, D E; Pearson, J P

    2001-05-01

    After transposition into the urinary tract, intestinal segments continue to produce mucus. We determine the effectiveness of muco-regulatory drugs, including N-acetylcysteine, aspirin and ranitidine, in reducing mucus secretion and urine viscosity in patients with transposed segments. Our trial was a prospective randomized, double-blind placebo controlled crossover study involving 12 patients who underwent ileal conduit and 31 who underwent bladder reconstruction. Each treatment lasted 3 weeks with a 2-week washout. Pretreatment and posttreatment 24-hour urine samples were analyzed for mucin and viscosity after papain digestion, sodium dodecyl sulfate-polyacrylamide gel electrophoresis and periodic acid-Schiff assay. A disease specific questionnaire and SF-36 quality of life survey were completed. According to the questionnaire, mucus production did not decrease with time in 67% of patients. Mucin comprised 3% of the total nondialyzable material in urine (65 mg./24-hour for ileal conduit and 60 mg./24-hour for bladder reconstruction). Analysis of questionnaires and laboratory results failed to demonstrate any benefit of taking muco-regulatory agents compared with placebo. The use of N-acetylcysteine, aspirin and ranitidine did not result in a reduction in mucin production, urine viscosity or improvement in quality of life.

  7. 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.

  8. A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes

    Science.gov (United States)

    2016-07-03

    Prostate Cancer; Local Anesthesia; Prostate-Specific Antigen/Blood; Biopsy/Methods; Image-guided Biopsy/Methods; Prostatic Neoplasms/Diagnosis; Prostate/Pathology; Prospective Studies; Humans; Male; Ultrasonography, Interventional/Methods

  9. 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

  10. Mini-flared Kelman tip, reverse tip, and sidewinder tip with torsional phaco: a prospective randomized comparative study

    National Research Council Canada - National Science Library

    Hida, Wilson Takashi; Tzelikis, Patrick Frensel; Nakano, Celso Takashi; Motta, Antonio Francisco Pimenta; Alves, Milton Ruiz

    2015-01-01

    ...: In this prospective, comparative, masked study, patients were randomly assigned to have torsional coaxial microincision cataract surgery using the mini-flared 45-degree Kelman tip, reversed mini...

  11. 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

  12. 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

  13. 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

    2011-01-01

    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

  14. Botulinum toxin versus trihexyphenidyl in cervical dystoni - A prospective, randomized, double-blind controlled trial

    NARCIS (Netherlands)

    Brans, JWM; Lindeboom, R; Snoek, JW; Zwarts, MJ; vanWeerden, TW; Brunt, ERP; vanHilten, JJ; vanderKamp, W; Prins, MH; Speelman, J.D.

    1996-01-01

    Background: Botulinum toxin type A (BTA) is replacing trihexyphenidyl as the treatment of choice for idiopathic cervical dystonia (ICD), but there has never been a direct comparative study. Methods: This trial compares the effectiveness of BTA with that of trihexyphenidyl in a prospective, randomize

  15. 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

  16. 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 devic

  17. A randomized, prospective study of adjunctive Ampicillin in preterm labor

    Directory of Open Access Journals (Sweden)

    Tehranian A

    1999-09-01

    Full Text Available Acute amniotic fluid infection has emerged as a possible cause of many heretofore unexplained preterm births. Our purpose was to determine the effect of ampicillin in the prolongation of pregnancies receiving tocolysis for preterm labor. A blinded, placebo-controlled, randomized trial was conducted to study ampicillin in women hospitalized for preterm labor between 24 and 37 weeks' gestation. A total of 60 patients with intact membranes and without chorioamnionitis who were receiving magnesium sulfate were screened. Thirty women with preterm labor received ampicillin, and 30 received placebos. The primary end point was prolongation of gestation. There was no difference in age of delivery (37.6±9.7 days vs 36.08±3.9 days, P=0.085 and no difference in retardation of delivery (4.7±3.1 vs 4.1±2.1, P=0.39. The mean degree of preterm delivery were 0.62±1.93 and 1.8±3.3 weeks in ampicillin and placebo groups, respectively (not significant, P>0.1. Conclusions: Ampicillin had no effect on interval to delivery or duration of pregnancy in women treated for preterm labor. So rotine clinical use of ampicillin during tocolysis should not be recommended.

  18. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    OpenAIRE

    Young-Dae Kim; In Heo; Byung-Cheul Shin; Cindy Crawford; Hyung-Won Kang; Jung-Hwa Lim

    2013-01-01

    To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD) in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional th...

  19. 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.

  20. 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

  1. 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

    2016-01-14

    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.

  2. Randomized prospective evaluation of nephrostomy tube configuration: impact on postoperative pain

    Directory of Open Access Journals (Sweden)

    Derek Weiland

    2007-06-01

    Full Text Available OBJECTIVE: Conduct a prospective randomized single-blind comparison of two nephrostomy catheter designs, evaluating specifically intraoperative placement and postoperative comfort. MATERIALS AND METHODS: The single-blind, prospective randomized trial was conducted with institutional review board approval. All patients undergoing percutaneous nephrolithotomy who gave informed consent were randomized to placement of either a Boston Scientific Flexima 8.3F pigtail nephrostomy tube #27-180 (PIG or a Boston Scientific 8.2F nephroureteral stent #410-126 (NUS. Randomization was concealed from the surgeon until time of placement. Subjective intraoperative placement characteristics were rated by the surgeon on a scale of 1 = excellent, 2 = fair, 3 = good and 4 = poor. The patient's postoperative pain intensity was evaluated with a Visual Analog Pain Score (0 = no pain to 10 = worst pain. RESULTS: Nine patients were randomized to each group. The PIG group was rated significantly better than the NUS group with regards to ease of placement (p = 0.007 and radiopacity of the tube (p = 0.007 by surgeon. Visual analog pain scores on postoperative day one, was significantly lower in the PIG group (mean = 2+/-2 than the NUS group (mean = 5+/-1 (p = 0.004. The mean amount of intra-venous morphine equivalent given in the PIG group (mean = 1+/4 Eq morphine was less on average compared to the NUS group (mean = 6+/13 Eq morphine, but the differences did not reach statistical significance (p = 0.06. CONCLUSIONS: Following percutaneous nephrolithotomy, use of a small pig-tail nephrostomy tube results in greater ease of placement and less postoperative pain than a nephroureteral catheter.

  3. Prospective randomized study of viscous lidocaine versus benzocaine in a GI cocktail for dyspepsia.

    Science.gov (United States)

    Vilke, Gary M; Jin, Albert; Davis, Daniel P; Chan, Theodore C

    2004-07-01

    We hypothesized that Benzocaine (Hurricaine) would work as quickly and effectively as viscous Lidocaine in this preparation. This was a prospective randomized, single-blinded comparison between Benzocaine and Lidocaine as the topical anesthetic in a gastrointestinal (GI) cocktail. Patients 18 years or older were approached for participation when a GI cocktail was ordered by the Emergency Physician. Patients were randomized to equivalent doses of either Benzocaine or viscous Lidocaine in addition to 30 cc of Maalox and 10 cc of Donnatal. Assessment using a visual analog pain scale occurred at time intervals of 0, 5, 15, and 30 min. Eighty-two patients were enrolled (44 to Benzocaine, 38 to viscous Lidocaine), with each group having a statistically significant improvement in pain (p Benzocaine and viscous Lidocaine groups in terms of the relief of symptoms at each of the assessment times. There were no adverse outcomes in either group.

  4. Prospective randomized comparison of sodium tetradecyl sulfate and polidocanol as variceal sclerosing agents.

    Science.gov (United States)

    Bhargava, D K; Singh, B; Dogra, R; Dasarathy, S; Sharma, M P

    1992-02-01

    A prospective randomized controlled study was designed to evaluate differences in efficacy and complication rate between the two most commonly used sclerosing agents, sodium tetradecyl sulfate (STD) and polidocanol. Of 52 patients with esophageal variceal bleeding, 26 were randomized to receive sclerotherapy with 1.5% STD and 26 to receive 1% polidocanol at weekly intervals. Eradication of varices was achieved in 88% patients each of the STD and polidocanol group. There was no significant difference between patients injected with STD and polidocanol with regard to re-bleeding (27% vs. 15%) and mortality (11.5% in both). The use of STD, in contrast to polidocanol, was associated with a higher incidence of complications in terms of severe retrosternal pain (27% vs. 4%), deep ulceration (53% vs. 23%), dysphagia (88% vs. 46%), and stricture formation (27% vs. 8%). It was concluded that these two agents were similar in efficacy. However, polidocanol was superior due to a lower incidence of complications.

  5. [Periprostatic anaesthesic infiltration for prostatic biopsy: a prospective, randomized, double blind and placebo-controlled study].

    Science.gov (United States)

    Valero, Gonzalo; González, E U Roxana

    2005-06-01

    A prospective, randomized, double blind and placebo-controlled study to evaluate the effectiveness of periprostatic infiltration with lidocaine to reduce pain of prostatic biopsy. In a thirteen months period of time, 115 patients were randomized to receive 10 ml of lidocaine 1% (n=60) or saline (n=55). Evaluating the pain with visual analogue scale (0-10), the first group referred average pain of 3.83 and the second group of 6.87, being this difference clearly significant (panesthesic puncture. The periprostatic infiltration is easy to perform without complications and it is effective in reducing the pain of this procedure. It should be used as a routine procedure in prostatic biopsy.

  6. 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.

  7. Prospective Randomized Controlled Trial of Liberal Vs Restricted Perioperative Fluid Management in Patients Undergoing Pancreatectomy.

    Science.gov (United States)

    Grant, Florence; Brennan, Murray F; Allen, Peter J; DeMatteo, Ronald P; Kingham, T Peter; D'Angelica, Michael; Fischer, Mary E; Gonen, Mithat; Zhang, Hao; Jarnagin, William R

    2016-10-01

    The aim of this study is to examine, by a prospective randomized controlled trial, the influence of liberal (LIB) vs restricted (RES) perioperative fluid administration on morbidity following pancreatectomy. Randomized controlled trials in patients undergoing major intra-abdominal surgery have challenged the historical use of LIB fluid administration, suggesting that a more restricted regimen may be associated with fewer postoperative complications. Patients scheduled to undergo pancreatic resection were consented for randomization to a LIB (n = 164) or RES (n = 166) perioperative fluid regimen. Sample size was designed with 80% power to decrease Grade 3 complications from 35% to 21%. Between July 2009 and July 2015, we randomized 330 patients undergoing pancreaticoduodenectomy (PD, n = 218), central (n = 16), or distal pancreatectomy (DP, n = 96). Patients were equally distributed for all demographic and intraoperative characteristics. Intraoperatively, LIB patients received crystalloid 12 mL/kg/h and RES patients 6 mL/kg/h. Cumulative crystalloid given (median, range, mL) days 0 to 3 was LIB: 12,252 (6600 to 21,365), RES 7808 (2700 to 16,274) P LIB and 27% of RES patients (P = 0.6). Median length of stay was 7 and 5 days for PD and DP, respectively, in both arms. In a high volume institution, major perioperative complications from pancreatic resection were not significantly influenced by fluid regimens that differed approximately 1.6-fold.

  8. Early dexamethasone treatment for septic shock patients: a prospective randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Domingos Dias Cicarelli

    Full Text Available CONTEXT AND OBJECTIVE: Sepsis and septic shock are very common conditions among critically ill patients that lead to multiple organ dysfunction syndrome (MODS and death. Our purpose was to investigate the efficacy of early administration of dexamethasone for patients with septic shock, with the aim of halting the progression towards MODS and death. DESIGN AND SETTING: Prospective, randomized, double-blind, single-center study, developed in a surgical intensive care unit at Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo. METHODS: The study involved 29 patients with septic shock. All eligible patients were prospectively randomized to receive either a dose of 0.2 mg/kg of dexamethasone (group D or placebo (group P, given three times at intervals of 36 hours. The patients were monitored over a seven-day period by means of the sequential organ failure assessment score. RESULTS: Patients treated with dexamethasone did not require vasopressor therapy for as much time over the seven-day period as did the placebo group (p = 0.043. Seven-day mortality was 67% in group P (10 out of 15 and 21% in group D (3 out of 14 (relative risk = 0.31, 95% confidence interval 0.11 to 0.88. Dexamethasone enhanced the effects of vasopressor drugs. CONCLUSIONS: Early treatment with dexamethasone reduced the seven-day mortality among septic shock patients and showed a trend towards reduction of 28-day mortality.

  9. Lidocaine versus mepivacaine in sedated pediatric dental patients: randomized, prospective clinical study.

    Science.gov (United States)

    Çalış, Aylin Sipahi; Cagiran, Esra; Efeoglu, Candan; Ak, Aslı Topaloglu; Koca, Huseyın

    2014-01-01

    Dental anxiety is usually seen in the pediatric patients. specially in the case of minor oral surgical procedures and exodontia, cooperation of the patients and their families with the dentist will lead to superior treatment outcomes. Pain control is important in dentistry. The aim of this randomized prospective clinical study is to compare the local anaesthetic and haemodynamic effects of 2% lidocaine (Group 1) and 3% mepivacaine (Group 2) in sedated pediatric patients undergoing primary tooth extraction. 60 pediatric patients undergoing sedation for elective primary tooth extraction was prospectively included in the study in a randomized fashion. Inclusion and exclusion criteria were assigned. Patients were given premedication via oral route. Local anesthesia was achieved before extraction(s). There were no significant differences between the groups in patient demographics, number of teeth extracted, duration of the operation and time from the end of the procedure to discharge (p ≥ 0.05). FLACC pain scale scores were not statistically significant between the groups, except at 20 minutes post-operatively when the score is significantly lower in Group 2 (p=0.029). Prevention of pain during dental procedures can nurture the relationship of the patient and dentist. Tooth extraction under sedation in pediatric patients could be safe with both local anesthetics.

  10. Resting heart rate variability after yogic training and swimming: A prospective randomized comparative trial.

    Science.gov (United States)

    Sawane, Manish Vinayak; Gupta, Shilpa Sharad

    2015-01-01

    Resting heart rate variability (HRV) is a measure of the modulation of autonomic nervous system (ANS) at rest. Increased HRV achieved by the exercise is good for the cardiovascular health. However, prospective studies with comparison of the effects of yogic exercises and those of other endurance exercises like walking, running, and swimming on resting HRV are conspicuous by their absence. Study was designed to assess and compare the effects of yogic training and swimming on resting HRV in normal healthy young volunteers. Study was conducted in Department of Physiology in a medical college. Study design was prospective randomized comparative trial. One hundred sedentary volunteers were randomly ascribed to either yoga or swimming group. Baseline recordings of digital electrocardiogram were done for all the subjects in cohorts of 10. After yoga training and swimming for 12 weeks, evaluation for resting HRV was done again. Percentage change for each parameter with yoga and swimming was compared using unpaired t-test for data with normal distribution and using Mann-Whitney U test for data without normal distribution. Most of the HRV parameters improved statistically significantly by both modalities of exercise. However, some of the HRV parameters showed statistically better improvement with yoga as compared to swimming. Practicing yoga seems to be the mode of exercise with better improvement in autonomic functions as suggested by resting HRV.

  11. Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial).

    Science.gov (United States)

    Haverkamp, Leonie; Brenkman, Hylke J F; Seesing, Maarten F J; Gisbertz, Suzanne S; van Berge Henegouwen, Mark I; Luyer, Misha D P; Nieuwenhuijzen, Grard A P; Wijnhoven, Bas P L; van Lanschot, Jan J B; de Steur, Wobbe O; Hartgrink, Henk H; Stoot, Jan H M B; Hulsewé, Karel W E; Spillenaar Bilgen, Ernst J; Rütter, Jeroen E; Kouwenhoven, Ewout A; van Det, Marc J; van der Peet, Donald L; Daams, Freek; Draaisma, Werner A; Broeders, Ivo A M J; van Stel, Henk F; Lacle, Miangela M; Ruurda, Jelle P; van Hillegersberg, Richard

    2015-07-29

    For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy. The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness. In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5

  12. Erythropoietin therapy after allogeneic hematopoietic cell transplantation: a prospective, randomized trial.

    Science.gov (United States)

    Jaspers, Aurélie; Baron, Frédéric; Willems, Evelyne; Seidel, Laurence; Hafraoui, Kaoutar; Vanstraelen, Gaetan; Bonnet, Christophe; Beguin, Yves

    2014-07-01

    We conducted a prospective randomized trial to assess hemoglobin (Hb) response to recombinant human erythropoietin (rhEPO) therapy after hematopoietic cell transplantation (HCT). Patients (N = 131) were randomized (1:1) between no treatment (control arm) or erythropoietin at 500 U/kg per week (EPO arm). Patients were also stratified into 3 cohorts: patients undergoing myeloablative HCT with rhEPO to start on day (D)28, patients given nonmyeloablative HCT (NMHCT) with rhEPO to start on D28, and patients also given NMHCT but with rhEPO to start on D0. The proportion of complete correctors (ie, Hb ≥13 g/dL) before D126 posttransplant was 8.1% in the control arm (median not reached) and 63.1% in the EPO arm (median, 90 days) (P < .001). Hb levels were higher and transfusion requirements decreased (P < .001) in the EPO arm, but not during the first month in the nonmyeloablative cohort starting rhEPO on D0. There was no difference in rates of thromboembolic events or other complications between the 2 arms. This is the first randomized trial to demonstrate that rhEPO therapy hastens erythroid recovery and decreases transfusion requirements when started one month after allogeneic HCT. There was no benefit to start rhEPO earlier after NMHCT.

  13. A randomized prospective comparison between intrauterine insemination and fallopian sperm perfusion for the treatment of infertility.

    Science.gov (United States)

    Karande, V C; Rao, R; Pratt, D E; Balin, M; Levrant, S; Morris, R; Dudkeiwicz, A; Gleicher, N

    1995-09-01

    To determine if the pregnancy rates (PRs) in infertile women could be improved with fallopian sperm perfusion in comparison with IUI. Randomized prospective analysis. Academically affiliated infertility center. Consecutive patients undergoing controlled ovarian hyperstimulation (COH). After hCG administration, patients were randomized to either IUI or fallopian sperm perfusion. Pregnancy rates with the two treatment modalities. Of 240 COH cycles, those randomized to IUI included 44 clomiphene citrate (CC) (group I) and 76 gonadotropin (group III) cycles. Patients receiving fallopian sperm perfusion included 44 cycles of CC (group II) and 76 cycles of gonadotropin (group IV) treatment. The overall PRs per cycle (10.8% versus 10.8%) were similar for IUI and fallopian sperm perfusion, respectively. The PRs were also similar when compared for ovulation induction with CC (6.8% versus 9.1%) and gonadotropins (13.2% versus 11.8%). We conclude that fallopian sperm perfusion offers no advantage over IUI. Because the process of fallopian sperm perfusion is more time consuming and more costly (because of increased media usage), fallopian sperm perfusion does not seem indicated as a routine infertility therapy and should not replace IUI.

  14. 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 surgical and histopathologic staging. RESULTS: A total of 104 patients underwent EUS; 36 had surgical resection of the tumor, 26 surgical exploration without resection, and 42 did not undergo surgery. Comparison of the TNM staging results for the two echoendoscopies gave high kappa values (T, 0.77; N, 0.......75; M, 0.89), indicating excellent agreement. The accuracy of curved array echoendoscopy and radial echoendoscopy by component of the TNM staging system were, respectively, T, 72% and 73%; N, 70% and 77%; and M, 61% and 57%. Mean procedure time for the curved array and radial examinations was...

  15. 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.

  16. 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...... in the neck and arm. Two years after the operation, 86.1% of the patients treated with cage stated a good outcome versus 76.7% in the discectomy group (P = 0.44). The rate of fusion was 83.3% in the cage group versus 81.0% in the discectomy group (P = 0.30). Furthermore, after 2 years, also the rates of new...

  17. Prospective randomized comparison of cefepime and cefotaxime for treatment of bacterial meningitis in infants and children.

    Science.gov (United States)

    Sáez-Llorens, X; Castaño, E; García, R; Báez, C; Pérez, M; Tejeira, F; McCracken, G H

    1995-04-01

    Ninety infants and children were prospectively randomized to receive cefepime (n = 43) or cefotaxime (n = 47) for therapy of bacterial meningitis. The two treatment groups were comparable in terms of age, duration of illness before enrollment, history of seizures, clinical status on admission, and etiology. Six (7%) patients died--two treated with cefepime and four treated with cefotaxime. Clinical response, cerebrospinal fluid sterilization, development of complications, antibiotic toxicity, and hospital stay were similar for the two treatment regimens. Concentrations of cefepime in cerebrospinal fluid varied from 55 to 95 times greater than the maximal MIC required by the causative pathogens. Audiologic and/or neurologic sequelae were found in 16% of the cefepime-treated patients and 15% of the cefotaxime-treated patients examined 2 to 6 months after discharge. We conclude that cefepime is safe and therapeutically equivalent to cefotaxime for management of bacterial meningitis in infants and children.

  18. Prospective randomized clinical study of arterial pumps used for routine on pump coronary bypass grafting.

    Science.gov (United States)

    Keyser, Andreas; Hilker, Michael K; Diez, Claudius; Philipp, Alois; Foltan, Maik; Schmid, Christof

    2011-05-01

    In a number of studies, centrifugal blood pumps--in comparison with roller pumps--have been shown to attenuate trauma to blood components. Nevertheless, the impact of these results on the postoperative course needs to be discussed controversially. In a prospective randomized study, 240 consecutive adult patients underwent elective myocardial revascularization with cardiopulmonary bypass employing five different pumps (Roller, Avecor, Sarns, Rotaflow, Bio-Medicus). We analyzed clinical course, blood loss, damage of blood components, and impairment of the hemostatic system. The study population was homogenous with respect to age, gender, myocardial function, and operative data. No differences were found with respect to time of ventilation, duration of intensive care stay, hospitalization, and laboratory data. The choice of arterial pump during standard extracorporeal bypass for elective coronary artery bypass grafting is no matter of concern.

  19. Cryotherapy temperature differences after total knee arthroplasty: a prospective randomized trial.

    Science.gov (United States)

    Radkowski, Christopher A; Pietrobon, Ricardo; Vail, Thomas P; Nunley, James A; Jain, Nitin B; Easley, Mark E

    2007-01-01

    In spite of its widespread use after orthopaedic procedures, the literature evaluating the clinical efficacy of cryotherapy is controversial. The purpose of this prospective randomized trial was to compare two different temperatures for administering cryotherapy after total knee arthroplasty with regards to short-term postoperative outcomes. Sixty-four subjects were assigned either the 45 degrees F group or the 75 degrees F group. Subjects in the 45 degrees group were as likely to report a lower pain score at the time of follow-up compared to the 75 degrees group. Our results demonstrate no additional analgesic effect associated with the lower temperature of cryotherapy. Postoperative narcotic consumption, postoperative drainage, self-reported knee function, and range of motion were not affected by the different cryotherapy temperatures. No adverse effects were reported with the cryotherapy treatment.

  20. Conservative treatment, plate fixation, or prosthesis for proximal humeral fracture. A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Launonen Antti P

    2012-09-01

    Full Text Available Abstract Background Proximal humerus fracture is the third most common fracture type after hip and distal radius fracture in elderly patients. A comprehensive study by Palvanen et al. demonstrated an increase in the annual fracture rate of 13.7% per year over the past 33 years. Should this trend continue, the fracture rate would triple over the next three decades. The increasing incidence of low-energy fractures raises questions about the optimal treatment in terms of functional outcome, pain, and rehabilitation time, as well as the economical impact. Despite the high incidence and costs of proximal humerus fractures, there is currently no valid scientific evidence for the best treatment method. Several publications, including a Cochrane review outline the need for high-quality, well-designed randomized controlled trials. Methods/Design The study is a prospective, randomized, national multi-center trial. The hypothesis of the trial is that surgical treatment of displaced proximal humerus fractures achieves better functional outcome, pain relief, and patient satisfaction compared to conservative treatment. The trial is designed to compare conservative and surgical treatment of proximal humerus fractures in patients 60 years and older. The trial includes two strata. Stratum I compares surgical treatment with locking plates to conservative treatment for two-part fractures. Stratum II compares multi-fragmented fractures, including three- and four-part fractures. The aim of Stratum II is to compare conservative treatment, surgical treatment with the Philos locking plate, and hemiarthroplasty with an Epoca prosthesis. The primary outcome measure will be the Disabilities of the Arm, Shoulder and Hand (DASH score and the secondary outcome measures will be the EuroQol-5D (EQ-5D value, OSS, Constant-Murley Score, VAS, and 15D. Recruiting time will be 3 years. The results will be analyzed after the 2-year follow-up period. Discussion This publication

  1. Height and Breast Cancer Risk: Evidence From Prospective Studies and Mendelian Randomization

    Science.gov (United States)

    Zhang, Ben; Shu, Xiao-Ou; Delahanty, Ryan J.; Zeng, Chenjie; Michailidou, Kyriaki; Bolla, Manjeet K.; Wang, Qin; Dennis, Joe; Wen, Wanqing; Long, Jirong; Li, Chun; Dunning, Alison M.; Chang-Claude, Jenny; Shah, Mitul; Perkins, Barbara J.; Czene, Kamila; Darabi, Hatef; Eriksson, Mikael; Bojesen, Stig E.; Nordestgaard, Børge G.; Nielsen, Sune F.; Flyger, Henrik; Lambrechts, Diether; Neven, Patrick; Wildiers, Hans; Floris, Giuseppe; Schmidt, Marjanka K.; Rookus, Matti A.; van den Hurk, Katja; de Kort, Wim L. A. M.; Couch, Fergus J.; Olson, Janet E.; Hallberg, Emily; Vachon, Celine; Rudolph, Anja; Seibold, Petra; Flesch-Janys, Dieter; Peto, Julian; dos-Santos-Silva, Isabel; Fletcher, Olivia; Johnson, Nichola; Nevanlinna, Heli; Muranen, Taru A.; Aittomäki, Kristiina; Blomqvist, Carl; Li, Jingmei; Humphreys, Keith; Brand, Judith; Guénel, Pascal; Truong, Thérèse; Cordina-Duverger, Emilie; Menegaux, Florence; Burwinkel, Barbara; Marme, Frederik; Yang, Rongxi; Surowy, Harald; Benitez, Javier; Zamora, M. Pilar; Perez, Jose I. A.; Cox, Angela; Cross, Simon S.; Reed, Malcolm W. R.; Andrulis, Irene L.; Knight, Julia A.; Glendon, Gord; Tchatchou, Sandrine; Sawyer, Elinor J.; Tomlinson, Ian; Kerin, Michael J.; Miller, Nicola; Chenevix-Trench, Georgia; Haiman, Christopher A.; Henderson, Brian E.; Schumacher, Fredrick; Marchand, Loic Le; Lindblom, Annika; Margolin, Sara; Hooning, Maartje J.; Martens, John W. M.; Tilanus-Linthorst, Madeleine M. A.; Collée, J. Margriet; Hopper, John L.; Southey, Melissa C.; Tsimiklis, Helen; Apicella, Carmel; Slager, Susan; Toland, Amanda E.; Ambrosone, Christine B.; Yannoukakos, Drakoulis; Giles, Graham G.; Milne, Roger L.; McLean, Catriona; Fasching, Peter A.; Haeberle, Lothar; Ekici, Arif B.; Beckmann, Matthias W.; Brenner, Hermann; Dieffenbach, Aida Karina; Arndt, Volker; Stegmaier, Christa; Swerdlow, Anthony J.; Ashworth, Alan; Orr, Nick; Jones, Michael; Figueroa, Jonine; Garcia-Closas, Montserrat; Brinton, Louise; Lissowska, Jolanta; Dumont, Martine; Winqvist, Robert; Pylkäs, Katri; Jukkola-Vuorinen, Arja; Grip, Mervi; Brauch, Hiltrud; Brüning, Thomas; Ko, Yon-Dschun; Peterlongo, Paolo; Manoukian, Siranoush; Bonanni, Bernardo; Radice, Paolo; Bogdanova, Natalia; Antonenkova, Natalia; Dörk, Thilo; Mannermaa, Arto; Kataja, Vesa; Kosma, Veli-Matti; Hartikainen, Jaana M.; Devilee, Peter; Seynaeve, Caroline; Van Asperen, Christi J.; Jakubowska, Anna; Lubiński, Jan; Jaworska-Bieniek, Katarzyna; Durda, Katarzyna; Hamann, Ute; Torres, Diana; Schmutzler, Rita K.; Neuhausen, Susan L.; Anton-Culver, Hoda; Kristensen, Vessela N.; Grenaker Alnæs, Grethe I.; Pierce, Brandon L.; Kraft, Peter; Peters, Ulrike; Lindstrom, Sara; Seminara, Daniela; Burgess, Stephen; Ahsan, Habibul; Whittemore, Alice S.; John, Esther M.; Gammon, Marilie D.; Malone, Kathleen E.; Tessier, Daniel C.; Vincent, Daniel; Bacot, Francois; Luccarini, Craig; Baynes, Caroline; Ahmed, Shahana; Maranian, Mel; Healey, Catherine S.; González-Neira, Anna; Pita, Guillermo; Alonso, M. Rosario; Álvarez, Nuria; Herrero, Daniel; Pharoah, Paul D. P.; Simard, Jacques; Hall, Per; Hunter, David J.; Easton, Douglas F.

    2015-01-01

    Background: Epidemiological studies have linked adult height with breast cancer risk in women. However, the magnitude of the association, particularly by subtypes of breast cancer, has not been established. Furthermore, the mechanisms of the association remain unclear. Methods: We performed a meta-analysis to investigate associations between height and breast cancer risk using data from 159 prospective cohorts totaling 5216302 women, including 113178 events. In a consortium with individual-level data from 46325 case patients and 42482 control subjects, we conducted a Mendelian randomization analysis using a genetic score that comprised 168 height-associated variants as an instrument. This association was further evaluated in a second consortium using summary statistics data from 16003 case patients and 41335 control subjects. Results: The pooled relative risk of breast cancer was 1.17 (95% confidence interval [CI] = 1.15 to 1.19) per 10cm increase in height in the meta-analysis of prospective studies. In Mendelian randomization analysis, the odds ratio of breast cancer per 10cm increase in genetically predicted height was 1.22 (95% CI = 1.13 to 1.32) in the first consortium and 1.21 (95% CI = 1.05 to 1.39) in the second consortium. The association was found in both premenopausal and postmenopausal women but restricted to hormone receptor–positive breast cancer. Analyses of height-associated variants identified eight new loci associated with breast cancer risk after adjusting for multiple comparisons, including three loci at 1q21.2, DNAJC27, and CCDC91 at genome-wide significance level P < 5×10–8. Conclusions: Our study provides strong evidence that adult height is a risk factor for breast cancer in women and certain genetic factors and biological pathways affecting adult height have an important role in the etiology of breast cancer. PMID:26296642

  2. 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.

  3. [Laparoscopic inguinal hernia repair "IPOM" vs "open tension free". Preliminary results of a prospective randomized study].

    Science.gov (United States)

    Catani, M; De Milito, R; Spaziani, E; Chiaretti, M; Manili, G; Capitano, S; Di Filippo, A; Simi, M

    2003-12-01

    The authors report the preliminary results of a prospective comparison of IPOM (group A) and "open tension free" (group B) hernioplasty in 50 patients having a mono or bilateral primitive hernia. In group A (26 patients) hernia repair was performed using "Gore-Tex DualMesh Plus biomaterial with holes Corduroy" and in group B (24 patients) using the patch and plug technique with Marlex prosthesis. No intraoperative complications occurred and, in group A, no conversion was necessary. Four minor complications were obser-ved in group A (10.8%): 3 seromas and 1 transient paresthesia; 5 in group B (16%): 4 hematomas and 1 wound infection (p=n.s.). In group A only 2 patients (7.6%) needed analgesics after the first 24 hours and 12 patients (50%) in group B (p<0.001). Mean resumption of normal activity was 8 days in group A and 17 days in group B (p<0.001). At a 12-month-follow-up, no recurrence was reported in both groups. The results of this prospective randomized study show that IPOM may be not only a feasible and effective procedure in the treatment of recurrent and bilateral hernia or when hernia repair is performed during other laparoscopic procedures, but also in particular cases of primitive hernia such as in very active young males or heavy duty workers. However it is necessary to definitely ascertain the true incidence of recurrence in non limited series and in longer follow-up and the preliminary results of this study encourage the authors to complete the randomized study.

  4. A prospective randomized study of the efficacy of "Turning Point," an inpatient violence intervention program.

    Science.gov (United States)

    Loveland-Jones, Catherine; Ferrer, Lucas; Charles, Scott; Ramsey, Frederick; van Zandt, Andrea; Volgraf, Jill; Santora, Thomas; Pathak, Abhijit; Dujon, Jay; Sjoholm, Lars; Rappold, Joseph; Goldberg, Amy

    2016-11-01

    From 2002 to 2011, there were more than 17,000 shootings in Philadelphia. "Turning Point," Temple University Hospital's inpatient violence intervention program, takes advantage of the teachable moment that occurs after violent injury. In addition to receiving traditional social work services, Turning Point patients watch their trauma bay resuscitation video and a movie about violence, meet with a gunshot wound survivor and an outpatient case manager, and also undergo psychiatric assessment. The purpose of this study was to determine the efficacy of Turning Point in changing attitudes toward guns and violence among victims of penetrating trauma. This prospective randomized study was conducted from January 2012 to January 2014. Patients who sustained a gunshot or stab wound were randomized to standard of care, which involved traditional social work services only, or Turning Point. The Attitudes Toward Guns and Violence Questionnaire was administered to assess attitude change. Analysis was performed with repeated-measures analysis of variance. A p violence. Turning Point is effective in changing attitudes toward guns and violence among victims of penetrating trauma. Longer follow-up is necessary to determine if this program can truly be a turning point in patients' lives. Therapeutic/care management study, level II.

  5. Antibiotic use in post-adenotonsillectomy morbidity: a randomized prospective study.

    Science.gov (United States)

    Guerra, Marja Michelin; Garcia, Eduardo; Pilan, Renata Ribeiro de Mendonça; Rapoport, Priscila Bogar; Campanholo, Caio Barbosa; Martinelli, Eli Onivaldo

    2008-01-01

    Tonsillectomy with or without adenoidectomy still is one of the most commonly performed surgical procedures in the world, mostly in the pediatric population. to study the impact of amoxicillin for 7 days in post-adenotonsillectomy recovery, comparing results with a control group. prospective, randomized, controlled study with 120 patients. the patients were randomized according to surgery time to receive 7 days of amoxicillin associated with pain killers, or analgesic alone. During the first week of postoperative, we assessed the level of pain, oral intake acceptance, nausea and vomits, fever and return to daily activities. It was only in the fourth post-operative day that the group receiving antibiotic agents showed a statistically significant difference as far as pain is concerned. There was no difference between the two groups for other data analyzed. considering the results from our study and reviewing the literature on the use of antibiotic agents, we agree that there is no improvement in patient recovery after adenotonsillectomy with the use of amoxicillin for 7 days in the postoperative.

  6. Intraarticular lidocaine versus intravenous analgesic for reduction of acute anterior shoulder dislocations. A prospective randomized study.

    Science.gov (United States)

    Matthews, D E; Roberts, T

    1995-01-01

    We performed a prospective, randomized study to evaluate the use of injected lidocaine as an anesthetic for closed reduction of acute anterior shoulder dislocations. Thirty consecutive patients who presented at the emergency department with acute anterior shoulder dislocations were randomly placed in one of two groups. One group received an intraarticular injection of 20 ml of 1% lidocaine and the other group, intravenous injections of morphine sulfate and midazolam. The groups were compared regarding time of reduction maneuver, difficulty of reduction, subjective pain, complications, and total time spent in the emergency department. The lidocaine provided adequate anesthesia and secondary relief of muscle spasm in 15 of 15 (100%) patients. When compared with the intravenous sedation group, the lidocaine group showed no statistically significant difference in time for reduction maneuver, difficulty of reduction, or subjective pain. The lidocaine group had no complications and had a statistically significant shorter emergency department visit when compared with the intravenous sedation group (mean, 78 minutes versus 186 minutes; P = 0.004). Lidocaine provides excellent anesthesia for patients with uncomplicated anterior shoulder dislocations and can be very beneficial when sedation is contraindicated. Lidocaine injections also proved to be cost effective in our institution, reducing total costs by as much as 62%.

  7. 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.

  8. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    Directory of Open Access Journals (Sweden)

    Young-Dae Kim

    2013-01-01

    Full Text Available To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs and 2 uncontrolled clinical trials (UCTs out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs. One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  9. Acupuncture for posttraumatic stress disorder: a systematic review of randomized controlled trials and prospective clinical trials.

    Science.gov (United States)

    Kim, Young-Dae; Heo, In; Shin, Byung-Cheul; Crawford, Cindy; Kang, Hyung-Won; Lim, Jung-Hwa

    2013-01-01

    To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD) in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were "acupuncture" and "PTSD." No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs) and 2 uncontrolled clinical trials (UCTs) out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT) were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs). One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  10. Is the Use of a Drain for Thyroid Surgery Realistic? A Prospective Randomized Interventional Study

    Directory of Open Access Journals (Sweden)

    Ugur Deveci

    2013-01-01

    Full Text Available Background. The use of a suction drain in thyroid surgery is common practice in order to avoid hematomas or seromas. The aim of this study was to determine the efficacy of routine drainage after thyroid surgery. Methods. In this prospective randomized trial, 400 patients who underwent either a total thyroidectomy or lobectomy for thyroid disorders were randomly allocated to either the nondrainage (group 1 or the drainage (group 2 group. The volume of fluid collection in the operative bed, postoperative pain, complications, and length of hospital stay were then recorded. Results. Both groups were homogeneous according to age, gender, thyroid volume, type of procedure performed, and histopathological diagnosis. After assessment by USG, no significant difference was found between the groups in the fluid collection of the thyroid bed (, but the length of hospital stay was significantly reduced in group 1 (. Conclusions. In our experience, the use of drain for thyroid surgery is not a routine procedure. However, it should be used in the presence of extensive dead space, particularly when there is retrosternal or intrathoracic extension, or when the patient is on anticoagulant treatment. This trial was registered with clinical Trials.gov NCT01771523.

  11. 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.

  12. Abdominal wound closure. A randomized prospective study of 571 patients comparing continuous vs. interrupted suture techniques.

    Science.gov (United States)

    Richards, P C; Balch, C M; Aldrete, J S

    1983-01-01

    A randomized, prospective study was designed to compare a continuous with an interrupted technique for closing an abdominal incision. Five hundred seventy-one patients were randomized between the closure methods and stratified as to type of wound: clean, clean-contaminated, or contaminated. In mid-line incisions, the dehiscence rate was 2.0% (5/244) for the continuous group versus 0.9% (2/229) for the interrupted group. The difference was not statistically significant. Ventral hernias formed in 2.0% (4/201) of the continuous group vs. 0.5% (1/184) of the interrupted group. The type of wound had no influence on the results. In oblique incisions, 0% (0/39) of wounds closed continuously dehised while 2% (1/50) of incisions closed interruptedly dehised. No ventral hernias formed. Further analysis of the data indicated that dehiscence was more likely related to improper surgical technique than to the method of closure. An abdominal incision could be closed with a continuous suture in approximately half the time required for placing interrupted sutures (20 vs. 40 minutes). A continuous closure is preferred because it is more expedient and because it has the same incidence of wound disruption compared with an interrupted closure. PMID:6297417

  13. Prospective Randomized Trial of Right-Sided Paracolic Adhesiolysis for Chronic Pelvic Pain

    Science.gov (United States)

    Sharma Gera, Puja; Olive, David L.

    2006-01-01

    Background: Prior study has shown that right paracolic adhesions are found in 90% of patients with chronic pelvic pain and less frequently in pain-free patients. We set out to determine whether paracolic adhesiolysis will reduce site-specific pain. Methods: This was a prospective, randomized trial of right paracolic adhesiolysis at the time of diagnostic and operative laparoscopy for chronic pelvic pain. Twenty-five patients with a diagnosis of chronic pelvic pain were randomized to either undergo or withhold lysis of right paracolic adhesions at the time of operative laparoscopy. Results: Right paracolic adhesions were found in 100% of our patients. For all subjects, there was a significant reduction of right and left lower quadrant pain (P<0.001) following the operative laparoscopy. Those who underwent right paracolic adhesiolysis had significantly greater right pelvic pain reduction than those who did not (P=0.014). There was no difference in the reduction of left or mid pelvic pain between the treatment and control groups. Conclusions: Right paracolic adhesiolysis reduces short-term site-specific tenderness in patients with chronic pelvic pain. Patients who would benefit from diagnostic or operative laparoscopy are likely to benefit further from paracolic adhesiolysis. PMID:17575754

  14. [Bipolar versus monopolar transurethral resection of the prostate: a prospective randomized study].

    Science.gov (United States)

    Ghozzi, S; Ghorbel, J; Ben Ali, M; Dridi, M; Maarouf, J; Khiari, R; Ben Rais, N

    2014-02-01

    To compare bipolar with standard monopolar transurethral resection of the prostate (TURP). A prospectively randomized study was conducted between January 2010 and September 2011. Primary end points studied were efficacy (maximum flow rate [Qmax], International Prostate Symptom Score) and safety (adverse events, decline in postoperative serum sodium [Na+] and haemoglobin [Hb] levels). Secondary end points were operation time and duration of irrigation, catheterization, and hospitalization. Sixty consecutive patients were randomized and completed the study, with 29 patients in the monopolar TURP group and 31 in the TURIS group. At baseline, the two groups were comparable in age, prostate volume, mean prostate-specific antigen value, International Prostate Symptom Score, and they had at least 12 months of follow-up. Declines in the mean postoperative serum Na+ for bipolar and monopolar TURP groups were 1.2 and 8.7 mmol/L, respectively. However, there was no statistical difference in the decline in postoperative Hb between the two groups. The mean catheterization time was 26.6 and 52 hours in the bipolar and standard groups, respectively. This difference was statistically significant as was the difference in the time to hospital discharge. The IPSS and Qmax improvements were comparable between the two groups at 12 months of follow-up. No clinically relevant differences in short-term efficacy are existed between the two techniques, but bipolar TURP is preferable due to a more favorable safety profile and shorter catheterization duration. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  15. 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.

  16. 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.

  17. Comparison of Postoperative Analgesic Efficacy of Penile Block, Caudal Block and Intravenous Paracetamol for Circumcision: A prospective Randomized Study

    OpenAIRE

    Ahmet Hakan Haliloglu; Mehmet Ilker Gokce; Semih Tangal; Mehmet Salih Boga; Hakan Tapar; Ebru Aladag

    2013-01-01

    Purpose To evaluate the postoperative analgesic efficacy of penile block, caudal block and intravenous paracetamol administration following circumcision. Materials and Methods In this prospective randomized study a total of 159 patients underwent circumcision under general anesthesia at urology clinic of Ufuk University Faculty of Medicine and Sorgun State Hospital between May 2012 and September 2012. The patients were randomized to three groups to receive penile block (Group 1), caudal blo...

  18. Irrigation versus suction alone during laparoscopic appendectomy for perforated appendicitis: a prospective randomized trial.

    Science.gov (United States)

    St Peter, Shawn D; Adibe, Obinna O; Iqbal, Corey W; Fike, Frankie B; Sharp, Susan W; Juang, David; Lanning, David; Murphy, J Patrick; Andrews, Walter S; Sharp, Ronald J; Snyder, Charles L; Holcomb, George W; Ostlie, Daniel J

    2012-10-01

    The efficacy of irrigating the peritoneal cavity during appendectomy for perforated appendicitis has been debated extensively. To date, prospective comparative data are lacking. Therefore, we conducted a prospective, randomized trial comparing peritoneal irrigation to suction alone during laparoscopic appendectomy in children. Children younger than 18 years with perforated appendicitis were randomized to peritoneal irrigation with a minimum of 500 mL normal saline, or suction only during laparoscopic appendectomy. Perforation was defined as a hole in the appendix or fecalith in the abdomen. The primary outcome variable was postoperative abscess. Using a power of 0.8 and alpha of 0.05, a sample size of 220 patients was calculated. A battery-powered laparoscopic suction/irrigator was used in all cases. Pre- and postoperative management was controlled. Data were analyzed on an intention-to-treat basis. A total of 220 patients were enrolled between December 2008 and July 2011. There were no differences in patient characteristics at presentation. There was no difference in abscess rate, which was 19.1% with suction only and 18.3% with irrigation (P = 1.0). Duration of hospitalization was 5.5 ± 3.0 with suction only and 5.4 ± 2.7 days with group (P = 0.93). Mean hospital charges was $48.1K in both groups (P = 0.97). Mean operative time was 38.7 ± 14.9 minutes with suction only and 42.8 ± 16.7 minutes with irrigation (P = 0.056). Irrigation was felt to be necessary in one case (0.9%) randomized to suction only. In the patients who developed an abscess, there was no difference in duration of hospitalization, days of intravenous antibiotics, duration of home health care, or abscess-related charges. There is no advantage to irrigation of the peritoneal cavity over suction alone during laparoscopic appendectomy for perforated appendicitis. The study was registered with clinicaltrials.gov at the inception of enrollment (NCT00981136).

  19. Is the routine drainage after surgery for thyroid necessary? - A prospective randomized clinical study [ISRCTN63623153

    Directory of Open Access Journals (Sweden)

    Chintamani

    2005-05-01

    Full Text Available Abstract Background Drains are usually left after thyroid surgery to prevent formation of hematoma and seroma in the thyroid bed. This is done to reduce complications and hospital stay. Objective evaluation of the amount collected in the thyroid bed by ultrasonography (USG can help in assessing the role of drains. Methods A randomized prospective control study was conducted on 94 patients undergoing 102 thyroid surgeries, over a period of fifteen months. Patients included in the study were randomly allocated to drain and non-drain group on the basis of computer generated random number table. The surgeon was informed of the group just before the closure of the wound Postoperatively USG neck was done on first and seventh postoperative day by the same ultrasonologist each time. Any swelling, change in voice, tetany and tingling sensation were also recorded. The data was analyzed using two-sample t-test for calculating unequal variance. Results Both groups were evenly balanced according to age, sex, and size of tumor, type of procedure performed and histopathological diagnosis. There was no significant difference in collection of thyroid bed assessed by USG on D1 & D7 in the two groups (p = 0.313 but the hospital stay was significantly reduced in the non-drain group (p = 0.007. One patient in the drain group required needle aspiration for collection in thyroid bed. No patient in either group required re-operation for bleeding or haematoma. Conclusion Routine drainage of thyroid bed following thyroid surgery may not be necessary. Not draining the wound results in lesser morbidity and decreased hospital stay.

  20. Endoscopic versus microscopic type 1 tympanoplasty in the same patients: a prospective randomized controlled trial.

    Science.gov (United States)

    Kaya, Isa; Sezgin, Baha; Sergin, Demet; Ozturk, Arin; Eraslan, Sevinc; Gode, Sercan; Bilgen, Cem; Kirazli, Tayfun

    2017-07-01

    The aim of this study was to compare the audiologic outcomes of the patients who underwent endoscopy on one ear and microscopic tympanoplasty on the other, and to investigate the operative time, graft success, postoperative pain and health status. This prospective randomized controlled study was carried out in Ege University ENT Department between February 2015 and September 2016. The patients who had bilateral chronic otitis media, normal middle ear mucosa and a hearing loss difference of 10 dB or less between the two ears randomly underwent microscopic tympanoplasty in one ear and endoscopic tympanoplasty in the contralateral ear, with 6-month intervals. 13 patients were included in the study with a mean age of 36.17 ± 3.61 years (range 17-53 years, 7 female, 6 male). The improvement in air-bone gap for groups 1 (endoscopic) and 2 (microscopic) was 9.48 ± 5.23 and 9.89 ± 2.79 dB, respectively. The duration of the surgery in group 1 was significantly lower than that in group 2 (p microscopic surgery. In addition, endoscopic surgery offers comparable improvement in air-bone gap and similar graft success. The endoscopic approach has comparable audiological and morphological graft outcomes with the microscopic one. The endoscopic approach yielded better health and pain status for the same patients. Level of evidence This is an individual randomized controlled trial. The level of evidence is 1b.

  1. 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

    1994-01-01

    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 r

  2. 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...

  3. 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...

  4. Intravenous fluids versus gastric-tube feeding in hospitalized infants with viral bronchiolitis: a randomized, prospective pilot study.

    Science.gov (United States)

    Kugelman, Amir; Raibin, Karine; Dabbah, Husein; Chistyakov, Irina; Srugo, Isaac; Even, Lea; Bzezinsky, Nurit; Riskin, Arieh

    2013-03-01

    The American Academy of Pediatrics recommends intravenous fluids for infants with bronchiolitis who are unable to sustain oral feedings. Our randomized, prospective pilot study shows that gastric tube feeding (in 31 infants) is feasible and demonstrated comparable clinical outcomes with intravenous fluids (in 20 infants) among hospitalized infants ≤6 months of age with moderate bronchiolitis.

  5. Impact of increased authenticity in instructional format on preclerkship students' performance: a two-year, prospective, randomized study

    NARCIS (Netherlands)

    LaRochelle, J.S.; Durning, S.J.; Pangaro, L.N.; Artino, A.R.; Vleuten, C.P.M. van der; Schuwirth, L.

    2012-01-01

    PURPOSE: To address whether increasingly authentic instructional formats are more effective in improving preclerkship medical students' performance. METHOD: From 2007 to 2009, the authors conducted a prospective, randomized, crossover study with second-year medical students in a clinical reasoning c

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

    NARCIS (Netherlands)

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

    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, internation

  7. Social Media and Peer-Reviewed Medical Journal Readership: A Randomized Prospective Controlled Trial.

    Science.gov (United States)

    Hawkins, C Matthew; Hunter, Makeba; Kolenic, Giselle E; Carlos, Ruth C

    2017-05-01

    To prospectively evaluate the impact of increasing levels of social media engagement on page visits and web-link clicks for content published in the Journal of the American College of Radiology. A three-arm prospective trial was designed using a control group, a basic Twitter intervention group (using only the Journal's @JACRJournal Twitter account), and an enhanced Twitter intervention group (using the personal Twitter accounts of editorial board members and trainees). Overall, 428 articles published between June 2013 and July 2015 were randomly assigned to the three groups. Article-specific tweets for both intervention arms were sent between September 14, 2015, and October 28, 2015. Primary end points included article-specific weekly and monthly page visits on the journal's Elsevier website (Amsterdam, Netherlands). For the two intervention groups, additional end points included 7-day and 30-day Twitter link clicks. Weekly page visits for the enhanced Twitter arm (mean 18.2; 95% confidence interval [CI] 15.6-20.7) were significantly higher when compared with the weekly page visits for the control arm (mean 7.6; 95% CI 1.7-13.6). However, there was no demonstrable increase in weekly page visits (mean 9.4; 95% CI 7.4-11.5) for the basic Twitter arm compared with the control arm. No intervention effects over control, regardless of Twitter arm assignment, were demonstrated for monthly page visits. The enhanced Twitter intervention resulted in a statistically significant increase in both 7-day and 30-day Twitter link clicks compared with the basic Twitter intervention group. An organized social media strategy, with focused social media activity from editorial board members, increased engagement with content published in a peer-reviewed radiology journal. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  8. Feeding premature infants while low umbilical artery catheters are in place: a prospective, randomized trial.

    Science.gov (United States)

    Davey, A M; Wagner, C L; Cox, C; Kendig, J W

    1994-05-01

    The objective of this prospective, randomized clinical trial was to test the hypothesis that there is no difference in the frequency of feeding problems and necrotizing enterocolitis between a group of premature infants who received early enteral feedings while low umbilical artery catheters (LUACs) were in place, and a late group who were not fed until 24 hours after removal of LUACs. Twenty-nine premature infants (born at 28.5 +/- 3.0 SD weeks of gestational age) who were in stable condition received early enteral feedings at a median of 2 days while a LUAC was in place; 31 infants (born at 28.6 +/- 2.7 SD weeks of gestational age) received late enteral feedings at a median of 5 days of age, 24 hours after the removal of the LUAC. Feeding complications and interventions and nutritional characteristics were recorded prospectively. There were no differences in the baseline perinatal characteristics of the two groups. The incidence of gastric residua and the incidence of abdominal distention were the same in both groups. The early feeding group had significantly fewer percutaneous central venous catheters, evaluations for sepsis, and episodes of receiving nothing by mouth while a gastric suction tube was in place. Infants in the early group received parenteral alimentation-lipid emulsion infusions for a median of 13 days versus 30 days for the late-fed group (p = 0.0028 by Wilcoxon test). There were two cases of necrotizing enterocolitis in the early group versus four cases in the late group. Premature infants in stable condition who receive enteral feedings while LUACs are in place do not have an increased incidence of feeding problems compared with infants who do not receive enteral feedings until 24 hours after removal of LUACs.

  9. Delayed cord clamping with and without cord stripping: a prospective randomized trial of preterm neonates.

    Science.gov (United States)

    Krueger, Margaret S; Eyal, Fabien G; Peevy, Keith J; Hamm, Charles R; Whitehurst, Richard M; Lewis, David F

    2015-03-01

    Autologous blood transfusion from the placenta to the neonate at birth has been proven beneficial. Transfusion can be accomplished by either delayed cord clamping or cord stripping. Both are equally effective in previous randomized trials. We hypothesized that combining these 2 techniques would further improve outcomes in preterm neonates. This was a prospective randomized trial for singleton deliveries with estimated gestational ages between 22 and 31 6/7 weeks. The control protocol required a 30-second delayed cord clamping, whereas the test protocol instructed a concurrent cord stripping during the delay. The primary outcome was initial fetal hematocrit. We also examined secondary outcomes of neonatal mortality, length of time on the ventilator, days to discharge, peak bilirubin, number of phototherapy days, and neonatal complication rates. Of the 67 patients analyzed, 32 were randomized to the control arm and 35 were randomized to the test arm. The gestational ages and fetal weights were similar between the arms. Mean hematocrit of the control arm was 47.75%, and the mean hematocrit for the test arm was 47.71% (P = .98). These results were stratified by gestational age, revealing the infants less than 28 weeks had an average hematocrit of 41.2% in the control arm and 44.7% in the test arm (P = .12). In the infants with gestational ages of 28 weeks or longer, the control arm had an average hematocrit of 52.9%, which was higher than the test arm, which averaged 49.5% (P = .04). The control arm received an average of 1.53 blood transfusions, whereas the test arm received 0.97 (P = .33). The control arm had 3 neonatal deaths, and the test arm had none (P = .10). The average number of days until discharge was 71.2 for the control arm and 67.8 for the test arm (P = .66). The average number of days on the ventilator was 4.86 for the control arm and 3.06 for the test arm (P = .34). Adding cord stripping to the delayed cord clamp does not result in an increased

  10. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study

    Directory of Open Access Journals (Sweden)

    Phuttharak Warinthorn

    2008-03-01

    Full Text Available Abstract Background An acute complication of thyroidectomy is fatal hematoma, which can produce an upper airway obstruction needing immediate intubation or tracheostomy. After neck surgery, we usually apply a pressure dressing with a non-woven, adhesive fabric to reduce bleeding and fluid collection at the operative bed. We conducted a prospective, randomized, controlled study to evaluate a pressure vs. a non-pressure dressing after thyroid surgery by monitoring blood and serum in the operative bed. Methods We studied 108 patients who underwent 116 thyroid surgeries at Srinagarind Hospital, Khon Kaen University, between December 2006 and September 2007. The patients were randomized to either the pressure dressing or non-pressure dressing group. Ultrasound of the neck was performed 24 ± 3 hours after surgery. The volume of fluid collection in the operative bed was calculated. All patients were observed for any post-operative respiratory distress, wound complications, tingling sensation or tetany. Results The distributions of age, sex, surgical indications and approaches were similar between the two groups. There was no statistically significant difference in the volume of fluid collection in the operative bed (p = 0.150 and the collected drained content (p = 0.798. The average time a drain was retained was 3 days. One patient in the pressure dressing group suffered cutaneous bruising while one patient in the non-pressure dressing group developed immediate hemorrhage after the skin sutures. Conclusion Pressure dressing after thyroidectomy does not have any significant impact on decreasing fluid collection at the operative bed. The use of pressure dressing after thyroidectomy may not therefore be justified. Trial Registration NCT00400465, ISRCTN52660978

  11. A prospective randomized blister prevention trial assessing paper tape in endurance distances (Pre-TAPED).

    Science.gov (United States)

    Lipman, Grant S; Ellis, Mark A; Lewis, Erica J; Waite, Brandee L; Lissoway, John; Chan, Garrett K; Krabak, Brian J

    2014-12-01

    Friction foot blisters are a common injury occurring in up to 39% of marathoners, the most common injury in adventure racing, and represent more than 70% of medical visits in multi-stage ultramarathons. The goal of the study was to determine whether paper tape could prevent foot blisters in ultramarathon runners. This prospective randomized trial was undertaken during RacingThePlanet 155-mile (250-km), 7-day self-supported ultramarathons in China, Australia, Egypt, Chile, and Nepal in 2010 and 2011. Paper tape was applied prerace to one randomly selected foot, with the untreated foot acting as the own control. The study end point was development of a hot spot or blister on any location of either foot. One hundred thirty-six participants were enrolled with 90 (66%) having completed data for analysis. There were 36% women, with a mean age of 40 ± 9.4 years (range, 25-40 years) and pack weight of 11 ± 1.8 kg (range, 8-16 kg). All participants developed blisters, with 89% occurring by day 2 and 59% located on the toes. No protective effect was observed by the intervention (47 versus 35; 52% versus 39%; P = .22), with fewer blisters occurring around the tape on the experimental foot than under the tape (23 vs 31; 25.6% versus 34.4%), yet 84% of study participants when queried would choose paper tape for blister prevention in the future. Although paper tape was not found to be significantly protective against blisters, the intervention was well tolerated with high user satisfaction. Copyright © 2014 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

  12. Control of Intraoperative Shivering Under Spinal Anaesthesia- A Prospective Randomized Comparative Study of Butorphanol with Tramadol

    Directory of Open Access Journals (Sweden)

    Astha Palan

    2017-01-01

    Full Text Available Background: Shivering is very uncomfortable and distressing for the patient, anaesthesiologist and the surgeon, especially when the patient is under regional anaesthesia. Aim and Objectives: The present study was designed to evaluate the efficacy of butorphanol and tramadol in the control of shivering under spinal anaesthesia and to compare their side effects. To compare the efficacy, potency, response time, hemodynamic alterations, and adverse effects of intravenously administered tramadol and butorphanol for relief of shivering occurring during spinal anaesthesia. Material and Methods: This randomized prospective study was conducted in 100 patients who developed shivering under spinal anaesthesia during various abdominal, orthopaedic, urological and gynaecological procedures. Patients with fever, acute infections, drug allergy and compromised cardiorespiratory functions were not included in the study. On shivering, patients were randomly allocated in two groups of 50 patients each who received intravenously 1mg of butorphanol or 50 mg of tramadol in a double blinded manner. Control of shivering, time taken for cessation, recurrence, hemodynamic changes, axillary temperatures and side effects were noted and compared for both the groups. Collected data were analysed using Chi square test and Student's unpaired t test. Results: All patients were relieved of shivering after butorphanol, 58% within 1 min, 82% within 3min and 100% within 5 min. Tramadol relieved shivering in 98% of patients, 32% within 1 min, 60% within 3 min, 98% within 5 mins (p<0.05. There was higher incidence of side effects like nausea and vomiting with tramadol (16% and 12% respectively as compared to butorphanol. Conclusion: Both the drugs, tramadol and butorphanol are effective to control shivering after spinal anaesthesia. Butorphanol is better as compared to tramadol in treating shivering under spinal anaesthesia because of its quicker onset of action, higher success rate

  13. Hypertonic fluid administration in patients with septic shock: a prospective randomized controlled pilot study.

    Science.gov (United States)

    van Haren, Frank M P; Sleigh, James; Boerma, E Christiaan; La Pine, Mary; Bahr, Mohamed; Pickkers, Peter; van der Hoeven, Johannes G

    2012-03-01

    We assessed the short-term effects of hypertonic fluid versus isotonic fluid administration in patients with septic shock. This was a double-blind, prospective randomized controlled trial in a 15-bed intensive care unit. Twenty-four patients with septic shock were randomized to receive 250 mL 7.2% NaCl/6% hydroxyethyl starch (HT group) or 500 mL 6% hydroxyethyl starch (IT group). Hemodynamic measurements included mean arterial blood pressure (MAP), central venous pressure, stroke volume index, stroke volume variation, intrathoracic blood volume index, gastric tonometry, and sublingual microcirculatory flow as assessed by sidestream dark field imaging. Systolic tissue Doppler imaging velocities of the medial mitral annulus were measured using echocardiography to assess left ventricular contractility. Log transformation of the ratio MAP divided by the norepinephrine infusion rate (log MAP/NE) quantified the combined effect on both parameters. Compared with the IT group, hypertonic solution treatment resulted in an improvement in log MAP/NE (P = 0.008), as well as an increase in systolic tissue Doppler imaging velocities (P = 0.03) and stroke volume index (P = 0.017). No differences between the groups were found for preload parameters (central venous pressure, stroke volume variation, intrathoracic blood volume index) or for afterload parameters (systemic vascular resistance index, MAP). Hypertonic solution treatment decreased the need for ongoing fluid resuscitation (P = 0.046). No differences between groups were observed regarding tonometry or the sublingual microvascular variables. In patients with septic shock, hypertonic fluid administration did not promote gastrointestinal mucosal perfusion or sublingual microcirculatory blood flow in comparison to isotonic fluid. Independent of changes in preload or afterload, hypertonic fluid administration improved the cardiac contractility and vascular tone compared with isotonic fluid. The need for ongoing fluid

  14. Suction vs water seal after pulmonary resection: a randomized prospective study.

    Science.gov (United States)

    Marshall, M Blair; Deeb, Maher E; Bleier, Joshua I S; Kucharczuk, John C; Friedberg, Joseph S; Kaiser, Larry R; Shrager, Joseph B

    2002-03-01

    To evaluate whether suction or water seal is superior in the management of chest tubes after pulmonary resection. A prospective, randomized, controlled trial. After an initial, brief period of suction, patients were randomized to water seal or - 20 cm H(2)O suction. University hospital. Sixty-eight patients who underwent wedge resection, segmentectomy, or lobectomy were included in the study. Those patients who underwent reoperative surgery or lung volume reduction surgery were excluded. There were 34 patients in each group. The two groups were evenly matched for age, sex, operation performed, severity of lung disease, and nutritional status. Fifteen patients in each group (44%) had an air leak at the completion of surgery. The duration of the air leak was shorter in the water seal group than in the suction group (mean +/- SEM, 1.50 +/- 0.32 days vs 3.27 +/- 0.80 days, respectively; p = 0.05). The mean times to removal of chest tubes were 3.33 +/- 0.35 days in the water seal group and 5.47 +/- 0.98 days in the suction group (p = 0.06). The length of stapled parenchyma was measured for each patient and averaged 24.9 cm for the water seal group and 18.5 cm for the suction group (p = 0.18). When corrected for the length of staple lines, the duration of air leaks and days with chest tube were dramatically lower in the water seal group (p = 0.02 and p = 0.02, respectively). Placing chest tubes on water seal after a brief period of suction after pulmonary resection shortens the duration of the air leak and likely decreases the time that the chest tubes remain in place. Adoption of this practice may result in lower morbidity and lower hospital costs.

  15. Wu-Ling-San formula prophylaxis against recurrent calcium oxalate nephrolithiasis - a prospective randomized controlled trial.

    Science.gov (United States)

    Lin, Eugene; Ho, Lin; Lin, Mao-Sheng; Huang, Min-Ho; Chen, Wen-Chi

    2013-01-01

    Wu-Ling-San (WLS) formula has been proved to prevent calcium oxalate nephrolithiasis both in vitro and in vivo. This is the first prospective, randomized and placebo-controlled clinical trial of WLS in calcium oxalate nephrolithiasis prevention. All patients who enrolled were asked to drink enough fluid to urinate at least 2 L daily during the study period. A 24-hour urine collection was performed to establish the baseline levels of multiple urinary parameters before taking the medicine. The patients were randomized and divided into two groups. The medication group took 2 gm WLS formula three times daily for 1 month. The control group took 2 gm placebo three times daily for 1 month. A 24-hour urine collection was performed to evaluate multiple urinary and serum parameters from all patients during the study period. A total of 39 patients were enrolled and 28 patients completed the study. Fourteen patients were allocated to WLS group and 14 patients to placebo group. After treatment, the mean urine output level increased to 2796.4 ± 525.7 ml/day (percentage of change, 13.9 %) in the WLS formula group. With placebo therapy, the mean decreased slightly to 2521.4 ± 762.7ml/day (percentage of change, -5.7 %). The percentage of change was significantly different between the two groups (independent t-test, P=0.02). No patient complained of side effects, such as fatigue, dizziness, musculoskeletal symptoms, or gastrointestinal disturbance. WLS formula is a promising adjunct to surgical and medical management of kidney stones. Active therapy with WLS formula has a positive effect on diuresis without leading to electrolyte imbalance.

  16. Triclosan-coated sutures and sternal wound infections: a prospective randomized clinical trial.

    Science.gov (United States)

    Steingrimsson, S; Thimour-Bergström, L; Roman-Emanuel, C; Scherstén, H; Friberg, Ö; Gudbjartsson, T; Jeppsson, A

    2015-12-01

    Surgical site infection is a common complication following cardiac surgery. Triclosan-coated sutures have been shown to reduce the rate of infections in various surgical wounds, including wounds after vein harvesting in coronary artery bypass grafting patients. Our purpose was to compare the rate of infections in sternotomy wounds closed with triclosan-coated or conventional sutures. A total of 357 patients that underwent coronary artery bypass grafting were included in a prospective randomized double-blind single-center study. The patients were randomized to closure of the sternal wound with either triclosan-coated sutures (Vicryl Plus and Monocryl Plus, Ethicon, Inc., Somerville, NJ, USA) (n = 179) or identical sutures without triclosan (n = 178). Patients were followed up after 30 days (clinical visit) and 60 days (telephone interview). The primary endpoint was the prevalence of sternal wound infection according to the Centers for Disease Control and Prevention (CDC) criteria. The demographics in both groups were comparable, including age, gender, body mass index, and rate of diabetes and smoking. Sternal wound infection was diagnosed in 43 patients; 23 (12.8%) sutured with triclosan-coated sutures compared to 20 (11.2%) sutured without triclosan (p = 0.640). Most infections were superficial (n = 36, 10.1%), while 7 (2.0%) were deep sternal wound infections. There were 16 positive cultures in the triclosan group and 17 in the non-coated suture group (p = 0.842). The most commonly identified main pathogens were Staphylococcus aureus (45.4%) and coagulase-negative staphylococci (36.4%). Skin closure with triclosan-coated sutures did not reduce the rate of sternal wound infection after coronary artery bypass grafting. (clinicaltrials.gov: NCT01212315).

  17. Prospective randomized clinical trial of aggressive rehabilitation after acute Achilles tendon ruptures repaired with Dresden technique.

    Science.gov (United States)

    De la Fuente, Carlos; Peña y Lillo, Roberto; Carreño, Gabriel; Marambio, Hugo

    2016-03-01

    Rupture of the Achilles tendon is a common injury during working years. Aggressive rehabilitation may provide better outcomes, but also a greater chance of re-rupture. To determine if aggressive rehabilitation has better clinical outcomes for Achilles tendon function, Triceps surae function, one-leg heel rise capacity and lower complication rate during twelve weeks after percutaneous Achilles tendon repair compared to conventional rehabilitation. Randomized controlled trial. Thirty-nine patients were prospectively randomized. The aggressive group (n=20, 41.4 ± 8.3 years) received rehabilitation from the first day after surgery. The conventional group (n=19, 41.7 ± 10.7 years) rested for 28 days, before rehabilitation started. The statistical parameters were the Achilles tendon rupture score (ATRS), verbal pain scale, time to return to work, pain medication consumption, Achilles tendon strength, dorsiflexion range of motion (RoM), injured-leg calf circumference, calf circumference difference, one-leg heel rise repetition and difference, re-rupture rate, strength deficit rate, and other complication rates. Mixed-ANOVA and Bonferroni's post hoc test were performed for multiple comparisons. Student's t-test was performed for parameters measured on the 12th week. The aggressive group with respect to the conventional group had a higher ATRS; lower verbal pain score; lower pain medication consumption; early return to work; higher Achilles tendon strength; higher one-leg heel rise repetitions; and lower one-leg heel rise difference. The re-rupture rate was 5% and 5%, the strength deficit rate was 42% and 5%, and other complications rate was 11% and 15% in the conventional and aggressive group, respectively. Patients with Dresden repair and aggressive rehabilitation have better clinical outcomes, Achilles tendon function and one-leg heel rise capacity without increasing the postoperative complications rate after 12 weeks compared to rehabilitation with immobilization and

  18. 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

  19. A Prospective, Randomized, Double-Blind Study of Coblation versus Dissection Tonsillectomy in Adult Patients.

    Science.gov (United States)

    Rakesh, Singh; Anand, T S; Payal, Garg; Pranjal, Kulshreshtha

    2012-09-01

    This randomized double blind study was conducted prospectively to determine whether coblation tonsillectomy fared better than the conventional dissection method in terms of postoperative pain, bleeding, and rapidity of healing in adult Indian patients undergoing tonsillectomy. Sixty adult patients undergoing tonsillectomy for benign indications were randomized to have one tonsil removed by subcapsular radiofrequency ablation method and the other by conventional dissection method. The operative time and blood loss was noted for each side. Patients were evaluated at 6, 12, 24, 48, 72 h and then on 7th and 20th postoperative day for postoperative pain (by visual analog scale), bleeding, and tonsillar fossa healing. Statistical comparison was done using appropriate tests. The two groups were demographically matched. It took longer to perform the coblation procedure (15 vs 11 min) (P > 0.05). The operative blood loss on the radiofrequency side was 11 ml, vs 34 ml on the conventional side (P = 0.009). 77% patients said that the coblation side was less painful for the overall 20-day recovery period. There were significant differences seen at 6, 12, 24, 48, and 72 h in terms of postoperative pain scores. Beyond that, the pain was consistently less on the coblation side, but the difference was not significant. There was no case of reactionary or secondary hemorrhage in either arm. The healing took longer on the radiofrequency side. Coblation tonsillectomy is an easy to learn technique with significantly reduced operative blood loss and postoperative pain. Longer operative times maybe further reduced with experience.

  20. Physical therapy after prophylactic mastectomy with breast reconstruction: a prospective randomized study.

    Science.gov (United States)

    Unukovych, Dmytro; Johansson, Hemming; Johansson, Elizabeth; Arver, Brita; Liljegren, Annelie; Brandberg, Yvonne

    2014-08-01

    The rate of prophylactic mastectomies (PM) is increasing. Patients generally report high levels of health related quality of life and satisfaction after the procedure, whereas body image perception and sexuality may be negatively affected. The aim of the study was to evaluate the interest in physical therapy as a means of improving body image and sexuality in women after PM. Patients undergoing PM at Karolinska University Hospital between 2006 and 2010 were eligible. The following patient-reported outcome measures were used at study baseline and 2 years postoperatively: the body image scale (BIS), the sexual activity questionnaire (SAQ), the short-form health survey (SF-36), the hospital anxiety and depression scale (HAD), and a study specific "pain/motion/sensation scale". Out of 125 patients invited to participate in this prospective randomized study, 43 (34%) consented and were randomized into the intervention (n = 24, 56%) or control (n = 19, 44%) groups. There were no statistically significant between-group differences found with respect to BIS, SAQ, SF-36, HAD, and "pain/motion/sensation". Two years postoperatively, more than half of the patients in both groups reported problems like feeling less attractive, less sexually attractive, their body feeling less whole, and being dissatisfied with their body. A majority marked a decreased sensation in breast area. The interest in a physiotherapy intervention was limited among women who had undergone PM. The intervention did not show any substantial effects. A large proportion of patients reported specific body image related and pain/motion/sensation problems postoperatively. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. A prospective randomized antiplatelet trial of cilostazol versus clopidogrel in patients with bare metal stent

    Institute of Scientific and Technical Information of China (English)

    CHEN Yun-dai; LU Yan-ling; JIN Ze-ning; YUAN Fei; L(U) Shu-zheng

    2006-01-01

    Background Cilostazol is a newly developed antiplatelet drug that has been widely applied for clinical use. Its antiplatelet action appears to be mainly related to inhibition of intracellular phosphodiesterase activity. Recently,cilostazol has been used for antiplatelet therapy after coronary bare metal stent implantation for thrombosis and restenosis prevention. This prospective randomized and double blind trial was designed to investigate the safety and efficacy of cilostazol for the prevention of late restenosis and acute or subacute stent thrombosis.Methods One hundred and twenty patients who underwent elective stent were randomly assigned to treatment group with cilostazol 200 mg/d (n = 60), clopidogrel 75 mg/d and aspirin 100 mg/d or to control group with clopidogrel treatment 75 mg/d (n = 60) and aspirin 100 mg/d. Follow-up coronary angiography was performed 6-9 months later.Results Nine months major adverse cardio-cerebral event (MACCE) were lower in treatment groups (P<0.05).The quantitative coronary angiography (QCA) at 6 months follow-up showed that minimum lumen diameter(MLD) was higher in treatment group than that of control group [(2.14±0.52)mm vs (1.82 ±0.36)mm, P<0.05].Late lumen loss (LL) [(0.82 ± 0.42)mm vs (1.31 ± 0.58)mm; P<0.01 ], restenosis rate (RR) (14% vs 32%; P<0.05)and target lesion revascularizaion (TLR) rate (5% vs 17%; P<0.05) were lower in treatment group than in control group.Conclusion Cilostazol therapy is an effective regimen for prevention not only stent thrombosis but also RR and TLR through reducing MLD without the risk of increasing bleeding.

  2. A second cycle of tamsulosin in patients with distal ureteric stones: a prospective randomized trial.

    Science.gov (United States)

    Porpiglia, Francesco; Fiori, Cristian; Ghignone, Gianpaolo; Vaccino, Davide; Billia, Michele; Morra, Ivano; Ragni, Francesca; Scarpa, Roberto M

    2009-06-01

    To evaluate, in a prospective randomized pilot study, the effectiveness and safety of tamsulosin, administered in patients with distal ureteric stones and who have already undergone an unsuccessful first cycle of medical expulsive therapy (MET). We evaluated the effectiveness and safety of tamsulosin, administered as a further therapy, in patients previously unsuccessfully treated with combined expulsive 10-day therapy (tamsulosin + deflazacort) for distal ureteric stones. Ninety-one patients were enrolled and randomized into two groups, each receiving a different therapy for 10 days. Group A (46 patients) received a further cycle of tamsulosin (0.4 mg daily), and group B (45) did not. Age, gender, stone size, time to expulsion, number of acute episodes of colic during treatment and analgesic consumption were recorded. Patients who were not stone-free after the study period had ureteroscopy. The results were compared statistically using Student's t-, chi-square test and Fisher's exact test. The groups were comparable in age, gender and stone size (5.93 mm for group A and 6.03 mm for group B). The expulsion rate was significantly higher in group A (80%) than in group B (49%) (P < 0.01), whilst there were no differences between the groups in the number of colic episodes and analgesic use. There were no reported side-effects of medical therapy. A second cycle of 10 days of MET with tamsulosin in nonresponders to a 10-day first cycle of MET with tamsulosin and deflazacort is safe and effective, and therefore should be considered as an option in the management of uncomplicated distal ureteric stones.

  3. EFFECT OF INTRATHECAL ROPIVACAINE WITH DEXMEDETOMIDINE FOR OPERATIVE AND POST OPERATIVE ANALGESIA: A PROSPECTIVE RANDOMIZED STUDY

    Directory of Open Access Journals (Sweden)

    Nitish Kumar

    2014-03-01

    Full Text Available BACKGROUND: This prospective randomized double blind study was conducted to evaluate the effect and safety of intrathecal dexmedetomidine added to isobaric ropivacaine. MATERIALS AND METHODS: 120 adult female patients, who underwent vaginal hysterectomies, were randomly allocated to receive intrathecally either 3 ml of 0.75% isobaric ropivacaine + 0.5 ml normal saline (Group R or 3 ml of 0.75% isobaric ropivacaine +5 μg dexmedetomidine in 0.5 ml of normal saline (Group D. Following intrathecal administration, duration of onset of sensory and motor blockade, maximum dermatomal level achieved, duration of analgesia, hemodynamic parameters and incidence of side effects were observed. RESULTS: Duration of onset of sensory block upto T10, T8 and the highest level of block achieved i. e. T6 were similar in both the groups. The mean time of sensory regression to S2 was 297.71±34.11 min in group D and 221.35±22.70 min in group R. Time to achieve Bromage score 0 was significantly slower with the addition of dexmedetomidine (229.37±28.74 min in group R vs. 258.55±30.46 min in group D. Duration of postoperative analgesia was significantly greater in group D (270.00±38.75 min as compared to group R (174.77±22.31 min. The maximum VAS score for pain was less in group D (4.42±0.69 as compared to group R (7.03±0.78. There were no significant difference in hemodynamic parameters and incidence of side effects in both the groups. CONCLUSION: The addition of dexmedetomidine to ropivacaine intrathecally produces significantly longer sensory and motor blockade along with better postoperative analgesia, and excellent hemodynamic stability without any significant side effects.

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

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    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.)

  5. Alemtuzumab in lung transplantation: an open-label, randomized, prospective single center study.

    Science.gov (United States)

    Jaksch, P; Ankersmit, J; Scheed, A; Kocher, A; Muraközy, G; Klepetko, W; Lang, G

    2014-08-01

    Induction therapy with alemtuzumab followed by lower maintenance immunosuppression (IS) has been associated with reduced morbidity and mortality in abdominal and heart transplantation (TX). In the current study, alemtuzumab, in combination with reduced levels of maintenance IS, was compared to thymoglobulin in combination with standard IS. Sixty consecutive patients who underwent lung transplantation (LUTX) at a single center were prospectively randomized in two groups: group A received alemtuzumab in conjunction with reduced doses of tacrolimus, steroids and mycophenolate mofetil. Group B received thymoglobulin in association with standard dose IS. Patient and graft survival, freedom from acute cellular rejection (ACR), lymphocytic bronchiolitis, bronchiolitis obliterans syndrome, kidney function, infectious complications and posttransplant lymphoproliferative disorder were analyzed. Alemtuzumab induction therapy resulted in complete the absence of ACR episodes ≥ A2 within the first year post-TX. The difference to thymoglobulin was significant (alemtuzumab 0 vs. ATG 0.33; p = 0.019). All other factors studied did not show any differences between the two groups. Alemtuzumab induction therapy after LUTX in combination with reduced maintenance IS significantly reduces higher-grade rejection rates. This novel therapeutic agent had no impact on survival, infections rates, kidney function and incidence of malignancies.

  6. 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.

  7. COMPARATIVE EFFICACY OF MISOPROSTOL AND OXYTOCIN AS LABOR PREINDUCTION AGENTS: A PROSPECTIVE RANDOMIZED TRIAL

    Directory of Open Access Journals (Sweden)

    Zh. Abedi Asl

    2007-09-01

    Full Text Available The purpose of this study was to compare the efficacy and safety of misoprostol and oxytocin for induction of labor. In this prospective and randomized controlled trial one hundred twenty women with an unfavorable cervix who underwent labor induction were assigned to receive either intravenous high dose oxytocin(6mIu/min or intravaginal misoprostol 50µg every 6 hours for two doses. Twelve hours later if labor was not stablished oxytocin induction was initiated per standardized protocol (3mIu/min. Mean Bishop Score change (± SD over the initial 12 hours interval was significantly greater in the misoprostol group (11.98± 1.55 compared with the oxytocin group (8.83 ± 2.61. There were no statistically significant differences in the median duration of labor ( 449±261.1 min, 514.5±288.5 min, respectively;p=0.22 , the mode of delivery or the adverse maternal /neonatal out come among the two groups.Use of misoprostol as a labor preinduction / labor induction agent results in greater Bishop score changes compared with high dose oxytocin and both of them are comparable.

  8. Laparoscopic total extraperitoneal repair under spinal anesthesia versus general anesthesia: a randomized prospective study

    Science.gov (United States)

    Donmez, Turgut; Erdem, Vuslat Muslu; Sunamak, Oguzhan; Erdem, Duygu Ayfer; Avaroglu, Huseyin Imam

    2016-01-01

    Background Laparoscopic total extraperitoneal (TEP) inguinal hernia repair is a well-known approach to inguinal hernia repair that is usually performed under general anesthesia (GA). To date, no reports compare the efficacy of spinal anesthesia (SA) with that of GA for laparoscopic hernia repairs. The purpose of this study was to compare the surgical outcome of TEP inguinal hernia repair performed when the patient was treated under SA with that performed under GA. Materials and methods Between July 2015 and July 2016, 50 patients were prospectively randomized to either the GA TEP group (Group I) or the SA TEP group (Group II). Propofol, fentanyl, rocuronium, sevoflurane, and tracheal intubation were used for GA. Hyperbaric bupivacaine (15 mg) and fentanyl (10 µg) were used for SA to achieve a sensorial level of T3. Intraoperative events related to SA, operative and anesthesia times, postoperative complications, and pain scores were recorded. Each patient was asked to evaluate the anesthetic technique by using a direct questionnaire filled in 3 months after the operation. Results All the procedures were completed by the allocated method of anesthesia as there were no conversions from SA to GA. Pain was significantly less for 1 h (Pinguinal hernia repair can be safely performed under SA, and SA was associated with less postoperative pain, better recovery, and better patient satisfaction than GA. PMID:27822053

  9. Residual Spinal Cord Compression Following Hemilaminectomy and Mini-Hemilaminectomy in Dogs: A Prospective Randomized Study

    Science.gov (United States)

    Svensson, Gustaf; Simonsson, Ulrika S. H.; Danielsson, Fredrik; Schwarz, Tobias

    2017-01-01

    The aim of this study was to compare the reduction of spinal cord compression after surgical treatment of dogs with acute thoracolumbar intervertebral disc (IVD) extrusion achieved using hemilaminectomy versus mini-hemilaminectomy techniques. This was a prospective randomized study with client-owned dogs presented with acute IVD extrusion that were allocated to surgical treatment using hemilaminectomy (n = 15) or mini-hemilaminectomy (n = 15) techniques. Plain and intravenous-contrast computed tomography was performed pre- and postoperatively. The preoperative minimal cross-sectional dimension of the spinal cord (MDSCpre) and the postoperative minimal cross-sectional dimension of the spinal cord (MDSCpost) were measured at the level of greatest compression. The minimal diameter of the uncompressed spinal cord was measured in a similar way both pre- (MDUSCpre) and postoperatively (MDUSCpost). Dogs in the mini-hemilaminectomy group had significantly greater reduction of compression (RC) (p < 0.01) after surgery compared to dogs in the hemilaminectomy group. The mean RC in the hemilaminectomy group was 34.6% and in the mini-hemilaminectomy group 62.6%. Our results showed a significantly greater reduction of spinal cord compression for mini-hemilaminectomy compared to hemilaminectomy. Additionally, mini-hemilaminectomy could be a preferred method due to its minimal invasiveness and easier access to lateral fenestration. PMID:28386545

  10. 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.

  11. 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

  12. Benign painful elbow syndrome. First results of a single center prospective randomized radiotherapy dose optimization trial

    Energy Technology Data Exchange (ETDEWEB)

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

    2012-10-15

    Background and purpose: The goal of the present study was to evaluate the efficacy of two different dose-fractionation schedules for radiotherapy (RT) of patients with painful elbow syndrome. Patients and methods: Between February 2006 and February 2010, 199 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received RT in orthovoltage technique. One RT course 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, right after, and 6 weeks after RT by a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 80% direct after and 91% 6 weeks after RT. The mean VAS values before, after and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 59.6 {+-} 20.2 and 55.7 {+-} 18.0 (p = 0.463), 32.1 {+-} 24.5 and 34.4 {+-} 22.5 (p = 0.256), and 27.0 {+-} 27.7 and 23.5 {+-} 21.6 (p = 0.818). The mean CPS before, after, and 6 weeks after treatment was 8.7 {+-} 2.9 and 8.1 {+-} 3.1 (p = 0.207), 4.5 {+-} 3.2 and 5.0 {+-} 3.4 (p = 0.507), 3.9 {+-} 3.6 and 2.8 {+-} 2.8 (p = 0.186), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.103) and delayed response (p = 0.246) were found. Conclusion: RT is an effective treatment option for the management of benign painful elbow syndrome. For radiation protection reasons the dose for a RT series is recommended not to exceed 3.0 Gy. (orig.)

  13. Radiotherapy for achillodynia. Results of a single-center prospective randomized dose-optimization trial

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

    2013-02-15

    Background and purpose: The aim of this study was to compare the efficacy of two different dose-fractionation schedules for radiotherapy of patients with achillodynia. Patients and methods: Between February 2006 and February 2010, 112 consecutive evaluable patients were recruited for this prospective randomized trial. All patients underwent radiotherapy with an orthovoltage technique. One radiotherapy course consisted of 6 single fractions over 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 with a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 84% directly after and 88% 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 55.7 {+-} 21.0 and 58.2 {+-} 23.5 (p = 0.526), 38.0 {+-} 23.2 and 30.4 {+-} 22.6 (p = 0.076), and 35.4 {+-} 25.9 and 30.9 {+-} 25.4 (p = 0.521), respectively. The mean CPS before, directly after, and 6 weeks after treatment was 8.2 {+-} 3.0 and 8.9 {+-} 3.3 (p = 0.239), 5.6 {+-} 3.1 and 5.4 {+-} 3.3 (p = 0.756), 4.4 {+-} 2.6 and 5.3 {+-} 3.8 (p = 0.577), respectively. No statistically significant differences were found between the two single-dose trial arms for early (p = 0.366) and delayed response (p = 0.287). Conclusion: Radiotherapy is an effective treatment option for the management of achillodynia. For radiation protection, the dose of a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

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

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    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

  15. Regulated tailored suction vs regulated seal: a prospective randomized trial on air leak duration.

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    Brunelli, Alessandro; Salati, Michele; Pompili, Cecilia; Refai, Majed; Sabbatini, Armando

    2013-05-01

    The objective of this study was to compare the air leak duration of two regulated chest tube modes following pulmonary lobectomy. This is a prospective randomized trial on 100 consecutive pulmonary lobectomies (2010-11) performed for lung cancer. A single 24-French chest tube was connected to an electronic system capable of maintaining the pleural pressure within preset values (regulated suction mode) or within a physiological range (regulated seal mode). Patients were randomized to two groups: Group 1, regulated individualized suction (range: -11 to -20 cmH2O, according to lobectomy type); Group 2, regulated seal (-2 cmH2O). The main endpoint was the duration of air leak (h) calculated from the end of the operation to a value consistently below 20 ml/min. Patients with prolonged air leak (>168 h) were connected to a portable device before discharge. Their air leak duration was considered as 192 h. The sample size was calculated to detect 1-day difference in air leak duration with a statistical power of 80%. The two groups were well matched for several baseline and surgical characteristics. No crossovers occurred between groups. The average air leak duration (Group 1: 28 vs Group 2: 22.2, P = 0.6), and the number of patients with prolonged air leak (Group 1: 5 vs Group 2: 4, P = 0.7) and with other complications (Group 1: 6 patients vs Group 2: 7 patients, P = 0.9) were similar between the groups. Sixteen patients of Group 1 and 21 of Group 2 had an air leak present immediately after extubation. Among them, patients of Group 2 (regulated seal) had an air leak lasting 34.5 h less than those of Group 1 (regulated suction) (52.9 vs 87.4, P = 0.07). Regulated seal is as effective and safe as regulated suction in managing chest tubes following lobectomy. This information demonstrates with objective data the non-superiority of regulated suction vs regulated seal and may assist in future investigations on regulated pleural pressure.

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

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    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

  17. Prospective Randomized Study of Oral Diazepam and Baclofen on Spasticity in Cerebral Palsy

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    Laisram, Nonica; Wadhwa, Ranjan Kumar; Kothari, Shashank Yashwant

    2016-01-01

    Introduction Spastic cerebral palsy (CP) is the most common form of CP. Diazepam and Baclofen are the most commonly used oral drugs to manage spasticity. Study was designed to evaluate and compare their effects and safety in CP children. Aim Study was aimed to assess and compare outcome of oral Diazepam and Baclofen in spastic cerebral palsy children in terms of extent of reduction of spasticity and side effects profile. Materials and Methods Randomized prospective follow-up study was done for one year after giving Diazepam and Baclofen in weekly incremental doses upto recommended maximum dose to 60 children for three months. Two primary outcome measures were spasticity reduction and adverse effect profile. Spasticity reduction was measured by Modified Ashworth’s Scale (MAS) and Range of Motion improvement (ROM). Results After random allocation, there was no baseline difference between groups. Mean MAS score improved from 1.96±0.4 at baseline to 1.63±0.40 and 1.41± 0.36 at 1 month and 3 months for Diazepam and from 1.84±0.64 to 1.57±0.59 and 1.31± 0.48 respectively for Baclofen. Within the group reduction was significant with p-value = 0.0001. Intergroup comparison showed no statistically significant difference with p-value of 0.48 and 0.22 at 1 and 3 months. Baseline ROM showed significant improvement at 1 and 3 months with p value of 0.004 and 0.001 for Diazepam and 0.01 and 0.000 for Baclofen respectively with no statistically significant difference among two groups. Drowsiness was most common observed side effect in both the groups. Conclusion Patients showed significant improvement in spasticity as measured by Mean MAS score and range of motion in Diazepam as well as Baclofen group. Both drugs were found safe for use in children. Study couldn’t establish any difference between the two drugs. However studies with bigger sample size and longer follow- up assessing functional improvement in patients will be required in near future. PMID:27504360

  18. A prospective randomized controlled trial of two different sedation sequences for third molar removal in adults.

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    Khader, Ruba; Oreadi, Daniel; Finkelman, Matthew; Jarmoc, Marcin; Chaudhary, Sanjeet; Schumann, Roman; Rosenberg, Morton

    2015-02-01

    In oral and maxillofacial outpatient surgery, sedation techniques are an important component in patient management for a wide variety of surgical procedures. Fentanyl and midazolam are commonly used sedatives with different mechanisms of action and specific analgesic or amnestic properties. This study examined whether the order of their administration would affect a patient's pain perception or procedural vital signs. After institutional review board approval and written informed consent, a prospective, randomized, parallel-group clinical trial was conducted in patients who planned to undergo removal of at least 2 third molars under intravenous moderate sedation. Patients were randomly assigned to 1 of 2 groups. The fentanyl-first group received fentanyl and then midazolam; the midazolam-first group received midazolam and then fentanyl. Recollection of the intraoperative pain score was assessed 24 hours after surgery using the Wong-Baker FACES pain scale. The Mann-Whitney U test was used to assess for the presence of a statistically significant difference between the 2 groups. Statistically significant differences in procedural vital sign fluctuations were examined using the t test. Patients' satisfaction with the procedure was assessed and intergroup comparisons were made. Sixty-six patients were enrolled, 1 of whom did not complete the study. Recollected procedural pain scores at 24 hours after surgery were not statistically different between groups. Median scores on the Wong-Baker FACES pain scale for the 2 groups were 2.0 (interquartile range, 3.1) for the fentanyl-first group and 1.5 (interquartile range, 2.5) for the midazolam-first group (P = .333). There was no statistical difference in the change in vital signs from baseline to 2 surgical end points in the 2 groups. In addition, patient satisfaction with the procedure did not statistically differ between the 2 groups. In this study, selective sequencing of midazolam or fentanyl during an intravenous

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

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    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

  20. I-ONE therapy in patients undergoing total knee arthroplasty: a prospective, randomized and controlled study

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    Moretti Biagio

    2012-06-01

    Full Text Available Abstract Background Total knee arthroplasty (TKA is often associated with a severe local inflammatory reaction which, unless controlled, leads to persistent pain up to one year after surgery. Standard and accelerated rehabilitation protocols are currently being implemented after TKA, but no consensus exists regarding the long-term effects. Biophysical stimulation with pulsed electromagnetic fields (PEMFs has been demonstrated to exert an anti-inflammatory effect, to promote early functional recovery and to maintain a positive long-term effect in patients undergoing joint arthroscopy. The aim of this study was to evaluate whether PEMFs can be used to limit the pain and enhance patient recovery after TKA. Methods A prospective, randomized, controlled study in 30 patients undergoing TKA was conducted. Patients were randomized into experimental PEMFs or a control group. Patients in the experimental group were instructed to use I-ONE stimulator 4hours/day for 60days. Postoperatively, all patients received the same rehabilitation program. Treatment outcome was assessed using the Knee Society Score, SF-36 Health-Survey and VAS. Patients were evaluated pre-operatively and one, two, six and 12 months after TKA. Joint swelling and Non Steroidal Anti Inflammatory Drug (NSAID consumption were recorded. Comparisons between the two groups were carried out using a two-tail heteroschedastic Student’s t-test. Analysis of variance for each individual subject during the study was performed using ANOVA for multiple comparisons, applied on each group, and a Dunnet post hoc test. A p value  Results Pre-operatively, no differences were observed between groups in terms of age, sex, weight, height, Knee-Score, VAS, SF-36 and joint swelling, with the exception of the Functional Score. The Knee-Score, SF-36 and VAS demonstrated significantly positive outcomes in the I-ONE stimulated group compared with the controls at follow-ups. In the I-ONE group, NSAID use was

  1. A comparison between orthogonal and parallel plating methods for distal humerus fractures: a prospective randomized trial.

    Science.gov (United States)

    Lee, Sang Ki; Kim, Kap Jung; Park, Kyung Hoon; Choy, Won Sik

    2014-10-01

    With the continuing improvements in implants for distal humerus fractures, it is expected that newer types of plates, which are anatomically precontoured, thinner and less irritating to soft tissue, would have comparable outcomes when used in a clinical study. The purpose of this study was to compare the clinical and radiographic outcomes in patients with distal humerus fractures who were treated with orthogonal and parallel plating methods using precontoured distal humerus plates. Sixty-seven patients with a mean age of 55.4 years (range 22-90 years) were included in this prospective study. The subjects were randomly assigned to receive 1 of 2 treatments: orthogonal or parallel plating. The following results were assessed: operating time, time to fracture union, presence of a step or gap at the articular margin, varus-valgus angulation, functional recovery, and complications. No intergroup differences were observed based on radiological and clinical results between the groups. In our practice, no significant differences were found between the orthogonal and parallel plating methods in terms of clinical outcomes, mean operation time, union time, or complication rates. There were no cases of fracture nonunion in either group; heterotrophic ossification was found 3 patients in orthogonal plating group and 2 patients in parallel plating group. In our practice, no significant differences were found between the orthogonal and parallel plating methods in terms of clinical outcomes or complication rates. However, orthogonal plating method may be preferred in cases of coronal shear fractures, where posterior to anterior fixation may provide additional stability to the intraarticular fractures. Additionally, parallel plating method may be the preferred technique used for fractures that occur at the most distal end of the humerus.

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

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    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.

  3. Rib approximation without intercostal nerve compression reduces post-thoracotomy pain: a prospective randomized study.

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    Bayram, Ahmet Sami; Ozcan, Metin; Kaya, Fatma Nur; Gebitekin, Cengiz

    2011-04-01

    One of the most important considerations in the care of thoracic surgery patients is the control of pain, which leads to increased morbidity and relevant mortality. Between February and May 2009, 60 patients undergoing full muscle-sparing posterior minithoracotomy were prospectively randomized into two groups, according to the thoracotomy closure techniques. In the first group (group A), two holes were drilled into the sixth rib using a hand perforator, and sutures were passed through the holes in the sixth rib and were circled from the upper edge of the fifth rib, thereby compressing the intercostal nerve underneath the fifth rib. In the second group (group B), the intercostal muscle underneath the fifth rib was partially dissected along with the intercostal nerve, corresponding to the holes on the sixth rib. Two 1/0 polyglactin (Vicyrl) sutures were passed through the holes in the sixth rib and above the intercostal nerve. There were 30 patients in each group. The visual analog score, observer verbal ranking scale (OVRS) scores for pain, and Ramsay sedation scores were used to follow-up on postoperative analgesia and sedation. The von Frey hair test was used to evaluate hyperalgesia of the patients. The patients in group B had lower visual analog scores at rest and during coughing. The patients in group B had lower OVRS scores than group A patients. The groups were not statistically different in terms of the Ramsay sedation scores and von Frey hair tests. Thoracotomy closure by a technique that avoids intercostal nerve compression significantly decreases post-thoracotomy pain. Copyright © 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

  4. Glare disability and spherical aberration with five foldable intraocular lenses: a prospective randomized study.

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    Casprini, Fabrizio; Balestrazzi, Angelo; Tosi, Gian Marco; Miracco, Flavia; Martone, Gianluca; Cevenini, Gabriele; Caporossi, Aldo

    2005-02-01

    To compare differences in subjective glare and spherical aberration between five foldable intraocular lenses (IOLs) made of different materials and to different designs. This prospective study comprised 175 cataract patients who underwent phacoemulsification and were randomized to receive one of five types of foldable IOL (AcrySof MA30BA, Alcon; Sensar AR40, AMO; AcrySof SA30AL, Alcon; Sensar AR40e, AMO, and Tecnis Z9000, Pharmacia & Upjohn). All patients received a questionnaire investigating the incidence of subjective photic phenomena. Two months postoperatively, we collected data regarding subjective glare and evaluated pupil size, visual acuity and wavefront aberration of the cornea and eye. With regard to difficulty in performing ordinary activities under different light conditions and light and dark adaptation, the difference between the groups was not significant (p > 0.05, chi-squared test). With respect to difficulty in driving at night, the MA30BA group had a significant higher incidence of photic phenomena than the SA30AL, AR40e and Z9000 groups (p < 0.05, chi-squared test). Wavefront measurements revealed a significant difference between the Z9000, AR40e and SA30AL groups, which showed the lowest values, and the MA30BA group, which showed the highest value (p < 0.05, anova with Tamhane posthoc test). New generation IOLs such as the Pharmacia Z9000, AMO AR40e and AcrySof SA30AL have a lower incidence of glare and spherical aberrations; however, their impact on future IOL design should be conditioned by further data, especially regarding posterior capsule opacification.

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

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    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.

  6. Backfill for iliac-crest donor sites: a prospective, randomized study of coralline hydroxyapatite.

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    Bojescul, John A; Polly, David W; Kuklo, Timothy R; Allen, Thomas W; Wieand, Kay E

    2005-08-01

    We report on a prospective randomized study of coralline hydroxyapatite (CH) used as backfill for iliac-crest donor sites. Autogenous iliac-crest bone graft is routinely harvested for spinal fusion. Donor-site morbidity is underappreciated; the presumption is that donor sites regenerate. In this study, we assessed the biological viability of the backfill CH (Pro OsteonTM Implant 500 Hydroxyapatite Bone Void Filler; Interpore, Irvine, Calif) and compared donor-site morbidity after harvest. Twelve patients (11 men, 1 woman) were enrolled: 5 in the backfill group and 7 in the no-backfill group. As part of routine evaluations done preoperatively and 6 weeks, 3 months, 6 months, and 1 year postoperatively, plain radiographs and computed tomography (CT) scans were used to assess bone ingrowth, and technetium bone scans were used to assess biological activity. Postoperative pain analysis was also done. Ten patients (9 men, 1 woman) completed the study. Of the 4 completers in the backfill group, 3 (75%) showed bony ingrowth on plain radiographs and CT scans at 1 year; the fourth patient showed bony ingrowth only on plain radiographs. All 4 patients showed biological activity on bone scans and reported mild pain to no pain. Of the 6 completers in the no-backfill group, 1 (17%) showed bony ingrowth on plain radiographs and CT scans. No patient showed biological activity on bone scans at 1 year. CH aids in iliac-crest healing after bone-graft harvesting by acting as a biological osteoconductive matrix. Postoperative pain at the bone-graft site is potentially reduced. More studies of larger numbers of patients are needed to assess the true long-term benefits of this material in a clinical setting.

  7. Prospective Randomized Trial Comparing Hepatic Venous Outflow and Renal Function after Conventional versus Piggyback Liver Transplantation.

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    Marília D'Elboux Guimarães Brescia

    Full Text Available This randomized prospective clinical trial compared the hepatic venous outflow drainage and renal function after conventional with venovenous bypass (n = 15 or piggyback (n = 17 liver transplantation.Free hepatic vein pressure (FHVP and central venous pressure (CVP measurements were performed after graft reperfusion. Postoperative serum creatinine (Cr was measured daily on the first week and on the 14th, 21st and 28th postoperative days (PO. The prevalence of acute renal failure (ARF up to the 28th PO was analyzed by RIFLE-AKIN criteria. A Generalized Estimating Equation (GEE approach was used for comparison of longitudinal measurements of renal function.FHVP-CVP gradient > 3 mm Hg was observed in 26.7% (4/15 of the patients in the conventional group and in 17.6% (3/17 in the piggyback group (p = 0.68. Median FHVP-CVP gradient was 2 mm Hg (0-8 mmHg vs. 3 mm Hg (0-7 mm Hg in conventional and piggyback groups, respectively (p = 0.73. There is no statistically significant difference between the conventional (1/15 and the piggyback (2/17 groups regarding massive ascites development (p = 1.00. GEE estimated marginal mean for Cr was significantly higher in conventional than in piggyback group (2.14 ± 0.26 vs. 1.47 ± 0.15 mg/dL; p = 0.02. The conventional method presented a higher prevalence of severe ARF during the first 28 PO days (OR = 3.207; 95% CI, 1.010 to 10.179; p = 0.048.Patients submitted to liver transplantation using conventional or piggyback methods present similar results regarding venous outflow drainage of the graft. Conventional with venovenous bypass technique significantly increases the harm of postoperative renal dysfunction.ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01707810.

  8. Prospective randomized study of patients with insomnia and mild sleep disordered breathing.

    Science.gov (United States)

    Guilleminault, Christian; Davis, Kala; Huynh, Nelly T

    2008-11-01

    Patients with insomnia may present with mild and often unrecognized obstructive sleep apnea (OSA). To evaluate both subjective and objective outcomes of patients with complaints of insomnia and mild OSA who receive surgical treatment for OSA versus behavioral treatment with cognitive behavioral therapy for insomnia (CBT-I). Prospective study with crossover design of 30 patients with complaints of insomnia and mild OSA. Thirty subjects, matched for age and gender, were randomized with stratification to receive either CBT-I or surgical treatment of OSA as primary treatment. Patients were reassessed after completing the initial intervention and reassigned if agreeable to the alternative treatment option and assessed again on completion of both treatment arms. Outcome measures included clinical impression, Epworth Sleepiness Scale (ESS) score, Fatigue Severity Scale (FSS) score, and polysomnography (PSG) results. Surgery resulted in greater improvements in total sleep time (TST), slow wave sleep and REM sleep duration, respiratory disturbance index, apnea-hypopnea index, minimum oxygen saturation, FSS, and ESS. CBT-I also improved TST and resulted in shorter sleep latency. Surgical intervention for the management of patients with complaints of insomnia and mild OSA demonstrated greater improvement in both subjective and objective outcome measures. Initial treatment of underlying OSA in patients with insomnia was more successful in improving insomnia than CBT-I alone. However CBT-I as initial treatment improved TST compared to baseline; following surgical intervention, it had the additional benefit of further increasing TST and helped to control sleep onset difficulties that may be related to conditioning due to unrecognized symptoms of mild OSA.

  9. Randomized Prospective Trial Comparing the Use of Intravenous versus Oral Acetaminophen in Total Joint Arthroplasty.

    Science.gov (United States)

    Politi, Joel R; Davis, Richard L; Matrka, Alexis K

    2017-04-01

    Multimodal pain management has had a significant effect on improving total joint arthroplasty recovery and patient satisfaction. There is literature supporting that intravenous (IV) acetaminophen reduces postoperative pain and narcotic use in the total joint population. However, there are no studies comparing the effectiveness of IV vs oral (PO) acetaminophen as part of a standard multimodal perioperative pain regimen. One hundred twenty patients undergoing hip and knee arthroplasty surgeries performed by one joint arthroplasty surgeon were prospectively randomized into 2 groups. Group 1 (63 patients) received IV and group 2 (57 patients) received PO acetaminophen in addition to a standard multimodal perioperative pain regimen. Each group received 1 gram of acetaminophen preoperatively and then every 6 hours for 24 hours. Total narcotic use and visual analog scale (VAS) scores were collected every 4 hours postoperatively. The 24-hour average hydromorphone equivalents given were not different between groups (3.71 vs 3.48) at 24 hours (P = .76), or at any of the individual 4-hour intervals. The 24-hour average visual analog scale scores in group 1 (IV) was 3.00 and in group 2 (PO) was 3.40 (P = .06). None of the 4-hour intervals were significantly different except the first interval (0-4 hour postoperatively), which favored the IV group (P = .03). The use of IV acetaminophen may have a role when given intraoperatively to reduce the immediate pain after surgery. Following that, it does not provide a significant benefit in reducing pain or narcotic use when compared with the much less expensive PO form. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. 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.

  11. Thoracoscopic decortication vs tube thoracostomy with fibrinolysis for empyema in children: a prospective, randomized trial

    Science.gov (United States)

    St. Peter, Shawn D.; Tsao, Kuojen; Harrison, Christopher; Jackson, Mary Ann; Spilde, Troy L.; Keckler, Scott J.; Sharp, Susan W.; Andrews, Walter S.; Holcomb, George W.; Ostlie, Daniel J.

    2011-01-01

    Purpose Management of empyema has been debated in the literature for decades. Although both primary video-assisted thoracoscopic surgery (VATS) and tube thoracostomy with pleural instillation of fibrinolytics have been shown to result in early resolution when compared to tube thoracostomy alone, there is a lack of comparative data between these modes of management. Therefore, we conducted a prospective, randomized trial comparing VATS to fibrinolytic therapy in children with empyema. Methods After Institutional Review Board approval, children defined as having empyema by either loculation on imaging or more than 10,000 white blood cells/μL were treated with VATS or fibrinolysis. Based on our retrospective data using length of postoperative hospitalization as the primary end point, a sample size of 36 patients was calculated for an α of .5 and a power of 0.8. Fibrinolysis consisted of inserting a 12F chest tube followed by infusion of 4 mg tissue plasminogen activator mixed with 40 mL of normal saline at the time of tube placement followed by 2 subsequent doses 24 hours apart. Results At diagnosis, there were no differences between groups in age, weight, degree of oxygen support, white blood cell count, or days of symptoms. The outcome data showed no difference in days of hospitalization after intervention, days of oxygen requirement, days until afebrile, or analgesic requirements. Video-assisted thoracoscopic surgery was associated with significantly higher charges. Three patients (16.6%) in the fibrinolysis group subsequently required VATS for definitive therapy. Two patients in the VATS group required ventilator support after therapy, one of whom required temporary dialysis. No patient in the fibrinolysis group clinically worsened after initiation of therapy. Conclusions There are no therapeutic or recovery advantages between VATS and fibrinolysis for the treatment of empyema; however, VATS resulted in significantly greater charges. Fibrinolysis may pose less

  12. A prospective randomized trial of transnasal ileus tube vs nasogastric tube for adhesive small bowel obstruction

    Institute of Scientific and Technical Information of China (English)

    Xiao-Li Chen; Fena Ji; Qi Lin; Yi-Peng Chen; Jian-Jiang Lin; Feng Ye; Ji-Ren Yu; Yi-Jun Wu

    2012-01-01

    AIM:To study the therapeutic efficacy of a new transnasal ileus tube advanced endoscopically for adhesive small bowel obstruction.METHODS:A total of 186 patients with adhesive small bowel obstruction treated from September 2007 to February 2011 were enrolled into this prospective randomized controlled study.The endoscopically advanced new ileus tube was used for gastrointestinal decompression in 96 patients and ordinary nasogastric tube (NGT) was used in 90 patients.The therapeutic efficacy was compared between the two groups.RESULTS:Compared with the NGT group,the ileus tube group experienced significantly shorter time for relief of clinical symptoms and improvement in the findings of abdominal radiograph (4.1 ± 2.3 d vs 8.5 ± 5.0 d) and laboratory tests (P < 0.01).The overall effectiveness rate was up to 89.6% in the ileus tube group and 46.7% in the NGT group (P < 0.01).And 10.4% of the patients in the ileus tube group and 53.3% of the NGT group underwent surgery.For recurrent adhesive bowel obstruction,ileus tube was also significantly more effective than NGT (95.8% vs 31.6%).In the ileus tube group,the drainage output on the first day and the length of hospital stay were significantly different depending on the treatment success or failure (P < 0.05).The abdominal radiographic improvement was correlated with whether or not the patient underwent surgery.CONCLUSION:Ileus tube can be used for adhesive small bowel obstruction.Endoscopic placement of the ileus tube is convenient and worthy to be promoted despite the potential risks.

  13. OZONE NUCLEOLYSIS IN LUMBAR INTERVERTEBRAL DISC HERNIATION: NON - RANDOMIZED PROSPECTIVE ANALYSIS

    Directory of Open Access Journals (Sweden)

    Vivekananda S

    2015-05-01

    Full Text Available STUDY DESI GN: Non - randomized, prospective analysis of 68 patients of lumbar disc herniation treated with ozone nucleolysis. OBJECTIVE: To assess the patients with lumbar disc herniation treated with intradiscal ozone, pre and post ozone nucleolysis, for pain using Visual Analog Scale (VAS functional & disability score using Japanese Orthopedic Association (JOA Clinical Symptom Score. SUMMARY OF BACKGROUN D DATA: Ozone therapy for disc herniation is becoming popu lar because of its minimal invasive, lesser recurrences and remarkably fewer side effects. Successful outcomes of ozone therapy have been reported from various European & Indian centers. METHODS: A series of 68 patients were treated with ozone therapy for lumbar disc herniation from January 2009 to January 2012. The procedure is done under C - arm guidance under local anesthesia by “Single sitting double injection technique”. All patients were assessed using VAS for radiation pain & back pain, Clinical Symptom Score of the Japanese Orthopaedic Association (JOA for a Patient with Lumbar Disc Herniation, pre op and post op, on day one, after a week, two weeks, first month, third months, sixth month one year second year. Were classified them as Good, Moder ate & Poor outcome. RESULTS: Out of 68 patients 89.7% (61/68 patients had good outcome, 7.35% (5/68 patients had moderate outcome, 2.95% (2/68 had poor outcome. Intra - op in 1 patient where ozone spread in Para spinal muscles but had no postoperative pro blem.4 patients had mild nausea, 2 had mild headache & No infection. CONCLUSIONS: Ozone nucleolysis is a new, minimally invasive procedure done under local anesthesia & has shown effective results in the treatment of contained intervertebral disc herniatio n with no side effects.

  14. Synthetic porous ceramic compared with autograft in scoliosis surgery. A prospective, randomized study of 341 patients.

    Science.gov (United States)

    Ransford, A O; Morley, T; Edgar, M A; Webb, P; Passuti, N; Chopin, D; Morin, C; Michel, F; Garin, C; Pries, D

    1998-01-01

    We have evaluated the use of a synthetic porous ceramic (Triosite) as a substitute for bone graft in posterior spinal fusion for idiopathic scoliosis. In a prospective, randomised study 341 patients at five hospitals in the UK and France were randomly allocated either to autograft from the iliac crest or rib segments (171) or to receive Triosite blocks (170). All patients were assessed after operation and at 3, 6, 12 and 18 months. The two groups were similar with regard to all demographic and baseline variables, but the 184 treated in France (54%) had Cotrel-Dubouset instrumentation and the 157 treated in the UK usually had Harrington-Luque implants. In the Triosite group the average Cobb angle of the upper curve was 56 degrees, corrected to 24 degrees (57%). At 18 months, the average was 26 degrees (3% loss). In the autograft group the average preoperative upper curve of 53 degrees was corrected to 21 degrees (60%). At 18 months the mean curve was 25 degrees (8% loss). Pain levels after operation were similar in the two groups, being mild in most cases. In the Triosite group only three patients had problems of wound healing, but in the autograft group, 14 patients had delayed healing, infection or haematoma in the spinal wound. In addition, 15 autograft patients had pain at the donor site at three months. Seven had infections, two had haematoma and four had delayed healing. The haematological and serum biochemistry results showed no abnormal trends and no significant differences between the groups. There were no adverse events related to the graft material and no evidence of allergenicity. Our results suggest that Triosite synthetic porous ceramic is a safe and effective substitute for autograft in these patients. Histological findings on biopsy indicate that Triosite provides a favourable scaffolding for the formation of new bone and is gradually incorporated into the fusion mass.

  15. Cocktail sedation containing propofol versus conventional sedation for ERCP: a prospective, randomized controlled study

    Directory of Open Access Journals (Sweden)

    Angsuwatcharakon Phonthep

    2012-08-01

    Full Text Available Abstract Background ERCP practically requires moderate to deep sedation controlled by a combination of benzodiazepine and opiod. Propofol as a sole agent may cause oversedation. A combination (cocktail of infused propofol, meperidine, and midazolam can reduce the dosage of propofol and we hypothesized that it might decrease the risk of oversedation. We prospectively compare the efficacy, recovery time, patient satisfactory, and side effects between cocktail and conventional sedations in patients undergoing ERCP. Methods ERCP patients were randomized into 2 groups; the cocktail group (n = 103 and the controls (n = 102. For induction, a combination of 25 mg of meperidine and 2.5 mg of midazolam were administered in both groups. In the cocktail group, a bolus dose of propofol 1 mg/kg was administered and continuously infused. In the controls, 25 mg of meperidine or 2.5 mg/kg of midazolam were titrated to maintain the level of sedation. Results In the cocktail group, the average administration rate of propofol was 6.2 mg/kg/hr. In the control group; average weight base dosage of meperidine and midazolam were 1.03 mg/kg and 0.12 mg/kg, respectively. Recovery times and patients’ satisfaction scores in the cocktail and control groups were 9.67 minutes and 12.89 minutes (P = 0.045, 93.1and 87.6 (P P Conclusions Cocktail sedation containing propofol provides faster recovery time and better patients’ satisfaction for patients undergoing ERCP. However, mild degree of desaturation may still develop. Trial registration ClinicalTrials.gov, NCT01540084

  16. 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.

  17. Laparoscopic total extraperitoneal repair under spinal anesthesia versus general anesthesia: a randomized prospective study

    Directory of Open Access Journals (Sweden)

    Donmez T

    2016-10-01

    Full Text Available Turgut Donmez,1 Vuslat Muslu Erdem,2 Oguzhan Sunamak,3 Duygu Ayfer Erdem,2 Huseyin Imam Avaroglu1 1Department of General Surgery, 2Department of Anesthesiology and Reanimation, Lutfiye Nuri Burat State Hospital, 3Department of General Surgery, Haydarpasa Numune Training and Research Hospital, Istanbul, Turkey Background: Laparoscopic total extraperitoneal (TEP inguinal hernia repair is a well-known approach to inguinal hernia repair that is usually performed under general anesthesia (GA. To date, no reports compare the efficacy of spinal anesthesia (SA with that of GA for laparoscopic hernia repairs. The purpose of this study was to compare the surgical outcome of TEP inguinal hernia repair performed when the patient was treated under SA with that performed under GA. Materials and methods: Between July 2015 and July 2016, 50 patients were prospectively randomized to either the GA TEP group (Group I or the SA TEP group (Group II. Propofol, fentanyl, rocuronium, sevoflurane, and tracheal intubation were used for GA. Hyperbaric bupivacaine (15 mg and fentanyl (10 µg were used for SA to achieve a sensorial level of T3. Intraoperative events related to SA, operative and anesthesia times, postoperative complications, and pain scores were recorded. Each patient was asked to evaluate the anesthetic technique by using a direct questionnaire filled in 3 months after the operation. Results: All the procedures were completed by the allocated method of anesthesia as there were no conversions from SA to GA. Pain was significantly less for 1 h (P<0.0001 and 4 h (P=0.002 after the procedure for the SA and GA groups, respectively. There was no difference between the two groups regarding complications, hospital stay, recovery, or surgery time. Generally, patients were more satisfied with SA than GA (P<0.020. Conclusion: TEP inguinal hernia repair can be safely performed under SA, and SA was associated with less postoperative pain, better recovery, and better

  18. Navigation of total knee arthroplasty: rotation of components and clinical results in a prospectively randomized study

    Directory of Open Access Journals (Sweden)

    Efe Turgay

    2011-01-01

    Full Text Available Abstract Background Navigation was introduced into total knee arthroplasty (TKA to improve accuracy of component position, function and survival of implants. This study was designed to assess the outcome of navigated TKA in comparison with conventional implantation with the focus on rotational component position and clinical mid-term results. Methods In a prospectively randomized single-blinded approach, 90 patients with primary gonarthrosis were assigned to three different groups. Thirty patients each were assigned to NexGen LPS without and with navigation (groups 1 and 2, and 30 patients to navigation with the Stryker Scorpio PS (group 3. The navigation system used was the imageless Stryker KneeTrac, version 1.0. Clinical outcome was assessed by a blinded observer applying the Knee Society Score (KSS and a visual analogue scale (VAS for pain. CT scans and radiographs were conducted prior to and 12 weeks after index surgery. Results Seventy-nine patients were available for clinical evaluation at 3 ± 0.4 years follow-up. Four implants had to be revised for early loosening or infection (4.4%. Four patients had died and three patients were not able to follow the invitation for clinical assessment. Functional results in the KSS were significantly lower after navigated TKA. Operation time and incisions with navigation were significantly longer. Significantly less radiological outliers with navigation were found for coronal alignment of the femur, only. Conclusion In this series, no beneficial effect for navigation in TKA could be shown assessing clinical data, as functional results in the presented series seemed to be lower after first generation navigated TKA. The clinical mid- to long-term value of navigation remains to be evaluated in larger patient series or meta-analyses at longer follow-up. Trial registration number DRKS 00000430

  19. Preoperative nutritional support in cancer patients with no clinical signs of malnutrition—prospective randomized controlled trial

    OpenAIRE

    Kabata, Paweł; Jastrzębski, Tomasz; Kąkol, Michał; Król, Karolina; Bobowicz, Maciej; Kosowska, Anna; Jaśkiewicz, Janusz

    2014-01-01

    Purpose Preoperative nutrition is beneficial for malnourished cancer patients. Yet, there is little evidence whether or not it should be given to nonmalnourished patients. The aim of this study was to assess the need to introduce preoperative nutritional support in patients without malnutrition at qualification for surgery. Methods This was a prospective, two-arm, randomized, controlled, open-label study. Patients in interventional group received nutritional supplementation for 14 days before...

  20. Juvéderm Volbella with Lidocaine for Lip and Perioral Enhancement: A Prospective, Randomized, Controlled Trial

    OpenAIRE

    Hervé Raspaldo, MD; Jonquille Chantrey, MD; Lakdhar Belhaouari, MD; Roy Saleh, MD; Diane K. Murphy, MBA; for the Juvéderm Volbella Study Group

    2015-01-01

    Background: Juvéderm Volbella with Lidocaine is a new hyaluronic acid dermal filler. Methods: In this prospective, randomized, multicenter study, 280 subjects desiring lip volume enhancement were treated with Juvéderm Volbella with Lidocaine or Restylane-L. Investigators rated treatment outcomes on Allergan’s Lip Fullness Scale, Perioral Lines Scale, and Oral Commissures Severity Scale. A blinded independent central reviewer (ICR) assessed 3-dimensional digital photographs using these scal...

  1. Adjunctive Self-hypnotic Relaxation for Outpatient Medical Procedures: A Prospective Randomized Trial with Women Undergoing Large Core Breast Biopsy

    OpenAIRE

    Lang, Elvira V.; Berbaum, Kevin S.; Faintuch, Salomao; Hatsiopoulou, Olga; Halsey, Noami; Li, Xinyu; Berbaum, Michael L.; Laser, Eleanor; Baum, Janet

    2006-01-01

    Medical procedures in outpatient settings have limited options of managing pain and anxiety pharmacologically. We therefore assessed whether this can be achieved by adjunct self-hypnotic relaxation in a common and particularly anxiety provoking procedure. 236 women referred for large core needle breast biopsy to an urban tertiary university-affiliated medical center were prospectively randomized to receive standard care (n=76), structured empathic attention (n= 82), or self-hypnotic relaxatio...

  2. Effect of water-soluble contrast in colorectal surgery: A prospective randomized trial

    Institute of Scientific and Technical Information of China (English)

    Jia-Hui Chen; Chung-Bao Hsieh; Pei-Chieh Chao; Hsiao-Dung Liu; Chung-Jueng Chen; Yao-Chi Liu; Jyh-Cherng Yu

    2005-01-01

    AIM: Postoperative gastrointestinal-tract motility is normally delayed. Early feeding after colorectal surgery has beenreposed recently, but late feeding is common. Gastrografin not only enhances bowel peristalsis, but also decreases bowel-wall edema. Whether contrast medium allows early oral feeding and reduces the duration of hospitalization requires clarification.METHODS: Fifty patients underwent elective colorectal surgery in a regional medical center. Patients were prospectively randomized into a Gastrografin group or control group (n = 25 each). Patients in the Gastrografin group began their feeding schedule with 100 mL of 5% dextrose water with 100 mL of Gastrografin on postoperative d 3 and were advanced to a full liquid diet when the contrast reached the colon in 4 h. Patients in the control group began their feeding schedule with 200 mL of 5% dextrosewater on postoperative d 3 and were advanced to a full liquid diet after the passage of flatus and stool. Nasogastric tubes were inserted for persistent postoperative vomiting. Fullness, nausea, vomiting, complications, time of anesthesia, time of operation, time of mobilization, time of oral feeding, and duration of hospital stay were recorded and analyzed with Student's t-test.RESULTS: In the Gastrografin group, one patient hadaspiration pneumonia and one patient had anastomotic leakage resulting in sepsis and eventual death. This mortality was excluded from the subsequent statistical analysis. In the control group, two patients had wound infections. There was no significant difference between the two groups at the time of anesthesia, time of operation, or time of mobilization. There were significant differences between the two groups in the time of oral feeding (3.3±0.3 d in the Gastrografin group vs4.8±0.4 d in the control group; P = odds ratio--, 95%CI [-0.5 to +0.7 d]) and in the length of hospital stay (7.6±1.1 d in the Gastrografingroup vs10.2±1.3 d in the control group; P = odds ratio--, 95% CI

  3. Video-assisted thoracic surgery reduces early postoperative stress. A single-institutional prospective randomized study

    Science.gov (United States)

    Asteriou, Christos; Lazopoulos, Achilleas; Rallis, Thomas; Gogakos, Apostolos S; Paliouras, Dimitrios; Tsakiridis, Kosmas; Zissimopoulos, Athanasios; Tsavlis, Drosos; Porpodis, Konstantinos; Hohenforst-Schmidt, Wolfgang; Kioumis, Ioannis; Organtzis, John; Zarogoulidis, Konstantinos; Zarogoulidis, Paul; Barbetakis, Nikolaos

    2016-01-01

    Background Video-assisted thoracic surgery (VATS) has been shown to effectively reduce postoperative pain, enhance mobilization of the patients, shorten in-hospital length of stay, and minimize postoperative morbidity rates. The aim of this prospective study is to evaluate neuroendocrine and respiratory parameters as stress markers in cancer patients who underwent lung wedge resections, using both mini muscle-sparing thoracotomy and VATS approach. Methods The patients were randomly allocated into two groups: Group A (n=30) involved patients who were operated on using the VATS approach, while in group B (n=30), the mini muscle-sparing thoracotomy approach was used. Neuroendocrine and biological variables assessed included blood glucose levels, C-reactive protein (CRP) levels, cortisol, epinephrine, and adrenocorticotropic hormone (ACTH) levels. Arterial oxygen (PaO2) and carbon dioxide (PaCO2) partial pressure were also evaluated. All parameters were measured at the following time points: 24 hours preoperatively (T1), 4 hours (T2), 24 hours (T3), 48 hours (T4), and 72 hours (T5), after the procedure. Results PaO2 levels were significantly higher 4 and 24 hours postoperatively in group A vs group B, respectively (T2: 94.3 vs 77.9 mmHg, P=0.015, T3: 96.4 vs 88.7 mmHg, P=0.034). Blood glucose (T2: 148 vs 163 mg/dL, P=0.045, T3: 133 vs 159 mg/dL, P=0.009) and CRP values (T2: 1.6 vs 2.5 mg/dL, P=0.024, T3: 1.5 vs 2.1 mg/dL, P=0.044) were found increased in both groups 4 and 24 hours after the procedure. However, their levels were significantly lower in the VATS group of patients. ACTH and cortisol values were elevated immediately after the operation and became normal after 48 hours in both groups, without significant difference. Postoperative epinephrine levels measured in group A vs group B, respectively, (T2: 78.9 vs 115.6 ng/L, P=0.007, T3: 83.4 vs 122.5 ng/L, P=0.012, T4: 67.4 vs 102.6 ng/L, P=0.021). The levels were significantly higher in group B. Conclusion This

  4. 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

  5. Behavioral approach with or without surgical intervention to the vulvar vestibulitis syndrome : A prospective randomized and non randomized study

    NARCIS (Netherlands)

    Schultz, WCMW; Gianotten, WL; vanderMeijden, WI; vandeWiel, HBM; Blindeman, L; Chadha, S; Drogendijk, AC

    1996-01-01

    This article describes the outcome of a behavioral approach with or without preceding surgical intervention in 48 women with the vulvar vestibulitis syndrome. In the first part of the study, 14 women with the vulvar vestibulitis syndrome were randomly assigned to one of two treatment programs: eithe

  6. 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 height-

  7. A Randomized Prospective Comparison of Patient-Assessed Satisfaction and Clinical Outcomes with Radioactive Seed Localization versus Wire Localization.

    Science.gov (United States)

    Bloomquist, Erica V; Ajkay, Nicolas; Patil, Sujata; Collett, Abigail E; Frazier, Thomas G; Barrio, Andrea V

    2016-01-01

    Radioactive seed localization (RSL) has emerged as an alternative to wire localization (WL) in patients with nonpalpable breast cancer. Few studies have prospectively evaluated patient satisfaction and outcomes with RSL. We report the results of a randomized trial comparing RSL to WL in our community hospital. We prospectively enrolled 135 patients with nonpalpable breast cancer between 2011 and 2014. Patients were randomized to RSL or WL. Patients rated the pain and the convenience of the localization on a 5-point Likert scale. Characteristics and outcomes were compared between groups. Of 135 patients enrolled, 10 were excluded (benign pathology, palpable cancer, mastectomy, and previous ipsilateral cancer) resulting in 125 patients. Seventy patients (56%) were randomized to RSL and 55 (44%) to WL. Fewer patients in the RSL group reported moderate to severe pain during the localization procedure compared to the WL group (12% versus 26%, respectively, p = 0.058). The overall convenience of the procedure was rated as very good to excellent in 85% of RSL patients compared to 44% of WL patients (p patient satisfaction with RSL provides another incentive for surgeons to strongly consider RSL as an alternative to WL.

  8. 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

  9. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions

    Energy Technology Data Exchange (ETDEWEB)

    Mooney, V. (Univ. of California, Irvine (USA))

    1990-07-01

    A randomized double-blind prospective study of pulsed electromagnetic fields for lumbar interbody fusions was performed on 195 subjects. There were 98 subjects in the active group and 97 subjects in the placebo group. A brace containing equipment to induce an electromagnetic field was applied to patients undergoing interbody fusion in the active group, and a sham brace was used in the control group. In the active group there was a 92% success rate, while the control group had a 65% success rate (P greater than 0.005). The effectiveness of bone graft stimulation with the device is thus established.

  10. Norfloxacin as prophylaxis against urethral strictures following transurethral resection of the prostate: an open, prospective, randomized study.

    Science.gov (United States)

    Hammarsten, J; Lindqvist, K

    1993-11-01

    An open, prospective, randomized study was performed to investigate the effect of norfloxacin prophylaxis on stricture formation and operative outcome after transurethral resection of the prostate. After resection, the 359 patients studied were randomly divided into 2 groups: 1) those given norfloxacin as prophylaxis for 15 days following removal of the catheter (norfloxacin group) and 2) those given no antimicrobial prophylaxis during the same period (control group). Of the patients 94 were excluded. At followup 6 to 12 months postoperatively, the number of strictures in the anterior urethra was 2 of 135 in the norfloxacin group and 22 of 130 in the control group (p norfloxacin group, fewer patients in that group were dissatisfied with the operative outcome. The results suggest that norfloxacin provides effective prophylaxis against stricture formation after transurethral resection of the prostate.

  11. The use of cold therapy after anterior cruciate ligament reconstruction. A prospective, randomized study and literature review.

    Science.gov (United States)

    Konrath, G A; Lock, T; Goitz, H T; Scheidler, J

    1996-01-01

    We performed a randomized, prospective study to assess the effectiveness of postoperative cold therapy in patients who had anterior cruciate ligament reconstructions. Drain output, length of hospital stay, range of motion, and use of pain medication were all assessed. Patients were randomized into one of four groups after surgery. Group 1 patients had a cooling pad applied to the knee postoperatively and set at a temperature of 40 degrees to 50 degrees F, Group 2 had the cooling pad set at 70 degrees to 80 degrees F, Group 3 received ice packs, and Group 4 received no cold therapy of any kind. The skin temperatures in Groups 1 and 3 were significantly lower than the skin temperatures in Groups 2 and 4 (P cold therapy were seen in any group. Thus, both ice packs and cooling pads significantly decreased knee temperature, but we found no objective benefits in the early postoperative course due to this decrease in temperature.

  12. 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 suppository = 3; P suppository = 44; P suppository = 24; P = 0.016, Fisher's exact). Endoscopist data available for 151 patients (enema = 76; suppository = 75) revealed: average depth of insertion (enema = 53.6 +/- 11.6 cm; suppository 46.3 +/- 13.7 cm; P suppository = 34 (45.3%); P suppositories.

  13. 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.

  14. [Caudal epidural steroid injection in the treatment of chronic discogenic low back pain. Comparative, prospective and randomized study].

    Science.gov (United States)

    Cervera-Irimia, J; Tomé-Bermejo, F

    2013-01-01

    There is no consensus on the treatment of chronic low back pain of disc origin in the medical literature. The few prospective, randomized, controlled studies evaluating the effectiveness of caudal epidural steroid injections (CESI) have obtained contradictory results. The aim of this study is to evaluate the efficacy of CEI in reducing pain and improving the associated disability. This is a prospective, randomized, case-control study of a group of 46 patients with chronic low back disc pain. Patients were randomly allocated into 2 groups to either receive fluoroscopy guided CESI (CESI-group), or oral non-steroidal anti-inflammatory drugs (NSAID-group). All patients were clinically evaluated at 4, 12, and 24 weeks, and according to the indications of the Spanish Society for Study of Diseases of the Spine (GEER). Lumbar pain, measured by the visual analog scale (VAS) and the Oswestry Low Back Pain Disability Questionnaire (ODQ), did not improve significantly during follow-up in any of the two study groups (P>.05). Younger patients, women, patients with shorter duration of symptoms, low physical job demand, without leg pain, and sport-active, included in CESI-group showed a trend towards better results, but none reached statistical significance (P>.05). The present study has not demonstrated the superiority of CESI over NSAIDs in treating chronic low back pain of disc origin. While CESI could show some improvement in patients with degenerative lumbar disc disease, we consider it should be used with caution, informing patients about realistic expectations on the success of treatment. Copyright © 2013 SECOT. Published by Elsevier Espana. All rights reserved.

  15. 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.

  16. 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.

  17. 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.

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

    DEFF Research Database (Denmark)

    Bisgaard, T; Klarskov, B; Trap, R;

    2002-01-01

    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...

  19. Scandinavian Prospects for a Place-Based Randomized Experiment on Burglary Reduction

    DEFF Research Database (Denmark)

    Sorensen, David Woodrow Mattson

    2007-01-01

    Despite their widespread implementation, there is a surprising absence of clear-cut, unambiguous evidence concerning the effectiveness of situational crime prevention approaches (e.g. alarms, neighborhood watch, property-marking) on residential burglary. This absence of evidence - which should no......-based, randomized experimental design - which this author argues should be easier to implement in Scandinavia than elsewhere....

  20. Big data: Are large prospective randomized trials obsolete in the future?

    Science.gov (United States)

    Hudis, Clifford A

    2015-11-01

    Big data represents a new opportunity to increase our understanding of cancer care as it is practiced globally and to improve it through the refinement of clinic guidelines and the identification of knowledge gaps. Here we review the historical approach to evidence development (randomized clinical trials), some of their limitations, and the complementary role that big data analytics may play.

  1. Evaluation of 5 versus 10 granulocyteaphaeresis sessions in steroid-dependent ulcerative colitis: A pilot, prospective, multicenter, randomized study

    Institute of Scientific and Technical Information of China (English)

    Elena Ricart; Maria Esteve; Montserrat Andreu; Francesc Casellas; David Monfort; Miquel Sans; Natalia Oudovenko; Raúl Lafuente; Julián Panés

    2007-01-01

    AIM: To evaluate the efficacy of 5 compared to 10 granulocyteaphaeresis sessions in patients with active steroid-dependent ulcerative colitis.METHODS: In this pilot, prospective, multicenter randomized trial, 20 patients with moderately active steroid-dependent ulcerative colitis were randomized to 5 or 10 granulocyteaphaeresis sessions. The primary objective was clinical remission at wk 17. Secondary measures included endoscopic remission and steroid consumption.RESULTS: Nine patients were randomized to 5 granulocyteaphaeresis sessions (group 1) and L1 patients to 10 granulocyteaphaeresis sessions (group 2). At wk 17, 37.5% of patients in group 1 and 45.45% of patients in group 2 were in clinical remission. Clinical remission was accompanied by endoscopic remission in all cases.Eighty-six percent of patients achieving remission were steroid-free at wk 17. Daily steroid requirements were significantly lower in group 2. Eighty-nine per cent of patients remained in remission during a one year follow-up. One serious adverse event, not related to the study therapy, was reported.CONCLUSION: Granulocyteaphaeresis is safe and effective for the treatment of steroid-dependent ulcerative colitis. In this population, increasing the number of aphaeresis sessions is not associated with higher remission rates, but affords a significant steroid-sparing effect.

  2. A prospective, randomized study of empirical antifungal therapy for the treatment of chemotherapy-induced febrile neutropenia in children.

    Science.gov (United States)

    Caselli, Désirée; Cesaro, Simone; Ziino, Ottavio; Ragusa, Pietro; Pontillo, Alfredo; Pegoraro, Anna; Santoro, Nicola; Zanazzo, Giulio; Poggi, Vincenzo; Giacchino, Mareva; Livadiotti, Susanna; Melchionda, Fraia; Chiodi, Marcello; Aricò, Maurizio

    2012-07-01

    Given that the rationale for empirical antifungal therapy in neutropenic children is limited and based on adult patient data, we performed a prospective, randomized, controlled trial that evaluated 110 neutropenic children with persistent fever. Those at high risk for invasive fungal infections (IFI) received caspofungin (Arm C) or liposomal amphotericinB (Arm B); those with a lower risk were randomized to receive Arm B, C, or no antifungal treatment (Arm A). Complete response to empirical antifungal therapy was achieved in 90/104 patients (86·5%): 48/56 at high risk (85·7%) [88·0% in Arm B; 83·9% in Arm C (P = 0·72)], and 42/48 at low risk (87·5%) [87·5% in control Arm A, 80·0% Arm B, 94·1% Arm C; (P = 0·41)]. None of the variables tested by multiple logistic regression analysis showed a significant effect on the probability to achieve complete response. IFI was diagnosed in nine patients (8·2%, 95% confidence interval, 3·8-15·0). This randomized controlled study showed that empirical antifungal therapy was of no advantage in terms of survival without fever and IFI in patients aged <18 years and defined with low risk of IFI. Higher risk patients, including those with relapsed cancer, appear to be the target for empirical antifungal therapy during protracted febrile neutropenia.

  3. 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.

  4. Taurolidine reduces the tumor stimulating cytokine interleukin-1beta in patients with resectable gastrointestinal cancer: a multicentre prospective randomized trial

    Directory of Open Access Journals (Sweden)

    Mueller Joachim M

    2009-03-01

    Full Text Available Abstract Background The effect of additional treatment strategies with antineoplastic agents on intraperitoneal tumor stimulating interleukin levels are unclear. Taurolidine and Povidone-iodine have been mainly used for abdominal lavage in Germany and Europe. Methods In the settings of a multicentre (three University Hospitals prospective randomized controlled trial 120 patients were randomly allocated to receive either 0.5% taurolidine/2,500 IU heparin (TRD or 0.25% povidone-iodine (control intraperitoneally for resectable colorectal, gastric or pancreatic cancers. Due to the fact that IL-1beta (produced by macrophages is preoperatively indifferent in various gastrointestinal cancer types our major outcome criterion was the perioperative (overall level of IL-1beta in peritoneal fluid. Results Cytokine values were significantly lower after TRD lavage for IL-1beta, IL-6, and IL-10. Perioperative complications did not differ. The median follow-up was 50.0 months. The overall mortality rate (28 vs. 25, p = 0.36, the cancer-related death rate (17 vs. 19, p = .2, the local recurrence rate (7 vs. 12, p = .16, the distant metastasis rate (13 vs. 18, p = 0.2 as well as the time to relapse were not statistically significant different. Conclusion Reduced cytokine levels might explain a short term antitumorigenic intraperitoneal effect of TRD. But, this study analyzed different types of cancer. Therefore, we set up a multicentre randomized trial in patients undergoing curative colorectal cancer resection. Trial registration ISRCTN66478538

  5. Taurolidine reduces the tumor stimulating cytokine interleukin-1beta in patients with resectable gastrointestinal cancer: a multicentre prospective randomized trial

    Science.gov (United States)

    Braumann, Chris; Gutt, Carsten N; Scheele, Johannes; Menenakos, Charalambos; Willems, Wilhelm; Mueller, Joachim M; Jacobi, Christoph A

    2009-01-01

    Background The effect of additional treatment strategies with antineoplastic agents on intraperitoneal tumor stimulating interleukin levels are unclear. Taurolidine and Povidone-iodine have been mainly used for abdominal lavage in Germany and Europe. Methods In the settings of a multicentre (three University Hospitals) prospective randomized controlled trial 120 patients were randomly allocated to receive either 0.5% taurolidine/2,500 IU heparin (TRD) or 0.25% povidone-iodine (control) intraperitoneally for resectable colorectal, gastric or pancreatic cancers. Due to the fact that IL-1beta (produced by macrophages) is preoperatively indifferent in various gastrointestinal cancer types our major outcome criterion was the perioperative (overall) level of IL-1beta in peritoneal fluid. Results Cytokine values were significantly lower after TRD lavage for IL-1beta, IL-6, and IL-10. Perioperative complications did not differ. The median follow-up was 50.0 months. The overall mortality rate (28 vs. 25, p = 0.36), the cancer-related death rate (17 vs. 19, p = .2), the local recurrence rate (7 vs. 12, p = .16), the distant metastasis rate (13 vs. 18, p = 0.2) as well as the time to relapse were not statistically significant different. Conclusion Reduced cytokine levels might explain a short term antitumorigenic intraperitoneal effect of TRD. But, this study analyzed different types of cancer. Therefore, we set up a multicentre randomized trial in patients undergoing curative colorectal cancer resection. Trial registration ISRCTN66478538 PMID:19309495

  6. Prospective randomized study comparing the Teleflex Medical SaphLITE Retractor to the Ethicon CardioVations Clearglide Endoscopic System

    Directory of Open Access Journals (Sweden)

    Schultz Scot C

    2006-09-01

    Full Text Available Abstract Background Several minimally invasive saphenous vein harvesting techniques have been developed to reduce morbidities associated with coronary artery bypass grafting. This prospective, randomized study was designed to compare two commonly used minimally invasive saphenous vein harvesting techniques, the SaphLITE Retractor System (Teleflex Medical and the Clearglide Endoscopic Vessel Harvesting System (Ethicon CardioVations, Inc.. Methods Between January 2003 and March 2004, a total of 200 patients scheduled for primary, nonemergent coronary artery bypass grafting, with or without concomitant procedures were randomized into two groups: SaphLITE (n = 100 and Clearglide (n = 100. Pre-, intra- and postoperative data was collected and subjected to statistical analysis. Randomization provided homogenous groups with respect to preoperative risk factors. Results Harvest location for the SaphLITE group was thigh (n = 40, lower leg (n = 5 and both lower leg and thigh (n = 55. The location of harvest for the Clearglide group was thigh (n = 3, lower leg (n = 16 and both lower leg and thigh (n = 81. The mean incision length was 3.6 cm (range, 2–6 in the SaphLITE group versus 2.1 cm (range, 1–4 in the Clearglide group (p Conclusion The saphenous vein can be safely harvested utilizing the SaphLITE and Clearglide systems. While the Clearglide system allows for fewer incisions (number and length and less harvest time, these benefits may be outweighed by the increased cost of the Clearglide system compared to the SaphLITE retractor.

  7. A Multifaceted Prospective Memory Intervention to Improve Medication Adherence: Design of a Randomized Control Trial

    Science.gov (United States)

    Insel, Kathie C.; Einstein, Gilles O.; Morrow, Daniel G.; Hepworth, Joseph T.

    2012-01-01

    Adherence to prescribed antihypertensive agents is critical because control of elevated blood pressure is the single most important way to prevent stroke and other end organ damage. Unfortunately, nonadherence remains a significant problem. Previous interventions designed to improve adherence have demonstrated only small benefits of strategies that target single facets such as understanding medication directions. The intervention described here is informed by prospective memory theory and performance of older adults in laboratory-based paradigms and uses a comprehensive, multifaceted approach to improve adherence. It incorporates multiple strategies designed to support key components of prospective remembering involved in taking medication. The intervention is delivered by nurses in the home with an education control group for comparison. Differences between groups in overall adherence following the intervention and 6 months later will be tested. Systolic and diastolic blood pressure levels also will be examined between groups and as it relates to adherence. Intra-individual regression is planned to examine change in adherence over time and its predictors. Finally, we will examine the association between executive function/working memory and adherence, predicting that adherence will be related to executive/working memory in the control group but not in the intervention group. PMID:23010608

  8. Prospective randomized controlled trial investigating the type of sutures used during hepatectomy

    Institute of Scientific and Technical Information of China (English)

    Norifumi Harimoto; Ken Shirabe; Tomoyuki Abe; Takafumi Yukaya; Eiji Tsujita; Tomonobu Gion; Kiyoshi Kajiyama; Takashi Nagaie

    2011-01-01

    AIM: To determine whether absorbable sutures or non-absorbable sutures are better in preventing surgical site infection (SSI), in this paper we discuss the results of a randomized clinical trial which examined the type of sutures used during hepatectomy. METHODS: All hepatic resections performed from January 2007 to November 2008 at the Department of Surgery at Iizuka Hospital in Japan were included in this study. There were 125 patients randomly assigned to an absorbable sutures (Vicryl) group or non-absorbable sutures (Silk) group. RESULTS: SSI was observed in 13.6% (17/125) patients participating in this study, 11.3% in the Vicryl group and 15.8% in the Silk group. Incisional SSI including superficial and deep SSI, was observed in 8% of the Vicryl group and 9.5% of the Silk group. Organ/ space SSI was observed in 3.2% of the Vicryl group and 6.0% of the Silk group. There were no significant differences, but among the patients with SSI, the period for recovery was significantly shorter for the Vicryl group compared to the Silk group. CONCLUSION: The incidence of SSI in patients receiving absorbable sutures and silk sutures is not significantly different in this randomized controlled study; however, the period for recovery in patients with SSI was significantly shorter for absorbable sutures.

  9. Comparison between proximal row carpectomy and four-corner fusion for treating osteoarthrosis following carpal trauma: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Edgard Novaes França Bisneto

    2011-01-01

    Full Text Available OBJECTIVE: To compare the functional results of carpectomy and four-corner fusion surgical procedures for treating osteoarthrosis following carpal trauma. METHODS: In this prospective randomized study, 20 patients underwent proximal row carpectomy or four-corner fusion to treat wrist arthritis and their functional results were compared. The midcarpal joint was free of lesions in all patients. RESULTS: Both proximal row carpectomy and four-corner fusion reduced the pain. All patients had a decreased range of motion after surgery. The differences between groups were not statistically significant. CONCLUSIONS: Functional results of the two procedures were similar as both reduced pain in patients with scapholunate advanced collapse/scaphoid non-union advanced collapse (SLAC/SNAC wrist without degenerative changes in the midcarpal joint.

  10. 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.

  11. Qualitative bacteriology in malignant wounds- a prospective, randomized, clinical study to compare the effect of honey and silver dressings

    DEFF Research Database (Denmark)

    Lund-Nielsen, Betina; Adamsen, Lis; Gottrup, Finn

    2011-01-01

    ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ Between 5% and 10% of cancer patients develop malignant wounds. In vitro and some clinical studies suggest that silver- or honey-coated dressings may have an antibacterial effect in nonmalignant wounds, but their possible antibacterial effect in malignant wounds remains unknown...... antibacterial effect of the honey or silver dressing could not be confirmed in these malignant wounds. Routine wound swabbing of malignant wounds is of little value and should be restricted to cases where signs of infection requiring antibiotic intervention are observed or where resistant organisms require....... A prospective, randomized, single-blind controlled clinical study was conducted to evaluate the bacteriology of malignant wounds and compare the effect of a honey-coated (Group A) to a silver-coated (Group B) dressing on the qualitative bacteriology of malignant wounds. All wound interventions were performed...

  12. A randomized prospective study to assess the efficacy of two cold-therapy treatments following carpal tunnel release.

    Science.gov (United States)

    Hochberg, J

    2001-01-01

    A prospective randomized study was performed comparing the efficacy of controlled cold therapy (CCT) with the efficacy of ice therapy in the postoperative treatment of 72 patients with carpal tunnel syndrome. Immediately after surgery, patients applied either a temperature-controlled cooling blanket (CCT) or a standard ice pack over their surgical dressings. Pain was assessed by visual analog scale and swelling by wrist circumference preoperatively, immediately after surgery, and on postoperative day 3. Patients kept log books of daily treatment times. Narcotic use (of Vicodin ES) was determined by pill count at day 3 and by daily log book recordings. Patients who used CCT showed significantly greater reduction in pain, edema (wrist circumference), and narcotic use at postoperative day 3 than did those using ice therapy. This study indicates that after carpal tunnel surgery, the use of CCT, compared with traditional ice therapy, provides patients with greater comfort and lessens the need for narcotics.

  13. Safety of fondaparinux for prevention of postoperative venous thromboembolism in urological malignancy: A prospective randomized clinical trial.

    Science.gov (United States)

    Hata, Kenichi; Kimura, Takahiro; Tsuzuki, Shunsuke; Ishii, Gen; Kido, Masahito; Yamamoto, Toshihiro; Sasaki, Hiroshi; Miki, Jun; Yamada, Hiroki; Furuta, Akira; Miki, Kenta; Egawa, Shin

    2016-11-01

    To prospectively evaluate the safety of postoperative fondaparinux in comparison with low molecular weight heparin in patients undergoing uro-oncological surgery. The present study was a prospective, single-blind, non-inferiority randomized trial. A total of 359 patients undergoing surgery for urological malignancy were enrolled from January 2011 to December 2012. A total of 298 of these patients (fondaparinux group, 152; low molecular weight heparin group, 146) were evaluable for the intention-to-treat-analysis. Patients were randomly assigned to low-dose unfractionated heparin, 5000 units twice daily until postoperative day 1 plus either fondaparinux 2.5 mg once daily or low molecular weight heparin 2000 units twice daily until postoperative day 5. The primary end-point was postoperative bleeding as by independent review, and the study was powered to show the non-inferiority of fondaparinux versus low molecular weight heparin. The other adverse events were evaluated. D-dimer and soluble fibrin monomer complex levels were measured perioperatively. Bleeding occurred in 21 patients (12 in the fondaparinux group and 9 in low molecular weight heparin group, respectively). No significant differences were detected in the incidence of postoperative bleeding and the other adverse events between the two groups. The D-dimer was elevated on postoperative day 1 in one patient (16.6 μg/mL). In another patient, the soluble fibrin monomer complex was elevated (109 μg/mL). Fondaparinux is non-inferior to low molecular weight heparin with respect to risk of bleeding. The favorable safety profile of fondparinux supports its prophylactic use as an alternative to low molecular weight heparin after surgery for urological malignancy. © 2016 The Japanese Urological Association.

  14. Recurrence of paroxysmal atrial fibrillation after pulmonary vein isolation: is repeat pulmonary vein isolation enough? A prospective, randomized trial.

    Science.gov (United States)

    Fichtner, Stephanie; Sparn, Korbinian; Reents, Tilko; Ammar, Sonia; Semmler, Verena; Dillier, Roger; Buiatti, Alexandra; Kathan, Susanne; Hessling, Gabriele; Deisenhofer, Isabel

    2015-09-01

    In patients with paroxysmal atrial fibrillation (pAF), pulmonary vein isolation (PVI) has become an accepted treatment option with single procedure success rates of 60-80%. A repeat ablation is performed in ∼30% of patients because of arrhythmia recurrence. The strategy for this repeat procedure is not defined. Patients with pAF recurrence after PVI were prospectively randomized and underwent a second ablation procedure with either PVI of all reconnected veins or PVI with an additional left atrial anterior line. Follow-up in our arrhythmia clinic was every 3 months up to 12 months including 7 day Holter monitoring. A total of 77 patients (mean age 63 ± 9 years, 69% males) were included in the analysis. A repeat PVI was performed in 41 patients, PVI + anterior line in 36 patients. After a follow-up of 12 months, 26 of 41 (63%) patients after repeat PVI and 18 of 36 (50%) patients with PVI + anterior line were in stable sinus rhythm off antiarrhythmic medication (P = 0.26). In most patients (12 of 15 patients with PVI and 14 of 18 patients with PVI + anterior line) with an arrhythmia recurrence after the second procedure, the recurring arrhythmia was paroxysmal AF. In 2 of 15 patients of the PVI group and in 4 of 18 patients of the PVI + anterior line group atypical flutter was the reoccurring arrhythmia (P = NS). In this prospective randomized trial, patients with a recurrence of paroxysmal AF had no better outcome after repeat PVI + one left atrial line compared with patients with repeat PVI only. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

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

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    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.

  16. Prospective randomized trial of surgery combined with preoperative and postoperative radiotherapy for rectal carcinoma

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    Objective To assess the effect of surgery combined with preoperative and postoperative radiotherapy(sandwich treatment)in rectal carcinoma.Methods From October 1990 to January 2002,260 patients with stage Ⅱ(117 patients)and stage Ⅲ(143 patients)rectal carcinoma were randomly divided into three groups:sandwich group(92 patients,group A),postoperative radiotherapy group(98 patients,Group B)and operation group(70 patients,Group C).The preoperative accelerated hyperfractionation(15Gy/6f/3d)was given for sandwic...

  17. 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 (SpO2), 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.

  18. Transcutaneous Electrical Nerve Stimulation Reduces Post-Thoractomy Ipsilateral Shoulder Pain. A Prospective Randomized Study.

    Science.gov (United States)

    Esteban González, Pedro; Novoa, Nuria M; Varela, Gonzalo

    2015-12-01

    The patient's position during an axillary thoracotomy can cause postoperative pain and decrease mobility of the ipsilateral shoulder. In this study, we assessed whether the implementation of a standardized analgesia program using transcutaneous electrical nerve stimulation (TENS) decreases local pain and improves ipsilateral shoulder mobility. Randomized, single-blind, single-center clinical trial of 50 patients who had undergone anatomical lung resection via axillary muscle-sparing thoracotomy. Patients were treated with TENS devices for 30 minutes every 8 hours, beginning on postoperative day 1. Pain and mobility of the affected limb were recorded at the same time on postoperative days 1 through 3. A visual analogue scale was used for pain assessment and shoulder mobility was assessed with a goniometer. Results were compared using a non-parametric test. Twenty-five patients were randomized to each group. Mean age of the control group was 62.7±9.3 years and 63.4±10.2 years in the experimental group. Shoulder mobility parameters were similar in both groups on all postoperative days. However, pain during flexion significantly decreased on day 2 (P=.03) and day 3 (P=.04) in the experimental group. The use of TENS decreases pain from shoulder flexion in patients undergoing axillary thoracotomy for pulmonary resection. Copyright © 2014 SEPAR. Published by Elsevier Espana. All rights reserved.

  19. Comparison of Postoperative Analgesic Efficacy of Penile Block, Caudal Block and Intravenous Paracetamol for Circumcision: A prospective Randomized Study

    Directory of Open Access Journals (Sweden)

    Ahmet Hakan Haliloglu

    2013-07-01

    Full Text Available Purpose To evaluate the postoperative analgesic efficacy of penile block, caudal block and intravenous paracetamol administration following circumcision. Materials and Methods In this prospective randomized study a total of 159 patients underwent circumcision under general anesthesia at urology clinic of Ufuk University Faculty of Medicine and Sorgun State Hospital between May 2012 and September 2012. The patients were randomized to three groups to receive penile block (Group 1, caudal block (Group 2 and intravenous paracetamol administration (group 3. Pain measurement of the patients was done via CHEOPS scoring system at 30,60,120 and 180 minutes postoperatively and compared. Statistical tests were performed with a conventional statistics program and statistical significance was set at a p value of < 0.05. Results The mean age of the patients was 5.7 years. Patients in group 1 had significantly lower pain score at 30 minutes compared to other two groups. At 60 minutes groups 1 and 2 had significantly lower score compared to group 3. At 120 and 180 minutes no difference between the groups was observed. No significant major complications were observed in all 3 groups. Conclusion Penile block and caudal block provide similar pain scores and painless postoperative periods after circumcision under general anesthesia. Intravenous paracetamol is insufficient at the early postoperative period. The three procedures were shown to be safe for analgesia following circumcision.

  20. Peristaltic pneumatic compression of the legs reduces fluid demand and improves hemodynamic stability during surgery: a randomized, prospective study.

    Science.gov (United States)

    Kiefer, Nicholas; Theis, Judith; Putensen-Himmer, Gabriele; Hoeft, Andreas; Zenker, Sven

    2011-03-01

    Perioperative fluid restriction might be beneficial in specific clinical settings. In this prospective, randomized and blinded study, we assessed whether peristaltic pneumatic compression of the legs can support restrictive fluid management strategies by reducing intraoperative fluid demand and improving hemodynamic stability. Seventy patients scheduled for minor surgery were randomly assigned to receive either intraoperative peristaltic pneumatic compression or placebo compression. Both groups received fluid therapy according to a goal-directed protocol with a crystalloid base rate of 2 ml · kg⁻¹ · h⁻¹ and bolus infusions of 250 ml crystalloids triggered by hypotension, tachycardia, or high Pleth Variability Index. Patients treated with peristaltic pneumatic compression received less intravenous fluid: median (interquartile range) 286 (499) versus 921 (900) ml (P pneumatic peristaltic compression group (P pneumatic peristaltic compression, the median cumulative time of hypotension was shorter (0 [12.5] vs. 22.6 [22.8] min; P = 0.002), fewer hypotensive events were recorded (39 vs. 137; P = 0.001), and median lowest individual systolic pressure was higher (92 [8] vs. 85 [16] mmHg; P = 0.002). This study demonstrates that peristaltic pneumatic compression of the legs significantly improves hemodynamic stability and reduces fluid demand during minor surgery.

  1. Efficacy of perioperative parecoxib injection on postoperative pain relief after laparoscopic cholecystectomy: A prospective,randomized study

    Institute of Scientific and Technical Information of China (English)

    Thawatchai Akaraviputh; Charay Leelouhapong; Varut Lohsiriwat; Somkiat Aroonpruksakul

    2009-01-01

    AIM: To determine the efficacy of perioperative parecoxib injection on postoperative pain relief after laparoscopic cholecystectomy.METHODS: A prospective, double-blind, randomized,placebo-controlled study was conducted on 70 patients who underwent elective laparoscopic cholecystectomy under general anesthesia at Siriraj Hospital, Bangkok,from January 2006 to December 2007. Patients were randomized to receive either 20 mg parecoxib infusion 30 min before induction of anesthesia and at 12 h after the first dose (treatment group), or normal saline infusion, in the same schedule, as a placebo (control group). The degree of the postoperative pain was assessed every 3 h in the first 24 h after surgery, and then every 12 h the following day, using a visual analog scale. The consumption of analgesics was also recorded.RESULTS: There were 40 patients in the treatment group, and 30 patients in the control group. The pain scores at each time point, and analgesic consumption did not differ between the two groups. However,there were fewer patients in the treatment group than placebo group who required opioid infusion within the first 24 h (60% vs 37%, P = 0.053).

  2. 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.

  3. Efficacy of IP6 + inositol in the treatment of breast cancer patients receiving chemotherapy: prospective, randomized, pilot clinical study.

    Science.gov (United States)

    Bacić, Ivan; Druzijanić, Nikica; Karlo, Robert; Skifić, Ivan; Jagić, Stjepan

    2010-02-12

    Prospective, randomized, pilot clinical study was conducted to evaluate the beneficial effects of inositol hexaphosphate (IP6) + Inositol in breast cancer patients treated with adjuvant therapy. Patients with invasive ductal breast cancer where polychemotherapy was indicated were monitored in the period from 2005-2007. Fourteen patients in the same stage of ductal invasive breast cancer were involved in the study, divided in two randomized groups. One group was subjected to take IP6 + Inositol while the other group was taking placebo. In both groups of patients the same laboratory parameters were monitored. When the treatment was finished, all patients have filled questionnaires QLQ C30 and QLQ-BR23 to determine the quality of life. Patients receiving chemotherapy, along with IP6 + Inositol did not have cytopenia, drop in leukocyte and platelet counts. Red blood cell counts and tumor markers were unaltered in both groups. However, patients who took IP6 + Inositol had significantly better quality of life (p = 0.05) and functional status (p = 0.0003) and were able to perform their daily activities. IP6 + Inositol as an adjunctive therapy is valuable help in ameliorating the side effects and preserving quality of life among the patients treated with chemotherapy.

  4. [Effects levocabastine ophthalmic solution (H1 receptor antagonist) on symptoms of vernal conjunctivitis. A prospective, randomized double-blind study].

    Science.gov (United States)

    Graue, E

    1994-01-01

    A double blind, prospective and randomized study was carried out in forty patients with clinical diagnosis of vernal conjunctivitis and eosinophilia in conjunctival scrapings. They were divided in two randomized groups of 20 patients each. One of the groups received levocabastine ophthalmic solution and the other saline solution drops. The mean age of the study group was 9.1 years old with a vernal conjunctivitis history of 44 months. The control group mean age was 10.1 years old and a history of vernal conjunctivitis of 48 months prior the enter of the study. One group received levocabastine 0.5 mgrs/ml while the other balanced saline solution, one drop every 12 hours per seven days. The patients evaluated their symptoms through a visual analogic scale (every day). Data collected was analyzed, for the first, third and seventh day, through U-Mann Whitney statistical analysis. Epiphora and photophobia showed a significant improvement. Itching, edema and foreign body sensation showed improvement in the levocabastine group but without statistical significance. Hyperthermia remained the same in both groups studied.

  5. Postoperative morbidity and histopathologic characteristics of tonsillar tissue following coblation tonsillectomy in children: a prospective randomized single-blind study.

    Science.gov (United States)

    Roje, Zeljka; Racić, Goran; Dogas, Zoran; Pisac, Valdi Pesutić; Timms, Michael

    2009-03-01

    The aim of this prospective randomized single blind study was to determine the depth of thermal damage to tonsillar tissue due to coblation, and to compare it with thermal damage to tonsillar tissue following conventional tonsillectomy; to correlate the depth of thermal damage to tonsillar tissue with the parameters of postoperative morbidity, to compare intraoperative blood loss, postoperative pain severity, time to resuming normal physical activity, and incidence of postoperative bleeding between two groups of tonsillectomized children aged up to 16 years. 72 children aged 3-16 years scheduled for tonsillectomy randomly assigned into two groups submitted either to conventional tonsillectomy with bipolar diathermy coagulation or to coblation tonsillectomy, with a 14-day follow up. Statistically significant differences were observed in the depth of thermal damage to tonsillar tissue (p < 0.001), intraoperative blood loss (p < 0.004), in postoperative pain severity (p < 0.05) and in time to resuming normal physical activity between the two groups (p < 0.001). There was no case of reactionary or secondary bleeding in either group. In this paper for the first time we have correlated postoperative morbidity and thermal tissue damage: less thermal damage is associated with less postoperative morbidity.

  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. A comparative study of continuous versus pulsed radiofrequency discectomy for management of low backache: Prospective randomized, double-blind study

    Science.gov (United States)

    Jena, Bhagya Ranjan; Paswan, Anil; Singh, Yashpal; Loha, Sandeep; Singh, Anil Prasad; Rastogi, Virendra

    2016-01-01

    Background: Radiofrequency (RF) is a minimally invasive target-selective technique that has been used with success for many years in the treatment of different pathologies, such as low back pain, trigeminal neuralgia, and others. Aim: The aim of this study is to compare different mode of RF - continuous RF (CRF) versus pulsed RF (PRF) along with steroid in the management of low back pain of discogenic origin. Setting and Design: Prospective, randomized, double-blind trial. Materials and Methods: Forty patients with chronic discogenic low back pain were randomized to receive CRF plus intradiscal triamcinolone 40 mg (Group 1) or to receive PRF plus intradiscal triamcinolone 40 mg (Group 2). Outcome measured includes immediate as well as long-term pain relief using visual analog scale, the Oswestry Disability Index and straight leg raising test. Statistical Analysis: The continuous variables were compared by one-way analysis of variance test. Discrete variables were compared by Fisher's exact test/Chi-square test/Student's t-test, whichever appropriate. The value of P PRF was insignificant. Conclusion: CRF with steroid seems to be better for treatment of chronic discogenic low back pain than PRF with steroid. PMID:27746559

  8. 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.

  9. High- vs low-power holmium laser lithotripsy: a prospective, randomized study in patients undergoing multitract minipercutaneous nephrolithotomy.

    Science.gov (United States)

    Chen, Shushang; Zhu, Lingfeng; Yang, Shunliang; Wu, Weizhen; Liao, Lianming; Tan, Jianming

    2012-02-01

    To determine the efficacy and safety of high-power holmium: yttrium aluminum-garnet (Ho:YAG) laser lithotripsy for multitract modified minimally invasive percutaneous nephrolithotomy (MPCNL) in the treatment of patients with large staghorn renal calculi. A randomized, prospective study was conducted. Two-hundred seventy-three consecutive patients (291 renal units) with large staghorn renal calculi were randomized to undergo multitract MPCNL with 30-W low-power or 70-W high-power Ho:YAG laser lithotripsy. Both groups were compared in terms of perioperative findings and postoperative outcomes, including procedure time, stone-free rate, length of hospital stay, transfusion rates, renal function recovery, and other complications. The average patient age was 49.2 years (range 22-73) and mean stone size was 5.54±0.7 cm. The 2 groups had some comparable perioperative findings and outcome, including tracts required per operated renal unit (n), blood loss, postoperative fever, postoperative hospital stay, stone-free rate, and improvement of operated renal function. The operation time in the high-power group was significantly shorter than that in the low-power group (129.20±17.2 vs 105.18±14.2, Ppower Ho:YAG laser lithotripsy can greatly decrease the operative time without increasing the intraoperative complications or delaying postoperative renal function recovery when compared with low-power Ho:YAG laser lithotripsy. Copyright © 2012 Elsevier Inc. All rights reserved.

  10. A PROSPECTIVE, RANDOMIZED CONTROL STUDY EVALUATING THE POSTOPERATIVE ANALGESIA USING RECTAL DICLOFENAC IN PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY SURGERIES

    Directory of Open Access Journals (Sweden)

    Padmaja

    2015-05-01

    Full Text Available BACKGROUND: To assess the efficacy of rectal diclofenac suppository in patients undergoing elective laparoscopic cholecystectomy surgeries in management of postoperative pain, in reduction of intra operative opioid requirement and in prolongation of postoperative anal gesic initiation time. OBJECTIVES: This prospective randomized single blinded clinical trial evaluates the efficacy of rectal diclofenac suppository for the management of postoperative pain. MATERIALS AND METHODS: 100 patients undergoing elective laparosco pic cholecystectomy surgeries were randomized into two groups, Group 1 patients receiving 100mg diclofenac rectal suppository after induction of general anaesthesia, Group 2 patients does not receive any diclofenac rectal suppository. Intra operative hemod ynamic monitoring, post - operative VAS score and adverse reactions were recorded over period of 24 hrs. Intra operative opioid (fentanyl was repeated when heart rate and blood pressure variability of more than 20% from base line are noted. Post operatively if VAS score is more than 4 rescue analgesia with inj. Tramadol is given intramuscularly. RESULTS: Administration of single dose of rectal diclofenac had statistically significant reduction in VAS score post operatively compared to control group, reduced requirement of intra operative opioids (fentanyl. Post - operative rescue analgesia initiation time is prolonged in group 1 mean 9.56 hrs compared to group 2, mean 0.72 hrs (p - 0.000. CONCLUSION: Rectal Diclofenac used in laparoscopic cholecystectomy cases provide adequate, effective prolonged analgesia in the post - operative period with good safety profile

  11. Neurosurgeons' perspectives on psychosurgery and neuroenhancement: a qualitative study at one center.

    Science.gov (United States)

    Mendelsohn, Daniel; Lipsman, Nir; Bernstein, Mark

    2010-12-01

    Advances in the neurosciences are stirring debate regarding the ethical issues surrounding novel neurosurgical interventions. The application of deep brain stimulation (DBS) for treating refractory psychiatric disease, for instance, has introduced the prospect of altering disorders of mind and behavior and the potential for neuroenhancement. The attitudes of current and future providers of this technology and their position regarding its possible future applications are unknown. The authors sought to gauge the opinions of neurosurgical staff and trainees toward various uses of neuromodulation technology including psychosurgery and neuroenhancement. The authors conducted a qualitative study involving in-depth interviews with 47 neurosurgery staff, trainees, and other neuroclinicians at a quaternary care center. Several general themes emerged from the interviews. These included universal support for psychosurgery given adequate informed consent and rigorous scientific methodology, as well as a relative consensus regarding the priority given to patient autonomy and the preservation of personal identity. Participants' attitudes toward the future use of DBS and other means of neuromodulation for cognitive enhancement and personality alteration revealed less agreement, although most participants felt that alteration of nonpathological traits is objectionable. There is support in the neurosurgical community for the surgical management of refractory psychiatric disease. The use of neuromodulation for the alteration of nonpathological traits is morally and ethically dubious when it is out of sync with the values of society at large. Both DBS and neuromodulation will have far-reaching and profound public health implications.

  12. A prospective, randomized, double blind, placebo controlled clinical trial to study efficacy and safety of benzydamine 0.15% gargles in prevention of postoperative sore throat

    OpenAIRE

    Smita M Gaikwad; Kanchan R. Rupwate; Bharati A Tendolkar

    2016-01-01

    Background: Postoperative sore throat (POST) is an undesirable outcome of general anesthesia. The aim of the study was to evaluate the effectiveness of benzydamine preoperative gargles in reducing the incidence and severity of POST. Methods: A randomized double blind prospective study involving 200 adult male and female patients was performed to assess the incidence of sore throat, cough and hoarseness of voice following tracheal intubation. The patients were randomly divided into two gro...

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

    Science.gov (United States)

    Rivera, Renee; Cochran, Ashly; Tungol, Jose Gabriel; Fayazmanesh, Nima; Weinmann, Eva

    2017-01-01

    Background 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. Methods 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. Results 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

  14. Effects of gastric irrigation on bacterial counts before endoscopic submucosal dissection: a randomized case control prospective study.

    Directory of Open Access Journals (Sweden)

    Hirohito Mori

    Full Text Available OBJECTIVE: The antiseptic effect of gastric irrigation before endoscopic submucosal dissection (ESD has not yet been reported. The aim of the randomized prospective study is to evaluate the antiseptic effects of gastric irrigation of saline solution before ESD by evaluating bacterial count. METHODS: This prospective randomized controlled trial included 50 patients diagnosed with early gastric cancer who were randomly divided into 2 groups (25 patients in each group by using the opaque envelope method: the clean group (irrigation with 2 L saline solution before ESD and the regular group (no irrigation. The gastric juice was collected and cultured before ESD. The entire stomach was irrigated using a water jet attached to an endoscope. After ESD with resection and removal of the tumor specimen, a postoperative culture of the gastric juice was obtained using the same method as the preoperative culture. RESULTS: The mean log bacterial count of the post-gastric irrigation gastric juice was 5.08±0.75 in the regular group and 1.86±0.86 in the clean group. The difference in the bacterial counts was significant between the groups (P = 0.0004. The difference in the white blood cells (WBC count on POD 1 was significant (P = 0.044. WBC count on POD 2 did not significantly differ between the groups (P = 0.3. The difference in the body temperature (BT on POD 1 was significant (P = 0.017, On POD 2 the BT was not significant between the groups (P = 0.5. On POD 1, 88% of the patients in the regular group and 16% of the patients in the clean group had mild to moderate spontaneous pain (P = 0.0026. On POD 2 the proportion with mild to moderate spontaneous pain was 36% and 24% in the regular group and the clean group, respectively (P = 0.1. CONCLUSION: Pre-ESD gastric irrigation with saline solution is effective and feasible for suppressing infection during the ESD procedure with favorable clinical outcomes. TRIAL REGISTRATION

  15. Intravaginal Misoprostol for Cervical Ripening and Labor Induction in Nulliparous Women: A Double-blinded, Prospective Randomized Controlled Study

    Institute of Scientific and Technical Information of China (English)

    Yu Zhang; Hao-Ping Zhu; Jian-Xia Fan; Hong Yu; Li-Zhou Sun; Lian Chen; Qing Chang

    2015-01-01

    Background:In China,no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now.This study is to evaluate the efficacy and safety of intravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women.Methods:This was a double-blinded,prospective randomized controlled study including nulliparous women from 6 university hospitals across China.Subjects were randomized into misoprostol or placebo group with the sample size ratio set to 7:2.Intravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h (repeated up to 3 times) for labor induction.Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h.Safety assessments included the incidences of maternal morbidity and adverse fetal/neonatal outcomes.Results:A total of 173 women for misoprostol group and 49 women for placebo were analyzed.The incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h was higher in the misoprostol group than in the placebo (64.2% vs.22.5%,relative risk [RR]:2.9,95% confidence interval [CI]:1.4-6.0).The incidence of onset of labor within 24 h was significantly higher in the misoprostol group than in the placebo group (48.0% vs.18.4%,RR:2.6,95% CI:1.2-5.7);and the induction-onset of labor interval was significantly shorter in the misoprostol group (P =0.0003).However,there were no significant differences in the median process time of vaginal labor (6.4 vs.6.8 h;P =0.695),incidence (39.3% vs.49.0%,RR:0.8,95% CI:0.4-1.5) and indications (P =0.683) of cesarean section deliveries,and frequencies of maternal,fetal/neonatal adverse events between the groups.Conclusion:Intravaginal misoprostol 25 μg every 4 h is efficacious and safe in labor induction and cervical ripening.

  16. Intravaginal Misoprostol for Cervical Ripening and Labor Induction in Nulliparous Women: A Double-blinded, Prospective Randomized Controlled Study

    Science.gov (United States)

    Zhang, Yu; Zhu, Hao-Ping; Fan, Jian-Xia; Yu, Hong; Sun, Li-Zhou; Chen, Lian; Chang, Qing; Zhao, Nai-Qing; Di, Wen

    2015-01-01

    Background: In China, no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now. This study is to evaluate the efficacy and safety of intravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women. Methods: This was a double-blinded, prospective randomized controlled study including nulliparous women from 6 university hospitals across China. Subjects were randomized into misoprostol or placebo group with the sample size ratio set to 7:2. Intravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h (repeated up to 3 times) for labor induction. Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h. Safety assessments included the incidences of maternal morbidity and adverse fetal/neonatal outcomes. Results: A total of 173 women for misoprostol group and 49 women for placebo were analyzed. The incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h was higher in the misoprostol group than in the placebo (64.2% vs. 22.5%, relative risk [RR]: 2.9, 95% confidence interval [CI]: 1.4–6.0). The incidence of onset of labor within 24 h was significantly higher in the misoprostol group than in the placebo group (48.0% vs. 18.4%, RR: 2.6, 95% CI: 1.2–5.7); and the induction-onset of labor interval was significantly shorter in the misoprostol group (P = 0.0003). However, there were no significant differences in the median process time of vaginal labor (6.4 vs. 6.8 h; P = 0.695), incidence (39.3% vs. 49.0%, RR: 0.8, 95% CI: 0.4–1.5) and indications (P = 0.683) of cesarean section deliveries, and frequencies of maternal, fetal/neonatal adverse events between the groups. Conclusion: Intravaginal misoprostol 25 μg every 4 h is efficacious and safe in labor induction and cervical ripening. PMID:26481739

  17. Electromyography in evaluation of pain after different types of tonsillectomy: prospective randomized study.

    Science.gov (United States)

    Vaiman, Michael; Gavrieli, Haim; Krakovski, Daniel

    2007-01-01

    Combined surface electromyography (sEMG) and visual analogue scale (VAS) pain assessment was performed on randomly assigned adults following tonsillectomy to research the effect of fibrin sealant (Group 1, n = 25), CO(2) laser (Group 2, n = 18) and electrocoagulation (Group 3, n = 40) on postsurgical pain. Timing and amplitude of sEMG activity of masseter, infrahyoid and submandibular muscles were measured during swallowing simultaneously with VAS assessment and compared to normative database. Postsurgical electric activity of masseter and infrahyoid was significantly higher in comparison with normative database. sEMG and VAS data showed that tonsillectomy ended with fibrin sealant caused less pain than laser or electrocoagulation techniques with no correlation between the VAS score and duration of swallows. Tonsillectomy affects muscle activity significantly by involving additional muscles (infrahyoid) in swallowing. Combined sEMG and VAS data indicated electrocautery as the most painful, laser as less painful, and fibrin sealant as the least painful technique.

  18. Effect of topical tetracycline on seroma formation in the Lichtenstein technique: a prospective randomized study.

    Science.gov (United States)

    Turk, Emin; Karagulle, Erdal; Coban, Gokcen; Yildirim, Erkan; Moray, Gokhan

    2014-01-01

    We sought to investigate whether application of topical tetracycline has a limiting effect on seroma formation in patients undergoing hernia repair using a polypropylene mesh. This study was conducted in 96 patients undergoing an elective groin hernia repair. Patients were randomized and divided into 2 groups. After the graft was placed, and before external oblique muscle aponeurosis was closed, 5 mL tetracycline was administered on the graft in the tetracycline group (tetra group, n = 50), and 5 mL isotonic saline was administered in the control group (n = 46) without putting in a drain. Seroma checks via surface ultrasonography were done. Seroma amounts measured on the first day were significantly higher in the tetra group (P = 0.04). There were no significant differences regarding seroma measurements on the seventh day or in the first and second months. Topical tetracycline application has no limiting effect on seroma formation after a groin hernia operation.

  19. Patient Satisfaction With Propofol for Outpatient Colonoscopy: A Prospective, Randomized, Double-Blind Study.

    Science.gov (United States)

    Padmanabhan, Anantha; Frangopoulos, Christoforos; Shaffer, Lynn E T

    2017-10-01

    Previous literature has shown that propofol has ideal anesthetic properties for patients undergoing colonoscopy, a common procedure at outpatient surgery centers. However, there is a paucity of information regarding patient satisfaction with propofol. The aim of this study was to evaluate patient satisfaction with propofol compared with nonpropofol (fentanyl/midazolam) anesthesia for outpatient colonoscopies. Safety and complications were secondary end points. This study was a double-blind, randomized, parallel-group controlled clinical trial (NCT 02937506). This study was conducted at a single ambulatory surgery center at an urban teaching community health system. Patients were scheduled for outpatient colonoscopy. Those with high-risk cardiac or pulmonary disease were excluded. Anesthesia personnel administered either fentanyl/midazolam (n = 300) or propofol (n = 300) for sedation during outpatient colonoscopy. A single, highly experienced endoscopist performed all colonoscopies. The primary outcomes measured were patient satisfaction (5-point Likert scale) and procedure complications. Data were collected on the day of endoscopy by the nursing staff of the postanesthesia care unit. A subinvestigator blinded to the randomization called patients 24 to 72 hours after discharge to obtain data on postprocedure problems and status of resumption of normal activities. Analysis was intention-to-treat. Fewer patients who received propofol remembered being awake during the procedure (2% vs 17% for fentanyl, p propofol (p propofol group (2.7% vs 11.7%, p propofol over a combination of fentanyl/midazolam as their anesthetic for outpatient colonoscopies. From a patient and provider perspective, propofol appears to be superior to fentanyl/midazolam for outpatient colonoscopy. See Video Abstract at http://links.lww.com/DCR/A445.

  20. Prospective randomized controlled trial comparing 1- versus 7-day manipulation following collagenase injection for dupuytren contracture.

    Science.gov (United States)

    Mickelson, Dayne T; Noland, Shelley S; Watt, Andrew J; Kollitz, Kathleen M; Vedder, Nicholas B; Huang, Jerry I

    2014-10-01

    To compare the efficacy, tolerance, and safety of manual manipulation at day 7 to day 1 following collagenase Clostridium histolyticum (CCH) injection for Dupuytren contracture. Eligible patients were randomized to manipulation at day 1 versus day 7 following CCH injection. Preinjection, premanipulation, postmanipulation, and 30-day follow-up metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joint contractures were measured. Pain scores were recorded at each time point. Data were stratified per cohort based on primary joint treated (MCP vs PIP). Means were compared using paired and unpaired t-tests. Forty-three patients with 46 digits were eligible and were randomized to 1-day (22 digits) and 7-day (24 digits) manipulation. For MCP joints, there were no significant differences in flexion contractures between 1- and 7-day cohorts for initial (47° vs 46°), postmanipulation (0° vs 2°), or 30-day follow-up (1° vs 2°) measurements. Premanipulation, the residual contracture was significantly lower in the 7-day group (23° vs 40°). For PIP joints, there were no significant differences between 1- and 7-day cohorts for initial (63° vs 62°), premanipulation (56° vs 52°), postmanipulation (13° vs 15°), or 30-day (14° vs 16°) measurements. There were no significant differences in pain or skin tears between the 2 groups. No flexor tendon ruptures were observed. The effectiveness of CCH in achieving correction of Dupuytren contractures was preserved when manipulation was performed on day 7, with no differences in correction, pain, or skin tears. These data suggest that manipulation can be scheduled at the convenience of the patient and surgeon within the first 7 days after injection. Therapeutic I. Copyright © 2014 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Wright Bruce

    2010-10-01

    Full Text Available Abstract Background 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. Methods 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. Results 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 Conclusions When preceptors are physicians, content expertise is not a prerequisite to teach first year medical students within a structured small group environment; preceptors with process expertise result in at least equivalent, if not

  2. Triple rubber band ligation for hemorrhoids: prospective, randomized trial of use of local anesthetic injection.

    Science.gov (United States)

    Law, W L; Chu, K W

    1999-03-01

    Rubber band ligation is a common office procedure for hemorrhoids. Triple rubber band ligation in a single session has been shown to be a safe and economical way of treating hemorrhoids. However, postligation discomfort after triple rubber band ligation is not uncommon. The aim of this study was to evaluate the effectiveness of local anesthetic injection to the banded hemorrhoidal tissue in reducing postligation discomfort. Patients attending an outpatient clinic for symptomatic hemorrhoids suitable for triple rubber band ligation were randomly assigned to two groups. In the treatment group rubber band ligation was performed at three columns of hemorrhoids, and 1 to 2 ml of 2 percent lignocaine was injected into the banded hemorrhoidal tissue. In the control group triple rubber band ligation was performed in a similar manner, but local anesthetic was not given. Patients were followed up by telephone at the second week and in the clinic after six weeks. From April to August 1996, 101 patients entered the trial and were treated with triple rubber band ligation. Sixty-two patients were randomly assigned to the local anesthetic injection group and 39 to the control group. Overall good to excellent results occurred in 89 percent of patients, and there was no difference between the two groups. Postligation pain occurred in 26 and 20 percent of patients in the treatment and control groups, respectively (P > 0.05). Postligation tenesmus occurred in 32 and 41 percent of patients in the treatment and control groups, respectively (P > 0.05). No patients suffered from septic complications or bleeding that required transfusion. Triple rubber band ligation in a single session is a safe, economical, and effective way of treating symptomatic hemorrhoids. Postligation pain and tenesmus occurred in 24 and 37 percent, respectively. Discomfort was usually tolerable. Local anesthetic injection to the banded hemorrhoidal tissue did not help to reduce postligation discomfort.

  3. Evaluation of minimal dose of atracurium for cataract surgery in children: A prospective randomized double-blind study

    Science.gov (United States)

    Darlong, Vanlal; Garg, Rakesh; Pandey, Ravinder; Khokhar, Sudarshan; Chandralekha; Sinha, Renu; Punj, Jyotsna; Sinha, Rajesh

    2015-01-01

    Background: Cataract surgery when performed under general anesthesia, especially without neuromuscular blocking agents, eccentric position of the eye has been reported. However, no evidence exists for the need and optimal dose of neuromuscular blocking agents for surgical reasons when the anesthetic management may be done without its need. We hypothesize that the minimal dose atracurium may accomplish the surgical requirement of cataract surgery in children. Materials and Methods: After ethical committee approval, this double-blind, prospective, randomized study was conducted in children scheduled for cataract surgery under general anesthesia. Anesthesia was induced in a standardized manner and using laryngeal mask airway. The patients were randomized into four groups of 55 patients each and atracurium was administered as per group allocation: Group 0: No atracurium was administered; Group 50: Received atracurium at 50% dose of ED95; Group 75: Received atracurium at 75% dose of ED95; Group 100: Received atracurium of 100% dose of ED95. Surgeon was asked to grade surgical condition just after the stab incision in the cornea. The primary outcome variable included the need of atracurium supplementation based on grading of surgical conditions by the operating surgeon who was blinded to the randomized group. Results: The need of atracurium due to unacceptable surgical conditions based on surgeon satisfaction score was statistically significant when compared among the groups being maximum in Group 0 (P < 0.001). Also, the surgeon satisfaction score was statistically significant among the groups (P < 0.0001) with the least satisfaction in Group 0. The laryngeal mask airway (LMA) insertion score was statistically significant in the four groups (P - 0.001). However, number of attempts for LMA placement was comparable among the four groups (P - 0.766). Conclusion: We conclude that a balanced anesthetic technique including atracurium provided better surgical condition for

  4. Evaluation of minimal dose of atracurium for cataract surgery in children: A prospective randomized double-blind study

    Directory of Open Access Journals (Sweden)

    Vanlal Darlong

    2015-01-01

    Full Text Available Background: Cataract surgery when performed under general anesthesia, especially without neuromuscular blocking agents, eccentric position of the eye has been reported. However, no evidence exists for the need and optimal dose of neuromuscular blocking agents for surgical reasons when the anesthetic management may be done without its need. We hypothesize that the minimal dose atracurium may accomplish the surgical requirement of cataract surgery in children. Materials and Methods: After ethical committee approval, this double-blind, prospective, randomized study was conducted in children scheduled for cataract surgery under general anesthesia. Anesthesia was induced in a standardized manner and using laryngeal mask airway. The patients were randomized into four groups of 55 patients each and atracurium was administered as per group allocation: Group 0: No atracurium was administered; Group 50: Received atracurium at 50% dose of ED 95 ; Group 75: Received atracurium at 75% dose of ED 95 ; Group 100: Received atracurium of 100% dose of ED 95 . Surgeon was asked to grade surgical condition just after the stab incision in the cornea. The primary outcome variable included the need of atracurium supplementation based on grading of surgical conditions by the operating surgeon who was blinded to the randomized group. Results: The need of atracurium due to unacceptable surgical conditions based on surgeon satisfaction score was statistically significant when compared among the groups being maximum in Group 0 (P < 0.001. Also, the surgeon satisfaction score was statistically significant among the groups (P < 0.0001 with the least satisfaction in Group 0. The laryngeal mask airway (LMA insertion score was statistically significant in the four groups (P - 0.001. However, number of attempts for LMA placement was comparable among the four groups (P - 0.766. Conclusion: We conclude that a balanced anesthetic technique including atracurium provided better

  5. Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial

    Science.gov (United States)

    Hollander, Judd E; Schaffer, Jason T; Kline, Jeffrey A; Torres, Carlos A; Diercks, Deborah B; Jones, Russell; Owen, Kelly P; Meisel, Zachary F; Demers, Michel; Leblanc, Annie; Shah, Nilay D; Inselman, Jonathan; Herrin, Jeph; Castaneda-Guarderas, Ana; Montori, Victor M

    2016-01-01

    Objective To compare the effectiveness of shared decision making with usual care in choice of admission for observation and further cardiac testing or for referral for outpatient evaluation in patients with possible acute coronary syndrome. Design Multicenter pragmatic parallel randomized controlled trial. Setting Six emergency departments in the United States. Participants 898 adults (aged >17 years) with a primary complaint of chest pain who were being considered for admission to an observation unit for cardiac testing (451 were allocated to the decision aid and 447 to usual care), and 361 emergency clinicians (emergency physicians, nurse practitioners, and physician assistants) caring for patients with chest pain. Interventions Patients were randomly assigned (1:1) by an electronic, web based system to shared decision making facilitated by a decision aid or to usual care. The primary outcome, selected by patient and caregiver advisers, was patient knowledge of their risk for acute coronary syndrome and options for care; secondary outcomes were involvement in the decision to be admitted, proportion of patients admitted for cardiac testing, and the 30 day rate of major adverse cardiac events. Results Compared with the usual care arm, patients in the decision aid arm had greater knowledge of their risk for acute coronary syndrome and options for care (questions correct: decision aid, 4.2 v usual care, 3.6; mean difference 0.66, 95% confidence interval 0.46 to 0.86), were more involved in the decision (observing patient involvement scores: decision aid, 18.3 v usual care, 7.9; 10.3, 9.1 to 11.5), and less frequently decided with their clinician to be admitted for cardiac testing (decision aid, 37% v usual care, 52%; absolute difference 15%; P<0.001). There were no major adverse cardiac events due to the intervention. Conclusions Use of a decision aid in patients at low risk for acute coronary syndrome increased patient knowledge about their risk, increased

  6. No important influence of limited steroid exposure on bone mass during the first year after renal transplantation: a prospective, randomized, multicenter study.

    NARCIS (Netherlands)

    Meulen, C.G. ter; Riemsdijk, I.C. van; Hene, R.J.; Christiaans, M.H.; Borm, G.F.; Corstens, F.H.M.; Gelder, T. van; Hilbrands, L.B.; Weimar, W.; Hoitsma, A.J.

    2004-01-01

    BACKGROUND: Steroid-related bone loss is a recognized complication after renal transplantation. In a prospective, randomized, multicenter study we compared the influence of a steroid-free immunosuppressive regimen with a regimen with limited steroid exposure on the changes in bone mass after renal t

  7. Differences in Blood Pressure in Infants After General Anesthesia Compared to Awake Regional Anesthesia (GAS Study-A Prospective Randomized Trial)

    NARCIS (Netherlands)

    McCann, Mary Ellen; Withington, D E; Arnup, S J; Davidson, A J; Disma, N; Frawley, G; Morton, N S; Bell, G; Hunt, R W; Bellinger, D C; Polaner, D M; Leo, A; Absalom, A R; von Ungern-Sternberg, B S; Izzo, F; Szmuk, P; Young, V; Soriano, S G; de Graaff, J C

    BACKGROUND: The General Anesthesia compared to Spinal anesthesia (GAS) study is a prospective randomized, controlled, multisite, trial designed to assess the influence of general anesthesia (GA) on neurodevelopment at 5 years of age. A secondary aim obtained from the blood pressure data of the GAS

  8. Prospective Randomized Trial Comparing the 1-Stage with the 2-Stage Implantation of a Pulse Generator in Patients with Pelvic Floor Dysfunction Selected for Sacral Nerve Stimulation.

    NARCIS (Netherlands)

    Everaert, Karel; Kerckhaert, Wim; Caluwaerts, Hilde; Audenaert, M; Vereecke, Hugo Eric Marc; De Cuypere, G; Boelaert, A; Van den Hombergh, U; Oosterlinck, Wim A

    2004-01-01

    Abstract Objective: The aim of this study was to evaluate in a prospective, randomized setting if the 2-stage implant, compared to a 1-stage implant, leads to a superior subjective or objective outcome of sacral nerve stimulation after implantation of the pulse generator in patients with lower urina

  9. Care and Aftercare Related to Implant-Retained Dental Crowns in the Maxillary Aesthetic Region : A 5-Year Prospective Randomized Clinical Trial

    NARCIS (Netherlands)

    Visser, Anita; Raghoebar, Gerry M.; Meijer, Henny J. A.; Meijndert, Leo; Vissink, Arjan

    2011-01-01

    Aim: To prospectively assess surgical and prosthetic care and aftercare related to the placement of implant-retained dental crowns after local bone augmentation in patients missing one tooth in the maxillary aesthetic region. Methods: Ninety-three patients were randomly allocated to one of three loc

  10. 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....

  11. Urinary follicle-stimulating hormone for normogonadotropic clomiphene-resistant anovulatory infertility: prospective, randomized comparison between low dose step-up and step-down dose regimens

    NARCIS (Netherlands)

    E.J. van Santbrink (Evert); B.C.J.M. Fauser (Bart)

    1997-01-01

    textabstractA low dose step-up and step-down regimen for induction of ovulation using urinary FSH was compared in a prospective randomized fashion in 37 normogonadotropic clomiphene-resistant oligo- or amenorrheic infertile women. The objectives was to assess potential

  12. 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...

  13. The prophylactic effect of ceftazidime on early bacterial infection after autologous peripheral blood stem cell transplantation: a prospective randomized controlled trial

    Institute of Scientific and Technical Information of China (English)

    段明辉

    2013-01-01

    Objective To evaluate the efficacy and safety of prophylactic ceftazidime on early bacterial infection in APBSCT recipients during neutropenia.Methods APBSCT recipients were prospectively randomly assigned to intravenous ceftazidime treatment group and control group (no prophylaxis of antibiotics) .The treatment started from the first day until resolution of neutropenia or the

  14. Prospective Randomized Trial Comparing the 1-Stage with the 2-Stage Implantation of a Pulse Generator in Patients with Pelvic Floor Dysfunction Selected for Sacral Nerve Stimulation.

    NARCIS (Netherlands)

    Everaert, Karel; Kerckhaert, Wim; Caluwaerts, Hilde; Audenaert, M; Vereecke, Hugo Eric Marc; De Cuypere, G; Boelaert, A; Van den Hombergh, U; Oosterlinck, Wim A

    2004-01-01

    Abstract Objective: The aim of this study was to evaluate in a prospective, randomized setting if the 2-stage implant, compared to a 1-stage implant, leads to a superior subjective or objective outcome of sacral nerve stimulation after implantation of the pulse generator in patients with lower urina

  15. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients : a prospective randomized multicentre study

    NARCIS (Netherlands)

    Scheeren, Thomas W. L.; Wiesenack, Christoph; Gerlach, Herwig; Marx, Gernot

    2013-01-01

    Perioperative hemodynamic optimisation improves postoperative outcome for patients undergoing high-risk surgery (HRS). In this prospective randomized multicentre study we studied the effects of an individualized, goal-directed fluid management based on continuous stroke volume variation (SVV) and st

  16. Etomidate plus propofol versus propofol alone for sedation during gastroscopy: a randomized prospective clinical trial.

    Science.gov (United States)

    Zhou, Xiang; Li, Bi-Xi; Chen, Li-Min; Tao, Jun; Zhang, Sui; Ji, Meng; Wu, Ming-Chun; Chen, Min; Zhang, Yan-Hui; Gan, Guo-Shen; Song, Xiao-Yang

    2016-11-01

    Sedation with propofol alone during gastroscopy has many side effects. Etomidate has advantages in terms of circulation and respiration compared to propofol. We hypothesized that etomidate plus propofol during gastroscopy would be more safe and effective than propofol alone. Four hundred (n = 400) patients were randomly divided into a propofol group (P group) and a etomidate plus propofol group (EP group). The P group was given the first dose of 1 % propofol 1 mg/kg before gastroscopy, and the EP group was given 1 % propofol 0.5 mg/kg plus etomidate 0.1 mg/kg. Repeated doses of 10-20 mg propofol or 5-10 mg propofol plus 1-2 mg etomidate were administered to maintain an adequate level of sedation. The sedation depth was maintained by bispectral index value of 40-60. The EP group had a lower incidence of systolic hypotension (13.0 vs. 32.5 %; P propofol had few effects on respiration and circulation in patients undergoing gastroscopy and was more safe and effective than propofol alone.

  17. Efficacy of JOINS on Cartilage Protection in Knee Osteoarthritis: Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Kim, Joong Il; Choi, Ja Young; Kim, Kwang Gi; Lee, Myung Chul

    2017-09-01

    In this study, we compared the clinical efficacy of JOINS (SKI306X, SK Chemicals) with placebo on cartilage protection using magnetic resonance imaging (MRI). Sixty-nine patients were randomized to the JOINS group (200 mg, three times daily for 1 year; n=33) or the placebo group (n=36). Changes in cartilage volume and thickness were measured using MRI. Changes in the delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) index, subchondral bone marrow abnormality scores, and clinical scores including knee pain visual analog scale (VAS) score and Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC) were also evaluated. Changes in cartilage thickness and volume and subarticular bone marrow abnormality scores were not different between groups. Changes in the dGEMRIC index in the lateral tibial plateau were greater in the JOINS group than in the placebo group (19.64±114.33 msec vs. -57.77±123.30 msec; p=0.011). Significantly greater changes in VAS were observed in the JOINS group than in the placebo group (-26.00±12.25 vs. -12.47±21.54; p=0.002) and K-WOMAC (-15.42 ± 7.73 vs. -8.15±13.71; p=0.003). Compared with placebo, JOINS had superior clinical efficacy in regard to cartilage protection.

  18. Mechanical instability after acute ankle ligament injury: randomized prospective comparison of two forms of conservative treatment

    Directory of Open Access Journals (Sweden)

    Marcelo Pires Prado

    2013-08-01

    Full Text Available OBJECTIVE: This trial has the objective to investigate the incidence of mechanical ankle instability after the conservative treatment of first episode, severe ankle ligamentar lesions. This common lesion affects young, professional and physical active patients, causing important personal and economic consequences. There are difficulties related to adequate diagnosis and treatment for these lesions. METHOD: 186 patients with severe ankle ligament lesions were included in this trial. They were randomized in two treatment options. In group A patients were treated using ankle long orthoosis, weight bearing allowed as confortable, pain care, ice, elevation with restricted joint mobilization for three weeks. After that they were maintained in short, functional orthosis (air cast, starting the reabilitation program. In group B patients were immobilized using a functional orthosis (air cast, following the same other sequences that patients in group A. RESULTS: We did not find significant differences in relation to the residual mechanical ankle instability between both groups. We did not find differences in the intensity of pain, but the functional evaluation using AOFAS score system showed better results in the functional treatment group. CONCLUSION: The functional treatment (Group B had better AOFAS score and few days off their professional activities, comparing with patients treated with rigid orthosis (Group A, without increased chance in developing ankle mechanical instability.

  19. H pylori eradication:A randomized prospective study of triple therapy with or without ecabet sodium

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    AIM:To investigate whether adding ecabet sodium to the standard triple therapy for Hpylori infection improve eradication rate.METHODS:Two hundred and fifty-seven H pyloriinfected patients were randomly assigned to standard triple therapy (group A, n=129) or triple therapy plus ecabet sodium(group B, n=128).Successful eradication was defined as a negative 13C-urea breath test 6-8 wk after completion of treatment.RESULTS:After completion of therapy,194/257 patients showed negative 13C-urea breath test results.According to intention-to-treat analysis,the infection was eradicated in 93/129(72.1%)patients in group A and 101/128 (78.9%) in group B (P=0.204).Per-protocol analysis showed successful eradication in 93/118(78.8%)patients from group A and 101/114 (88.6%) from group B (P = 0.044).There were no significant differences in the side effects experienced by the patients in the two treatment groups.CONCLUSION:Our results suggest that the addition of ecabet sodium improves the efficacy of the standard triple therapy for H pylori.

  20. Prospective randomized comparison of transumbilical two-port laparoscopic and conventional laparoscopic varicocele ligation

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    Guo-Xi Zhang

    2017-01-01

    Full Text Available We have established a novel method named transumbilical two-port laparoscopic varicocele ligation (TTLVL for varicocele, which is still needed to evaluate. In this study, 90 patients with left idiopathic symptomatic varicoceles of grades II-III according to the Dubin grading system were randomly assigned to TTLVL (n = 45 and conventional laparoscopic varicocele ligation (CLVL (n = 45. The demographic, intraoperative, postoperative, and follow-up data were recorded and compared between the two groups. All the procedures in the two groups were completed successfully with no intraoperative complications and no conversions to open surgery. No significant difference was found in the operative time, resuming ambulation, bowel recovery, postoperative hospital stay, and postoperative resolution of scrotal pain between the two groups (P > 0.05. However, the postoperative mean visual analog pain scale scores for TTLVL group were all less at 24 h, 48 h, 72 h, and 7 days postoperatively compared to CLVL (P = 0.001, 0.010, 0.006, and 0.027, respectively. The mean patient scar assessment questionnaire score in postoperative month 3 was 29.7 for TTLVL group compared with 32.1 for CLVL group (P < 0.001. There was no testicular atrophy observed in both groups during the follow-up period. The study shows that TTLVL is a safe, feasible, and effective minimally invasive surgical alternative to CLVL for the treatment of varicocele. Compared with CLVL, TTLVL may decrease postoperative pain and improve the cosmetic outcomes.

  1. Cardiac Autonomic Changes After Thoracic Sympathectomy: A Prospective, Randomized Study.

    Science.gov (United States)

    Fiorelli, Alfonso; Messina, Giovanni; Chiodini, Paolo; Costanzo, Saveria; Viggiano, Andrea; Monda, Marcellino; Vicidomini, Giovanni; Santini, Mario

    2017-01-01

    We evaluated whether cardiac autonomic changes could be associated with different extent of sympathetic nerve resection in the management of essential palmar hyperhidrosis. Sixty patients with essential palmar hyperhidrosis were randomly allocated to undergo excision of T3 ganglia (sympathicectomy group; n = 30) or to interruption of sympathetic chain at the T2 to T3 level with ganglion sparing (sympathicotomy group; n = 30). Time and frequency domains were measured with a 24-Holter monitor during daytime, nighttime, and 24-hour periods at different interval points (7 days before operation; 24 hours; and 1, 3, and 6 months later), and the differences were statistically compared. Clinical outcomes were also evaluated. Twenty-eight of 30 patients of the sympathectomy and 29 of 30 patients of the sympathicotomy group completed the study. In both groups, we observed a significant increase (p 50 ms; high frequency; and a significant decrease (p sympathectomy group than in the sympathicotomy group. Clinical outcomes were similar between the two groups. Endoscopic thoracic sympathectomy caused a shift of sympathovagal balance toward parasympathetic tone that seems to be associated with the extent of denervation. This trial was registered at clinicaltrials.gov as NCT02733497. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

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

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    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.)

  3. Prospective randomized comparison of transumbilical two-port laparoscopic and conventional laparoscopic varicocele ligation

    Science.gov (United States)

    Zhang, Guo-Xi; Yang, Jun; Long, Da-Zhi; Liu, Min; Zou, Xiao-Feng; Yuan, Yuan-Hu; Xiao, Ri-Hai; Xue, Yi-Jun; Zhong, Xin; Liu, Quan-Liang; Liu, Fo-Lin; Jiang, Bo; Xu, Rui-Quan; Xie, Kun-Lin

    2017-01-01

    We have established a novel method named transumbilical two-port laparoscopic varicocele ligation (TTLVL) for varicocele, which is still needed to evaluate. In this study, 90 patients with left idiopathic symptomatic varicoceles of grades II–III according to the Dubin grading system were randomly assigned to TTLVL (n = 45) and conventional laparoscopic varicocele ligation (CLVL) (n = 45). The demographic, intraoperative, postoperative, and follow-up data were recorded and compared between the two groups. All the procedures in the two groups were completed successfully with no intraoperative complications and no conversions to open surgery. No significant difference was found in the operative time, resuming ambulation, bowel recovery, postoperative hospital stay, and postoperative resolution of scrotal pain between the two groups (P > 0.05). However, the postoperative mean visual analog pain scale scores for TTLVL group were all less at 24 h, 48 h, 72 h, and 7 days postoperatively compared to CLVL (P = 0.001, 0.010, 0.006, and 0.027, respectively). The mean patient scar assessment questionnaire score in postoperative month 3 was 29.7 for TTLVL group compared with 32.1 for CLVL group (P < 0.001). There was no testicular atrophy observed in both groups during the follow-up period. The study shows that TTLVL is a safe, feasible, and effective minimally invasive surgical alternative to CLVL for the treatment of varicocele. Compared with CLVL, TTLVL may decrease postoperative pain and improve the cosmetic outcomes. PMID:26732104

  4. Early versus delayed postoperative oral hydration after general anesthesia: a prospective randomized trial

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    Yin, Xiaorong; Ye, Ling; Zhao, Liang; Li, Lisha; Song, Jinping

    2014-01-01

    The purpose of our study was to determine the safety and tolerability of early oral hydration (EOH) compared with delayed oral hydration (DOH) after general anesthesia. One thousand anesthesiology (ASA) I to III adult patients undergoing non-gastrointestinal surgery with general anesthesia were randomized assigned into two groups: DOH (n=500, patients were given water 4 h after general anesthesia), EOH (n=500, patients were given 0.5 ml/kg water once recovered from general anesthesia.) in the postanesthesia care unit (PACU). Patients were evaluated for nausea, vomiting, drink desire, thirsty scale, oropharyngeal discomfort scale, and satisfaction scale. Statistical analysis was performed with Student’s t and Chi-Square tests. Complete data were available for 983 patients (EOH=488, DOH=495). Twenty minutes after receiving water the incidence of vomiting in EOH group was very low. And there was no significant difference between the two groups at the same time point (p > 0.05). Compared with DOH group, after receiving water there was a significant decrease of patients’ thirsty scales (p < 0.0001) and oropharyngeal discomfort scales (p < 0.0001) in EOH group. Significantly more patients’ satisfaction were reported in EOH group (p < 0.001). No serious adverse effects were reported during the study period. For patients undergoing non-gastrointestinal surgery, early oral hydration after recovery from general anesthesia was safe, with lower thirsty scale and oropharyngeal discomfort scales, and higher satisfaction. PMID:25419388

  5. SPINAL ANAESTHESIA VERSUS GENERAL ANAESTHESIA FOR LAPAROSCOPIC CHOLECYSTECTOMY - A PROSPECTIVE RANDOMIZED CONTROLLED STUDY

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    Prasad

    2014-02-01

    Full Text Available INTRODUCTION: Combining minimal invasive surgical and lesser invasive anesthesia technique reduces morbidity and mortality. The aim of the study is to compare spinal anesthesia with the gold standard general anesthesia for elective laparoscopic cholecystectomy. MATERIALS & METHODS: 60 healthy patients were randomized under spinal anesthesia (n=30 & General Anesthesia (n=30 . Hyperbaric 3ml bupivacaine plus 25mcg fenta nyl was administered for spinal group and conventional general anesthesia for GA group. Intraoperative parameters and post - operative pain and recovery were noted. Under spinal group any intraoperative discomfort were taken care by reassurance , drugs or con verted to GA. Questionnaire forms were provided for patients and surgeons to comment about the operation. RESULTS: None of the patients had significant hemodynamic and respiratory disturbance except for transient hypotension and bradycardia. Operative time was comparable. 6patients under spinal anesthesia had right shoulder pain , 2 patients were converted to GA and 4 patients were managed by injection midazolam and infiltration of lignocaine over the diaphragm. There was significant post - operative pain reli ef in spinal group. All the patients were comfortable and surgeons satisfied. CONCLUSION: Spinal anesthesia is adequate and safe for laparoscopic cholecystectomy in otherwise healthy patients and offers better postoperative pain control than general anesth esia without limiting recovery , but require cooperative patient , skilled surgeon , a gentle surgical technique and an enthusiastic anesthesiologist

  6. Written Educational Material Relieves Anxiety after Endoscopic Biopsy: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Kim, Hae Won; Jung, Da Hyun; Youn, Young Hoon; Kim, Jie-Hyun; Kim, Jae Jin; Park, Hyo Jin

    2016-02-01

    Patients who undergo endoscopic biopsy suffer anxiety until results are confirmed. This study assesses the effects of written educational material on the anxiety level of patients following endoscopic biopsy. This study was a randomized controlled study trial with 83 patients divided into the following three groups: a biopsy group given written educational material prepared by our institution following the biopsy (intervention group, n=28), a biopsy group without written material (biopsy only group, n=25), and a control group without biopsy (control group, n=30). The anxiety level of each patient was evaluated three times using Spielberger's State-Trait Anxiety Inventory (STAI): for baseline at the first visit to our institution, at the day of endoscopy, one day later, and one week after the procedure. We compared baseline characteristics, STAI scores at each visit, and differences in STAI scores among the three groups. No difference was found in STAI score among groups at baseline and before and after the endoscopic procedure. However, the STAI-state score of the intervention group was slightly lower than biopsy only group one day post-procedure (40.3 ± 7.7 vs. 43.9 ± 7.1, p=0.135). The STAI-state score significantly decreased from pre- to post-procedure only in the intervention group (-2.75 ± 6.1 vs. 0.92 ± 4.0, pmaterial for patients having biopsy might lessen their anxiety level.

  7. 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

  8. Carboprost Versus Oxytocin for Active Management of Third Stage of Labor: A Prospective Randomized Control Study.

    Science.gov (United States)

    Sunil Kumar, K S; Shyam, Sundar; Batakurki, Pavitra

    2016-10-01

    Postpartum hemorrhage is the single largest and leading cause of maternal morbidity and mortality not only in developing countries but also in developed countries. The present study is an attempt to evaluate the scope of using prophylactic intramuscular carboprost tromethamine 125 μg in comparison with intramuscular oxytocin 10 units for the active management of third stage of labor. Two hundred pregnant women at term with spontaneous onset of labor were included in the study and were randomly divided into 2 groups of 100 women each. Group A and group B were given injection oxytocin 10 units and injection carboprost tromethamine 125 μg intramuscularly, respectively, at the time of delivery of anterior shoulder. The main outcome measures with respect to third stage of labor were: duration, blood loss by volume, difference in hemoglobin, need for additional oxytocics and side effects. Subjects who received carboprost tromethamine 125 μg showed a significant reduction in duration of third stage of labor (p oxytocin 10 units. Likelihood of occurrence of postpartum hemorrhage was reduced without significant side effects except for diarrhea. Additional need for other uterotonics after carboprost was significantly less compared to oxytocin. Intramuscular carboprost 125 μg is a better cost-effective alternative as compared to 10 units intramuscular oxytocin in active management of third stage of labor.

  9. Adult male circumcision with a circular stapler versus conventional circumcision: A prospective randomized clinical trial.

    Science.gov (United States)

    Jin, X D; Lu, J J; Liu, W H; Zhou, J; Yu, R K; Yu, B; Zhang, X J; Shen, B H

    2015-06-01

    Male circumcision is the most frequently performed procedure by urologists. Safety and efficacy of the circumcision procedure requires continual improvement. In the present study, we investigated the safety and efficacy of a new male circumcision technique involving the use of a circular stapler. In total, 879 consecutive adult male patients were randomly divided into 2 groups: 441 underwent stapler circumcision, and 438 underwent conventional circumcision. The operative time, pain score, blood loss volume, healing time, treatment costs, and postoperative complications were compared between the two groups. The operative time and blood loss volume were significantly lower in the stapler group than in the conventional group (6.8 ± 3.1 vs 24.2 ± 3.2 min and 1.8 ± 1.8 vs 9.4 ± 1.5 mL, respectively; Pcircumcision required removal of residual staple nails. Overall, the present study has shown that stapler circumcision is a time-efficient and safe male circumcision technique, although it requires further improvement.

  10. Prospective randomized trial to evaluate effectiveness of periprostatic nerve block in prostatic biopsy

    Directory of Open Access Journals (Sweden)

    P Lavania

    2006-01-01

    Full Text Available Objectives: The objective of the study was to evaluate the efficacy of local anesthetic infiltration, in decreasing the discomfort experienced by patients undergoing trans-rectal ultrasound (TRUS guided biopsy of prostate. Materials and methods: Between January 2002 and February 2003, we investigated consecutively, asymptomatic men, suspected of having prostatic cancer. About 39 patients were randomized to receive 10 ml of 2% Lidocaine periprostatic block + intrarectal Lidocaine gel (group 1 = 20, or intarectal Lidocaine gel only (group 2 = 19 during prostatic biopsy. Immediately following the TRUS-guided biopsy, patients were asked to grade the pain they experienced using the 11-point visual analogue score (VAS. Results: The mean pain score in the patients of group 1 were significantly lower than the patients of group 2 ( P < 0.001, suggesting that periprostatic block produced a significant reduction in the perceived pain. Conclusions: Local anesthetic infiltration by TRUS-guided injection of Lidocaine is effective for decreasing pain associated with prostatic biopsy.

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

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    Oebek, C.; Oezkan, B.; Tunc, B.; Can, G.; Yalcin, V.; Solok, V. [University of Istanbul (Turkey). Cerrahpasa School of Medicine. Depts. of Urology and Public Health (GC)

    2004-09-15

    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)

  12. Shortening Infusion Time for High-Dose Methotrexate Alters Antileukemic Effects: A Randomized Prospective Clinical Trial

    Science.gov (United States)

    Mikkelsen, Torben S.; Sparreboom, Alex; Cheng, Cheng; Zhou, Yinmei; Boyett, James M.; Raimondi, Susana C.; Panetta, John C.; Bowman, W. Paul; Sandlund, John T.; Pui, Ching-Hon; Relling, Mary V.; Evans, William E.

    2011-01-01

    Purpose To determine whether shortening the infusion duration of high-dose methotrexate (HDMTX; 1 g/m2) affects the in vivo accumulation of active methotrexate polyglutamates (MTXPG1-7) in leukemia cells and whether this differs among major acute lymphoblastic leukemia (ALL) subtypes. Methods From June 2000 through October 2007, 356 children with ALL were randomly assigned to receive initial single-agent treatment with HDMTX (1 g/m2) as either a 24-hour infusion or a 4-hour infusion at two pediatric hospitals in the United States. The primary outcome measures were the accumulation of MTXPG1-7 in leukemia cells and the antileukemic effects (eg, inhibition of de novo purine synthesis in bone marrow ALL cells, and decrease in circulating ALL cells). Results The 24-hour infusion resulted in significantly higher amounts of MTXPG1-7 in bone marrow leukemia cells (median: 1,695 v 1,150 pmol/109 cells, P = .0059), and better antileukemic effects. The 24-hour infusion had the greatest effect on MTXPG1-7 accumulation in hyperdiploid ALL (median: 3,919 v 2,417 pmol/109 cells, P = .0038); T-cell ALL exhibited smaller differences in MTXPG1-7 but greater antileukemic effects with the longer infusion (median decrease in leukemia cells: 88.4% v 51.8%, P = .0075). In contrast, infusion duration had no significant impact on MTXPG1-7 accumulation or antileukemic effects in ALL with the t(12;21)/(ETV6-RUNX1) chromosomal translocation. Conclusion Shortening the infusion time of HDMTX reduces accumulation of active methotrexate in leukemia cells and decreases antileukemic effects, with differing consequences among major ALL subtypes. PMID:21444869

  13. CONTROLLED HYPOTENSIVE ANAESTHESIA WITH DEXMEDETOMIDINE FOR FUNCTIONAL ENDOSCOPIC SINUS SURGERY: A PROSPECTIVE RANDOMIZED DOUBLE BLIND STUDY

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    Sunil

    2014-08-01

    Full Text Available : OBJECTIVE: Controlled hypotension is commonly used to achieve a bloodless operative field which is needed for successful FESS. This study was carried out to assess the hypotensive effect of dexmedetomidine (DEX during FESS. METHODS: Fifty ASA grades I and II patients of either sex aged 20–50 years undergoing FESS were randomly divided into two groups of 25 each. Group D received 10–15 min prior to induction of anesthesia 1 μg/kg IV bolus DEX diluted in 10 ml of normal saline over 10 min. Immediately thereafter an infusion of 0.4 μg/kg/hr of DEX commenced. Group C received placebo bolus and infusion of saline at a rate similar to DEX in Group D. Standard anesthetic technique was used. The surgical field was assessed using Average Category Scale and average blood loss was calculated. Hemodynamic variables (MAP and HR; emergence time and total recovery from anesthesia (Aldrete score ≥9 were recorded. RESULT: Group D reached the desired MAP (55-65 mmHg. In group D patients the average MAP was 55.9±5.3 mm of Hg, where as in group C it was 86.2±11.4 mm of Hg. Patients in group D had a better surgical field, and the duration of surgery was significantly reduced(78.34±16.7mins in group D vs 103.2±113.1 mins in group C The mean awakening time was significantly reduced in patients of Group D (9.1±2.7 mins in group D vs12.8±2.2 mins in group C when compared to patients of Group C. CONCLUSION: This study demonstrated that dexmedetomidine is a safe agent for controlled hypotension and is effective in providing ideal surgical field during FESS.

  14. 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

    2017-08-29

    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 < .05). In the RET group, the cases caused by dens evaginatus achieved increased root length and root thickness compared with those caused by trauma (P < .05). RET and apexification achieved a comparable outcome in regard to the resolution of symptoms and 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.

  15. Orthosis for thoracolumbar burst fractures without neurologic deficit: A systematic review of prospective randomized controlled trials

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    Gabriel Alcala-Cerra

    2014-01-01

    Full Text Available Background: Traditionally, conservative treatment of thoracolumbar (TL burst fractures without neurologic deficit has encompassed the application of an extension brace. However, their effectiveness on maintaining the alignment, preventing posttraumatic deformities, and improving back pain, disability and quality of life is doubtful. Objective: The objective was to identify and summarize the evidence from randomized controlled trials (RCTs to determine whether bracing patients who suffer TL fractures adds benefices to the conservative manage without bracing. Materials and Methods: Seven databases were searched for relevant RCTs that compared the clinical and radiological outcomes of orthosis versus no-orthosis for TL burst fractures managed conservatively. Primary outcomes were: (1 Loss of kyphotic angle; (2 failure of conservative management requiring subsequent surgery; and (3 disability and pain outcomes. Secondary outcomes were defined by health-related quality of life and in-hospital stay. Results: Based on predefined inclusion criteria, only two eligible high-quality RCTs with a total of 119 patients were included. No significant difference was identified between the two groups regarding loss of kyphotic angle, pain outcome, or in-hospital stay. The pooled data showed higher scores in physical and mental domains of the Short-Form Health Survey 36 in the group treated without orthosis. Conclusion and Recommendation: The current evidence suggests that orthosis could not be necessary when TL burst fractures without neurologic deficit are treated conservatively. However, due to limitations related with number and size of the included studies, more RCTs with high quality are desirable for making recommendations with more certainty.

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

    Science.gov (United States)

    Jeon, Ho Joon; Choo, Min Soo

    2017-01-01

    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. PMID:28097266

  17. 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.

  18. Anal self-massage in the treatment of acute anal fissure: a randomized prospective study.

    Science.gov (United States)

    Gaj, Fabio; Biviano, Ivano; Candeloro, Laura; Andreuccetti, Jacopo

    2017-01-01

    An anal fissure (AF) is a tear in the epithelial lining of the anal canal. This is a very common condition, but the choice of treatment is unclear. The use of anal dilators is effective, economic, and safe. The aim of the study was to compare the efficacy of two conservative treatments, the use of anal dilators or a finger for anal dilatation, in reducing anal pressure and resolving anal fissures. Fifty patients with a clinical diagnosis of AF were randomly assigned to one of the treatments, self-massage of the anal sphincter (group A, 25 patients) or passive dilatation using dilators (group B, 25 patients). All patients were evaluated at baseline, at the end of treatment, and after 12 weeks and 6 months. Pain was measured using a visual analog scale. After the treatment, 60% of patients treated with dilators and 80% of patients treated with anal self-massage using a finger showed disappearance of their anal fissures. A comparison between signs and symptoms reported by the patients in the two groups showed a statistically significant reduction in anal pain (group A, P=0.0001; group B, P=0.0001) and bleeding after defecation (group A, P=0.001, group B, P=0.001). At 6 months after treatment, a significantly greater reduction in anal pain was observed in Group A compared to Group B (P=0.02). The use of anal self-massage with a finger appears to induce a better resolution of acute anal fissure than do anal dilators, and in a shorter time.

  19. Prepackaged central line kits reduce procedural mistakes during central line insertion: a randomized controlled prospective trial.

    Science.gov (United States)

    Fenik, Yelena; Celebi, Nora; Wagner, Robert; Nikendei, Christoph; Lund, Frederike; Zipfel, Stephan; Riessen, Reimer; Weyrich, Peter

    2013-04-30

    Central line catheter insertion is a complex procedure with a high cognitive load for novices. Providing a prepackaged all-inclusive kit is a simple measure that may reduce the cognitive load. We assessed whether the use of prepackaged all-inclusive central line insertion kits reduces procedural mistakes during central line catheter insertion by novices. Thirty final year medical students and recently qualified physicians were randomized into two equal groups. One group used a prepackaged all-inclusive kit and the other used a standard kit containing only the central vein catheter and all other separately packaged components provided in a materials cart. The procedure was videotaped and analyzed by two blinded raters using a checklist. Both groups performed central line catheter insertion on a manikin, assisted by nursing students. The prepackaged kit group outperformed the standard kit group in four of the five quality indicators: procedure duration (26:26 ± 3:50 min vs. 31:27 ± 5:57 min, p = .01); major technical mistakes (3.1 ± 1.4 vs. 4.8 ± 2.6, p = .03); minor technical mistakes (5.2 ± 1.7 vs. 8.0 ± 3.2, p = .01); and correct steps (83 ± 5% vs. 75 ± 11%, p = .02). The difference for breaches of aseptic technique (1.2 ± 0.8 vs. 3.0 ± 3.6, p = .06) was not statistically significant. Prepackaged all-inclusive kits for novices improved the procedure quality and saved staff time resources in a controlled simulation environment. Future studies are needed to address whether central line kits also improve patient safety in hospital settings.

  20. Effectiveness of pit and fissure sealants bonded with different adhesive systems: a prospective randomized controlled trial.

    Science.gov (United States)

    Erbas Unverdi, Gizem; Atac, Stephan Atilla; Cehreli, Zafer Cavit

    2016-11-30

    To evaluate and compare the clinical retention of a resin-based fissure sealant placed with an intermediate layer of etch-and-rinse (ER) or self-etch (SE) adhesives. Two hundred twenty-eight sealants were placed in 57 children with previously unsealed, caries-free permanent first molars, employing a split-mouth design. The teeth were randomized into four groups (n = 57 teeth/groups) according to the adhesive system placed under the tested sealant (Delton FS+; Dentsply). Group 1 (control): no bonding agent (conventional acid-etch sealant); group 2: prior enamel etch + ER adhesive (XP Bond; Dentsply); group 3: SE adhesive (Clearfil SE Bond; Kuraray) without prior etching; and group 4: prior enamel etch + SE adhesive (Clearfil SE Bond). Clinical assessments were performed according to modified USPHS criteria at 1, 3, 6, 12, 18, and 24 months. The data were analyzed statistically using Fisher's Exact test, the Kaplan-Meier analysis, and the Log-rank test. At 24 months, sealants bonded with XP Bond and Clearfil SE Bond with prior enamel etching showed similar retention rates (p > 0.05), and these rates were significantly better than the rates of the conventional sealant and Clearfil-SE groups (p  0.05). The cumulative survival rates on palatal/buccal surfaces showed similar outcomes as with occlusal surfaces: XP Bond (94%), Clearfil SE Bond + acid-etch (94%), conventional sealant (52%), and Clearfil SE Bond only (37%). Application of the tested ER adhesive and the SE adhesive with enamel etching significantly improved the clinical retention of Delton-FS over the 24-month period. The use of a resin-based fissure sealant placed with ER or SE adhesive with prior acid-etching yielded better retention than the conventional sealant over the 24-month period.

  1. Local injection of bupivacaine after rubber band ligation of hemorrhoids: prospective, randomized study.

    Science.gov (United States)

    Hooker, G D; Plewes, E A; Rajgopal, C; Taylor, B M

    1999-02-01

    The aim of this study was to determine if local injection of bupivacaine after hemorrhoidal banding causes a decrease in pain and in the incidence of associated symptoms. After hemorrhoidal banding, patients were randomly assigned to receive a local injection of bupivacaine with 1:200,000 epinephrine, an injection of normal saline, or no injection, just superior to each band. Pain was graded by the patient and by the study nurse within 30 minutes, and any associated symptoms were recorded. At intervals 6, 24, and 48 hours postbanding, the patient recorded pain, limitation of activities, and analgesic requirements. Associated symptoms while at home were recorded. Of 115 patients studied, 42 received bupivacaine injection, 42 received normal saline injection, and 31 received no injection. In patients receiving bupivacaine compared with no injection, within 30 minutes postbanding there was a significant reduction in pain graded by the patient (P = 0.000002) and by the nurse (P = 0.000005) and a significant reduction in incidence of nausea (P = 0.01) and shaking (P = 0.008). However, in the bupivacaine group compared with the other two groups, at the intervals of 6, 24, and 48 hours postbanding there was no sustained reduction in the severity of pain and no reduction in analgesic requirements or limitation of normal activities. In the week after banding, there was no difference between groups in symptoms of nausea, shaking, lightheadedness, urinary retention, or bleeding. Bupivacaine injection may be useful for reducing pain and associated symptoms long enough to tolerate a trip home from the outpatient department but does not show a sustained effect.

  2. 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.

  3. 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

    2017-07-31

    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

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

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    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

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

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    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

  6. Prospective randomized comparison of oral sodium phosphate and polyethylene glycol lavage for colonoscopy preparation

    Institute of Scientific and Technical Information of China (English)

    Kai-Lin Hwang; William Tzu-Liang Chen; Koung-Hong Hsiao; Hong-Chang Chen; Ting-Ming Huang; Chien-Ming Chiu; Ger-Haur Hsu

    2005-01-01

    AIM: To compare the effectiveness, patient acceptability, and physical tolerability of two oral lavage solutions prior to colonoscopy in a Taiwanese population. METHODS: Eighty consecutive patients were randomized to receive either standard 4 L of polyethylene glycol (PEG) or 90 mL of sodium phosphate (NaP) in a split regimen of two 45 mL doses separated by 12 h, prior to colonoscopic evaluation. The primary endpoint was the percent of subjects who had completed the preparation. Secondary endpoints included colonic cleansing evaluated with an overall assessment and segmental evaluation, the tolerance and acceptability assessed by a selfadministered structured questionnaire, and a safety profile such as any unexpected adverse events, electrolyte tests, physical exams, vital signs, and body weights. RESULTS: A significantly higher completion rate was found in the NaP group compared to the PEG group(84.2% vs 27.5%, P<0.001). The amount of fluid suctioned was significantly less in patients taking NaP vs PEG (50.13±54.8 cc vs 121.13±115.4 cc, P<0.001),even after controlling for completion of the oral solution(P = 0.031). The two groups showed a comparable overall assessment of bowel preparation with a rate of "good" or "excellent" in 78.9% of patients in the NaPgroup and 82.5% in PEG group (P = 0.778). Patients taking NaP tended to have significantly better colonic segmental cleansing relative to stool amount observedin the descending (94.7% vs 70%, P = 0.007) andtransverse (94.6% vs 74.4%, P = 0.025) colon. Slightly more patients graded the taste of NaP as "good" or "very good" compared to the PEG patients (32.5% vs 12.5%;P = 0.059). Patients' willingness to take the same preparation in the future was 68.4% in the NaP compared to 75% in the PEG group (P = 0.617). There was a significant increase in serum sodium and a significant decrease in phosphate and chloride levels in NaP group on the day following the colonoscopy without any clinical sequelae. Prolonged (

  7. Impact of biatrial defragmentation in patients with paroxysmal atrial fibrillation: results from a randomized prospective study.

    Science.gov (United States)

    Nührich, Jana Mareike; Steven, Daniel; Berner, Imke; Rostock, Thomas; Hoffmann, Boris; Servatius, Helge; Sultan, Arian; Lüker, Jakob; Treszl, András; Wegscheider, Karl; Willems, Stephan

    2014-09-01

    Single procedure success rates of pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF) are still unsatisfactory. In patients with persistent atrial fibrillation (AF), ablation of complex fractionated atrial electrograms (CFAEs) after PVI results in improved outcomes. We aimed to investigate if PAF-patients with intraprocedurally sustained AF after PVI might benefit from additional CFAE ablation. A total of 1134 consecutive patients underwent a first catheter ablation procedure of PAF between June 2008 and December 2012. In most patients, AF was either not inducible or terminated during PVI. In 68 patients (6%), AF sustained after successful PVI. These patients were randomized to either cardioversion (PVI-alone group; n = 33) or additional CFAE ablation (PVI+CFAE group; n = 35) and followed up every 1-3 months and serial Holter recordings were also obtained. The primary end point was the recurrence of AF/atrial tachycardia (AT) after a blanking period of 3 months. Procedure duration (127 ± 6 minutes vs 174 ± 10 minutes), radiofrequency application time (44 ± 3 minutes vs 74 ± 5 minutes), and fluoroscopy time (26 ± 2 minutes vs 41 ± 3 minutes) were longer in the PVI+CFAE group (all P PVI+CFAE group, ablation terminated AF. There was no significant group difference with respect to freedom from AF/AT (22 of 33 [67%] vs 22 of 35 [63%]; P = .66). Subsequently, 10 of 11 patients in the PVI-alone group (91%) and 11 of 13 patients in PVI+CFAE group (85%) underwent repeat ablation (P = 1.00). Overall, 29 of 33 [88%] vs 30 of 35 [86%] patients (P = 1.00) were free from AF/AT after 1.4 ± 0.1 vs 1.4 ± 0.2 (P = .87) procedures. Patients with sustained AF after PVI in a PAF cohort are rare. Regarding AF/AT recurrence, these patients did not benefit from further CFAE ablation compared to PVI alone, but are exposed to longer procedure duration, fluoroscopy time, and radiofrequency application time. Copyright © 2014 Heart Rhythm Society

  8. A comparative prospective randomized clinical study of MTA and IRM as root-end filling materials in single-rooted teeth in endodontic surgery.

    Science.gov (United States)

    Lindeboom, Jerome A H; Frenken, Joost W F H; Kroon, Frans H M; van den Akker, Hans P

    2005-10-01

    Randomized clinical prospective study to evaluate the application of MTA and IRM as retrograde sealers in surgical endodontics. One hundred single-rooted teeth were surgically treated. After randomization, MTA or IRM was used as a retrosealer. Radiographs were taken 1 week, 3 months, and 1 year postoperatively. Assessment was performed by 2 independent assessors 1 year after surgery. Both treatment groups were homogeneous in their composition, and clinical features and radiographic findings were classified according to Rud's classification. Complete healing was observed in 64% of the MTA-treated teeth vs 50% of the IRM-treated teeth. Incomplete healing was seen in 28% (MTA) vs 36% (IRM), and unsatisfactory in 6% (MTA) vs 14% (IRM). Only 1 failure was seen (MTA). No statistically significant differences were found between the 2 retrofilling materials. As root-end filling materials in this clinical prospective randomized design on single rooted teeth, MTA and IRM had the same clinical effectiveness.

  9. Clinical efficacy of intra-articular injections in knee osteoarthritis: a prospective randomized study comparing hyaluronic acid and betamethasone

    Science.gov (United States)

    Trueba Davalillo, Cesáreo Ángel; Trueba Vasavilbaso, Cesáreo; Navarrete Álvarez, José Mario; Coronel Granado, Pilar; García Jiménez, Ozcar Alejandro; Gimeno del Sol, Mercedes; Gil Orbezo, Félix

    2015-01-01

    Background Osteoarthritis (OA) is the most common joint disease and leading cause of disability. Intra-articular (IA) administration of hyaluronic acid (HA) or corticosteroids (CS) have been previously studied, though using insufficient number of patients or short follow-up periods. Objective We evaluate HA and CS in patients with knee OA in terms of clinical efficacy over 12 months. Methods We used a prospective, randomized study with parallel groups. Randomized patients received IA injections of HA or betamethasone (BM). The primary outcomes were improvement in pain using Visual Analog Scale and function in the Western Ontario and McMaster University Osteoarthritis Index (Likert scale). Follow-up visits were scheduled at 3 months, 6 months, 9 months, and 12 months. Results A total of 200 patients were included. Pain was significantly reduced in both groups at the first follow-ups. At 12 months, the mean pain reduction in the HA group was 33.6% (95% CI: 31.1–36.1) compared to 8.2% (95% CI: 5.2–11.1) in BM (P<0.0001). Function improvement was higher in HA through every visit, and mean improvement at 12 months was 47.5% (95% CI: 45.6–49.3) in HA patients vs 13.2% (95% CI: 11.4–14.9) in the BM group (P<0.0001). All patients from both groups achieved the Minimal Clinically Important Improvement (MCII) for both pain and function up to 6 months. At 9 months and 12 months, the MCII figures were higher in HA group with ≥80% compared to ≤10% in BM group (P<0.0001). Adverse reactions were rare and related to the administration procedure. Conclusion Both treatments effectively controlled OA symptoms. BM showed higher short-term effectiveness, while HA showed better long-term effectiveness, maintaining clinical efficacy in a large number of patients 1 year after administration.

  10. Prospective randomized study of clinical performance of 3 aspheric and 2 spherical intraocular lenses in 250 eyes.

    Science.gov (United States)

    Caporossi, Aldo; Martone, Gianluca; Casprini, Fabrizio; Rapisarda, Lorenzo

    2007-09-01

    To compare the quality of vision with aspheric and spherical intraocular lenses (IOLs) in pseudophakic patients. This prospective, comparative, randomized study included 250 eyes of 125 patients with bilateral cataracts. Patients were randomly assigned to receive either IOLs with a spherical biconvex optic (Acrysof SN6OAT [Alcon] or Sensar AR40e [Advanced Medical Optics, AMO]) or IOLs with an aspheric optic (Acrysof IQ SN6OWF [Alcon], Tecnis Z9000 [AMO], or Sofport L161AO [Bausch & Lomb]). Ophthalmologic examination including best spectacle-corrected visual acuity, pupil size, ocular dominance investigation, contrast sensitivity under mesopic and photopic conditions, and wavefront analysis was performed 2 months postoperatively. Aspheric IOLs showed better contrast sensitivity compared to spherical IOLs at spatial frequencies of 6, 12, and 18 cycles per degree (cpd) under photopic conditions and at all spatial frequencies under mesopic conditions. There was no significant difference among the three aspheric IOLs at all spatial frequencies under either photopic or mesopic conditions. Mean total spherical aberration was statistically lower in dominant eyes with aspheric IOLs (0.05 +/- 0.06, 0.11 +/- 0.1, and 0.19 +/- 0.08 pm for the Tecnis Z9000, Acrysof IQ SN6OWF, and Sofport L161AO, respectively) compared with eyes with spherical IOLs (0.62 +/- 0.24 and 0.46 +/- 0.19 microm for the Acrysof SN6OAT and Sensar AR40e, respectively) for a 5-mm pupil diameter. The aspheric IOLs had less wavefront aberrations and performed better under both photopic and mesopic contrast sensitivity compared to the spherical IOLs. These findings confirm it is possible to improve the optical performance of IOLs by modifying the surfaces.

  11. Safety and efficacy of vertebroplasty in the treatment of osteoporotic vertebral compression fractures: a prospective multicenter international randomized controlled study

    Science.gov (United States)

    Leali, Paolo Tranquilli; Solla, Federico; Maestretti, Gianluca; Balsano, Massimo; Doria, Carlo

    2016-01-01

    Summary Background Vertebral compression fractures (VCFs) treated non-operatively can diminish function and quality of life, and lead to chronic health effects. The short-term safety and effectiveness of vertebroplasty for symptomatic VCFs are well-documented, but long-term follow-up is needed. Purpose The aim of this paper was to analyse a multicenter international experience of 200 compression fractures treated with percutaneous vertebroplasty (VP) and compare the results of this procedure with the result of 200 patients treated conservatively. To estimate cost-effectiveness of VP compared to conservative care in terms of: pain reduction, quality of life, complications, secondary fractures and mortality. Materials and methods 400 patients have been enrolled in a prospective randomized controlled study with painful VCFs with bone edema on MR imaging, local back pain for 6 weeks or less, osteoporosis and aged 55 years or older; after obtaining informed consent patients are included and randomized for VP or conservative care. Before treatment and at follow-up with regular intervals during 1-year period were administered to patients standard questionnaires addressing: clinical symptoms, pain medication, Visual Analogue Scale (VAS) score for pain, Oswestry Disability Index (ODI) score to evaluate functional activity. Results 200 patients treated with PV compared with 200 patients treated conservatively had significantly better VAS and used less analgesics 1 day after treatment. Twenty-four hours after VP, there was a reduction in pain scores and an improvement in physical functions, whereas remain unchanged in the patients treated conservatively. Conclusions Pain relief and improvement of mobility and function after PV is immediate and significantly better in the short term compared with non-surgical care treatment. PMID:28228788

  12. [A prospective, randomized, double-blinded control study on comparison of tramadol, clonidine and dexmedetomidine for post spinal anesthesia shivering].

    Science.gov (United States)

    Venkatraman, Rajagopalan; Karthik, Krishnamoorthy; Pushparani, Anand; Mahalakshmi, Annadurai

    2017-05-22

    Shivering, a common intraoperative problem under spinal anesthesia increases the oxygen consumption considerably and is uncomfortable and distressing to the patient, anesthesiologist as well as surgeon. The present study was designed to explore the effectiveness of tramadol, clonidine and dexmedetomidine in the treatment of post spinal anesthesia shivering and to look for their adverse effects. This prospective, randomized, double blinded control study was done on 90 patients who developed shivering under spinal anesthesia. They were randomly allocated into three groups with Group T receiving tramadol 1mg.kg(-1), Group C getting clonidine 1mcg.kg(-1) and Group D patients receiving dexmedetomidine 0.5mcg.kg(-1). The time taken to control shivering, recurrence rate, hemodynamic variables, sedation score and adverse effects were observed. Dexmedetomidine was faster in the control of shivering in 5.7±0.79minutes (min) whereas tramadol took 6.76±0.93min and clonidine was slower with 9.43±0.93min. The recurrence rate was much lower in the dexmedetomidine group with 3.3% than for clonidine (10%) and tramadol (23.3%) group. The sedation achieved with dexmedetomidine was better than clonidine and tramadol. The tramadol group had more cases of vomiting (four) and dexmedetomidine group had six cases of hypotension and two cases of bradycardia. Two of the clonidine patients encountered bradycardia and hypotension. Dexmedetomidine is better than tramadol and clonidine in the control of shivering because of its faster onset and less recurrence rate. Though complications are encountered in the dexmedetomidine group, they are treatable. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  13. 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.

  14. Retroperitoneal decortication of simple renal cysts vs decortication with wadding using perirenal fat tissue: results of a prospective randomized trial.

    Science.gov (United States)

    Porpiglia, Francesco; Fiori, Cristian; Billia, Michele; Renard, Julien; Di Stasio, Andrea; Vaccino, Davide; Bertolo, Riccardo; Scarpa, Roberto Mario

    2009-06-01

    OBJECTIVES To evaluate, in a pilot prospective randomized trial, the safety, effectiveness and radiological recurrence of retroperitoneal renal cyst decortication compared with retroperitoneal decortication with wadding using perirenal pedicled fat tissue. PATIENTS AND METHODS From March 2004 to December 2007, 40 patients with simple renal cysts were enrolled and randomized; 22 (group A) had a simple retroperitoneal decortication (SRD) and 18 (group B) a decortication with wadding of the cyst using perirenal fat tissue (RDCW). The following variables were recorded: age, gender, side, size on ultrasonography/computed tomography (CT), location, operative duration, blood loss, complications, pathology, presence or absence of flank pain, hypertension, urinary tract compression or urinary infection. The primary endpoint of this trial was to evaluate and compare the efficacy of both treatments. Secondary endpoints were safety and pain, hypertension and the resolution of urinary tract obstruction. RESULTS In all, 40 cysts were treated; there were no bilateral cysts. The mean (sd) size on CT was 11.9 (1.84) cm in group A and 12.8 (1.25) cm in group B (P = 0.1). All the procedures were completed laparoscopically and no conversion was necessary. There were no intraoperative complications. The mean (range) hospital stay was 3.4 (3-6) days. There was no statistically significant difference between the groups for all variables assessed. There was a radiological recurrence in three patients (14%) in group A, but none in group B (all successful). CONCLUSION To be completely successful, with maximum safety and to prevent recurrences in the treatment of renal cysts, RCDW is recommended when a retroperitoneal approach is chosen, especially if the cyst is located anteriorly. When symptom relief is considered, RCDW duplicates the results obtained with SRD.

  15. Efficacy of splinting and oral steroids in the treatment of carpal tunnel syndrome: A prospective randomized clinical and electrophysiological study

    Directory of Open Access Journals (Sweden)

    Mishra Sanjay

    2006-01-01

    Full Text Available Objective: To study the efficacy of splinting and oral steroids in the management of carpal tunnel syndrome (CTS. Design: Prospective, randomized, open-label, clinical and electrophysiological study with 3-month follow-up. Materials and Methods: Forty patients with CTS were randomly divided into splint group (N-20, wearing splint in neutral position for 4 weeks; and steroid group (N-20, who received oral prednisolone 20 mg/day for 2 weeks followed by 10 mg/day for 2 weeks. Clinical and electrophysiological evaluations were done at baseline and at 1-month and 3-month follow-up. Independent ′t′ test and paired ′t′ test were used for statistical analysis. Outcome Measures: Primary outcome measure was the symptom severity score and functional status score. Secondary outcome measures were median nerve sensory and motor distal latency and conduction velocity. Results: At the end of 3 months, statistically significant improvement was seen in symptom severity score and functional status score in both groups ( P P =0.001 at 3 months in steroid group, while insignificant improvement ( P =0.139 was observed in splint group. On comparing the clinical and electrophysiological improvement between the two groups, except for the functional status score, there was no significant difference at 3-month follow-up. Improvement in functional status score was significantly more in steroid group ( P =0.03. Conclusion : There was significant improvement in both groups, clinically as well as electrophysiologically, at 3 months. On comparing the efficacy of the two treatment methods, except for the functional status score, there was no significant difference between the two groups.

  16. 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.

  17. The Effect of Patella Eversion on Clinical Outcome Measures in Simultaneous Bilateral Total Knee Arthroplasty: A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Zan, Pengfei; Wu, Zhong; Yu, Xiao; Fan, Lin; Xu, Tianyang; Li, Guodong

    2016-03-01

    During total knee arthroplasty (TKA), surgical exposure requires mobilization technique of the patella. With this trial, we intended to investigate the effect of patella eversion on clinical outcome measures in simultaneous bilateral TKA. We prospectively enrolled 44 patients (88 knees) from April 2008 to June 20l4.One knee was operated with patella eversion (group A) and the other with patella lateral retraction (group B) randomly. Follow-up results, including the operation time, complications, and the time of achieving straight leg raise (SLR) and 90° knee flexion, were recorded. The data of range of motion (ROM) and Visual Analogue Scale score were collected separately at 7 days, 3 months, 6 months, and 1 year postoperatively. The time of achieving SLR was 2.7 ± 0.8 days in group A and 2.1 ± 0.7 DAYS in group B, which were significantly different (P = .032). Significant difference was found on active and passive ROM during the follow-up times between groups A and B, except the passive ROM at 6 months postoperatively. No significant difference was found on operation time, complications, patella baja or tilt, time of achieving 90°knee flexion, and Visual Analogue Scale score during the follow-up times. Patellar eversion was adverse to the early knee function recovery after TKA; it would delay the time of achieving SLR and decrease the passive and active ROM. In addition, more carefully and scientifically designed randomized controlled trials are still required to further prove the claim. Copyright © 2016 Elsevier Inc. All rights reserved.

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

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    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

  19. The important role of positioning in nasogastric tube insertion in unconscious patients: A prospective, randomized, double-blind study.

    Science.gov (United States)

    Zhao, Wangmiao; Ge, Chunyan; Zhang, Wanzeng; Sun, Zhaosheng; Li, Xiaowei

    2017-05-25

    To investigate whether positioning the body in a lateral decubitus position will facilitate nasogastric tube insertion in unconscious patients. Inserting a nasogastric tube into unconscious patients can be challenging because these patients cannot cooperate with the operator. The piriform sinus and arytenoid cartilage are the most commonly reported impaction sites. However, we found that the first impaction site was the backward displaced tongue when inserting a nasogastric tube in unconscious patients who often exhibited glossoptosis. Performing an intubation in the lateral decubitus position could make this procedure easy. This prospective, double-blind, parallel, randomized controlled trial was conducted in Hengshui City, Hebei Province, China. 110 cases of unconscious patients were enrolled. The patients were randomly assigned to a conventional group (group C) or a lateral decubitus position group (group L). In group C, the nasogastric tube was inserted while the patients were in a supine position using the conventional technique, and in group L, the tube was inserted in a lateral decubitus position or further tilting the body to a prone decubitus position 20-30 degrees. We discussed reasonable intubation methods in unconscious patients by comparing the success rate on first insertion, the overall success rate, the intubation time and the complication rates between the two groups. Group L had a higher success rate on first insertion and overall success rate than group C (Ppassage. Nasogastric tube insertions in the lateral decubitus position are recommended in unconscious patients because of the higher success rate, reduced intubation time and lower complication rate. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  20. Resurfacing of the patella in total knee arthroplasty. A prospective, randomized, double-blind study.

    Science.gov (United States)

    Barrack, R L; Wolfe, M W; Waldman, D A; Milicic, M; Bertot, A J; Myers, L

    1997-08-01

    During a two-year period, eighty-nine patients who were scheduled to have a total knee arthroplasty for the treatment of degenerative osteoarthrosis were randomly assigned to one of two groups: resurfacing of the patella or retention of the patella. All patients received the same posterior cruciate-sparing prosthesis, and all operations were performed by, or under the direct supervision of, one of us. Three patients died in the early postoperative period. The remaining eighty-six patients (118 knees; fifty-eight that had had resurfacing of the patella and sixty that had not) formed the study group. They were followed for a mean of thirty months (range, twenty-four to forty-four months). Evaluation was performed with use of the clinical scoring system of The Knee Society, a patient-satisfaction questionnaire, specific questions regarding patellofemoral symptoms and function, and radiographs. All clinical evaluations were performed by the same research nurse, without the involvement of a physician, in a blinded manner (neither the nurse nor the patient had knowledge of whether the patella had been resurfaced). Preoperatively, the mean Knee Society score, on a scale ranging from 0 to 200 points, was 89.7 points (range, 33 to 132 points); postoperatively, this score improved to a mean of 172.7 points (range, 98 to 200 points). With the numbers available for study, we could detect no significant difference between the knees that had had patellar resurfacing and those that had not with regard to the over-all score (p = 0.63), the subscore for pain (p = 0.56), or the subscore for function (p = 0.77). We also could detect no difference between the treatment groups, with the numbers available, with regard to patient satisfaction or the responses to questions involving the function of the patellofemoral joint, including the ability to exit from an automobile, to rise from a chair, and to climb stairs. Thirty-two patients had bilateral total knee replacement with resurfacing

  1. Does visceral osteopathic treatment accelerate meconium passage in very low birth weight infants?- A prospective randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Nadja Haiden

    Full Text Available To determine whether the complementary approach of visceral manipulative osteopathic treatment accelerates complete meconium excretion and improves feeding tolerance in very low birth weight infants.This study was a prospective, randomized, controlled trial in premature infants with a birth weight <1500 g and a gestational age <32 weeks who received a visceral osteopathic treatment 3 times during their first week of life or no treatment.Passage of the last meconium occurred after a median of 7.5 days (95% confidence interval: 6-9 days, n = 21 in the intervention group and after 6 days (95% confidence interval: 5-9 days, n = 20, in the control group (p = 0.11. However, osteopathic treatment was associated with a 8 day longer time to full enteral feedings (p = 0.02, and a 34 day longer hospital stay (Median = 66 vs. 100 days i.e.; p=0.14. Osteopathic treatment was tolerated well and no adverse events were observed.Visceral osteopathic treatment of the abdomen did not accelerate meconium excretion in VLBW (very low birth weight-infants. However infants in the osteopathic group had a longer time to full enteral feedings and a longer hospital stay, which could represent adverse effects. Based on our trial results, we cannot recommend visceral osteopathic techniques in VLBW-infants.Clinical trials.gov: NCT02140710.

  2. Do alcohol-based hand rubs reduce the incidence of acute diarrhea during military deployments? A prospective randomized trial.

    Science.gov (United States)

    Succo, Tiphanie; De Laval, Franck; Sicard, Sébastien; Belleoud, Didier; Marimoutou, Catherine; Mayet, Aurélie; Sagaon-Teyssier, Luis; Michel, Rémy

    Acute diarrhea remains a public health concern in armed forces deployed in tropical areas where access to water and soap is limited. This study aims to assess the effectiveness of alcohol-based hand rubs (ABHR) on incidence of diarrhea in poor hygiene conditions. A prospective randomized trial was conducted between November 2014 and January 2015 among French military troops deployed in Africa to compare a group of soldiers receiving usual hand hygiene recommendations (control group), to a group of soldiers who received ABHR in addition to usual hand hygiene recommendations (intervention group). Data on diarrhea and hygiene behaviors were collected using self-questionnaires. The incidence rate of diarrhea episodes in groups was compared. Participation rate was 59% (236/400). The proportion of individuals who used ABHR was 97% in the intervention group and 62% in the control group. The overall incidence rate of diarrheal episodes was observed to be in the region of 60 per 100 persons-month without any significant difference between groups after adjustment on confounding factors (p = 0.93). Handwashing with soap was used on average 4 times a day in the control group and twice a day in the intervention group (p = 0.93). It was the only significant protective factor for diarrhea (p soap and good quality water should be a priority on the field. Copyright © 2016. Published by Elsevier Ltd.

  3. [A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution].

    Science.gov (United States)

    Lu, Quan

    2010-03-01

    To evaluate efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution for the treatment of cough, expectoration, nasal congestion and runny nose in children. This was a prospective multicenter randomized single-blind, parallel-controlled clinical study. A total of 10 centers participated in this study, the actual number of cases in line with the program was 412, of whom 205 cases in trial group were treated with Guaifenesin compound pseudoephedrine hydrochloride oral solution, and 207 cases in control group with ambroxol hydrochloride oral solution, treatment of both groups persisted for 7 days. The improvement rate of each single symptom and the combined symptoms and the overall effective rate were compared between the two groups. The adverse drug reactions and compliance were assessed as well. The treatment of both groups showed efficacy. Except sputum stickiness, the improvement of all symptoms in trial group was superior to that in the control group on the 3rd day after treatment (P Guaifenesin compound pseudoephedrine hydrochloride oral solution was 82.9% and the overall efficacy rate was 89.3%. Guaifenesin compound Pseudoephedrine hydrochloride oral solution had higher compliance and its adverse event rate was merely 0.92%. Guaifenesin compound pseudoephedrine hydrochloride oral solution showed significant efficacy and safety in children for treatment of cough, expectoration, nasal congestion and runny nose caused by common cold or acute tracheobronchitis.

  4. AUGMENTATION VS NONAUGMENTATION TECHNIQUES FOR OPEN REPAIRS OF ACHILLES TENDON RUPTURES WITH EARLY FUNCTIONAL TREATMENT: A PROSPECTIVE RANDOMIZED STUDY

    Directory of Open Access Journals (Sweden)

    Gündüz Tezeren

    2006-12-01

    Full Text Available A prospective randomized study was conducted in order to compare augmentation technique versus nonaugmentation technique, followed by early functional postoperative treatment, for operative repair of Achilles tendon ruptures. Twenty-four consecutive patients were assigned to two groups. Group I included 12 patients treated with Lindholm augmentation technique, whereas group II included 12 patients treated with modified Kessler end-to-end repair. Thereafter, these patients had postoperative management with a below-knee-cast for three weeks. The physioteraphy was initiated immediately after the cast was removed. Full weight bearing was allowed after five weeks postoperatively in the both groups. Two patients had reruptures in group II, whereas group I had prolonged operative time significantly. The patients with reruptures underwent reoperations and at the most final follow-up, it was observed that they could not resume to sporting activities. The other objective and subjective results were similar between two groups. Because of quite high rerupture rate in the group of patients treated with nonaugmentation technique, we favor functional postoperative treatment with early ankle movement in the patients treated with augmentation technique for the management of acute rupture of the Achilles tendon

  5. 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.

  6. 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.

  7. Adjunctive self-hypnotic relaxation for outpatient medical procedures: a prospective randomized trial with women undergoing large core breast biopsy.

    Science.gov (United States)

    Lang, Elvira V; Berbaum, Kevin S; Faintuch, Salomao; Hatsiopoulou, Olga; Halsey, Noami; Li, Xinyu; Berbaum, Michael L; Laser, Eleanor; Baum, Janet

    2006-12-15

    Medical procedures in outpatient settings have limited options of managing pain and anxiety pharmacologically. We therefore assessed whether this can be achieved by adjunct self-hypnotic relaxation in a common and particularly anxiety provoking procedure. Two hundred and thirty-six women referred for large core needle breast biopsy to an urban tertiary university-affiliated medical center were prospectively randomized to receive standard care (n=76), structured empathic attention (n=82), or self-hypnotic relaxation (n=78) during their procedures. Patients' self-ratings at 1 min-intervals of pain and anxiety on 0-10 verbal analog scales with 0=no pain/anxiety at all, 10=worst pain/anxiety possible, were compared in an ordinal logistic regression model. Women's anxiety increased significantly in the standard group (logit slope=0.18, pempathy group (slope=-0.04, p=0.45), and decreased significantly in the hypnosis group (slope=-0.27, pempathy=0.37, hypnosis=0.34; all pempathy than standard care (p=0.024 and p=0.018, respectively). Room time and cost were not significantly different in an univariate ANOVA despite hypnosis and empathy requiring an additional professional: 46 min/161 dollars for standard care, 43 min/163 dollars for empathy, and 39 min/152 dollars for hypnosis. We conclude that, while both structured empathy and hypnosis decrease procedural pain and anxiety, hypnosis provides more powerful anxiety relief without undue cost and thus appears attractive for outpatient pain management.

  8. Postoperative radiation therapy for rectal cancer. An interim analysis of a prospective, randomized multicenter trial in The Netherlands

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    Treurniet-Donker, A.D.; van Putten, W.L.; Wereldsma, J.C.; Bruggink, E.D.; Hoogenraad, W.J.; Roukema, J.A.; Snijders-Keilholz, A.; Meijer, W.S.; Meerwaldt, J.H.; Wijnmaalen, A.J. (Dr. Daniel den Hoed Cancer Center, Rotterdam (Netherlands))

    1991-04-15

    The authors assessed the potential benefit of postoperative radiation therapy for rectal cancer in a two-arm, prospective multicenter trial. One hundred seventy-two patients who had undergone surgical resection for rectal adenocarcinoma were randomly assigned to either treatment consisting of external irradiation to a dose of 5000 cGy in 5 weeks or a control group (no adjuvant therapy). It was assumed that the number of cells remaining after radical surgery would be low and that the dose of 5000 cGy would be adequate in eradicating the majority of those cells. The number of local recurrences was lower in the treated group of patients, but the difference was not statistically significant. It was assumed that if a significant reduction in the number of local recurrences could be obtained, improved (disease-free) survival would result. No influence on disease-free or overall survival could be detected. These results were in agreement with those reported in Europe and the US, and it was concluded that postoperative radiation therapy alone cannot be justified as a routine procedure in the primary management of resectable rectal cancer.

  9. Postoperative radiation therapy for rectal cancer. An interim analysis of a prospective, randomized multicenter trial in The Netherlands.

    Science.gov (United States)

    Treurniet-Donker, A D; van Putten, W L; Wereldsma, J C; Bruggink, E D; Hoogenraad, W J; Roukema, J A; Snijders-Keilholz, A; Meijer, W S; Meerwaldt, J H; Wijnmaalen, A J

    1991-04-15

    The authors assessed the potential benefit of postoperative radiation therapy for rectal cancer in a two-arm, prospective multicenter trial. One hundred seventy-two patients who had undergone surgical resection for rectal adenocarcinoma were randomly assigned to either treatment consisting of external irradiation to a dose of 5000 cGy in 5 weeks or a control group (no adjuvant therapy). It was assumed that the number of cells remaining after radical surgery would be low and that the dose of 5000 cGy would be adequate in eradicating the majority of those cells. The number of local recurrences was lower in the treated group of patients, but the difference was not statistically significant. It was assumed that if a significant reduction in the number of local recurrences could be obtained, improved (disease-free) survival would result. No influence on disease-free or overall survival could be detected. These results were in agreement with those reported in Europe and the US, and it was concluded that postoperative radiation therapy alone cannot be justified as a routine procedure in the primary management of resectable rectal cancer.

  10. Efficacy and safety of ecabet sodium on functional dyspepsia :A prospective, double-blinded, randomized, multi-center controlled trial

    Institute of Scientific and Technical Information of China (English)

    Jun Haeng Lee; Soo Teik Lee; Eun Hyun Lee; Jong Chul Rhee; Jae J Kim; Ki-Baik Hahm; Dong Ho Lee; Nayoung Kim; Sung Kook Kim; Jong Jae Park; Seok Reyol Choi; Jong Hun Lee

    2006-01-01

    AIM: To compare ecabet sodium and cimetidine in relieving symptoms of functional dyspepsia.METHODS: We performed a multi-center, prospective,randomized, double-blinded controlled trial to compare the clinical efficacy of ecabet sodium and cimetidine in patients with functional dyspepsia. Two-hundred and seventy-two patients with dyspeptic symptoms fulfilling the Rome-Ⅱ criteria were enrolled from 7 centers. In the study group (115 patients), 1.5 g ecabet sodium was given twice a day. In the control group (121 patients),400 mg cimetidine was given twice a day. Symptoms and parameters of quality of life were analyzed at baseline, 3,14, and 28 d after initiating the treatment.RESULTS: Two-hundred and thirty-six patients completed the clinical trial. After 4 wk of treatment,the rates of improvement in patients with dyspeptic symptoms were not different between two groups (77.4% in the ecabet group and 79.3% in the cimetidine group, respectively, P > 0.05). Likewise, the rates of symptomatic improvement were not different at 3 d and 14 d. The parameters of quality of life did not change significantly during the study period in both groups.There was no clinically significant adverse event in both groups.CONCLUSION: In patients with functional dyspepsia,ecabet sodium has similar clinical efficacy with cimetidine.

  11. 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

  12. 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

  13. To compare the effect of Telmisartan with Metoprolol on arterial stiffness in hypertension: Prospective randomized parallel group trial

    Science.gov (United States)

    Sumbria, Minakshi; Negi, Prakash C.; Sahai, Ashok K.; Kaundal, Purshotam K.

    2014-01-01

    Background Hypertension is often complicated by increased arterial stiffness and is an independent predictor of adverse cardiovascular (CV) outcome. Beta blockers and angiotensin receptor blockers (ARBs) are commonly used antihypertensive agents. The effect of beta blockers and ARBs on arterial stiffness has not been compared adequately. The aim of the present study is to compare the effect of telmisartan with metoprolol on arterial stiffness in hypertensive patients in prospective open label randomized parallel group intervention study. Methods 100 patients of hypertension, not on any antihypertensive agents, were enrolled after obtaining informed consent. Baseline recording of data related to demographics, CV risk factors, anthropometry and BP were made. Arterial stiffness was measured noninvasively by recording pulse wave velocity (PWV) using periscope (Genesis medical system). Left ventricular (LV) mass was measured using 2D guided M-mode echocardiography. Blood sugar, renal function, lipids and uric acid estimations were done in fasting state. Patients were randomized to receive metoprolol and telmisartan using stratified randomization technique. Dose of the study drugs were titrated to achieve target BP of <140/90 mmHg. Data related to PWV, BP, anthropometry and blood biochemistry was repeated after 6 months of treatment with study drugs. Results Telmisartan resulted in significantly greater reduction in arterial stiffness index (ASI) in left and right lower limb arterial bed (39.9 ± 11.7 vs. 46.8 ± 17.0 m/s, p < 0.02) and (36.4 ± 9.6 vs. 44.86 ± 15.1 m/s, p < 0.002) respectively and systolic blood pressure (SBP) (−4.9 mmHg with 95% C.I. of −8.0–1.7 mmHg, p < 0.003) compared to metoprolol. Reduction in diastolic blood pressure (DBP) in telmisartan and metoprolol groups was not different statistically (−1.0 mmHg with 95% C.I. of −3.3–1.2 mmHg, p < 0.3). The change in LV mass was not significantly different between the

  14. The effects of parental presence in the postanesthetic care unit on children's postoperative behavior: a prospective, randomized, controlled study.

    Science.gov (United States)

    Lardner, David R; Dick, Bruce D; Crawford, Susan

    2010-04-01

    The effects on children of parental presence in the postanesthesia care unit (PACU) have not been extensively studied. The few published studies are retrospective, nonrandomized, or lack adequate controls. They suggest that parental presence in the PACU decreases crying and negative behavior change postoperatively. We performed this prospective, randomized, controlled study to determine whether the presence of a parent affected crying behaviors in the PACU and behavior change 2 weeks postoperatively. Randomly selected patients, aged 2.0 to 8 years 11 months, ASA physical status I or II, and scheduled for elective outpatient surgery with an anticipated PACU stay of >10 minutes were randomly assigned to the parent present group (n = 150) or parent absent group (n = 150) in the PACU. All parents underwent the same preparation program. Reunification occurred once children's eyes had opened for the parent present group. In the PACU, crying was scored each minute after eye opening using a 5-point scale. Negative behavior change 2 weeks after discharge was determined using the Post Hospitalization Behavior Questionnaire. Because the anesthesia technique to be used was not determined a priori, data on the technique used were collected to ensure that groups were similar. Multiple and logistic regression techniques were used to determine predictors of crying in the PACU and behavior change 2 weeks postoperatively. Parental presence in the PACU made no difference in crying in the PACU. Negative behavior change 2 weeks postoperatively occurred more frequently in the parent absent group than the parent present group (45.8% vs 29.3%; P = 0.007). Multiple regression identified the following significant factors as predictive of larger proportion of time spent crying in the PACU (R(2) = 0.256, F[5, 273] = 15.66, P < 0.001): age <5 years (P < 0.001) and higher Children's Hospital of Eastern Ontario Pain Scale score at 15 minutes after arrival in day surgery (P < 0.001). Parental

  15. The cyclicity of the period annulus of a quadratic reversible system with one center of genus one

    OpenAIRE

    PENG, Linping; Sun, Yannan

    2014-01-01

    This paper is concerned with a quadratic reversible and non-Hamiltonian system with one center of genus one. By using the properties of related elliptic integrals and the geometry of some planar curves defined by them, we prove that the cyclicity of the period annulus of the considered system under small quadratic perturbations is two. This verifies Gautier's conjecture about the cyclicity of the related period annulus.

  16. The cyclicity of the period annulus of a quadratic reversible system with one center of genus one

    OpenAIRE

    PENG, Linping; Sun, Yannan

    2011-01-01

    This paper is concerned with a quadratic reversible and non-Hamiltonian system with one center of genus one. By using the properties of related elliptic integrals and the geometry of some planar curves defined by them, we prove that the cyclicity of the period annulus of the considered system under small quadratic perturbations is two. This verifies Gautier's conjecture about the cyclicity of the related period annulus.

  17. 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

  18. Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies

    Science.gov (United States)

    Azad, Meghan B.; Abou-Setta, Ahmed M.; Chauhan, Bhupendrasinh F.; Rabbani, Rasheda; Lys, Justin; Copstein, Leslie; Mann, Amrinder; Jeyaraman, Maya M.; Reid, Ashleigh E.; Fiander, Michelle; MacKay, Dylan S.; McGavock, Jon; Wicklow, Brandy; Zarychanski, Ryan

    2017-01-01

    BACKGROUND Nonnutritive sweeteners, such as aspartame, sucralose and stevioside, are widely consumed, yet their long-term health impact is uncertain. We synthesized evidence from prospective studies to determine whether routine consumption of non-nutritive sweeteners was associated with long-term adverse cardiometabolic effects. METHODS We searched MEDLINE, Embase and Cochrane Library (inception to January 2016) for randomized controlled trials (RCTs) that evaluated interventions for nonnutritive sweeteners and prospective cohort studies that reported on consumption of non-nutritive sweeteners among adults and adolescents. The primary outcome was body mass index (BMI). Secondary outcomes included weight, obesity and other cardiometabolic end points. RESULTS From 11 774 citations, we included 7 trials (1003 participants; median follow-up 6 mo) and 30 cohort studies (405 907 participants; median follow-up 10 yr). In the included RCTs, nonnutritive sweeteners had no significant effect on BMI (mean difference −0.37 kg/m2; 95% confidence interval [CI] −1.10 to 0.36; I2 9%; 242 participants). In the included cohort studies, consumption of nonnutritive sweeteners was associated with a modest increase in BMI (mean correlation 0.05, 95% CI 0.03 to 0.06; I2 0%; 21 256 participants). Data from RCTs showed no consistent effects of nonnutritive sweeteners on other measures of body composition and reported no further secondary outcomes. In the cohort studies, consumption of nonnutritive sweeteners was associated with increases in weight and waist circumference, and higher incidence of obesity, hypertension, metabolic syndrome, type 2 diabetes and cardiovascular events. Publication bias was indicated for studies with diabetes as an outcome. INTERPRETATION Evidence from RCTs does not clearly support the intended benefits of nonnutritive sweeteners for weight management, and observational data suggest that routine intake of nonnutritive sweeteners may be associated with

  19. Clinical efficacy of intra-articular injections in knee osteoarthritis: a prospective randomized study comparing hyaluronic acid and betamethasone

    Directory of Open Access Journals (Sweden)

    Trueba Davalillo CA

    2015-01-01

    Full Text Available Cesáreo Ángel Trueba Davalillo,1,2 Cesáreo Trueba Vasavilbaso,2 José Mario Navarrete Álvarez,2 Pilar Coronel Granado,3 Ozcar Alejandro García Jiménez,2 Mercedes Gimeno del Sol,3 Félix Gil Orbezo2 1School of Medicine (UNAM, México DF, Mexico; 2Orthopedic Service, Hospital Español de México, México DF, Mexico; 3Scientific Department, TEDEC-MEIJI FARMA,SA, Alcalá de Henares, Spain Background: Osteoarthritis (OA is the most common joint disease and leading cause of disability. Intra-articular (IA administration of hyaluronic acid (HA or corticosteroids (CS have been previously studied, though using insufficient number of patients or short follow-up periods.Objective: We evaluate HA and CS in patients with knee OA in terms of clinical efficacy over 12 months.Methods: We used a prospective, randomized study with parallel groups. Randomized patients received IA injections of HA or betamethasone (BM. The primary outcomes were improvement in pain using Visual Analog Scale and function in the Western Ontario and McMaster University Osteoarthritis Index (Likert scale. Follow-up visits were scheduled at 3 months, 6 months, 9 months, and 12 months.Results: A total of 200 patients were included. Pain was significantly reduced in both groups at the first follow-ups. At 12 months, the mean pain reduction in the HA group was 33.6% (95% CI: 31.1–36.1 compared to 8.2% (95% CI: 5.2–11.1 in BM (P<0.0001. Function improvement was higher in HA through every visit, and mean improvement at 12 months was 47.5% (95% CI: 45.6–49.3 in HA patients vs 13.2% (95% CI: 11.4–14.9 in the BM group (P<0.0001. All patients from both groups achieved the Minimal Clinically Important Improvement (MCII for both pain and function up to 6 months. At 9 months and 12 months, the MCII figures were higher in HA group with ≥80% compared to ≤10% in BM group (P<0.0001. Adverse reactions were rare and related to the administration procedure.Conclusion: Both treatments

  20. 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 < .001), shoulder abduction (P <.001), shoulder external rotation (P = .01), and elbow flexion (P = .004) ROM from baseline to 6 months as measured with goniometry. Subjects also showed significant gains in elbow flexion (P = .04) during hand to head and shoulder flexion (P = .04) during high reach. There was no difference in ROM gains between the groups. Within group comparison showed that the VGT group had significantly more recovery of ROM during the first 3 weeks than any other timeframe in the study, whereas ST had most gains at 3 months. There was a significant difference between the groups in the subjects' pain response. ST subjects

  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. EVALUATION OF TRACHEAL INTUBATING CONDITIONS AND SERUM POTASSIUM LEVELS WITH DIFFERENT DOSES OF SUCCINYLCHOLINE : A PROSPECTIVE RANDOMIZED COMPARATIVE STUDY

    Directory of Open Access Journals (Sweden)

    Shravan Kumar

    2015-08-01

    Full Text Available BACKGROUND: Utility of succinylcholine for rapid sequence induction is a common practice for more than last 50 years. The ED 95 dose of succinylcholine is 0.3mg/kg. Regularly 2 - 3 times ED 95 doses of non - depolarizing muscle relaxants are being used for tracheal intubation, but succinylcholine is being used traditionally in a dose of 1mg/kg which is more than 3.5 times ED 95. However, according to the available literature evidence doses as smal l as 0.4 mg /kg may also provide clinically acceptable intubating conditions with the possibility of earlier return of neuromuscular function which avoids critical hemoglobin desaturation in unanticipated difficult airway& CVCI situations. We did a study to evaluate the ease of tracheal intubation with low doses of succinylcholine in Indian population. AIM: To evaluate tracheal intubating conditions and serum potassium levels with different doses of succinylcholine. DESIGN: A prospective randomized double bli nd comparative study. METHODS: 80 patients belonging to ASA PS I&II were randomly divided into 4 groups A,B,C&D who received 0.5mg/kg,0.6mg/kg,0.7mg/kg& 1mg/kg of succinylcholine respectively. All the patients were pre - medicated with Tab. Alprazolam 0.25 mg PO previous night and fentanyl 1mcg/kg 5 min before induction, induced with sleep dose of thiopentone followed by administration of test drug. After 1 min , 3yrs experienced anesthesiologist attempted tracheal intubation& assessment of intubating conditions w ere done using Cooper& colleagues criteria. N - M effects were monitored preoperatively and up to 3 min after dug administration. Haemodynamic parameters& serum potassium were measured preoperatively , continued up to 5 min & 1 hour after drug administration res pectively. RESULTS: Clinical intubation cumulative scores in GROUP A were significantly different from other GROUPS ( B, C, D with ( p<0.05 on ANOVA. N - M monitoring has revealed significant twitch height depression in Group D

  3. Bispectral index monitoring prevent awareness during total intravenous anesthesia: a prospective, randomized,double-blinded, multi-center controlled trial

    Institute of Scientific and Technical Information of China (English)

    ZHANG Chen; GUO Jian-rong; JIN Yao-jun; WU Gang; YUAN Wei; YUAN Zhi-guo; YUE Yun; XU Liang; MA Ya-qun; SUN Yan-xia; LI Yan-hong; ZHANG Liang; FENG Chun-sheng; LUO Bing; ZHAO Zhen-long

    2011-01-01

    Background Awareness is a serious complication of general anesthesia.In China,the incidence of intraoperative awareness was 1% in patients undergoing total intravenous anesthesia (TIVA).In this study,we compared the incidence of awareness between Bispectral index (BIS)-guided and routine TIVA protocol and evaluated the effect of BIS on preventing awareness.Methods A prospective,randomized,double-blinded,multicenter controlled trial was performed.Patients (≥18 years of age) undergoing TIVA were randomly divided into BIS-guided group (Group A,BIS was monitored and recommended to maintain between 40-60) and control group (Group B,BIS was monitored but the screen was covered).The intraoperative BIS values were downloaded and the BIS trends of confirmed awareness cases were analyzed to determine whether light anesthesia existed.Results Of the total 5228 patients,2919 patients were assigned to Group A and 2309 to Group B.Four cases of confirmed awareness (0.14%) were reported in the BIS-guided group and 15 (0.65%) in the control group (P=0.002,OR=0.21,95% confidence intervals:0.07-0.63).The incidence of possible awareness (0.14% vs.0.26%,P=0.485) and dreaming (3.1% vs.3.1%,P=0.986) was comparable between BIS-guided group and the control group.Among the 19 confirmed awareness cases,intraoperative BIS trends of six cases were downloaded and identified.Five of them showed signs of light anesthesia as BIS >60 and lasted 19-106 minutes,whereas one case had a stable BIS trend and the values were within 60 during the operation.Another five awareness cases were reviewed for anesthesia procedures,of which improper light anesthesia were confirmed.Conclusions BIS-guided TIVA (BIS was recommended to maintain between 40-60) decreased the risk of awareness compared with routine TIVA.The main reason for awareness was light anesthesia.

  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. Radiofrequency catheter ablation of atrioventricular nodal reentrant tachycardia guided by magnetic navigation system: a prospective randomized comparison with conventional procedure

    Institute of Scientific and Technical Information of China (English)

    ZHANG Yu-xiao; LU Cai-yi; XUE Qiao; LI Ke; YAN Wei; ZHOU Sheng-hua

    2012-01-01

    Background Atrioventricular nodal reentrant tachycardia (AVNRT) is one of the most common paroxysmal supraventricular tachyarrhythmias.The aim of the study was to prospectively compare the characteristics of radiofrequency catheter ablation of AVNRT guided by a magnetic navigation system with the conventional procedure.Methods Patients with AVNRT diagnosed by electrophysiological tests were randomized into two groups.In the conventional technique group (CMT),a common 4-mm-tip quadrapolar temperature-controlled ablation catheter was used. In the magnetic navigation system guidance group (MNS), a magnetic 4-mm-tip quadrapolar temperature-controlled ablation catheter was used.The following parameters were collected and compared between the two groups: ablation procedure time,patient fluoroscopy time,operator fluoroscopy time,energy delivery numbers,maximal energy per deployment,success rate,complication rate and operative cost.Results Forty patients were enrolled and randomized into CMT and MNS groups.The age,gender,tachycardia history and basic cardiovascular diseases of the two groups were comparable (P >0.05).All procedures were conducted successfully without complications.No tachycardia recurred during the follow-up period of (9.3±2.6) months.In the MNS group,the patient and operator fluoroscopy times ((11.5±4.3) min,(4.2±1.5) min),energy delivery numbers (3.2±0.9),and maximal energy per deployment ((16.9±3.4) W) were shorter or lower than those of the CMT group ((14.3±6.2) min,(13.6±3.5) min,6.3±2.1,(23.7±1.3) W,respectively) (P <0.05).But the operative cost for the MNS group was higher than that of the CMT group (P <0.01 ).Conclusion Magnetic navigation system guided radiofrequency catheter ablation of AVNRT has the advantages of shorter fluoroscopy time and lower energy delivery numbers and maximal energy per deployment compared to the present conventional ablation technique.

  6. PROSPECTIVE RANDOMIZED TRIAL OF EFFICACY AND SAFETY OF IODOPOVIDONE VS OXYTETRACYCLINE FOR PLEURODESIS IN SPONTANEOUS PNEUMOTHORAX AND RECURRENT PLEURAL EFFUSIONS

    Directory of Open Access Journals (Sweden)

    Uday C

    2016-02-01

    Full Text Available BACKGROUND Recurrent malignant pleural effusion and spontaneous pneumothorax can be treated by a procedure called pleurodesis by which the pleural space is obliterated. This can be done by surgical means using mechanical force or by introducing any one of the recommended agents into the pleural space via tube thoracostomy or during thoracoscopy. Examples of agents used are talc as powder or as slurry, tetracycline derivatives, antineoplastic agents (Bleomycin, mitoxantrone, quinacrine, silver nitrate, Corynebacterium parvum and iodopovidone. The aim of the present study was to evaluate the safety and efficacy of iodopovidone as a sclerosing agent in the treatment of recurrent pleural effusion and spontaneous pneumothorax. This was a randomized prospective interventional study comparing iodopovidone with oxytetracycline as the latter is now sparingly available for clinical use. MATERIAL AND METHODS Study was conducted in 44 patients above 12 years of age, admitted in the Dept. of Pulmonary Medicine, Goa Medical College. Patients with a diagnosis of spontaneous pneumothorax or recurrent malignant pleural effusion were randomly allocated to either iodopovidone or oxytetracycline group and pleurodesis was done as per British Thoracic Society Guidelines (BTS. 1 RESULTS Among 44 patients 23 were secondary spontaneous pneumothorax, 9 were primary spontaneous pneumothorax and 12 were malignant pleural effusion; 2 patients did not report for follow-up visits and the remaining 42 patients were followed up for 6 months. The success rate of oxytetracycline and iodopovidone pleurodesis is 81% and 95.2% respectively. All the patients had chest pain of varying severity during the procedure in either groups; 8 patients in oxytetracycline group and 6 patients in iodopovidone group had fever after the procedure; 2 patients in iodopovidone group developed hypotension after the procedure and there was no mortality in either group attributable to the procedure

  7. 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

  8. Clinical effects of lateral wedge arch support insoles in knee osteoarthritis: A prospective double-blind randomized study.

    Science.gov (United States)

    Hsieh, Ru-Lan; Lee, Wen-Chung

    2016-07-01

    We compared the short-term efficacy of rigid versus soft lateral wedge arch support (LWAS) insoles for patients with knee osteoarthritis (OA), as assessed using the International Classification of Functioning, Disability and Health (ICF) system, through a prospective, double-blind, randomized controlled trial.Participants who fulfilled the combined radiographic and clinical criteria for knee OA, as defined by the American College of Rheumatology, were randomly prescribed 1 pair of rigid or soft LWAS insoles. Body functions and structures were evaluated according to Kellgren-Lawrence scores, the Foot Posture Index, Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, postural stability, dynamic balance, and fall risk; activities and participation were assessed according to 10-m fast speed walking, stair climbing and chair rising times, and Chronic Pain Grade questionnaire responses; and knee OA-related health status was evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, physical activity, balance, Chronic Pain Grade questionnaire responses, and the KOOS were recorded before treatment and at 1-, 2-, and 3-month follow-ups.We enrolled 90 participants, 70 women and 20 men, with mean ages of 60.6 ± 10.8 and 63.1 ± 10.8 years in the rigid and soft LWAS insole groups, respectively. Repeated-measures analysis of covariance revealed significant time × group effect improvements in pain (P = 0.008 for the KOOS), stair ascent time (P = 0.003), daily living function (P = 0.003 for the KOOS), sports and recreation function (P = 0.012 for the KOOS), and quality of life (P = 0.021 for the KOOS) in the soft LWAS insole group.Patients with knee OA who used soft LWAS insoles for a short term showed more significant improvement than did those who used rigid LWAS insoles in pain, physical activity, daily living function, sports and recreation function

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2012-12-15

    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.)

  10. Manual versus target-controlled infusion of balanced propofol during diagnostic colonoscopy: A prospective randomized controlled trial

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    Vučićević Vera

    2016-01-01

    Full Text Available Introduction. There is an increasing interest in balanced propofol sedation (BPS for colonoscopy in outpatient settings. Propofol is a potent anesthetic agent for this purpose and has a narrow therapeutic range, which increases a risk of cardiovascular and respiratory complications in case of improper administration. Objective. The aim of this study was to compare patients’ safety and comfort of endoscopists in two methods of BPS targeting deep sedation - propofol target-controlled infusion (TCI and manual intravenous titration technique (MT - during colonoscopy. Methods. This prospective randomized controlled trial included 90 patients (class I or II of the American Society of Anesthesiologists deeply sedated with propofol, coadministered with small doses of midazolam and fentanyl. Propofol was given by MT technique (45 patients or by TCI (45 patients. The following adverse effects were recorded: hypotension, hypertension, bradycardia, tachycardia, hypoxemia, bradypnea, apnea, hiccupping, and coughing, as well as endoscopist’s comfort during colonoscopy by means of a questionnaire. Results. The MT group compared to the TCI group had a lower mean arterial pressure in the 10th minute after the beginning (p = 0.017, and at the end of colonoscopy (p = 0.006, higher oxygen saturation in the fifth minute (p = 0.033, and in the 15th minute (p = 0.008 after the beginning of colonoscopy, and lower heart rate at the beginning of the procedure (p = 0.001. There were no statistically significant differences in adverse events. Endoscopist’s comfort during colonoscopy was high 95.6% in the TCI group vs. 88.9% in the MT group (p = 0.069. Conclusion. MT is clinically as stable as TCI of propofol for deep sedation during colonoscopy, and endoscopists experienced the same comfort during colonoscopy in both groups. Thus, both combinations are suitable for deep sedation during diagnostic colonoscopy.

  11. Deep Tissue Massage and Nonsteroidal Anti-Inflammatory Drugs for Low Back Pain: A Prospective Randomized Trial

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    Marian Majchrzycki

    2014-01-01

    Full Text Available Objective. To investigate whether chronic low back pain therapy with deep tissue massage (DTM gives similar results to combined therapy consisting of DTM and non-steroid anti-inflammatory drugs (NSAID. Design. Prospective controlled randomized single blinded trial. Settings. Ambulatory care of rehabilitation. Participants. 59 patients, age 51.8 ± 9.0 years, with chronic low back pain. Interventions. 2 weeks of DTM in the treatment group (TG versus 2 weeks of DTM combined with NSAID in the control group (CG. Main Outcome Measures. Visual analogue scale, Oswestry disability index (ODI, and Roland-Morris questionnaire (RM. Results. In both the TG and the CG, a significant pain reduction and function improvement were observed. VAS decreased from 58.3 ± 18.2 to 42.2 ± 21.1 (TG and from 51.8 ± 18.8 to 30.6 ± 21.9 (CG. RM value decreased from 9.8 ± 5.1 to 6.4 ± 4.4 (TG, and from 9.3 ± 5.5 to 6.1 ± 4.6 (CG. ODI value decreased from 29.2 ± 17.3 to 21.4 ± 15.1 (TG and from 21.4 ± 9.4 to 16.6 ± 9.4 (CG. All pre-post-treatment differences were significant; however, there was no significant difference between the TG and the CG. Conclusion. DTM had a positive effect on reducing pain in patients with chronic low back pain. Concurrent use of DTM and NSAID contributed to low back pain reduction in a similar degree that the DTM did.

  12. Effect of a clown’s presence at botulinum toxin injections in children: a randomized, prospective study

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    Hansen LK

    2011-09-01

    Full Text Available Lars Kjaersgaard Hansen1, Maria Kibaek1, Torben Martinussen2, Lene Kragh3, Mogens Hejl11Department of Paediatrics, Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense; 2Roskilde Hospital, Roskilde; 3Department of Statistics, University of Southern Denmark, Odense, DenmarkBackground: The effect of the presence of a hospital clown during pediatric procedures has rarely been evaluated. In a pediatric ward, botulinum toxin injection is a painful procedure and a stressful experience for the child. We undertook a study of the effect of the presence of a hospital clown on children treated with botulinum toxin in an outpatient setting.Methods: In total, 60 children, the majority of whom had spastic cerebral palsy, were subjected to a total of 121 botulinum toxin treatment sessions. Thirty-two children were being treated for the first time. During a 2-year period, we enrolled 121 treatment sessions prospectively, and the children were randomized to either the presence of a female clown during treatment or to no presence of a clown. The duration of the child's crying during the procedure was used as an indicator of the effect of the presence of a clown.Results: The effect of the clown was significantly related to patient gender. Girls were found to have a significantly shorter period of crying when the clown was present. For children younger than 8 years, the effect on boys was negative. Children treated for the first time did not appear to benefit from the presence of the clown, and showed no difference in effect between genders.Conclusion: No effect of the clown was documented for children being treated for the first time. At repeat treatments, we saw a positive effect of the female clown in relation to girls, and a negative effect on boys younger than 8 years of age.Keywords: clown, injections, pain, botulinum toxin

  13. A prospective, non-randomized study of home use of mifepristone for medical abortion in the U.S.

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    Chong, Erica; Frye, Laura J; Castle, Jen; Dean, Gillian; Kuehl, Laurel; Winikoff, Beverly

    2015-09-01

    To determine the acceptability of taking mifepristone at home for early medical abortion in the United States. This prospective, non-randomized, open-label study at six Planned Parenthood centers gave women with pregnancies up to 63 days' gestation seeking medical abortion the choice of taking mifepristone in the center or at home. Participants were interviewed at a follow-up visit 1-2 weeks after mifepristone administration to assess their experience with the option they selected. Four-hundred women were enrolled between April 2013 and June 2014 of which 32% (n=128) chose to take mifepristone at home. Abortion success rates did not differ between home and center users (96% and 97%). Among home users, 82% reported taking the mifepristone at the time they planned with their provider and no participant took it after 63 days' gestation. The most common reason cited for selecting home use was scheduling flexibility and significantly more home users took misoprostol on the weekend (50% vs. 36%, p=.02). Home users were more likely than center users to report missing no days of work due to the abortion (47% vs. 28%, p=.08). Ninety-nine percent of home users reported that they would take mifepristone at home again and 96% would recommend home use to a friend. Offering this option did not increase the service delivery burden on study providers, who would recommend home use in the future for most participants. Home use of mifepristone is a highly acceptable practice for which there is current demand, and it should be offered as part of routine medical abortion services. Offering the option of home use of mifepristone to medical abortion patients can provide women and clinics with more flexibility while maintaining a safe, effective and acceptable service. These results provide support for telemedicine or pharmacy distribution. Copyright © 2015 Elsevier Inc. All rights reserved.

  14. Prospective randomized comparison of standard didactic lecture versus high-fidelity simulation for radiology resident contrast reaction management training.

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    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.

  15. EFFICACY OF TRANEXAMIC ACID IN DECREASING BLOOD LOSS DURING AND AFTER CAESAREAN SECTION: A RANDOMIZED CASE CONTROL PROSPECTIVE STUDY

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    Tullika

    2014-03-01

    Full Text Available : INTRODUCTION: To reduce maternal mortality and morbidity caused by bleeding, it is important to reduce the amount of bleeding during and after lower segment caesarean section (LSCS. Tranexamic acid helps to reduce bleeding during and after LSCS. OBJECTIVES: To study the efficacy and safety of Tranexamic acid in reducing blood loss during and after Lower segment Caesarean Section (LSCS. METHODS: A randomized case controlled prospective study was conducted on 200 women undergoing lower segment cesarean section. Hundreds of them that were given tranexamic acid immediately before LSCS were compared to hundred others to whom tranexamic acid was not given. Blood loss was collected and measured during the two periods, from plancental delivery to end of LSCS and second from end of LSCS to two hours postpartum. RESULTS: Tranexamic acid significantly reduced the quantity of blood loss from placental delivery to end of LSCS, 202.25ml in the study group vs392.20 ml in the control group (p<0.001; from the end of LSCS, to 2 hours postpartum 3.80ml in the study group versus 112.25ml in the control group (p<0.001; In totality, it significantly reduced the quantity of blood loss from placental delivery to two hours postpartum i.e. 27.05ml in the study group versus 510.45ml in the control group (p < 0.001. No complications or side effects were noted. CONCLUSION: Tranexamic acid significantly reduced the amount of blood loss during and after LSCS. Tranexamic acid can be used prophylactically; moreover it is safer and effective in women undergoing LSCS.

  16. Mini-flared Kelman tip, reverse tip, and sidewinder tip with torsional phaco: a prospective randomized comparative study

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    Wilson Takashi Hida

    2015-02-01

    Full Text Available Purpose: To compare the efficiency of surgical procedures using three phaco tip designs in torsional phacoemulsification using the bevel-down technique. Methods: In this prospective, comparative, masked study, patients were randomly assigned to have torsional coaxial microincision cataract surgery using the mini-flared 45-degree Kelman tip, reversed mini-flared 30-degree Kelman tip, or Sidewinder 30-degree Kelman tip. Clinical measurements included preoperative and 3-month postoperative corrected distance visual acuity (CDVA, endothelial cell counts (ECC, and preoperative and 1-day postoperative central corneal thickness (CCT. Intraoperative measurements included phaco time, torsional time, aspiration time, case time, cumulative dissipated energy (CDE, and balanced salt solution volume (BSS. Results: The study evaluated 150 eyes of 150 patients. Intraoperatively, there was no statistically significant difference in cumulative dissipated energy, case time, torsional time, and aspiration time between the three tip configurations. However, less phaco time was used with the mini-flared 45-degree Kelman tip (p=0.02 than that with the Sidewinder 30-degree Kelman tip or reversed mini-flared 30-degree Kelman tip. The mini-flared 45-degree Kelman tip and the reversed mini-flared 30-degree Kelman tip required significantly less balanced salt solution volume than that required by the Sidewinder 30-degree Kelman tip (p=0.009. There was no statistically significant difference in corrected distance visual acuity and endothelial cell counts between tips 3 months postoperatively (p>0.05. Conclusion: All three tips were effective with no intraoperative complications. When using torsional phacoemulsification through microincisions and the prefracture technique with the bevel-down technique, the mini-flared 45-degree Kelman tip required a lower mean phaco time than the reversed mini-flared 30-degree Kelman tip and the Sidewinder 30-degree Kelman tip.

  17. Mini-flared Kelman tip, reverse tip, and sidewinder tip with torsional phaco: a prospective randomized comparative study.

    Science.gov (United States)

    Hida, Wilson Takashi; Tzelikis, Patrick Frensel; Nakano, Celso Takashi; Motta, Antonio Francisco Pimenta; Alves, Milton Ruiz

    2015-01-01

    To compare the efficiency of surgical procedures using three phaco tip designs in torsional phacoemulsification using the bevel-down technique. In this prospective, comparative, masked study, patients were randomly assigned to have torsional coaxial microincision cataract surgery using the mini-flared 45-degree Kelman tip, reversed mini-flared 30-degree Kelman tip, or Sidewinder 30-degree Kelman tip. Clinical measurements included preoperative and 3-month postoperative corrected distance visual acuity (CDVA), endothelial cell counts (ECC), and preoperative and 1-day postoperative central corneal thickness (CCT). Intraoperative measurements included phaco time, torsional time, aspiration time, case time, cumulative dissipated energy (CDE), and balanced salt solution volume (BSS). The study evaluated 150 eyes of 150 patients. Intraoperatively, there was no statistically significant difference in cumulative dissipated energy, case time, torsional time, and aspiration time between the three tip configurations. However, less phaco time was used with the mini-flared 45-degree Kelman tip (p=0.02) than that with the Sidewinder 30-degree Kelman tip or reversed mini-flared 30-degree Kelman tip. The mini-flared 45-degree Kelman tip and the reversed mini-flared 30-degree Kelman tip required significantly less balanced salt solution volume than that required by the Sidewinder 30-degree Kelman tip (p=0.009). There was no statistically significant difference in corrected distance visual acuity and endothelial cell counts between tips 3 months postoperatively (p>0.05). All three tips were effective with no intraoperative complications. When using torsional phacoemulsification through microincisions and the prefracture technique with the bevel-down technique, the mini-flared 45-degree Kelman tip required a lower mean phaco time than the reversed mini-flared 30-degree Kelman tip and the Sidewinder 30-degree Kelman tip.

  18. Ultrasound Versus the Landmark Technique: A Prospective Randomized Comparative Study of Internal Jugular Vein Cannulation in an Intensive Care Unit

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    B R Shrestha

    2011-06-01

    Full Text Available OBJECTIVE: The aim of this study is to find out if an ultrasound technique has advantages over the conventional landmark technique. METHODS: This is a prospective randomized comparative study on 120 patients requiring central venous cannulation of the right internal jugular vein. The study comprised of two groups: ultrasound and landmark groups, each consisting of 60 patients. The outcome measures were compared between the groups. RESULTS: Cannulation of the internal jugular vein was successful in 58 patients in the ultrasound group and in 53 in the landmark group. The number of attempts was 1.5 (1 - 3 and 2 (1 - 3 in the ultrasound and landmark group respectively (p = 0.001. The time taken for the successful cannulation was 4.9 +/- 1.7 minutes in the ultrasound approach and 8.0 +/- 2.8 minutes in the landmark approach (p = 0.00. The internal jugular vein diameter in the supine position was 11.2 +/- 1.5 mm which increased to 15.04 +/- 1.5 mm with a 15 degrees head-down position in the USG group (p = 0.001. The first attempt success rate was 39/60 (63% in the ultrasound group and 19/60 (32% with the landmark technique. The seven (12% failure cases in the landmark group were rescued by the ultrasound technique. Inadvertent carotid artery puncture occurred in 2/60 (3% and 6/60 (10% of patients in the ultrasound and land mark group respectively. CONCLUSIONS: Ultrasound improves success rate, minimizes cannulation time and complications during internal jugular vein cannulation. It can be employed as a rescue technique in cases of a failed landmark technique. Keywords:cannulation, central, landmark, technique, ultrasound.

  19. Effect of mode of hydrocortisone administration on glycemic control in patients with septic shock: a prospective randomized trial

    Science.gov (United States)

    Loisa, Pekka; Parviainen, Ilkka; Tenhunen, Jyrki; Hovilehto, Seppo; Ruokonen, Esko

    2007-01-01

    Introduction Low-dose hydrocortisone treatment is widely accepted therapy for the treatment of vasopressor-dependent septic shock. The question of whether corticosteroids should be given to septic shock patients by continuous or by bolus infusion is still unanswered. Hydrocortisone induces hyperglycemia and it is possible that continuous hydrocortisone infusion would reduce the fluctuations in blood glucose levels and that tight blood glucose control could be better achieved with this approach. Methods In this prospective randomized study, we compared the blood glucose profiles, insulin requirements, amount of nursing workload needed, and shock reversal in 48 septic shock patients who received hydrocortisone treatment either by bolus or by continuous infusion with equivalent dose (200 mg/day). Duration of hydrocortisone treatment was five days. Results The mean blood glucose levels were similar in the two groups, but the number of hyperglycemic episodes was significantly higher in those patients who received bolus therapy (15.7 ± 8.5 versus 10.5 ± 8.6 episodes per patient, p = 0.039). Also, more changes in insulin infusion rate were needed to maintain strict normoglycemia in the bolus group (4.7 ± 2.2 versus 3.4 ± 1.9 adjustments per patient per day, p = 0.038). Hypoglycemic episodes were rare in both groups. No difference was seen in shock reversal. Conclusion Strict normoglycemia is more easily achieved if the hydrocortisone therapy is given to septic shock patients by continuous infusion. This approach also reduces nursing workload needed to maintain tight blood glucose control. Trial Registration Number ISRCTN98820688 PMID:17306016

  20. Alveolar ridge preservation using autogenous tooth graft versus beta-tricalcium phosphate alloplast: A randomized, controlled, prospective, clinical pilot study

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    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.

  1. [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.

  2. A prospective, randomized study: Evaluation of the effect of rosuvastatin in patients with chronic obstructive pulmonary disease and pulmonary hypertension

    Science.gov (United States)

    Chogtu, Bharti; Kuriachan, Sanitha; Magazine, Rahul; Shetty, K. Ranjan; Kamath, Asha; George, Manu Mathew; Tripathy, Amruta; Kumar, D. Mahesh

    2016-01-01

    Objectives: Statins by their anti-inflammatory and endothelial stabilizing effect can be beneficial in patients with chronic obstructive pulmonary disease (COPD) and pulmonary hypertension (PH). The present study was done to evaluate the effect of rosuvastatin on pulmonary functions and quality of life (QOL) in patients with concomitant COPD and PH. Materials and Methods: It was a prospective, randomized, double-blind, placebo-controlled, study conducted in patients with COPD and PH. A total of sixty patients were assigned to receive either rosuvastatin 10 mg or placebo once a day in addition to their conventional treatment for 12 weeks. Routine blood investigations, pulmonary functions, echocardiogram, exercise capacity, and QOL using a questionnaire were assessed at the baseline and after 12 weeks. Results: In patients of rosuvastatin group, there was a statistically significant increase in peak expiratory flow rate (PEFR) (P = 0.04) but no significant change in other pulmonary functions: Forced vital capacity (FVC), forced expiratory volume at 1 s (FVC, FEV1, FEV1/FVC), and echocardiogram parameters. There was a significant increase in 6-min walk test (6-min walk distance) (P = 0.03) at the end of 12 weeks. On comparing with placebo, rosuvastatin showed a significant reduction (P = 0.045) in COPD exacerbations while adverse effects did not differ. Conclusion: Statins have a favorable effect on patients with COPD and PH regarding the improvement in PEFR, COPD exacerbations, and exercise capacity. Such effects can be beneficial in these patients and more so in patients with concomitant coronary artery disease or hyperlipidemia where long-term benefits of statins have been established. PMID:27721534

  3. Endoscopic ablation of Barrett's esophagus using the second generation argon plasma coagulation: a prospective randomized controlled trail

    Institute of Scientific and Technical Information of China (English)

    Li Zhang; Lei Dong; Jia Liu; Xiaolan Lu; Jun Zhang

    2009-01-01

    Objective:To investigate the efficacy and safety of the second generation argon plasma coagulation(VIO APC) in the ablation of Barrett's Esophagus. Methods:A total of 35 patients with uncomplicated Barrett's esophagus entered into a prospective, randomized, unblinded study comparing the treatment VIO APC combined with a proton pump inhibiter with a proton pump inhibiter administered alone. VIO APC was performed at a power setting of 40W, and argon gas flow at 1.5-2.0 L/min, and "forced" mode. Ablative treatment was repeated until either no Barrett's epithelium remained or a maximum of 5 treatment sessions occurred. Results:In the ablation group, macroscopic complete ablation was achieved in 14 of 18 patients, and complete ablation confirmed by histology in 12 of 18 patients (P<0.01). Buried glands were observed in 2 patients who had achieved macroscopic ablation. The Barrett's mucosa averaged a reduction of 65%(range 50-75%) in the remaining 4 patients. In the control group, only 2 patients had partial regression, median 30%(range 20-40%).In the ablation group, post-treatment 4 patients had transient retrosternal pain, and 3 patients had mild epigastric discomfort. One patient had a small hemorrhage during the procedure, which ceased after norepinephrine and thrombosin were administered through the endoscope biopsy channel. No adverse events were observed in the control group. During 11.8(4-15) months follow-up, patients who had achieved the complete ablation have no evidence of relapse of Barrett's esophagus. Conclusion:VIO APC with a relatively low power setting can effectively ablate the Barrett's mucosa. No severe adverse events were observed. Long-term follow-up is needed to assess cancer prevention and the durability of the neo-squamous epithelium.

  4. Effect of diaper cream and wet wipes on skin barrier properties in infants: a prospective randomized controlled trial.

    Science.gov (United States)

    Garcia Bartels, Natalie; Lünnemann, Lena; Stroux, Andrea; Kottner, Jan; Serrano, José; Blume-Peytavi, Ulrike

    2014-01-01

    The effect of different diaper care procedures on skin barrier function in infants has been minimally investigated and may be assessed using objective methods. In a single-center, prospective trial, 89 healthy 9-month-old infants (±8 wks) were randomly assigned to three diaper care regimens: group I used water-moistened washcloths at diaper changes (n = 30), group II additionally applied diaper cream twice daily (n = 28), and group III used wet wipes and diaper cream twice daily (n = 31). Transepidermal water loss (TEWL), skin hydration (SCH), skin pH, interleukin 1α (IL-1α) levels, and microbiologic colonization were measured in diapered skin (upper outer quadrant of the buttocks), nondiapered skin (upper leg), and if diaper dermatitis (DD) occurred, using the most affected skin area at day 1 and weeks 4 and 8. Skin condition was assessed utilizing a neonatal skin condition score and diaper rash grade. On diapered skin, SCH decreased in groups II and III, whereas TEWL values were reduced in group II only. Skin pH increased in groups II and III. In general, SCH, skin pH, and IL-1α levels were higher in healthy diapered skin than in nondiapered skin. The incidence and course of DD was comparable in all groups. Areas with DD had greater TEWL and skin pH than unaffected skin areas. Infants who received diaper cream had lower SCH and TEWL and higher pH levels in the diapered area than on nondiapered skin. No correlation with the occurrence of DD was found. © 2014 Wiley Periodicals, Inc.

  5. [Repair of primary inguinal hernia: Lichtenstein versus Shouldice techniques. Prospective randomized study of pain and hospital costs].

    Science.gov (United States)

    Porrero, José L; Bonachía, Oscar; López-Buenadicha, Adolfo; Sanjuanbenito, Alfonso; Sánchez-Cabezudo, Carlos

    2005-02-01

    Hernia is one of the most widely studied processes, and the search for excellence has become the final aim. However, many controversies remain to be resolved. The objective of the present study was to analyze postoperative pain and costs using two techniques of primary inguinal hernia repair. We performed a prospective, randomized study of 54 patients who underwent surgical repair of inguinal hernia through either the Lichtenstein or the Shouldice technique between June 2001 and May 2002. The following variables were analyzed: age, location and type of hernia, evaluation of tolerance to local anesthesia, surgical technique, operating time, pain at days 1, 3 and 5 after surgery, analgesic consumption, days until driving could be resumed, days off work, and occupation. The patient groups were similar, with no significant differences in age, location or type of hernia. For Lichtenstein hernioplasty, operating time was lower (p < 0.01); pain evaluation showed no significant differences on days 1 and 3 after surgery but was higher on day 5 (p = 0.064). No significant differences were found in analgesic consumption, time before driving could be resumed, or days off work. Freelance patients returned to work earlier, independently of the surgical technique performed. The cost of the Lichtenstein technique was 235 euros compared with 180 euros for the Shouldice technique and this difference was statistically significant (p < 0.05). In the hands of expert surgeons, the Shouldice technique is the procedure of choice in the repair of primary hernias. The results are just as satisfactory as those obtained with Lichtenstein hernioplasty and hospital costs are lower.

  6. A prospective randomized controlled trial assessing the efficacy of adjunctive hyperbaric oxygen therapy in the treatment of hidradenitis suppurativa.

    Science.gov (United States)

    Yildiz, Hamza; Senol, Levent; Ercan, Erdinc; Bilgili, Memet Ersan; Karabudak Abuaf, Ozlem

    2016-02-01

    Hyperbaric oxygen therapy (HBOT) appears to enhance wound healing, increase bactericidal activity, and act synergistically with a number of antibiotics. The aim of this study was to evaluate the efficacy of HBOT as an adjunctive therapy in patients with hidradenitis suppurativa (HS) treated with a combination of systemic rifampicin and clindamycin. The study was a prospective, single-center, single-dose, open-label, randomized controlled clinical study of HBOT in patients with moderate to severe HS. Efficacy was measured by modified Sartorius score (SS), HS Severity Index (HSSI), Dermatology Life Quality Index (DLQI), and a visual analog scale (VAS) before treatment and after the completion of 4 and 10 weeks of treatment. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels were also measured. Forty-three patients were enrolled in the study. More patients in the HBOT than in the control group showed a decrease of ≥50% from baseline parameters at week 10 for SS (100%), HSSI (100%), DLQI (95.5%), VAS (100%), ESR (100%), and CRP (72.7%). Clinically and statistically significant improvements from baseline were observed at 4 and 10 weeks in HSSI (P = 0.009 at both), SS (P = 0.021 at both), and DLQI (P = 0.044 at week 4, P = 0.009 at week 10). Adjunctive HBOT was considered to be effective in significantly improving antibiotic treatment of HS. The treatment was well tolerated, and no unexpected safety issues were identified.

  7. The effect of hydroxyapatite coated screw in the lateral fragility fractures of the femur. A prospective randomized clinical study.

    Science.gov (United States)

    Pesce, V; Maccagnano, G; Vicenti, G; Notarnicola, A; Moretti, L; Tafuri, S; Vanni, D; Salini, V; Moretti, B

    2014-01-01

    Due to a growing numbers of lateral fragility fractures of the femur and their high social costs the need to work out an effective strategy in order to find a better solution for these patients is warranted. From January 2010 to July 2011, we carried out a prospective randomized clinical study comparing the results of patients with femoral lateral fractures treated by nail and cephalic hydroxyapatite coated screws (study group including 27 patients) compared to the patients with the same fractures treated with nail and head standard screws (control group including 27 patients). We defined the two parts of the femoral neck as ROI 1 (under the head screw) and ROI 2 (above the femoral screw) on the AP view. The bone density of the two areas was calculated using DEXA at T0 (1st day post-surgery), at T1 (40th day post-surgery), at T2 (3 months later), at T3 (1 year later). The clinical-radiography evaluations were based on the Harris Hip Score (HHS), ADL test and x-ray views of the hip. As far as the bone mineral density average of ROI 1 and ROI 2 is concerned, we found a significant statistical increase at T1 and T3 in the study group, while it was not significant in the control group. We could account for this data through the higher mechanical stability of hydroxyapatite coated screws than standard screws. In fact, this material was responsible for improved implant osteointegration. Thanks to a 1 year follow-up we were able to demonstrate the implant utility associated with augmentation and the importance of densitometry exams such as easily repeatable and low cost diagnostics to prevent the onset of complications linked to screw loosening.

  8. 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

  9. Comparison of Misoprostol and Dinoprostone for elective induction of labour in nulliparous women at full term: A randomized prospective study

    Directory of Open Access Journals (Sweden)

    Stefos Theodoros

    2004-09-01

    Full Text Available Abstract Background The objective of this randomized prospective study was to compare the efficacy of 50 mcg vaginal misoprostol and 3 mg dinoprostone, administered every nine hours for a maximum of three doses, for elective induction of labor in a specific cohort of nulliparous women with an unfavorable cervix and more than 40 weeks of gestation. Material and Methods One hundred and sixty-three pregnant women with more than 285 days of gestation were recruited and analyzed. The main outcome measures were time from induction to delivery and incidence of vaginal delivery within 12 and 24 hours. Admission rate to the neonatal intensive care unit within 24 hours post delivery was a secondary outcome. Results The induction-delivery interval was significantly lower in the misoprostol group than in the dinoprostone group (11.9 h vs. 15.5 h, p 0.05 but with the disadvantage of higher abnormal fetal heart rate (FHR tracings (22.5% vs. 12%, p > 0.05. From the misoprostol group more neonates were admitted to the intensive neonatal unit, than from the dinoprostone group (13.5% vs. 4.8%, p > 0.05. One woman had an unexplained stillbirth following the administration of one dose of dinoprostone. Conclusions Vaginal misoprostol, compared with dinoprostone in the regimens used, is more effective in elective inductions of labor beyond 40 weeks of gestation. Nevertheless, this is at the expense of more abnormal FHR tracings and more admissions to the neonatal unit, indicating that the faster approach is not necessarily the better approach to childbirth.

  10. 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.

  11. Effect of biofeedback and deep oscillation on Raynaud's phenomenon secondary to systemic sclerosis: results of a controlled prospective randomized clinical trial.

    Science.gov (United States)

    Sporbeck, Birte; Mathiske-Schmidt, Kirsten; Jahr, Silke; Huscher, Dörte; Becker, Mike; Riemekasten, Gabriela; Taufmann, Ines; Burmester, Gerd-Rüdiger; Pögel, Stephanie; Reisshauer, Anett

    2012-05-01

    Our aim was to evaluate the effect of deep oscillation and biofeedback on Raynaud's phenomenon (RP) secondary to systemic sclerosis (SSc). A prospective randomized study was performed in SSc patients receiving either deep oscillation (n = 10) or biofeedback (n = 8) thrice a week for 4 weeks, or patients were randomized into the waiting group untreated for vasculopathy (n = 10) in time of running the study interventions. Biofeedback resulted in an improvement of RP as determined by score reduction of visual analogue scale compared with patients of the control group (P physiotherapy for the treatment of SSc-related RP.

  12. Evaluation of laryngoscopic view, intubation difficulty and sympathetic response during direct laryngoscopy in sniffing position and simple head extension: a prospective and randomized comparative study

    OpenAIRE

    Rashmi Pal; Sangeeta Chauhan; Bhanu Kumar Ved; Shankar Rao Lad

    2015-01-01

    Background: Airway management is critical to the care of patients and direct laryngoscopy is the mainstay of airway management. Despite the proliferation of difficult airway devices, sniffing position for laryngoscopy remains the gold standard and ideal position. This prospective, randomized and single-blind study was done to evaluate and compare the laryngoscopic view, complexity of intubation and sympathetic response during laryngoscopy in sniffing position and simple head extension. Met...

  13. Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study

    OpenAIRE

    Mesejo, Alfonso; Montejo-González, Juan Carlos; Vaquerizo-Alonso, Clara; Lobo-Tamer, Gabriela; Zabarte-Martinez, Mercedes; Herrero-Meseguer, Jose Ignacio; Acosta-Escribano, Jose; Blesa-Malpica, Antonio; Martinez-Lozano, Fátima

    2015-01-01

    Introduction Although standard enteral nutrition is universally accepted, the use of disease-specific formulas for hyperglycemic patients is still controversial. This study examines whether a high-protein diabetes-specific formula reduces insulin needs, improves glycemic control and reduces ICU-acquired infection in critically ill, hyperglycemic patients on mechanical ventilation (MV). Methods This was a prospective, open-label, randomized (web-based, blinded) study conducted at nine Spanish ...

  14. Safety and efficacy of an olive oil-based triple-chamber bag for parenteral nutrition: a prospective, randomized, multi-center clinical trial in China

    OpenAIRE

    Jia, Zhen-Yi; Yang, Jun; XIA, Yang; Tong, Da-Nian; Gary P. Zaloga; Qin, Huan-Long; ,

    2015-01-01

    Background Small studies suggest differences in efficacy and safety exist between olive oil-based (OLIVE) and soybean oil-based (SOYBEAN) parenteral nutrition regimens in hospitalized adult patients. This large, prospective, randomized (1:1), open-label, multi-center, noninferiority study compared the delivery, efficacy, and safety of OLIVE (N = 226) with SOYBEAN (N = 232) in Chinese adults (≥18 years) admitted to a surgical service for whom parenteral nutrition was required. Methods Treatmen...

  15. Evaluation of efficacy and tolerability of eperisone and thiocolchicoside in treatment of low back pain associated with muscle spasm: An open label, prospective, randomized controlled trial

    OpenAIRE

    Syed H. Maaz; Prakash N. Khandelwal; Shiraz M. Baig; Sudhakar M. Doifode; Ulhas M. Ghotkar

    2016-01-01

    Background: Low back pain has a high prevalence in adult population. Because of reflex muscle spasm, muscle relaxants are frequently used either alone or in combination with analgesics. Eperisone inhibits voltage gated sodium channels in brain stem and Thiocolchicoside acts via GABA-mediated mechanism to relax muscle spasm and relieves pain. Methods: This was a prospective; open labeled, randomized, two-arm, parallel group, controlled, clinical trial. 113 patients were randomised to two gr...

  16. A Prospective Randomized Trial to Assess Oral Versus Intravenous Antibiotics for the Treatment of Postoperative Wound Infection After Extremity Fractures (POvIV Study).

    Science.gov (United States)

    Obremskey, William T; Schmidt, Andrew H; OʼToole, Robert V; DeSanto, Jennifer; Morshed, Saam; Tornetta, Paul; Murray, Clinton K; Jones, Clifford B; Scharfstein, Daniel O; Taylor, Tara J; Carlini, Anthony R; Castillo, Renan C

    2017-04-01

    Patients surgically treated for infection after extremity fractures are typically discharged with a 6- to 12-week antibiotic regimen. Intravenous (IV) antibiotics are associated with significant cost and potential complications of deep vein thrombosis, line clotting, and sepsis. Many of the pathogens that cause musculoskeletal infection have both oral (PO) and IV antibiotic options with adequate bioavailability and antibacterial effect, yet IV antibiotics remain the standard of care absent evidence that PO options are clinically as efficacious. The POvIV study is a prospective, multicenter, randomized trial to compare PO with IV antibiotic therapy in patients with postoperative wound infections after extremity fractures. Patients between the ages of 18 and 84 who have a culture-positive surgical site infection after internal fixation for fracture repair or arthrodesis are approached for this study, and if they provide consent, are randomly assigned to receive either PO or IV antibiotics. Antibiotic selection is based on culture and sensitivity results. Randomization determines the route of administration. Patients are followed for 1 year after study enrollment. This study will be the largest prospective randomized trial to evaluate the safety and effectiveness of PO antibiotic use for treatment of postoperative wound infections. Results will inform clinician decisions on antibiotic delivery in patients with postoperative wound infections.

  17. 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

  18. Recombinant human thrombopoietin promotes platelet engraftment after haploidentical hematopoietic stem cell transplantation: a prospective randomized controlled trial.

    Science.gov (United States)

    Han, Ting-ting; Xu, Lan-ping; Liu, Dai-hong; Liu, Kai-yan; Wang, Feng-rong; Wang, Yu; Yan, Chen-hua; Chen, Yu-hong; Sun, Yu-qian; Ji, Yu; Wang, Jing-zhi; Zhang, Xiao-hui; Huang, Xiao-jun

    2015-01-01

    Delayed platelet engraftment (DPE) is a common complication following allogeneic hematopoietic stem cell transplantation (allo-HSCT). This phenomenon is also a predictor of increased treatment-related mortality and poor survival. Therefore, therapies that promote platelet engraftment to prevent DPE are needed. This prospective randomized controlled trial was designed to investigate whether recombinant human thrombopoietin (rhTPO), administered subcutaneously at a daily dose of 15,000 U from the first day after transplantation, promotes platelet engraftment after haploidentical HSCT. The cumulative incidence of platelet engraftment (platelet recovery to ≥20 × 10(9)/L without transfusion support for seven consecutive days) on day 60 post-transplantation was significantly higher in the rhTPO group (n = 60) than in the control group (n = 60) (91.7 ± 3.8 % vs. 74.5 ± 5.8 %, P = 0.041). Additionally, the number of platelet transfusions from day 14 to day 60 was significantly lower in the rhTPO group than in the control group (4 ± 5 vs. 7 ± 9 Units, P = 0.018). No severe adverse effects were observed, with a median follow-up duration of 256 days (range, 48-586 days). The incidences of acute graft-versus-host disease (GVHD), chronic GVHD, and cytomegalovirus viremia and the probabilities of overall survival and disease-free survival did not differ between the two groups. A multivariate analysis of all patients revealed that regardless of assignment to the rhTPO group or the control group (hazard ratio (HR) = 1.514; 95 % CI (1.024-2.238); P = 0.038), the number of total infused CD34(+) cells (HR = 1.304; 95 % CI (1.148-1.482); P rhTPO promotes platelet engraftment and safely reduces the requirement for platelet transfusion in patients after unmanipulated haploidentical HSCT. This trial was registered with the Chinese Clinical Trial Registry ( www.chictr.org ) as ChiCTR-TRC-11001774. http

  19. Outcomes of transurethral resection and holmium laser enucleation in more than 60 g of prostate: A prospective randomized study

    Science.gov (United States)

    Jhanwar, Ankur; Sinha, Rahul J.; Bansal, Ankur; Prakash, Gaurav; Singh, Kawaljit; Singh, Vishwajeet

    2017-01-01

    Aim: Transurethral resection of prostate (TURP) is considered a gold standard surgical procedure. The management of benign prostatic hyperplasia (BPH) has undergone tremendous change in recent years and shifted from open to minimal invasive procedure. With the advancement in technology and skills of surgeons, lasers have been used more liberally, particularly holmium laser. Holmium laser enucleation of prostate (HoLEP) is seen as close rival of TURP. The objective if this study is to observe long- and short-term outcomes of transurethral resection and holmium laser enucleation in the prostate of more than 60 g. Materials and Methods: This prospective randomized study includes 164 patients. Inclusion criteria were age prostatic size >60 g, gross hematuria secondary to BPH, recurrent urinary tract infection, acute urinary retention, postvoid residual >150 ml, and Schafer Grade II or more. BPH associated with neurogenic bladder, stricture urethra, and carcinoma prostate were excluded from the study. Group 1 comprises patients who underwent TURP and Group 2 comprises who underwent HoLEP. Follow-up was done at 1, 3, 6, 12, and 24 months after the surgery. Results: Data of 144 patients were analyzed. The mean age of patients in TURP and HoLEP group was 66.78 ± 7.81 and 67.70 ± 7.44 years, respectively (P = 0.47), mean prostatic volume was 74.5 ± 12.56 and 75.6 ± 12.84 g, respectively (P = 0.60), operative time was 73.10 ± 10.49 and 89.56 ± 13.81 min, respectively (P = 0.0001). Mean resected tissue was 44.80 ± 9.87 and 48.49 ± 10.87, respectively (P = 0.03). The sexual function did not changed significantly in postoperative follow-up. Conclusion: HoLEP is associated with less blood loss, lower transfusion rates, and a shorter hospital stay. The disadvantage of HoLEP is longer operative time and postoperative dysuria. PMID:28216929

  20. Effects of Breast Shielding during Heart Imaging on DNA Double-Strand-Break Levels: A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Cheezum, Michael K; Redon, Christophe E; Burrell, Allison S; Kaviratne, Anthony S; Bindeman, Jody; Maeda, Daisuke; Balmakhtar, Houria; Pezel, Ashly; Wisniewski, Piotr; Delacruz, Panfilo; Nguyen, Binh; Bonner, William M; Villines, Todd C

    2016-10-01

    Purpose To examine the effect of breast shielding on blood lymphocyte deoxyribonucleic acid (DNA) double-strand-break levels resulting from in vivo radiation and ex vivo radiation at breast-tissue level, and the effect of breast shielding on image quality. Materials and Methods The study was approved by institutional review and commpliant with HIPAA guidelines. Adult women who underwent 64-section coronary computed tomographic (CT) angiography and who provided informed consent were prospectively randomized to the use (n = 50) or absence (n = 51) of bismuth breast shields. Peripheral blood samples were obtained before and 30 minutes after in vivo radiation during CT angiography to compare DNA double-strand-break levels by γ-H2AX immunofluorescence in blood lymphocytes. To estimate DNA double-strand-break induction at breast-tissue level, a blood sample was taped to the sternum for ex vivo radiation with or without shielding. Data were analyzed by linear regression and independent sample t tests. Results Breast shielding had no effect on DNA double-strand-break levels from ex vivo radiation of blood samples under shields at breast-tissue level (unadjusted regression: β = .08; P = .43 versus no shielding), or in vivo radiation of circulating lymphocytes (β = -.07; P = .50). Predictors of increased DNA double-strand-break levels included total radiation dose, increasing tube potential, and tube current (P radiation exposures (median, 3.4 mSv), breast shielding yielded a 33% increase in image noise and 19% decrease in the rate of excellent quality ratings. Conclusion Among women who underwent coronary CT angiography, breast shielding had no effect on DNA double-strand-break levels in blood lymphocytes exposed to in vivo radiation, or ex vivo radiation at breast-tissue level. At present relatively low radiation exposures, breast shielding contributed to an increase in image noise and a decline in image quality. The findings support efforts to minimize radiation by

  1. "Ultra" E.R.A.S. in laparoscopic colectomy for cancer: discharge after the first flatus? A prospective, randomized trial.

    Science.gov (United States)

    Garulli, Gianluca; Lucchi, Andrea; Berti, Pierluigi; Gabbianelli, Carlo; Siani, Luca Maria

    2017-04-01

    Enhanced Recovery After Surgery (E.R.A.S.) programs are now widely accepted in colonic laparoscopic resections because of faster recovery and less perioperative complications. The aim of this study was to assess safety and feasibility of discharging patients operated on by laparoscopic colectomy on postoperative day 2, so long as the first flatus has passed and in the absence of complication-related symptoms. This study was a non-inferiority, open-label, single-center, prospective, randomized study comparing "Ultra" to Classic E.R.A.S. with discharge on POD 2 and 4, respectively. Seven hundred and sixty-five patients with resectable non-metastatic colonic cancer were analyzed: 384 patients were assigned to "Ultra" E.R.A.S. and 381 to Classic E.R.A.S. Primary end-point was mortality; secondary end-points were morbidity, readmission and reoperation rate. Limitations are: it is a single-center experience; it is not double-blind, with the intrinsic risk of intentional or unconscious bias; exclusion criteria because of "non-compliance" may be considered arbitrary. Mortality was 0.89 % in "Ultra" E.R.A.S. group and 0.59 % in Classic E.R.A.S. (p = 0.571). Morbidity was 34.1 % for "Ultra" E.R.A.S. arm and 35.4 % for Classic E.R.A.S. (p = 0.753). Readmissions were 5.6 % for "Ultra" E.R.A.S. and 5.9 % for Classic E.R.A.S. (p = 0.359). Reoperation rate was 3.8 % for "Ultra" ERAS and 4.7 % for Classic E.R.A.S. (p = 0.713). Multivariate regression analyses using Cox's proportional hazard model showed that mortality (primary end-point), morbidity, reoperation and readmission (secondary end-points) were not significantly influenced by the two different perioperative regimens; conversely, the global cost of "Ultra" E.R.A.S. regimen was more economically effective. "Ultra" E.R.A.S. showed to be safe, actual and effective; discharge on postoperative day 2 after the first flatus passage, in the absence of complication-related symptoms, should be actively considered in

  2. 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 information delivery via PVM. PVM provides a novel method for providing education to nurses that improves knowledge retention and satisfaction with the educational process. © 2016 Sigma Theta

  3. Exit-site infection of peritoneal catheter is reduced by the use of polyhexanide. results of a prospective randomized trial.

    Science.gov (United States)

    Núñez-Moral, M; Sánchez-Álvarez, E; González-Díaz, I; Peláez-Requejo, B; Fernández-Viña, A; Quintana-Fernández, A; Rodríguez-Suárez, C

    2014-05-01

    One of the most common and severe complications affecting peritoneal dialysis (PD) patients is exit-site infection of the peritoneal catheter; it is therefore of vital importance to prevent it. This complication has a negative impact on the success of the technique. In spite of this, there are no clear guidelines concerning how to take care of the exit site. The objective of this study was to assess the efficacy of polyhexanide in preventing exit-site infection over a 12-month period. We designed a single-center, prospective, open-labeled, randomized controlled clinical trial with parallel groups. Requirements for participation in the study included implantation of the peritoneal catheter at least six weeks before entering the study and no infectious complications requiring either hospital admission or antibiotic treatment for at least three months before entering into the study. Patients were randomized to be daily cured as follows: Group A: traditional care with saline serum and povidone-iodine; and Group B: polyhexanide solution. Exit sites were evaluated at baseline and every four to six weeks or if any event occurred, according to the Twardowski criteria. Of the 60 included patients, 46 completed the 12-month follow-up period. Six underwent transplantation, five died and three were transferred to hemodialysis (HD). The treatment was well tolerated, with no side effects nor abandonments due to such effects. Throughout the study period, six patients (20%) undergoing traditional care and only two (6,7%) receiving polyhexanide developed an exit-site infection (p = 0.032). There were a total number of 12 infections; nine occurred in patients following the traditional approach and only three in patients treated with polyhexanide (p = 0.037). The germs responsible for the infections were: S. aureus (six cases), Corynebacterium jeikeium (two cases) and P. aeruginosa (one case) in the saline serum and povidone-iodine group and P. aeruginosa (three cases) in the

  4. 1,500 IU human chorionic gonadotropin administered at oocyte retrieval rescues the luteal phase when gonadotropin-releasing hormone agonist is used for ovulation induction: a prospective, randomized, controlled study

    DEFF Research Database (Denmark)

    Al Humaidan, Peter Samir Heskjær; Ejdrup Bredkjaer, Helle; Westergaard, Lars Grabow

    2010-01-01

    OBJECTIVE: To prospectively assess the reproductive outcome with a small bolus of hCG administered on the day of oocyte retrieval after ovulation induction with a GnRH agonist (GnRHa). DESIGN: Prospective, randomized trial. SETTING: Three hospital-based IVF clinics. PATIENT(S): Three hundred five...

  5. The effect of voice rest on the outcome of phonosurgery for benign laryngeal lesions: preliminary results of a prospective randomized study.

    Science.gov (United States)

    Kiagiadaki, Devora; Remacle, Marc; Lawson, George; Bachy, Vincent; Van der Vorst, Sebastien

    2015-05-01

    According to the literature, voice rest following phonosurgery, as recommended in clinical practice, varies between 3 and 7 days. However, up until now, no randomized trials have been published comparing voice rest of short versus long duration. This is an ongoing prospective randomized study, comparing strict voice rest of 5 versus 10 days on the voice following phonosurgery. Thirty-one elective patients operated on for benign laryngeal lesions were randomized. They completed pre- and postoperative assessments, including perceptual voice quality (Grade, Roughness, Breathiness, Asthenia, Strain, Instability scale), Voice Handicap Index total score, and voice analysis with both acoustic and aerodynamic measurements. Additional factors such as smoking, vocal abuse, reflux, and preoperative speech therapy were also taken into account. Sixteen patients were randomized to follow 5 days' voice rest and 15 patients were randomized to 10 days' voice rest. Statistical analysis showed no significant differences in pre- or postoperative measurements between the 2 groups. However, multilinear regression analysis for the effect of voice rest duration on postoperative values showed a significant improvement in maximum phonation time (MPT) with 10 days' voice rest. Preliminary results show a benefit of prolonged voice rest (10 days' duration) on MPT. © The Author(s) 2014.

  6. Anterior cruciate ligament reconstruction with BPTB autograft, irradiated versus non-irradiated allograft: a prospective randomized clinical study.

    Science.gov (United States)

    Sun, Kang; Tian, Shaoqi; Zhang, Jihua; Xia, Changsuo; Zhang, Cailong; Yu, Tengbo

    2009-05-01

    The effect of using gamma irradiation to sterilize bone-patellar tendon-bone (BPTB) allograft on the clinical outcomes of anterior cruciate ligament (ACL) reconstruction with irradiated allograft remains controversial. Our study was aimed to analyze the clinical outcomes of arthroscopic ACL reconstruction with irradiated BPTB allograft compared with non-irradiated allograft and autograft. All BPTB allografts were obtained from a single tissue bank and the irradiated allografts were sterilized with 2.5 Mrad of irradiation prior to distribution. A total of 102 patients undergoing arthroscopic ACL reconstruction were prospectively randomized consecutively into three groups. The same surgical technique was used in all operations done by the same senior surgeon. Before surgery and at the average of 31 months follow-up (range 24-47 months) patients were evaluated by the same observer according to objective and subjective clinical evaluations. Of these patients, 99 (autograft 33, non-irradiated allograft 34, irradiated allograft 32) were available for full evaluation. When compared the irradiated allograft group to non-irradiated allograft group or autograft group at 31 months follow-up by the Lachman test, ADT, pivot shift test and KT-2000 arthrometer testing, statistically significant differences were found. Most importantly, 87.8% of patients in the Auto group, 85.3% in the Non-Ir-Auto group and just only 31.3% in the Ir-Allo group had a side-to-side difference of less than 3 mm according to KT-2000. The failure rate of the ACL reconstruction with irradiated allograft (34.4%) was higher than that with autograft (6.1%) and non-irradiated allograft (8.8%). The anterior and rotational stability decreased significantly in the irradiated allograft group. According to the overall IKDC, functional, subjective evaluations and activity level testing, no statistically significant differences were found between the three groups. However, there was a trend that the functional and

  7. Ertapenem versus Ceftriaxone Followed by Appropriate Oral Therapy for Treatment of Complicated Urinary Tract Infections in Adults: Results of a Prospective, Randomized, Double-Blind Multicenter Study

    OpenAIRE

    Tomera, Kevin M.; Burdmann, Emmanuel A.; PAMO REYNA, OSCAR G.; Jiang, Qi; Wimmer, Wendy M.; Woods, Gail L.; Gesser, Richard M.

    2002-01-01

    The efficacy and safety of intravenous (i.v.) ertapenem (1 g once a day) with the option to switch to an oral agent for treatment of adults with complicated urinary tract infections (UTIs) were compared with that of i.v. ceftriaxone (1 g daily) with the same oral switch option in a multicenter, double-blind, prospective, randomized study. At entry, 592 patients were assigned to one of two strata: acute pyelonephritis or other complicated UTI without acute pyelonephritis. After a minimum of 3 ...

  8. 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

    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...NOTES 14. ABSTRACT The COMBAT (Control of Major Bleeding After Trauma ) study is a randomized clinical trial evaluating the early administration of

  9. Is There a Benefit to Drains with a Kocher-Langenbeck Approach? A Prospective Randomized Pilot Study

    Science.gov (United States)

    2010-11-01

    Athletic Care Dauterive Orthopaedics and Sports Med- icine Suite 280, 500 North Lewis New Iberia, LA 70563; Statistician, United States Institute of...HO, Kaukonen JP, Salo SA. Drainage is of no use in primary uncomplicated cemented hip and knee arthroplasty for osteoarthritis : a prospective

  10. 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

    2017-09-18

    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.

  11. Does Extended-Release Liposomal Bupivacaine Better Control Pain Than Bupivacaine After Total Knee Arthroplasty (TKA)? A Prospective, Randomized Clinical Trial.

    Science.gov (United States)

    Schroer, William C; Diesfeld, Paul G; LeMarr, Angela R; Morton, Diane J; Reedy, Mary E

    2015-09-01

    Liposomal bupivacaine periarticular injection (PAI) offers sustained bupivacaine release after TKA, but few prospective independent studies exist. In this prospective, blinded study, liposomal bupivacaine was randomized against bupivacaine and incorporated into a comprehensive multimodal pain management protocol. 111 primary TKAs were randomized to receive PAI: 58 patients received 266 mg (20cc) liposomal bupivacaine mixed with 75 mg (30cc) 0.25% bupivacaine, and 53 patients received 150 mg (60cc) 0.25% bupivacaine. Visual analog pain scores and narcotic use were determined. No pain score differences occurred between study and control patients: Day 1: 4.5/4.6 (P=0.73); Day 2: 4.4/4.8 (P=0.27); or Day 3: 3.5/3.7 (P=0.58). Narcotic use was similar during hospitalization, 51.8/54.2 (P=0.34). The study medication costs $285, and the control medication costs $2.80. This finding does not justify the routine use of liposomal bupivacaine.

  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. 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

  14. 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...

  15. Implant-supported mandibular overdentures retained with ball or bar attachments: a randomized prospective 5-year study

    DEFF Research Database (Denmark)

    Gotfredsen, K; Holm, B

    2001-01-01

    Astra Tech dental implants placed in the anterior part of the mandible. The denture attachment system for the patients was chosen randomly by drawing lots. Eleven patients drew the bar attachment system and fifteen patients drew the ball attachment system. Plaque Index, Gingival Index, and probing...

  16. 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...

  17. A prospective phase II randomized study of deferasirox to prevent iatrogenic iron overload in patients undertaking induction/consolidation chemotherapy for acute myeloid leukaemia.

    Science.gov (United States)

    Kennedy, Glen A; Morris, Kirk L; Subramonpillai, Elango; Curley, Cameron; Butler, Jason; Durrant, Simon

    2013-06-01

    This prospective randomized phase II study aimed to determine the safety and efficacy of deferasirox in preventing iatrogenic iron overload in patients receiving induction/consolidation chemotherapy for acute myeloid leukaemia (AML) ize. Serum ferritin, transferrin saturation and CRP were measured pre-, mid- and post- each chemotherapy cycle. Patients were randomized to receive either therapy with deferasirox vs. no deferasirox therapy once serum ferritin increased to >500 μg/l. The trial was stopped prematurely due to excess gastrointestinal (GI) and infectious toxicity demonstrable in the deferasirox arm, after 10 patients had been randomized to deferasirox and 6 patients to the control arm. Overall, deferasirox was poorly tolerated, with median maximum tolerated dose only 13·8 mg/kg/d and no patient able to tolerate doses >20 mg/kg/d. Median duration of deferasirox therapy was only 72 d (range 19-130 d), with 9/10 patients requiring unplanned dose interruptions and 4/10 patients unable to continue the drug predominantly due to GI effects. Although all 3 treatment-related deaths occurred in the deferasirox arm (P = 0·25), median overall survival was similar between treatment arms. Use of deferasirox to prevent iatrogenic iron overload in AML patients undertaking induction/consolidation is poorly tolerated and appears to be associated with excess GI and infectious toxicity.

  18. 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....

  19. Psychotherapeutic process of cognitive-behavioral intervention in HIV-infected persons: Results from a controlled, randomized prospective clinical trial

    OpenAIRE

    Znoj, H J; Messerli-Burgy, N; Tschopp, S; Weber, R.; Christen, L; Christen, S; Grawe, K

    2010-01-01

    The aim of this exploratory study was to examine the possible mechanisms of behavioral change in a cognitive-behavioral intervention supporting medication adherence in HIV-infected persons. A total of 60 persons currently under medical treatment were randomized to psychotherapy or usual care and were compared with a sociodemographically matched group of general psychotherapy clients. Outcome measures included therapy adherence using medication event-monitoring system psychotherapeutic process...

  20. Intra-articular sodium hyaluronate injections after arthroscopic debridement forosteoarthritis of the knee: a prospective, randomized, controlled study

    OpenAIRE

    Heybeli, Nurettin; Doral, Mahmut; Atay, Özgür; Leblebicioğlu, Gürsel

    2017-01-01

    Objectives: The purpose of this study was to evaluate the effect of intra-articular hyaluronic acid (HA) injections after arthroscopic debridement on pain and functional parameters in patients with mild-to-moderate knee osteoarthritis.Methods: Sixty-seven patients (21 men, 46 women; mean age 56 years; range 40 to 65 years) who underwent standard arthroscopic debridement for primary knee osteoarthritis of Kellgren-Lawrence grade II-III were randomly assigned to HA injections (n=33) or to only ...

  1. Video-based feedback of oral clinical presentations reduces the anxiety of ICU medical students: a multicentre, prospective, randomized study

    OpenAIRE

    Schmidt, Matthieu; Freund, Yonathan; Alves, Mickael; Monsel, Antoine; Labbe, Vincent; Darnal, Elsa; Messika, Jonathan; Bokobza, Jerome; Similowski, Thomas; Duguet, Alexandre

    2014-01-01

    International audience; Background: Oral presentations of clinical cases by medical students during medical rounds in hospital wards are a source of anxiety and little is known about how this anxiety can be alleviated. The objective of this study was to investigate whether video-based feedback of public oral presentations can reduce anxiety in 4th year medical students. Methods: Multicentre randomized study conducted in six intensive care units (ICU) and emergency departments (ED) in France o...

  2. A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures: Modern Ring External Fixators Versus Internal Fixation (FIXIT Study).

    Science.gov (United States)

    OʼToole, Robert V; Gary, Joshua L; Reider, Lisa; Bosse, Michael J; Gordon, Wade T; Hutson, James; Quinnan, Stephen M; Castillo, Renan C; Scharfstein, Daniel O; MacKenzie, Ellen J

    2017-04-01

    The treatment of high-energy open tibia fractures is challenging in both the military and civilian environments. Treatment with modern ring external fixation may reduce complications common in these patients. However, no study has rigorously compared outcomes of modern ring external fixation with commonly used internal fixation approaches. The FIXIT study is a prospective, multicenter randomized trial comparing 1-year outcomes after treatment of severe open tibial shaft fractures with modern external ring fixation versus internal fixation among men and women of ages 18-64. The primary outcome is rehospitalization for major limb complications. Secondary outcomes include infection, fracture healing, limb function, and patient-reported outcomes including physical function and pain. One-year treatment costs and patient satisfaction will be compared between the 2 groups, and the percentage of Gustilo IIIB fractures that can be salvaged without soft tissue flap among patients receiving external fixation will be estimated.

  3. A prospective study of anxiety in ICD patients with a pilot randomized controlled trial of cognitive behavioral therapy for patients with moderate to severe anxiety

    DEFF Research Database (Denmark)

    Qintar, Mohammed; George, Jason J; Panko, Melanie

    2015-01-01

    consisted of two parts: part 1 (N = 690) was a prospective cross-sectional observational study of consecutive ICD patients. Patients completed the Beck Anxiety Inventory (BAI), Generalized Anxiety Disorder Scale (GAD-7), Florida Shock Anxiety Scale (FSAS), and Florida Patient Acceptance Survey (FPAS......PURPOSE: Stress and anxiety are potential consequences from arrhythmias and implantable cardioverter defibrillator (ICD) shocks that can contribute to substantial morbidity. We assessed anxiety associated with an ICD and whether cognitive behavioral therapy (CBT) reduces anxiety. METHODS: The study......) psychometric tests. Part 2 (N = 29) was a pilot randomized controlled trial of CBT (three sessions in 3 months) vs. usual care (UC) in patients with BAI ≥ 19 from part 1. RESULTS: The median BAI and GAD-7 scores were 5 and 2, respectively. By BAI scores, 64.5 % had minimal and 3.9 % had severe anxiety. By GAD...

  4. Effect of OK-432 combined UFT in patients with stage III non-small cell lung cancer treated by radiotherapy. A randomized prospective study

    Energy Technology Data Exchange (ETDEWEB)

    Jingu, Kenichi [Fukuoka Univ. (Japan). School of Medicine; Ohmagari, Junichi; Masuda, Kouji [and others

    1997-06-01

    Distant metastasis and local recurrence are the causes of poor treatment results of unresectable non-small cell lung cancer patients. Inhibition of repair from radiation damage in tumors and distant metastases may improve the survival rate. Some authors of this paper previously reported that tegafur combined with OK-432 significantly improved the survival rate in these patients. We conducted a prospective randomized trial using UFT (mixed preparation of tegafur and uracil) with or without OK-432, after radiotherapy in these patients, to assess the effect of OK-432 on survival rate, the duration of continued response by previous treatment, and the effect on leucopenia due to UFT. However, unexpected results were obtained. OK-432 did not prolong response duration, did not improve the survival rate, and did not inhibit the leucopenia due to UFT. (author)

  5. A Prospective Quasi-Randomized Comparison of Intraoperatively Built Custom-Linked Seeds Versus Loose Seeds for Prostate Brachytherapy

    Energy Technology Data Exchange (ETDEWEB)

    Ishiyama, Hiromichi, E-mail: hishiyam@kitasato-u.ac.jp [Department of Radiology and Radiation Oncology, Kitasato University School of Medicine, Sagamihara (Japan); Satoh, Takefumi [Department of Urology, Kitasato University School of Medicine, Sagamihara (Japan); Kawakami, Shogo [Department of Radiology and Radiation Oncology, Kitasato University School of Medicine, Sagamihara (Japan); Tsumura, Hideyasu [Department of Urology, Kitasato University School of Medicine, Sagamihara (Japan); Komori, Shouko [Department of Radiology and Radiation Oncology, Kitasato University School of Medicine, Sagamihara (Japan); Tabata, Ken-ichi [Department of Urology, Kitasato University School of Medicine, Sagamihara (Japan); Sekiguchi, Akane [Department of Radiology and Radiation Oncology, Kitasato University School of Medicine, Sagamihara (Japan); Takahashi, Ryo [Department of Urology, Kitasato University School of Medicine, Sagamihara (Japan); Soda, Itaru; Takenaka, Kouji [Department of Radiology and Radiation Oncology, Kitasato University School of Medicine, Sagamihara (Japan); Iwamura, Masatsugu [Department of Urology, Kitasato University School of Medicine, Sagamihara (Japan); Hayakawa, Kazushige [Department of Radiology and Radiation Oncology, Kitasato University School of Medicine, Sagamihara (Japan)

    2014-09-01

    Purpose: To compare dosimetric parameters, seed migration rates, operation times, and acute toxicities of intraoperatively built custom-linked (IBCL) seeds with those of loose seeds for prostate brachytherapy. Methods and Materials: Participants were 140 patients with low or intermediate prostate cancer prospectively allocated to an IBCL seed group (n=74) or a loose seed group (n=66), using quasirandomization (allocated by week of the month). All patients underwent prostate brachytherapy using an interactive plan technique. Computed tomography and plain radiography were performed the next day and 1 month after brachytherapy. The primary endpoint was detection of a 5% difference in dose to 90% of prostate volume on postimplant computed tomography 1 month after treatment. Seed migration was defined as a seed position >1 cm from the cluster of other seeds on radiography. A seed dropped into the seminal vesicle was also defined as a migrated seed. Results: Dosimetric parameters including the primary endpoint did not differ significantly between groups, but seed migration rate was significantly lower in the IBCL seed group (0%) than in the loose seed group (55%; P<.001). Mean operation time was slightly but significantly longer in the IBCL seed group (57 min) than in the loose seed group (50 min; P<.001). No significant differences in acute toxicities were seen between groups (median follow-up, 9 months). Conclusions: This prospective quasirandomized control trial showed no dosimetric differences between IBCL seed and loose seed groups. However, a strong trend toward decreased postimplant seed migration was shown in the IBCL seed group.

  6. Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; design of a prospective randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Koes Bart W

    2009-05-01

    Full Text Available Abstract Background The usual surgical treatment of refractory sciatica caused by lumbar disc herniation, is open discectomy. Minimally invasive procedures, including percutaneous therapies under local anesthesia, are increasingly gaining attention. One of these treatments is Percutaneous Laser Disc Decompression (PLDD. This treatment can be carried out in an outpatient setting and swift recovery and return to daily routine are suggested. Thus far, no randomized trial into cost-effectiveness of PLDD versus standard surgical procedure has been performed. We present the design of a randomized controlled trial, studying the cost-effectiveness of PLDD versus conventional open discectomy in patients with sciatica from lumbar disc herniation. Methods/design The study is a randomized prospective multi-center trial, in which two treatment strategies are compared in a parallel group design. Patients (age 18–70 years visiting the neurosurgery department of the participating hospitals, are considered for inclusion in the trial when sciatica due to lumbar disc herniation has lasted more than 8 weeks. Patients with disc herniation smaller than 1/3 of the spinal canal diameter, without concomitant lateral recess stenosis or sequestration, are eligible for participation, and are randomized into one of two treatment arms; either Percutaneous Laser Disc Decompression or conventional discectomy. The functional outcome of the patient, as assessed by the Roland Disability Questionnaire for Sciatica at 8 weeks and 1 year after treatment, is the primary outcome measure. The secondary outcome parameters are recovery as perceived by the patient, leg and back pain, incidence of re-intervention, complications, quality of life, medical consumption, absence of work and secondary costs. Discussion Open discectomy is still considered to be the golden standard in the surgical treatment of lumbar disc herniation. Whether Percutaneous Laser Disc Decompression has at least as

  7. 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.

  8. Effectiveness of CO2-insufflated endoscopic submucosal dissection with the duodenal balloon occlusion method for early esophageal or gastric cancer: a randomized case control prospective study

    Directory of Open Access Journals (Sweden)

    Mori Hirohito

    2012-04-01

    Full Text Available Abstract Background Endoscopic submucosal dissection (ESD has typically been performed using air insufflation. Recently, however, insufflation of CO2 has been increasingly used to avoid complications. This prospective study was designed to compare the CO2 concentration, intestinal volume, and acid–base balance using the duodenal balloon procedure. Methods From June 2010 to February 2011, we enrolled 44 patients with esophageal or gastric cancer and randomly allocated them into two groups. We compared 22 patients undergoing CO2-insufflated ESD with a balloon placed into the duodenal bulb (duodenal balloon group and 22 patients undergoing regular CO2-insufflated ESD (regular group. Three-dimensional computed tomography was performed before and after the procedure to measure intestinal volume. CO2 concentrations were measured every 10 minutes. The visual analogue system (VAS scores for postoperative symptoms were recorded, and pH was measured immediately after the procedure. This was a prospective case control study randomized by the sealed envelope method. Results Intestinal CO2 gas volume before and after ESD was lower in the duodenal balloon group than in the regular group (P = 0.00027. The end-tidal CO2 level was significantly lower in the duodenal balloon group than in the regular group (P = 0.0001. No significant differences in blood ΔpH were found between the two groups. The VAS score for the occurrence of nausea due to abdominal distension after ESD indicated a significant difference (P = 0.031. Conclusions ESD using the duodenal balloon occlusion method is effective for reduction of post-ESD intestinal CO2 gas volume, resulting in a lower total amount of CO2 insufflation during ESD and reducing harmful influences on the human body to some extent.

  9. 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 < 0.001), resulting in an average saving of 0.20 units of allogeneic RBC per patient (weighted mean differences [WMD] = -0.20; 95% CI -0.22 to -0.18; P < 0.001), reduced risk of infection by 28% (RR = 0.72; 95% CI 0.54 to 0.97; P = 0.03), reduced length of hospital stay by 2.31 days (WMD = -2.31; 95% CI -2.50 to -2.11; P < 0.001), but did not significantly affect risk of mortality (RR = 0.92; 95% CI 0.63 to 1.34; P = 0.66). No statistical difference could be observed in the number of patients exposed to re-operation, plasma, 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.

  10. Fistulectomy versus fistulotomy with marsupialisation in the treatment of low fistula-in- ano: a prospective randomized controlled trial.

    Science.gov (United States)

    Chalya, Phillipo L; Mabula, Joseph B

    2013-07-01

    Low fistula-in-ano has traditionally been treated with fistulectomy and fistulotomy. Recent studies have shown that marsupialisation of the fistulotomy wounds can reduce the healing time. A randomized clinical trial was conducted at Bugando Medical Centre in north-western Tanzania between January 2008 and December 2012 to compare the efficacy of fistulectomy versus fistulotomy with marsupialisation in the treatment of low fistula in ano. Patients were randomized into two groups, namely Group A (fistulectomy) and Group B (fistulotomy with marsupialisation). A total of 162 patients were enrolled in the study and randomly assigned to Group A (n = 82) and Group B (n = 80). Both groups were comparable with respect to age, sex ratio, duration of symptoms, type of fistula and radial distance of the external opening from the anal verge. The mean healing time was statistically significantly longer in group A than in group B (P = 0.002). The duration of postoperative wound discharge was statistically significantly shorter in group B than in group A (P = 0.012). There was no statistically significant difference in the mean operating time, mean operation wound size, mean postoperative pain score, rate of surgical site infection and postoperative hospital stay between the two groups (P > 0.05). None of the patients in either group had recurrence or was found to have anal incontinence. No differences in the extent of adverse effects of surgery on the physical, social and sexual lives of the patients in the two groups. We conclude that in comparison to a fistulectomy, a fistulotomy with marsupialisation results in faster wound healing and a shorter duration of wound discharge and should therefore be recommended as a standard surgical procedure in the treatment of low fistula-in-ano.

  11. Robot-assisted Versus Laparoscopic Surgery for Rectal Cancer: A Phase II Open Label Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Kim, Min Jung; Park, Sung Chan; Park, Ji Won; Chang, Hee Jin; Kim, Dae Yong; Nam, Byung-Ho; Sohn, Dae Kyung; Oh, Jae Hwan

    2017-05-25

    The phase II randomized controlled trial aimed to compare the outcomes of robot-assisted surgery with those of laparoscopic surgery in the patients with rectal cancer. The feasibility of robot-assisted surgery over laparoscopic surgery for rectal cancer has not been established yet. Between February 21, 2012 and March 11, 2015, patients with rectal cancer (cT1-3NxM0) were enrolled. Patients were randomized 1:1 to either robot-assisted or laparoscopic surgery, and stratified per sex and administration of preoperative chemoradiotherapy. The primary outcome was the quality of total mesorectal excision (TME) specimen. Secondary outcomes were the circumferential and distal resection margins, the number of harvested lymph nodes, morbidity, bowel function recovery, and quality of life. A total of 163 patients were randomly assigned to the robot-assisted (n = 81) and laparoscopic (n = 82) surgery groups, and 139 patients were eligible for the analyses (73 vs 66, respectively). One patient (1.2%) in the robot-assisted group was converted to open surgery. The TME quality did not differ between the robot-assisted and laparoscopic groups (80.3% vs 78.1% complete TME, respectively; 18.2% vs 21.9% nearly complete TME, respectively; P = 0.599). The resection margins, number of harvested lymph nodes, morbidity, and bowel function recovery also were not significantly different. On analyzing quality of life, scores of the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ C30) and EORTC QLQ CR38 were similar in the 2 groups, but in the EORTC QLQ CR 38 questionnaire, sexual function 12 months postoperatively was better in the robot-assisted group than in the laparoscopic group (P = 0.03). Robot-assisted surgery in rectal cancer showed TME quality comparable with that of laparoscopic surgery, and it demonstrated similar postoperative morbidity, bowel function recovery, and quality of life.

  12. Surgical site infections following colorectal cancer surgery: a randomized prospective trial comparing common and advanced antimicrobial dressing containing ionic silver

    Directory of Open Access Journals (Sweden)

    Biffi Roberto

    2012-05-01

    Full Text Available Abstract Background An antimicrobial dressing containing ionic silver was found effective in reducing surgical-site infection in a preliminary study of colorectal cancer elective surgery. We decided to test this finding in a randomized, double-blind trial. Methods Adults undergoing elective colorectal cancer surgery at two university-affiliated hospitals were randomly assigned to have the surgical incision dressed with Aquacel® Ag Hydrofiber dressing or a common dressing. To blind the patient and the nursing and medical staff to the nature of the dressing used, scrub nurses covered Aquacel® Ag Hydrofiber with a common wound dressing in the experimental arm, whereas a double common dressing was applied to patients of control group. The primary end-point of the study was the occurrence of any surgical-site infection within 30 days of surgery. Results A total of 112 patients (58 in the experimental arm and 54 in the control group qualified for primary end-point analysis. The characteristics of the patient population and their surgical procedures were similar. The overall rate of surgical-site infection was lower in the experimental group (11.1% center 1, 17.5% center 2; overall 15.5% than in controls (14.3% center 1, 24.2% center 2, overall 20.4%, but the observed difference was not statistically significant (P = 0.451, even with respect to surgical-site infection grade 1 (superficial versus grades 2 and 3, or grade 1 and 2 versus grade 3. Conclusions This randomized trial did not confirm a statistically significant superiority of Aquacel® Ag Hydrofiber dressing in reducing surgical-site infection after elective colorectal cancer surgery. Trial registration Clinicaltrials.gov: NCT00981110

  13. Hemodialysis without systemic anticoagulation: a prospective randomized trial to evaluate 3 strategies in patients at risk of bleeding.

    Directory of Open Access Journals (Sweden)

    Bruno Guéry

    Full Text Available 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 NCT

  14. 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....... No difference in the infection rate (13% vs. 11%, p=0.73), length of hospital stay, or wound complications was noted between the two groups. We conclude that although the Aquacel dressing needed significantly fewer changes than the conventional dressing, this did not influence the patient comfort. Moreover...

  15. A Prospective Cluster-Randomized Trial of Telehealth Coaching to Promote Bone Health and Nutrition in Deployed Soldiers

    Directory of Open Access Journals (Sweden)

    Mary S. McCarthy

    2014-12-01

    Full Text Available Findings from previous studies suggest that inadequate consumption of calcium and vitamin D and a decrease in exercise while deployed can be detrimental to bone health. This study enrolled 234 soldiers randomized to receive one-time nutrition and exercise education pre-deployment (n = 149, or telehealth coaching (n = 85, throughout the deployment cycle. Results suggest that online educational efforts may enhance sports activity, bone turnover, and vitamin D status. Improving vitamin D status and remaining active while deployed appears to sustain healthy bone density in young soldiers. Early and aggressive educational outreach to young adults may prevent chronic musculoskeletal conditions and disabling osteoporosis later in life.

  16. Symptomatic improvement with gluten restriction in irritable bowel syndrome: a prospective, randomized, double blinded placebo controlled trial

    OpenAIRE

    Zanwar, Vinay G.; Pawar, Sunil V; Gambhire, Pravir A; Jain, Samit S.; Surude, Ravindra G.; Shah, Vinaya B; Contractor, Qais Q; Rathi, Pravin M.

    2016-01-01

    Background/Aims The existence of non-celiac gluten sensitivity has been debated. Indeed, the intestinal and extra-intestinal symptoms of many patients with irritable bowel syndrome (IBS) but without celiac disease or wheat allergy have been shown to improve on a gluten-free diet. Therefore, this study set out to evaluate the effects of gluten on IBS symptoms. Methods We performed a double-blind randomized placebo-controlled rechallenge trial in a tertiary care hospital with IBS patients who f...

  17. Randomized prospective study comparing a single radioiodine dose and a single laser therapy session in autonomously functioning thyroid nodules

    DEFF Research Database (Denmark)

    Døssing, Helle; Bennedbaek, Finn Noe; Bonnema, Steen Joop

    2007-01-01

    OBJECTIVE: To compare the efficacy of interstitial laser photocoagulation (ILP) with radioiodine in hot thyroid nodules. DESIGN: Thirty consecutive outpatients with subclinical or mild hyperthyroidism and a scintigraphically solitary hot nodule with extraglandular suppression were randomized...... at inclusion and at 1, 3 and 6 months after treatment. RESULTS: Normalization of serum TSH was achieved in 7 out of 14 patients in the ILP group and in all 15 patients in the (131)I group (P=0.0025). In the ILP group, mean thyroid nodule volume reduction was 44+/-5% (s.e.m.; P

  18. 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

    , 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....... No difference in the infection rate (13% vs. 11%, p=0.73), length of hospital stay, or wound complications was noted between the two groups. We conclude that although the Aquacel dressing needed significantly fewer changes than the conventional dressing, this did not influence the patient comfort. Moreover......, the traditional dressing scheme was significantly less expensive....

  19. Football as a treatment for hypertension in untrained 30-55-year-old men: a prospective randomized study

    DEFF Research Database (Denmark)

    Andersen, L J; Randers, M B; 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...... to the treatment of mild-to-moderate arterial hypertension in untrained middle-aged men....... sessions per week) and a control group receiving physician-guided traditional recommendations on cardiovascular risk factor modification (doctoral advice group, DAG). After 3 months, systolic blood pressure (SBP) and diastolic blood pressure (DBP) were lowered (P

  20. Comparison of effectiveness of different surgical treatments for meralgia paresthetica: Results of a prospective observational study and protocol for a randomized controlled trial.

    Science.gov (United States)

    de Ruiter, Godard C W; Kloet, Alfred

    2015-07-01

    Various surgical procedures can be applied in the treatment of meralgia paresthetica. The two main ones are neurolysis and neurectomy of the lateral femoral cutaneous nerve. To date, no prospective or randomized controlled trial has compared the effectiveness of these procedures with standardized outcome measures. In this study we present our results for two prospectively followed cohorts and we present the protocol for a double blind randomized controlled trial (RCT). All patients that had an indication for surgical treatment of idiopathic meralgia paresthetica between August 2012 and April 2014 were included in the study. The patient decided on the type of treatment (neurolysis or neurectomy) after informed consent had been given. Primary outcome was measured using the Likert scale obtained 6 weeks after the surgery. Successful pain reduction was defined as Likert 1 or 2. Secondary outcome measures were the Numeric Rating Scale (NRS) and Bothersomeness Index (BSI). In case of neurectomy the BSI for numbness was also obtained. A total of 22 consecutive patients were included: neurolysis was performed in 8 patients and neurectomy in 14 patients (one bilateral case). Successful pain reduction was observed more frequently after neurectomy (93.3%) than after neurolysis (37.5%, P<0.05). Secondary outcome scores (NRS and BSI pain) were also better after neurectomy, although not significantly (respectively P=0.07 and 0.05). Paired analysis of the scores before and after the surgery showed an improvement in both the NRS and BSI after the neurectomy procedure (both P<0.001), while scores were not significantly different before and after the neurolysis procedure. Patient's scores for the BSI numbness after the neurectomy procedure were low (mean 1.4, SD±1.0, range 0-3). The results of our prospective study confirm results previous studies reported in the literature in that the percentage pain relief was better after neurectomy than after neurolysis. A RCT is needed to

  1. The Treatment of Idiopathic Sudden Sensorineural Hearing Loss Using Phle-botomy: A Prospective, Randomized, Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mohammad Taghi Goodarzi

    2009-12-01

    Full Text Available This randomized clinical trial aimed to assess the efficacy of phlebotomy on improvement of hearing loss. 71 patients with sudden sensorineural hearing loss were enrolled in this randomized clinical trial study. They were divided into two groups: group A received steroid and hydration therapy plus phlebotomy, while group B received the same regimen without phlebotomy. They were matched according to sex, age, Hb, and Htc. Pure tone audiometries were administered to examine the hearing levels before and after treatment. Statistical analysis showed higher improvement in 250-1000 Hz in patients whit phlebotomy (P<0.001. However, there was noticed no significant difference in hearing improvement in 2000-8000 Hz between two methods. The number (% of patients who had improvement was 29(85.3% in phlebotomy group and 21(56.8% in non-phlebotomy group. On the other hand, the number (% of patients who showed no improvement in A and B group was 5(14.7% and 16(43.2%, respectively (P=0.008. Using phlebotomy accompanied by steroid and hydration therapy leads to higher improvement in hearing loss especially in 250-1000 Hz. We think that this method has the ability to achieve better result in the management of patients with SSNHL.

  2. Symptomatic improvement with gluten restriction in irritable bowel syndrome: a prospective, randomized, double blinded placebo controlled trial.

    Science.gov (United States)

    Zanwar, Vinay G; Pawar, Sunil V; Gambhire, Pravir A; Jain, Samit S; Surude, Ravindra G; Shah, Vinaya B; Contractor, Qais Q; Rathi, Pravin M

    2016-10-01

    The existence of non-celiac gluten sensitivity has been debated. Indeed, the intestinal and extra-intestinal symptoms of many patients with irritable bowel syndrome (IBS) but without celiac disease or wheat allergy have been shown to improve on a gluten-free diet. Therefore, this study set out to evaluate the effects of gluten on IBS symptoms. We performed a double-blind randomized placebo-controlled rechallenge trial in a tertiary care hospital with IBS patients who fulfilled the Rome III criteria. Patients with celiac disease and wheat allergy were appropriately excluded. The participants were administered a gluten-free diet for 4 weeks and were asked to complete a symptom-based questionnaire to assess their overall symptoms, abdominal pain, bloating, wind, and tiredness on the visual analog scale (0-100) at the baseline and every week thereafter. The participants who showed improvement were randomly assigned to one of two groups to receive either a placebo (gluten-free breads) or gluten (whole cereal breads) as a rechallenge for the next 4 weeks. In line with the protocol analysis, 60 patients completed the study. The overall symptom score on the visual analog scale was significantly different between the two groups (Pgluten intervention group scored significantly higher in terms of abdominal pain, bloating, and tiredness (Pgluten diet may worsen the symptoms of IBS patients. Therefore, some form of gluten sensitivity other than celiac disease exists in some of them, and patients with IBS may benefit from gluten restrictions.

  3. Comparison of anterior subcutaneous and submuscular transposition of ulnar nerve in treatment of cubital tunnel syndrome: A prospective randomized trial

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    Abolghassem Zarezadeh

    2012-01-01

    Full Text Available Background: This study was designed to compare two methods of surgery, anterior subcutaneous transposition (ASCT and anterior submuscular transposition (ASMT of the ulnar nerve in treatment of cubital tunnel syndrome. Materials and Methods: This randomized trial study was conducted from October 2008 to March 2009 in the Department of Orthopedic Surgery at University Hospital. Forty-eight patients with confirmed cubital tunnel syndrome were randomized in two groups, and each patient received one of two different surgical treatment methods, either ASCT (n = 24 or ASMT (n = 24. In the ASCT technique, the ulnar nerve was transposed and retained in the subcutaneous bed, whereas in the ASMT, the nerve was retained deep in the transected muscular complex, near the median nerve. Patient outcomes, including pain, sensation, muscle strength, and muscle atrophy were compared between groups. Results: The two groups were similar in baseline characteristics. However, those treated with ASMT had a statistically significant reduction in their pain levels compared with ASCT (21 (87.5% vs 8 (33.3%, P 0.05. Conclusions: Our results indicate that ASMT are more efficient than ASCT for managing cubital tunnel syndrome. In patients who had ASMT, there were significant reductions of pain compared with ASCT.

  4. Are minimized perfusion circuits the better heart lung machines? Final results of a prospective randomized multicentre study.

    Science.gov (United States)

    El-Essawi, A; Hajek, T; Skorpil, J; Böning, A; Sabol, F; Ostrovsky, Y; Hausmann, H; Harringer, W

    2011-11-01

    Minimized perfusion circuits (MPCs), although aiming at minimizing the adverse effects of cardiopulmonary bypass, have not yet gained popularity. This can be attributed to concerns regarding their safety, as well as lack of sufficient evidence of their benefit. Described is a randomized, multicentre study comparing the MPC - ROCsafeRX to standard cardiopulmonary bypass in patients undergoing elective coronary artery bypass grafting and/ or aortic valve replacement. Five hundred patients were included in the study (252 randomized to the ROCsafeRX group and 248 to standard cardiopulmonary bypass). Both groups were well matched for demographic characteristics and type of surgery. No operative mortality and no device-related complications were encountered. Transfusion requirement (333 ± 603 vs. 587 ± 1010 ml; p=0.001), incidence of atrial fibrillation (16.3% vs. 24.2%; p=0.03) and the incidence of major adverse events (9.1% vs. 16.5%; p=0.02) were all in favour of the MPC group. These results confirm both the safety and efficacy of the ROCsafeRX MPC for a large variety of cardiac patients. Minimized perfusion circuits should, therefore, play a greater role in daily practice so that as many patients as possible can benefit from their advantages.

  5. Is Roux-Y Binding Pancreaticojejunal Anastomosis Feasible for Patients Undergoing Left Pancreatectomy? Results from a Prospective Randomized Trial

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    Anne Antila

    2014-01-01

    Full Text Available Background. After pancreaticoduodenectomy, the Finnish binding pancreaticojejunal anastomosis (FBPJ seems to reduce the risk for pancreatic fistula (POPF. Our aim was to investigate whether FBPJ is feasible and prevents the risk for POPF even after left pancreatectomy (LP. Patients and Methods. 47 consecutive patients underwent LP. 27 patients were recruited on the basis of CT and, of these, 16 patients were randomized on the basis of findings during surgery (transection line must be left of portal vein, as 2-3 cm pancreatic mobilization is required for FBPJ to receive either Roux-Y FBPJ or hand-sewn closure of the pancreatic remnant. Results. Only 34% (16/47 of the patients met the randomization criteria. Clinically significant POPF rate was higher in FBPJ group (60% compared to thand-sewn closure group (13%; P<0.05. POPF rate in FBPJ group was higher even when compared to all patients with hand-sewn closure (60% versus 37%; P<0.05. Overall, FBPJ was technically feasible for only 28% of patients. Conclusion. FBPJ cannot be recommended for the routine closure of the pancreatic remnant after LP, as it was not technically achievable in 72% of the cases. Moreover, the technique does not seem to reduce the risk for POPF compared to the hand-sewn closure.

  6. To determine block establishment time of supraclavicular brachial plexus block using blunt versus short bevel needle: A prospective randomized trial

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    V Ahuja

    2016-01-01

    Full Text Available Background: Unintentional intraneural injection under ultrasound guidance (USG with fine caliber needles and lower success rate with large caliber Tuohy needles in supraclavicular brachial plexus block (SCB have been reported. Materials and Methods: We undertook study to standardize the use of 20-gauge short versus blunt bevel needle for SCB. After approval of Institutional Ethics Committee and written informed consent, patients were randomized using computer-generated random number table to either of the two groups; blunt bevel needle group (n = 30: SCB under USG using 20-gauge Tuohy needle or short bevel needle group (n = 30: SCB under USG using 20-gauge short bevel needle. The primary outcome of the study was time to establishment of sensory and motor block of individual nerves, and secondary outcome was tolerability and any adverse effects. Results: The time to establishment of sensory and motor block in individual nerve territory was similar in both the groups. The complete sensory and motor anesthesia was achieved in 78.3% patients and complete sensory and motor anesthesia after supplementary block was achieved in 86.6% patients. Paresthesias during SCB were recorded in 15 patients. Out of these eight patients were of blunt bevel group and seven patients were of short bevel group. None of the patients experienced any neurological adverse effects. Conclusion: The establishment of sensory and motor blockade of individual nerves was similar to 20-gauge short and blunt bevel needle under ultrasound guide with no neurological adverse events.

  7. Ketamine or atropine: which one better prevents oculocardiac reflex during eye surgery? A prospective randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Ebrahim Espahbodi

    2015-03-01

    Full Text Available Profound bradycardia during eye surgery is a potentially serious event. In clinical practice oculo-cardiac reflex (OCR is most often encountered during squint surgery. The objective of this study was to assess the occurrence of OCR and prove the effect of ketamine as an induction drug and anticholinergic premedication (atropine to prevent OCR. This study comprised 90 patients (aged 4-10 years operated for squint surgery under general anesthesia. Patients were divided into three groups. Using block randomization, each patient enrolled in one of the three groups based on organized random table prepared by statistician. Group K received ketamine as an induction drug, Group A was premedicated with intravenous injection of atropine and Group C did not receive any premedication. Patients were monitored during operation for any bradycardia or dysrhythmias. The observed data showed occurrence of 63% OCR in Group C as compared to 43% in group A and only 20% in Group K. Current study showed that induction with ketamine in the patients of squint surgery under general anesthesia definitely obtunds OCR and prevents any untoward effects of dysrhythmias during eye surgery.

  8. Low-calorie sweeteners and body weight and composition: a meta-analysis of randomized controlled trials and prospective cohort studies123

    Science.gov (United States)

    Miller, Paige E; Perez, Vanessa

    2014-01-01

    Background: Replacement of caloric sweeteners with lower- or no-calorie alternatives may facilitate weight loss or weight maintenance by helping to reduce energy intake; however, past research examining low-calorie sweeteners (LCSs) and body weight has produced mixed results. Objective: The objective was to systematically review and quantitatively evaluate randomized controlled trials (RCTs) and prospective cohort studies, separately, that examined the relation between LCSs and body weight and composition. Design: A systematic literature search identified 15 RCTs and 9 prospective cohort studies that examined LCSs from foods or beverages or LCSs consumed as tabletop sweeteners. Meta-analyses generated weighted mean differences in body weight and composition values between the LCS and control groups among RCTs and weighted mean correlations for LCS intake and these parameters among prospective cohort studies. Results: In RCTs, LCSs modestly but significantly reduced all outcomes examined, including body weight (−0.80 kg; 95% CI: −1.17, −0.43), body mass index [BMI (in kg/m2): −0.24; 95% CI: −0.41, −0.07], fat mass (−1.10 kg; 95% CI: −1.77, −0.44), and waist circumference (−0.83 cm; 95% CI: −1.29, −0.37). Among prospective cohort studies, LCS intake was not associated with body weight or fat mass, but was significantly associated with slightly higher BMI (0.03; 95% CI: 0.01, 0.06). Conclusions: The current meta-analysis provides a rigorous evaluation of the scientific evidence on LCSs and body weight and composition. Findings from observational studies showed no association between LCS intake and body weight or fat mass and a small positive association with BMI; however, data from RCTs, which provide the highest quality of evidence for examining the potentially causal effects of LCS intake, indicate that substituting LCS options for their regular-calorie versions results in a modest weight loss and may be a useful dietary tool to improve

  9. Low-calorie sweeteners and body weight and composition: a meta-analysis of randomized controlled trials and prospective cohort studies.

    Science.gov (United States)

    Miller, Paige E; Perez, Vanessa

    2014-09-01

    Replacement of caloric sweeteners with lower- or no-calorie alternatives may facilitate weight loss or weight maintenance by helping to reduce energy intake; however, past research examining low-calorie sweeteners (LCSs) and body weight has produced mixed results. The objective was to systematically review and quantitatively evaluate randomized controlled trials (RCTs) and prospective cohort studies, separately, that examined the relation between LCSs and body weight and composition. A systematic literature search identified 15 RCTs and 9 prospective cohort studies that examined LCSs from foods or beverages or LCSs consumed as tabletop sweeteners. Meta-analyses generated weighted mean differences in body weight and composition values between the LCS and control groups among RCTs and weighted mean correlations for LCS intake and these parameters among prospective cohort studies. In RCTs, LCSs modestly but significantly reduced all outcomes examined, including body weight (-0.80 kg; 95% CI: -1.17, -0.43), body mass index [BMI (in kg/m²): -0.24; 95% CI: -0.41, -0.07], fat mass (-1.10 kg; 95% CI: -1.77, -0.44), and waist circumference (-0.83 cm; 95% CI: -1.29, -0.37). Among prospective cohort studies, LCS intake was not associated with body weight or fat mass, but was significantly associated with slightly higher BMI (0.03; 95% CI: 0.01, 0.06). The current meta-analysis provides a rigorous evaluation of the scientific evidence on LCSs and body weight and composition. Findings from observational studies showed no association between LCS intake and body weight or fat mass and a small positive association with BMI; however, data from RCTs, which provide the highest quality of evidence for examining the potentially causal effects of LCS intake, indicate that substituting LCS options for their regular-calorie versions results in a modest weight loss and may be a useful dietary tool to improve compliance with weight loss or weight maintenance plans. © 2014 American Society

  10. Shorter maintenance therapy in childhood Acute Lymphoblastic Leukemia. The experience of the prospective, randomized Brazilian GBTLI ALL-93 protocol.

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    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.

  11. Splenic irradiation before hematopoietic stem cell transplantation for chronic myeloid leukemia: long-term follow-up of a prospective randomized study.

    Science.gov (United States)

    Gratwohl, Alois; Iacobelli, Simona; Bootsman, Natalia; van Biezen, Anja; Baldomero, Helen; Arcese, William; Arnold, Renate; Bron, Dominique; Cordonnier, Catherine; Ernst, Peter; Ferrant, Augustin; Frassoni, Francesco; Gahrton, Gösta; Richard, Carlos; Kolb, Hans Jochem; Link, Hartmut; Niederwieser, Dietger; Ruutu, Tapani; Schattenberg, Anton; Schmitz, Norbert; Torres-Gomez, Antonio; Zwaan, Ferry; Apperley, Jane; Olavarria, Eduardo; Kröger, Nicolaus

    2016-05-01

    In the context of discussions on the reproducibility of clinical studies, we reanalyzed a prospective randomized study on the role of splenic irradiation as adjunct to the conditioning for hematopoietic stem cell transplantation (HSCT) for chronic myeloid leukemia (CML). Between 1986 and 1989, a total of 229 patients with CML were randomized; of these, 225 (98 %; 112 with, 113 without splenic irradiation) could be identified in the database and their survival updated. Results confirmed the early findings with no significant differences in all measured endpoints (overall survival at 25 years: 42.7 %, 32.0-52.4 % vs 52.9 %, 43.2-62.6 %; p = 0.355, log rank test). Additional splenic irradiation failed to reduce relapse incidence. It did not increase non-relapse mortality nor the risk of late secondary malignancies. Comforting are the long-term results from this predefined consecutive cohort of patients: more than 60 % were alive at plus 25 years when they were transplanted with a low European Society for Blood and Marrow Transplantation (EBMT) risk sore. This needs to be considered today when treatment options are discussed for patients who failed initial tyrosine kinase inhibitor therapy and have an available low risk HLA-identical donor.

  12. A prospective, randomized-controlled clinical trial to evaluate bone preservation using implants with different geometry placed into extraction sockets in the maxilla.

    Science.gov (United States)

    Sanz, Mariano; Cecchinato, Denis; Ferrus, Jorge; Pjetursson, E Bjarni; Lang, Niklaus P; Lindhe, Jan

    2010-01-01

    The primary objective of this study was to determine the association between the size of the void established by using two different implant configurations and the amount of buccal/palatal bone loss that occurred during 16 weeks of healing following their installation into extraction sockets. The clinical trial was designed as a prospective, randomized-controlled parallel-group multicenter study. Adults in need of one or more implants replacing teeth to be removed in the maxilla within the region 15-25 were recruited. Following tooth extraction, the site was randomly allocated to receive either a cylindrical (group A) or a tapered implant (group B). After implant installation, a series of measurements were made to determine the dimension of the ridge and the void between the implant and the extraction socket. These measurements were repeated at the re-entry procedure after 16 weeks. The study demonstrated that the removal of single teeth and the immediate placement of an implant resulted in marked alterations of the dimension of the buccal ridge (43% and 30%) and the horizontal (80-63%) as well as the vertical (69-65%) gap between the implant and the bone walls. Although the dimensional changes were not significantly different between the two-implant configurations, both the horizontal and the vertical gap changes were greater in group A than in group B. Implant placement into extraction sockets will result in significant bone reduction of the alveolar ridge.

  13. Patient-Specific CT-Based Instrumentation versus Conventional Instrumentation in Total Knee Arthroplasty: A Prospective Randomized Controlled Study on Clinical Outcomes and In-Hospital Data

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    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.

  14. Clinical Benefits of an Adherence Monitoring Program in the Management of Secondary Hyperparathyroidism with Cinacalcet: Results of a Prospective Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Valentina Forni Ogna

    2013-01-01

    Full Text Available Background/Aims. One of the causes of uncontrolled secondary hyperparathyroidism (sHPT is patient’s poor drug adherence. We evaluated the clinical benefits of an integrated care approach on the control of sHPT by cinacalcet. Methods. Prospective, randomized, controlled, multicenter, open-label study. Fifty hemodialysis patients on a stable dose of cinacalcet were randomized to an integrated care approach (IC or usual care approach (UC. In the IC group, cinacalcet adherence was monitored using an electronic system. Results were discussed with the patients in motivational interviews, and drug prescription adapted accordingly. In the UC group, drug adherence was monitored, but results were not available. Results. At six months, 84% of patients in the IC group achieved recommended iPTH targets versus 55% in the UC group (. The mean cinacalcet taking adherence improved by 10.8% in the IC group and declined by 5.3% in the UC group (. Concomitantly, the mean dose of cinacalcet was reduced by 7.2 mg/day in the IC group and increased by 6.4 mg/day in the UC group (. Conclusions. The use of a drug adherence monitoring program in the management of sHPT in hemodialysis patients receiving cinacalcet improves drug adherence and iPTH control and allows a reduction in the dose of cinacalcet.

  15. Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate.

    Science.gov (United States)

    Meyers, Paul A; Schwartz, Cindy L; Krailo, Mark; Kleinerman, Eugenie S; Betcher, Donna; Bernstein, Mark L; Conrad, Ernest; Ferguson, William; Gebhardt, Mark; Goorin, Allen M; Harris, Michael B; Healey, John; Huvos, Andrew; Link, Michael; Montebello, Joseph; Nadel, Helen; Nieder, Michael; Sato, Judith; Siegal, Gene; Weiner, Michael; Wells, Robert; Wold, Lester; Womer, Richard; Grier, Holcombe

    2005-03-20

    To determine whether the addition of ifosfamide and/or muramyl tripeptide (MTP) encapsulated in liposomes to cisplatin, doxorubicin, and high-dose methotrexate (HDMTX) could improve the probability for event-free survival (EFS) in newly diagnosed patients with osteosarcoma (OS). Six hundred seventy-seven patients with OS without clinically detectable metastatic disease were treated with one of four prospectively randomized treatments. All patients received identical cumulative doses of cisplatin, doxorubicin, and HDMTX and underwent definitive surgical resection of the primary tumor. Patients were randomly assigned to receive or not to receive ifosfamide and/or MTP in a 2 double dagger 2 factorial design. The primary end point for analysis was EFS. Patients treated with the standard arm of therapy had a 3-year EFS of 71%. We could not analyze the results by factorial design because we observed an interaction between the addition of ifosfamide and the addition of MTP. The addition of MTP to standard chemotherapy achieved a 3-year EFS rate of 68%. The addition of ifosfamide to standard chemotherapy achieved a 3-year EFS rate of 61%. The addition of both ifosfamide and MTP resulted in a 3-year EFS rate of 78%. The addition of ifosfamide in this dose schedule to standard chemotherapy did not enhance EFS. The addition of MTP to chemotherapy might improve EFS, but additional clinical and laboratory investigation will be necessary to explain the interaction between ifosfamide and MTP.

  16. An evaluation of the efficacy of aspirin and benzydamine hydrochloride gargle for attenuating postoperative sore throat: a prospective, randomized, single-blind study.

    Science.gov (United States)

    Agarwal, Anil; Nath, S S; Goswami, Debolina; Gupta, Devendra; Dhiraaj, Sanjay; Singh, Prabhat K

    2006-10-01

    Postoperative sore throat (POST), although a minor complication, remains a source of postoperative morbidity. We compared the efficacy of dispersible aspirin gargle to benzydamine hydrochloride (a topical nonsteroidal anti inflammatory drug) gargles for prevention of POST. We enrolled 60 consecutive female patients, 16-60 yr of age, ASA physical status I or II, undergoing elective modified radical mastectomy under general anesthesia in this prospective, randomized, placebo-controlled, single-blind study. Patients were randomly divided into 3 groups of 20 subjects each: Group 1 (C) mineral water; Group 2 (AS) tab aspirin 350 mg; and Group 3 (BH) 15 mL of benzydamine hydrochloride (0.15%). All the medications were made into 30 mL of solution. Patients were asked to gargle this mixture for 30 s, 5 min before induction of anesthesia. Grading of POST was done at 0, 2, 4, and 24 h postoperatively on a 4-point scale (0-3). Aspirin gargles reduced the incidence of POST for 4 h whereas benzydamine hydrochloride gargles reduced POST for 24 h. POST was more severe in the control group at 0 and 2 h (P benzydamine hydrochloride gargles significantly reduced the incidence and severity of POST (P < 0.05).

  17. Effects of Qianlie'an(前列安) Suppository in Patients with Chronic Prostatitis Syndrome: A Randomized Open-Labelled Prospective and Controlled Trial

    Institute of Scientific and Technical Information of China (English)

    邢俊平; 陈兴发; 杨志尚; 王明珠; 贺大林

    2003-01-01

    Objective: To evaluate the clinical efficacy of Qianlie'an(前列安,QLA) suppository via anal route administration in treating chronic prostatitis syndrome. Methods: A randomized open-labelled prospective controlled trial was carried out. The total of 120 patients with chronic prostatitis syndrome were randomly divided into 2 groups: 60 patients in the treated group who were treated with QLA suppository combined with ofloxacin, and the other 60 patients in the control group who were given ofloxacin alone. The efficacy was evaluated by WBC count in the expressed prostatic secretion (EPS) and the Chronic Prostatitis Symptom Index (CPSI) made by the National Institute of Health (NIH). The clinical effects were also observed in a 4-week follow-up. Results: All but six cases completed the trial and the follow-up.It showed that in the treated group recovery rate was 17. 2%, markedly effective rate 34. 5%, effective rate 32.8%, total markedly effective rate 51.7%, and total effective rate 84. 5%, all of which were superior to those in the control group (total markedly effective rate 32.1% and total effective rate 66.1%, respectively), P<0.01. Conclusion: Administration of QLA suppository via anal route combined with oral antibiotics is an effective therapy for chronic prostatitis syndrome. It can relieve the symptoms of chronic prostatitis syndrome markedly and rapidly. It is a new choice for treatment of the disease.

  18. 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.

  19. 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 (Pscore was significantly improved in both groups (Pscore was significantly decreased in the AT group (Pfilm stability and ocular surface, and DQS has a capability to improve them. PMID:28360509

  20. 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.

  1. A Prospective Randomized Controlled Study of Laser-Assisted Hatching on the Outcome of First Fresh IVF-ET Cycle in Advanced Age Women.

    Science.gov (United States)

    Shi, Wenhao; Hongwei, Tan; Zhang, Wei; Li, Na; Li, Mingzhao; Li, Wei; Shi, Juanzi

    2016-10-01

    There is no sufficient data to conclude the benefit of assisted hatching (AH) for advanced age patients. However, AH is routinely performed for advanced age patients undergoing in vitro fertilization (IVF) in China based on some retrospective evidence. It is important to assess the benefit of AH procedure for advanced age patients, especially by analyzing the data from China. This is a prospective randomized controlled trial to evaluate the effect of laser AH in the advanced age patients undergoing IVF. A total of 256 patients conformed to the inclusion criteria, and 78 were excluded by exclusion criteria. A total of 178 patients were eligible and randomized to 2 groups (82 AH group and 96 control group). Laser AH (zona thinning) was performed in the AH group. There were no statistical significance in basic clinical parameters between the 2 groups. No difference was found in implantation rate (AH vs control, 32.45% vs 39.29%) and clinical pregnancy rate (AH vs control, 48.78% vs 59.38%). Our data did not find any benefit of laser AH in improving implantation or pregnancy rates in advanced age women. Due to the potential risk and increasing financial burden, AH should not be routinely performed in first fresh IVF embryo transfer cycle for advanced age women.

  2. 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.

  3. Comparing the effectiveness of "plasma knife" tonsillectomy with two well-established tonsillectomy techniques: cold dissection and bipolar electrocautery. A prospective randomized study.

    Science.gov (United States)

    Sadikoglu, Fatih; Kurtaran, Hanifi; Ark, Nebil; Ugur, K Serife; Yilmaz, Turker; Gozdemir, Muhammed; Mutlu, Cemil; Aktas, Davut

    2009-09-01

    To evaluate the effectiveness of a new device "plasma knife" for tonsillectomy by comparing to two well-established tonsillectomy techniques: cold dissection, and bipolar electrocautery. A prospective, randomized study conducted on 110 patients undergoing tonsillectomy. Subjects were randomized to plasma knife (PKT), cold dissection (CDT) and bipolar electrocautery (BET) groups. Operative time, intraoperative blood loss and postoperative complications were recorded. Pain/discomfort level of patients and healing time of the tonsillar fossae were assessed postoperatively. Data were recorded and statistically analyzed. Operative time with plasma knife and bipolar electrocautery were associated with a significant decrease in operative time compared to cold dissection (pplasma knife, compared to cold dissection and bipolar electrocautery (pplasma knife compared to bipolar electrocautery but more postoperative pain was observed with both compared to CDT (pplasma knife and bipolar electrocautery, compared to cold dissection (pPlasma knife is a useful and safe device in tonsillectomy. Its use reduces intraoperative blood loss and provides a fast tonsillectomy with acceptable morbidity.

  4. Comparison of Mineral Trioxide Aggregate and iRoot BP Plus Root Repair Material as Root-end Filling Materials in Endodontic Microsurgery: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Zhou, Wei; Zheng, Qinghua; Tan, Xuelian; Song, Dongzhe; Zhang, Lan; Huang, Dingming

    2017-01-01

    This prospective randomized controlled study evaluated the clinical and radiographic outcome of endodontic microsurgery when using iRoot BP Plus Root Repair Material (BP-RRM; Innovative BioCeramix Inc, Vancouver, BC, Canada) or mineral trioxide aggregate (MTA) as the retrograde filling material and analyzed the relationship between some potential prognostic factors and the outcome of the surgery. By using strict inclusion and exclusion criteria, 240 teeth were successfully enrolled and randomly and equally allocated to either the MTA or BP-RRM treatment group. A standardized surgical procedure was performed by a single operator. The patients were followed up at 1 week, 3 months, 6 months, and 12 months; follow-up included clinical and radiographic examination. Clinical and radiographic evaluations acquired at the 12-month follow-up were taken as the primary outcome. For the identification of prognostic factors, the dichotomous outcome (success vs failure) was taken as the dependent variable. A total of 158 teeth were analyzed at the 12-month follow-up, including 87 teeth in the MTA group and 71 teeth in the BP-RRM group. The success rate in the MTA and BP-RRM groups was 93.1% (81/87 teeth) and 94.4% (67/71 teeth), respectively (P > .05). Three significant outcome predictors were identified: quality of root filling (P materials in endodontic microsurgery. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  5. Clinical Benefits of an Adherence Monitoring Program in the Management of Secondary Hyperparathyroidism with Cinacalcet: Results of a Prospective Randomized Controlled Study

    Science.gov (United States)

    Forni Ogna, Valentina; Pruijm, Menno; Zweiacker, Carole; Wuerzner, Grégoire; Tousset, Eric; Burnier, Michel

    2013-01-01

    Background/Aims. One of the causes of uncontrolled secondary hyperparathyroidism (sHPT) is patient's poor drug adherence. We evaluated the clinical benefits of an integrated care approach on the control of sHPT by cinacalcet. Methods. Prospective, randomized, controlled, multicenter, open-label study. Fifty hemodialysis patients on a stable dose of cinacalcet were randomized to an integrated care approach (IC) or usual care approach (UC). In the IC group, cinacalcet adherence was monitored using an electronic system. Results were discussed with the patients in motivational interviews, and drug prescription adapted accordingly. In the UC group, drug adherence was monitored, but results were not available. Results. At six months, 84% of patients in the IC group achieved recommended iPTH targets versus 55% in the UC group (P = 0.04). The mean cinacalcet taking adherence improved by 10.8% in the IC group and declined by 5.3% in the UC group (P = 0.02). Concomitantly, the mean dose of cinacalcet was reduced by 7.2 mg/day in the IC group and increased by 6.4 mg/day in the UC group (P = 0.03). Conclusions. The use of a drug adherence monitoring program in the management of sHPT in hemodialysis patients receiving cinacalcet improves drug adherence and iPTH control and allows a reduction in the dose of cinacalcet. PMID:23971019

  6. Ceramic on Ceramic or Ceramic-on-polyethylene for Total Hip Arthroplasty: A Systemic Review and Meta-analysis of Prospective Randomized Studies

    Directory of Open Access Journals (Sweden)

    Yu-Lei Dong

    2015-01-01

    Full Text Available Background: Wear debris of polyethylene has become a restraining factor of the durability for total hip arthroplasty (THA. Ceramic on ceramic (COC has better wear resistance while the squeaking sound and prosthesis fracture are of concern. It is still a controversy that bearing couples are better for THA. Methods: We performed a systematic review of all English articles identified from PubMed (1966-, Embase (1980- and the Cochrane Library. Clinical outcomes, complications, revision rates, and radiographic outcomes of COC-THA and ceramic on polyethylene (COP-THA were compared and evaluated. Results: Eight prospective randomized trials enrolling a total of 1508 patients and 1702 THA surgeries were identified. Our results demonstrated the prosthesis fracture and the squeaking sound is significantly higher in COC group and higher wear rate of the COP. Hip function, loosening rate, dislocation rate, revision rate, and the osteolysis rate were comparable between two groups. According to Grading of Recommendations Assessment, Development and Evaluation system assessment, the strength of evidence was high for prosthesis fracture, dislocation, osteolysis, and moderate for radiolucent line or loosening, hip noise, and revision. Conclusions: Up to now, there is insufficient evidence to identify any clinical advantage of COC compared with COP. Longer follow-up of larger randomized trial is needed to clarify the outcomes.

  7. Ceramic on Ceramic or Ceramic-on-polyethylene for Total Hip Arthroplasty: A Systemic Review and Meta-analysis of Prospective Randomized Studies

    Institute of Scientific and Technical Information of China (English)

    Yu-Lei Dong; Tao Li; Ke Xiao; Yan-Yan Bian; Xi-Sheng Weng

    2015-01-01

    Background:Wear debris of polyethylene has become a restraining factor of the durability for total hip arthroplasty (THA).Ceramic on ceramic (COC) has better wear resistance while the squeaking sound and prosthesis fracture are of concern.It is still a controversy that bearing couples are better for THA.Methods:We performed a systematic review of all English articles identified from PubMed (1966-),Embase (1980-) and the Cochrane Library.Clinical outcomes,complications,revision rates,and radiographic outcomes of COC-THA and ceramic on polyethylene (COP)-THA were compared and evaluated.Results:Eight prospective randomized trials enrolling a total of 1508 patients and 1702 THA surgeries were identified.Our results demonstrated the prosthesis fracture and the squeaking sound is significantly higher in COC group and higher wear rate of the COP.Hip function,loosening rate,dislocation rate,revision rate,and the osteolysis rate were comparable between two groups.According to Grading of Recommendations Assessment,Development and Evaluation system assessment,the strength of evidence was high for prosthesis fracture,dislocation,osteolysis,and moderate for radiolucent line or loosening,hip noise,and revision.Conclusions:Up to now,there is insufficient evidence to identify any clinical advantage of COC compared with COP.Longer follow-up of larger randomized trial is needed to clarify the outcomes.

  8. A prospective, randomized, double-blind comparison of 2% lidocaine with 1:100,000 and 1:50,000 epinephrine and 3% mepivacaine for maxillary infiltrations.

    Science.gov (United States)

    Mason, Rick; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike

    2009-09-01

    The purpose of this prospective, randomized, double-blind crossover study was to evaluate the anesthetic efficacy of 2% lidocaine with 1:100,000 and 1:50,000 epinephrine and 3% mepivacaine in maxillary lateral incisors and first molars. Sixty subjects randomly received, in a double-blind manner, maxillary lateral incisor and first molar infiltrations of 1.8 mL of 2% lidocaine with 1:100,000 epinephrine, 2% lidocaine with 1:50,000 epinephrine, and 3% mepivacaine at three separate appointments spaced at least 1 week apart. The teeth were pulp tested in 3-minute cycles for a total of 60 minutes. Anesthetic success and the onset of pulpal anesthesia were not significantly different between 2% lidocaine with either 1:100,000 or 1:50,000 epinephrine and 3% mepivacaine for the lateral incisor and first molar. Increasing the epinephrine concentration from 1:100,000 to 1:50,000 in a 2% lidocaine formulation significantly decreased pulpal anesthesia of short duration for the lateral incisor but not the first molar. For both the lateral incisor and first molar, 3% mepivacaine significantly increased pulpal anesthesia of short duration compared with 2% lidocaine with either 1:100,000 or 1:50,000 epinephrine.

  9. A prospective randomized study comparing 25-G and 22-G needles of a new platform for endoscopic ultrasound-guided fine needle aspiration of solid masses.

    Science.gov (United States)

    Carrara, Silvia; Anderloni, Andrea; Jovani, Manol; Di Tommaso, Luca; Rahal, Daoud; Hassan, Cesare; Ridola, Lorenzo; Federico, Davide; Loriga, Alessandra; Repici, Alessandro

    2016-01-01

    A new needle platform for endoscopic ultrasound-guided fine-needle aspiration biopsy has been developed that allows interchangeability of all needle sizes. To prospectively compare the efficacy of the new 25-G needles and 22-G needles for obtaining an adequate aspirate of solid masses. Randomized controlled trial of 144 patients referred for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic masses, intraparietal tumours, or lymph-nodes, randomized to the 25-G or 22-G needle arms. An adequate specimen was obtained from 74.3% of cases. The sample tended to be more adequate in the 25-G compared to the 22-G group (81% vs. 68%; p=0.09). Crossover was required in 14 (19%) and 12 (17%) cases in the 22-G and in the 25-G groups, respectively (p=0.7). The overall rate of adequacy improved from 74% before crossover to 90% after crossover (pneedle was superior to the 22-G needle for endoscopic ultrasound-guided fine-needle aspiration biopsy. The adequacy and diagnostic accuracy improved after crossover, reaching 90%. Copyright © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  10. Hemodynamic Consequences of Malignant Ascites in Epithelial Ovarian Cancer Surgery*: A Prospective Substudy of a Randomized Controlled Trial.

    Science.gov (United States)

    Hunsicker, Oliver; Fotopoulou, Christina; Pietzner, Klaus; Koch, Mandy; Krannich, Alexander; Sehouli, Jalid; Spies, Claudia; Feldheiser, Aarne

    2015-12-01

    Malignant ascites (MA) is most commonly observed in patients scheduled for epithelial ovarian cancer (EOC) surgery and is supposed as a major risk factor promoting perioperative hemodynamic deterioration. We aimed to assess the hemodynamic consequences of MA on systemic circulation in patients undergoing cytoreductive EOC surgery.This study is a predefined post-hoc analysis of a randomized controlled pilot trial comparing intravenous solutions within a goal-directed algorithm to optimize hemodynamic therapy in patients undergoing cytoreductive EOC surgery. Ascites was used to stratify the EOC patients prior to randomization in the main study. We analyzed 2 groups according to the amount of ascites (NLAS: none or low ascites [500 mL]). Differences in hemodynamic variables with respect to time were analyzed using nonparametric analysis for longitudinal data and multivariate generalized estimating equation adjusting the analysis for the randomized study groups of the main study.A total of 31 patients in the NLAS and 16 patients in the HAS group were analyzed. Although cardiac output was not different between groups suggesting a similar circulatory blood flow, the HAS group revealed higher heart rates and lower stroke volumes during surgery. There were no differences in pressure-based hemodynamic variables. In the HAS group, fluid demands, reflected by the time to reindication of a fluid challenge after preload optimization, increased steadily, whereas stroke volume could not be maintained at baseline resulting in hemodynamic instability after 1.5 h of surgery. In contrast, in the NLAS group fluid demands were stable and stroke volume could be maintained during surgery. Clinically relevant associations of the type of fluid replacement with hemodynamic consequences were particularly observed in the HAS group, in which transfusion of fresh frozen plasma (FFP) was associated to an improved circulatory flow and reduced vasopressor and fluid demands, whereas the

  11. Psychotherapeutic process of cognitive-behavioral intervention in HIV-infected persons: results from a controlled, randomized prospective clinical trial.

    Science.gov (United States)

    Znoj, Hans-Jörg; Messerli-Burgy, Nadine; Tschopp, Simone; Weber, Rainer; Christen, Lisanne; Christen, Stephan; Grawe, Klaus

    2010-03-01

    The aim of this exploratory study was to examine the possible mechanisms of behavioral change in a cognitive-behavioral intervention supporting medication adherence in HIV-infected persons. A total of 60 persons currently under medical treatment were randomized to psychotherapy or usual care and were compared with a sociodemographically matched group of general psychotherapy clients. Outcome measures included therapy adherence using medication event-monitoring system psychotherapeutic processes and changes of experience and behavior. The general psychotherapy group was initially more distressed than HIV psychotherapy patients and reached higher levels of psychotherapeutic effect. In the HIV psychotherapy patients, a significant effect was found for maintaining adherence to medical treatment (Weber et al., 2004). These findings show that psychotherapy is a beneficial intervention for HIV-infected persons, and therapeutic alliance and activation of resources do not differ from a general psychotherapy treatment. Differential effects were detected for specific process variables, namely problem actuation.

  12. 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...

  13. Prospective randomized comparison of oxybutynin, functional electrostimulation, and pelvic floor training for treatment of detrusor overactivity in women.

    Science.gov (United States)

    Arruda, Raquel M; Castro, Rodrigo A; Sousa, Gabriela C; Sartori, Marair G F; Baracat, Edmund C; Girão, Manoel J B C

    2008-08-01

    The purpose of this study is to compare the effectiveness of oxybutynin, functional electrostimulation (FES), and pelvic floor training (PFT) for treatment of women with detrusor overactivity. Sixty-four subjects were randomized to oxybutynin (n=22), FES (n=21), or PFT (n=21). Women were evaluated before and after completion of 12 weeks of treatment by subjective response, voiding diary, and urodynamic test. There was subjective symptomatic improvement in 77% of the women treated with oxybutynin, 52% with FES, and 76% with PFT. Urgency resolved in 64% of women treated with oxybutynin, 52% with FES, and in 57% with PFT. Urodynamic evaluation was normal in 36% treated with oxybutynin, 57% with FES, and 52% with PFT. Maximum detrusor involuntary contraction pressure decreased in all groups (p<0.05). All treatments were equally effective. Subjective reduction of urge-incontinence episodes was associated with symptomatic improvement.

  14. A Prospective, Randomized Study of Component Position in Two-Incision MIS Total Hip Arthroplasty: A Preliminary Study.

    Science.gov (United States)

    Meneghini, R Michael; Smits, Shelly A

    2011-12-01

    Controversy exists regarding the ability to position the implants reliably in minimally invasive surgery (MIS) total hip arthroplasty (THA). This study compared the ability to accurately position components in the MIS two-incision versus single-incision approaches. Twenty-four patients were randomized to THA through one of three approaches, including the two-incision approach. Component position was measured with computed tomography. The mean deviation from the target acetabular anteversion was 14.8 degrees in the two-incision MIS group versus 6.4 degrees in the other two approaches (p = 0.006). A mean of 9.8 degrees deviation from the target femoral anteversion in the two-incision MIS approach group was observed compared with 5.3 degrees in the single-incision groups (p = 0.05). These results suggest there is a decreased ability to accurately position the components in the two-incision approach.

  15. A prospective, randomized, controlled trial of robot-assisted vs freehand pedicle screw fixation in spine surgery.

    Science.gov (United States)

    Kim, Ho-Joong; Jung, Whan-Ik; Chang, Bong-Soon; Lee, Choon-Ki; Kang, Kyoung-Tak; Yeom, Jin S

    2017-09-01

    The purpose of this study was to compare the accuracy and safety of an instrumented posterior lumbar interbody fusion (PLIF) using a robot-assisted minimally invasive (Robot-PLIF) or a conventional open approach (Freehand-PLIF). Patients undergoing an instrumented PLIF were randomly assigned to be treated using a Robot-PLIF (37 patients) and a Freehand-PLIF (41 patients). For intrapedicular accuracy, there was no significant difference between the groups (P = 0.534). For proximal facet joint accuracy, none of the 74 screws in the Robot-PLIF group violated the proximal facet joint, while 13 of 82 in the Freehand-PLIF group violated the proximal facet joint (P Robot-PLIF and Freehand-PLIF groups, respectively (P Robotic-assisted pedicle screw placement was associated with fewer proximal facet joint violations and better convergence orientations. Copyright © 2016 John Wiley & Sons, Ltd.

  16. 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, ptherapy as an adjuvant treatment accelerates diabetic ulcer healing by six times in a six week period.

  17. Treatment of anterior vaginal wall prolapse with and without polypropylene mesh: a prospective, randomized and controlled trial - Part II

    Directory of Open Access Journals (Sweden)

    Jose Tadeu Nunes Tamanini

    2013-07-01

    Full Text Available Objective To compare the effects of two surgical procedures for the correction of anterior vaginal wall prolapse (AVWP on the lower urinary tract symptoms (LUTS using symptom questionnaires and quality of life (QoL. Materials and Methods One hundred women with Pelvic Organ Prolapse Quantification stage (POP-Q ≥ 2 were randomly distributed in two preoperatory groups. The first group (mesh (n = 45 received a polypropylene mesh (PM implant and the control group (n = 55 was submitted to anterior colporraphy with or without synthetic sling. Postoperatory follow-up was done after 12 months. The primary objective was to compare the effect of the surgeries on LUTS using the final scores of the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF and Overactive Bladder Questionnaire (OAB-V8, as well as the analysis of the incapacitating urinary symptoms and “de novo” urinary symptoms after 12 months of surgery in both groups. Results Although there was a different number of women in each group, randomization was adequate, resulted in homogeneous groups that could be compared regarding socio demographic, clinical and gynecological (POP-Q variables. Patients of both groups showed improvements regarding LUTS and QoL, whether using polypropylene mesh or not, based on the final scores of the ICIQ-UI SF and OAB-V8 questionnaires after 12-month follow-up. There were few incapacitating and “de novo” urinary symptoms, without any significant statistical difference between both groups after 12 months of surgery. Conclusion There was a general improvement of LUTS and QoL in both groups after 12-month follow-up. However, there was no significant difference of LUTS, as well as the more incapacitating and “de novo” urinary symptoms between both groups after 12 months of surgery.

  18. Prospective Randomized Comparison of the Effectiveness of Radiation Therapy and Local Steroid Injection for the Treatment of Plantar Fasciitis

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    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.

  19. Postoperative pain after conventional laparoscopic versus single-port sleeve gastrectomy: a prospective, randomized, controlled pilot study.

    Science.gov (United States)

    Morales-Conde, Salvador; Del Agua, Isaías Alarcón; Moreno, Antonio Barranco; Macías, María Socas

    2017-04-01

    Laparoscopic approach is the gold standard for surgical treatment of morbid obesity. The single-port (SP) approach has been demonstrated to be a safe and effective technique for the treatment of morbid obesity in several case control studies. Compare conventional multiport laparoscopy (LAP) with an SP approach for the treatment of morbid obesity using sleeve gastrectomy in terms of postoperative pain using a visual analog scale (VAS) 0-100, surgical outcome, weight loss, and aesthetical satisfaction at 6 months after surgery. University Hospital, Spain. Randomized, controlled pilot study. The trial enrolled patients suitable for bariatric surgery, with a body mass index lower than 50 kg/m(2) and xiphoumbilical distance lower than 25 cm. Patients were randomly assigned to receive LAP or SP sleeve gastrectomy. A total of 30 patients were enrolled; 15 were assigned to LAP group and 15 to SP group. No patients were lost during follow-up. Baseline characteristics were similar in both groups. A significantly higher level of pain during movement was noted for the patients in the LAP group on the first (mean VAS 49.3±12.2 versus 34.1±8.9, P = .046) and second days (mean VAS 35.9±10.2 versus 22.1±7.9, P = .044) but not the third day (mean VAS 20.1±5.2 versus 34.12.9 ±4.3, P = .620). No differences regarding pain at rest, operative time, complications, or weight loss at 6 months were observed. Higher aesthetical satisfaction was noticed in SP group. In selected patients, SP surgery presented less postoperative pain in sleeve gastrectomy compared with the conventional laparoscopic approach with similar surgical results. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  20. Platelet-Rich Plasma Injections for Advanced Knee Osteoarthritis: A Prospective, Randomized, Double-Blinded Clinical Trial

    Science.gov (United States)

    Joshi Jubert, Nayana; Rodríguez, Luciano; Reverté-Vinaixa, Maria Mercedes; Navarro, Aurora

    2017-01-01

    Background: Intra-articular injections of platelet-rich plasma (PRP) to treat symptoms of knee osteoarthritis (OA) have been successfully used in young patients and in the early stages of disease. No previous studies have analyzed outcomes of PRP injections during the late stages. Hypothesis: PRP reduces pain and leads to a more effective and lasting functional recovery than corticosteroid with local anesthetic. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A total of 75 patients with symptomatic knee OA (Kellgren-Lawrence grade 3 to 4) were enrolled in this study between August 2013 and July 2014. Patients were randomized to treatment either with a single leukocyte-reduced PRP or corticosteroid intra-articular injection. The primary variable was visual analog scale assessment at 1 month. Secondary outcomes were the Knee injury and Osteoarthritis Outcome Score (KOOS) and Short Form–36 (SF-36) at 1, 3, and 6 months after treatment. Patient satisfaction at final follow-up was assessed. Both groups were homogeneous and comparable in baseline characteristics. Results: All variables improved in both groups. Statistical differences between groups were not found for the majority of the outcome variables, although the magnitude of improvements tended to be greater in the PRP group. Quality-of-life differences between values at 3 and 6 months versus baseline increased significantly more in the study group (P = .05 and .03, respectively), and so did general health perception differences at 6 months (P = .018). Conclusion: A single PRP intra-articular injection is effective for relieving pain and improving activities of daily living and quality of life in late-stage knee OA. For patients with late-stage knee OA who are 67 years or older, 1 intra-articular injection of PRP has similar results to 1 shot of corticosteroid. PMID:28255569

  1. Electroacupuncture-reduced sedative and analgesic requirements for diagnostic EUS: a prospective, randomized, double-blinded, sham-controlled study.

    Science.gov (United States)

    Bun Teoh, Anthony Yuen; Ning Chong, Charing Ching; Wa Leung, Wing; Cheong Chan, Simon Kin; Kit Tse, Yee; Wai Ng, Enders Kwok; San Lai, Paul Bo; Yuen Wu, Justin Che; Wong Lau, James Yun

    2017-07-24

    The role of electroacupuncture (EA) in reducing sedative and analgesic requirements during EUS is uncertain. The aim of the current study is to investigate the efficacy of EA in reducing procedure-related pain and discomfort during EUS. This was a double-blinded randomized controlled study conducted between March 2014 and July 2016. Consecutive patients who were scheduled for diagnostic EUS were recruited and randomized to receive electroacupuncture (EA) or sham-electroacupuncture (SA). The primary outcome was the dosage of propofol used. Other outcome measurements included pain scores, anxiety scores, satisfaction scores, patients' willingness to repeat the procedure, total procedure time, and adverse events. One hundred twenty-eight patients were recruited to the study. The patients that received EA had significantly fewer PCA requirements. The median (IQR range) number of demands for PCA (2 [1 - 5] vs 16.5 [8.5 - 33.8], P<0.001), the number of successful demands (2 [1 - 4] vs 9 [5.3 - 13], P<0.001), the total dose of propofol (0.15 [0.08 - 0.34] vs 0.77 [0.38 - 1.09], P<0.001) and alfentanil (0.38 [0.20 - 0.86] vs 1.92 [0.94 - 2.72], P<0.001) were all significantly less. Patients that received EA also had significantly less procedural pain scores and anxiety scores (P<0.001), higher satisfaction scores (P<0.001), and they are more willing to repeat the procedure (P<0.001). Both being in the SA group and the procedural time were significant predictors to increased PCA demands (P < 0.001 and P = 0.009 respectively). In conclusion, the use of EA reduced sedative and analgesic demands, improved patient experience, and was associated with low risk of adverse events during diagnostic EUS. Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  2. Oral betamethasone versus intramuscular dexamethasone for the treatment of mild to moderate viral croup: a prospective, randomized trial.

    Science.gov (United States)

    Amir, Lisa; Hubermann, Henry; Halevi, Ayelet; Mor, Meirav; Mimouni, Marc; Waisman, Yehezkel

    2006-08-01

    Intramuscular dexamethasone is an effective, but painful, treatment for croup. The effectiveness of betamethasone, an oral, palatable, and equally potent glucocorticoid has not been studied. The purpose of this study was to compare the effectiveness of a single oral dose of betamethasone with intramuscular dexamethasone in the outpatient treatment of mild to moderate croup. Children aged 6 months to 6 years presenting to a tertiary care pediatric emergency department (ED) with a modified Westley croup score of 0 to 11 were randomized to receive either 0.6 mg/kg IM dexamethasone or 0.4 mg/kg PO betamethasone. Croup score, heart rate, respiratory rate, pulse oximetry, and need for supplemental treatments were recorded at study entry and at 1, 2, and 4 hours after treatment. Follow-up data were collected by daily telephone follow-up on persistence of symptoms and the need for additional treatment or physician visits up to 7 days after the ED visit. Each study group contained 26 patients. Despite randomization, the mean baseline croup score was higher in the dexamethasone group (3.6 +/- 2.6 vs. 2.0 +/- 2.4, P = 0.03). Patients in both groups showed a significant reduction in the croup score after treatment, and there were no significant differences between croup scores at 4 hours (P = 0.18). Similarly, there were no differences between groups in the hospital admission rate, time to resolution of symptoms, need for additional treatments, or number of return ED visits. There is no difference between oral betamethasone and intramuscular dexamethasonein the management of mild to moderate viral croup. It is palatable and does not require a nurse for administration, making it a good alternative for ambulatory management.

  3. Prospective double-blind randomized controlled trial of terazosin, finasteride and allylestrenol in the management of benign prostatic hyperplasia

    Directory of Open Access Journals (Sweden)

    Madhu S Agrawal

    2001-01-01

    Full Text Available Medical management is rapidly becoming a very im-portant part of the armamentarium of the urologist in-volved in the treatment of benign prostatic hyperplasia. The commonest options for medical management include alpha-blockers, 5-alpha reductase inhibitors, and pro-gestational anti-androgens. We present a double-blind randomized controlled trial evaluating the safety and efficacy of terazosin, finasteride and allylestrenol, the prototype drugs in each of these respective categories. A total of 140 patients who satisfied the inclusion and exclusion criteria were inducted into the trial after an informed consent. They were randomized into 4 groups, which received placebo, terazosin, finasteride and allylestrenol respectively for 6 months. Since 29 patients did not complete 6 months of therapy, there were 111 evaluable patients at the end of the study. We found that these 3 drugs produce comparable improvement in symp-tom score (-40%, flow rates (-60% and PVR (-50% which is significantly better than that in the placebo group. Both allylestrenol and finasteride bring about a comparable reduction in prostate volume (-23%, which is statistically significant as compared to the placebo and terazosin groups. Terazosin in doses of I and 2 mg/ day was, found to be effiective and well-tolerated in the vast majority of our cases. No adverse effects were seen in the placebo and finasteride groups, while 9.6% in the terazosin group had postural hypotension and 10.7% in the allylestrenol group had some loss of libido, prob-lems which were reversible upon cessation of therapy.

  4. Effect of Coffee on the Length of Postoperative Ileus After Elective Laparoscopic Left-Sided Colectomy: A Randomized, Prospective Single-Center Study.

    Science.gov (United States)

    Dulskas, Audrius; Klimovskij, Michail; Vitkauskiene, Marija; Samalavicius, Narimantas E

    2015-11-01

    Postoperative ileus is common problem after colorectal surgery. A positive effect of coffee to bowel movement has been described. It is still unclear whether coffee decreases the risk of postoperative ileus. The purpose of this study was to determine whether consuming a 100-mL cup of coffee is effective in preventing or reducing postoperative ileus. This was a prospective, single-center, randomized controlled study. The study was conducted at a university teaching hospital. All of the patients who were scheduled for elective laparoscopic left-sided colectomy at our hospital after the detection of malignant disease in a preoperative biopsy between January 2013 and December 2014 entered the study. The patients were assigned randomly before surgery to receive coffee with caffeine (first group), coffee without caffeine (second group), or water (third group) after the procedure (100 mL 3 times daily). The primary end point was time to first bowel movement; secondary end points were time to first flatus and time to tolerance of solid food. A total of 105 patients were randomly assigned, 35 to each group. Fifteen patients were excluded. Patient demographic characteristics were similar in the groups. The time until the first bowel movement (measured in days) was significantly (p flatus (1.47 versus 1.57 and 1.77 for decaffeinated coffee versus coffee with caffeine and water; p > 0.05) did not show statistical significance. Postoperative hospital stay was similar in all 3 of the groups. This is a single-center study with a relatively small sample size. Coffee consumption after colectomy was safe and in the decaffeinated group associated with a reduced time to first bowel action. Caffeine is not a main ingredient affecting the length of postoperative ileus.

  5. Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) With epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer.

    Science.gov (United States)

    Ross, P; Nicolson, M; Cunningham, D; Valle, J; Seymour, M; Harper, P; Price, T; Anderson, H; Iveson, T; Hickish, T; Lofts, F; Norman, A

    2002-04-15

    We report the results of a prospectively randomized study that compared the combination of epirubicin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) (ECF) with the combination of mitomycin, cisplatin, and PVI 5-FU (MCF) in previously untreated patients with advanced esophagogastric cancer. Five hundred eighty patients with adenocarcinoma, squamous carcinoma, or undifferentiated carcinoma were randomized to receive either ECF (epirubicin 50 mg/m(2) every 3 weeks, cisplatin 60 mg/m(2) every 3 weeks and PVI 5-FU 200 mg/m(2)/d) or MCF (mitomycin 7 mg/m(2) every 6 weeks, cisplatin 60 mg/m(2) every 3 weeks, and PVI 5-FU 300 mg/m(2)/d) and analyzed for survival, response, toxicity, and quality of life (QOL). The overall response rate was 42.4% (95% confidence interval [CI], 37% to 48%) with ECF and 44.1% (95% CI, 38% to 50%) with MCF (P =.692). Toxicity was tolerable, and there were only two toxic deaths. ECF resulted in more grade 3/4 neutropenia and grade 2 alopecia, but MCF caused more thrombocytopenia and plantar-palmar erythema. Median survival was 9.4 months with ECF and 8.7 months with MCF (P =.315); at 1 year, 40.2% (95% CI, 34% to 46%) of ECF and 32.7% (95% CI, 27% to 38%) of MCF patients were alive. Median failure-free survival was 7 months with both regimens. Global QOL scores were better with ECF at 3 and 6 months. This study confirms response, survival, and QOL benefits of ECF observed in a previous randomized study. The equivalent efficacy of MCF was demonstrated, but QOL was superior with ECF. ECF remains one of the reference treatments for advanced esophagogastric cancer.

  6. Pulmonary vein triggers play an important role in the initiation of atrial flutter: Initial results from the prospective randomized Atrial Fibrillation Ablation in Atrial Flutter (Triple A) trial.

    Science.gov (United States)

    Schneider, Ralph; Lauschke, Joerg; Tischer, Tina; Schneider, Cindy; Voss, Wolfgang; Moehlenkamp, Felix; Glass, Aenne; Diedrich, Doreen; Bänsch, Dietmar

    2015-05-01

    The incidence of atrial fibrillation (AF) after ablation of a cavotricuspid isthmus (CTI)-dependent atrial flutter (AFL) is high. The purpose of this study was to test the hypothesis that AFL and AF may be initiated by pulmonary vein triggers. This prospective randomized trial tested the efficacy of a standalone pulmonary vein isolation (PVI) in patients with AFL but without AF. Patients with AFL but without documented AF were randomly assigned to 1 of 3 treatment groups: (1) antiarrhythmic drugs (AAD), (2) CTI ablation, or (3) circumferential PVI. The primary end-point was defined as any recurrent atrial tachyarrhythmia and the secondary end-point as recurrence of AFL. In case of tachyarrhythmia recurrence in the PVI group, a second PVI was performed to close gaps in the ablation lines. Of the 60 patients, 17 were randomized to AAD, 23 to CTI ablation, and 20 to PVI. During follow-up of 1.42 ± 0.83 years, 14 of 17 patients (82.4%) in the AAD group, 14 of 23 patients (60.9%) in the CTI group, and 2 of 20 patients (10%) in the PVI group reached the primary end-point (P PVI procedures per patient. AFL reoccurred in 9 patients (52.9.%) in the AAD group, in 2 patients (8.7%) in the CTI group, and after a single PVI in 3 patients (15%) in the PVI group (P = .003). After closure of gaps, 1 patient (5%) in the PVI group presented with recurrent AFL. Pulmonary vein triggers play an important role in AFL. PVI can prevent the recurrence of AFL, even without CTI ablation. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  7. Eviprostat has an identical effect compared to pollen extract (Cernilton) in patients with chronic prostatitis/chronic pelvic pain syndrome: a randomized, prospective study.

    Science.gov (United States)

    Iwamura, Hiromichi; Koie, Takuya; Soma, Osamu; Matsumoto, Teppei; Imai, Atsushi; Hatakeyama, Shingo; Yoneyama, Takahiro; Hashimoto, Yasuhiro; Ohyama, Chikara

    2015-12-07

    Previously reported results of a prospective, randomized placebo-controlled study showed that the pollen extract (Cernilton) significantly improved total symptoms, pain, and quality of life in patients with inflammatory prostatitis/chronic pelvic pain syndrome (CP/CPPS) without severe side effects. A phytotherapeutic agent, Eviprostat, is reportedly effective in a rat model of nonbacterial prostatitis. The aim of the present study was to compare the efficacy and safety of Eviprostat to that of the pollen extract in the management of CP/CPPS. The patients with category III CP/CPPS were randomized to receive either oral capsules of Eviprostat (two capsules, q 8 h) or the pollen extract (two capsules, q 8 h) for 8 weeks. The primary endpoint of the study was symptomatic improvement in the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). Participants were evaluated using the NIH-CPSI and the International Prostate Symptom Score (IPSS) at baseline and after 4 and 8 weeks. In the intention-to-treat analysis, 100 men were randomly allocated to Eviprostat (n = 50) or the pollen extract (n = 50). Response (defined as a decrease in the NIH-CPSI total score by at least 25 %) in the Eviprostat group and the pollen extract group was 88.2 and 78.1 %, respectively. There was no significant difference in the total, pain, urinary, and quality of life (QOL) scores of the NIH-CPSI between the two groups at 8 weeks. This was also the case with the total, voiding, and storage symptoms of the IPSS. There were no severe adverse events observed in any patients in this study. Both the pollen extract and Eviprostat significantly reduced the symptoms of category III CP/CPPS without any adverse events. Eviprostat may have an identical effect on category III CP/CPPS compared the pollen extract. The study was registered with the University Hospital Medical Information Network Clinical Trials Registry in Japan (UMIN000019618); registration date: 3 November 2015.

  8. Prospective Randomized Trial Comparing Transperitoneal Versus Extraperitoneal Laparoscopic Aortic Lymphadenectomy for Surgical Staging of Endometrial and Ovarian Cancer: The STELLA Trial.

    Science.gov (United States)

    Díaz-Feijoo, Berta; Correa-Paris, Alejandro; Pérez-Benavente, Assumpció; Franco-Camps, Silvia; Sánchez-Iglesias, José Luis; Cabrera, Silvia; de la Torre, Javier; Centeno, Cristina; Puig, Oriol Puig; Gil-Ibañez, Blanca; Colas, Eva; Magrina, Javier; Gil-Moreno, Antonio

    2016-09-01

    There is an ongoing debate on which approach, transperitoneal or extraperitoneal, is superior for the performance of laparoscopic aortic lymphadenectomy (LPA-LND) for the surgical staging of gynecologic cancer. A prospective randomized trial (STELLA trial) was designed to compare the perioperative outcomes and node retrieval of extraperitoneal versus transperitoneal aortic lymphadenectomy by laparoscopy or robot-assisted laparoscopy. Patients with endometrial or ovarian carcinoma requiring aortic lymphadenectomy for surgical staging were randomized to an extraperitoneal or transperitoneal approach by laparoscopy or robot-assisted laparoscopy between June 2012 and July 2014. A total of 60 patients were entered into the study, 48 with endometrial cancer (80 %) and 12 with ovarian cancer (20 %). Thirty-one patients (51.6 %) were randomly assigned to the extraperitoneal group and 29 to the transperitoneal group (48.3 %). The means LPA-LND operating time was 90 min in both group (p = 0.343). The mean (range) blood loss was 105 (10-400) mL for extraperitoneal versus 100 (5-1000) mL for transperitoneal group (p = 0.541). There were no differences in the number of collected lymph nodes between the two groups [median (range) for extraperitoneal 12 (4-41) vs. 13 (4-29) for transperitoneal (p = 0.719)]. The extraperitoneal and transperitoneal approaches for laparoscopic and robotic aortic lymphadenectomy provide similar perioperative outcomes and nodal yields. The STELLA trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT01810874.

  9. Clomiphene citrate or letrozole as first-line ovulation induction drug in infertile PCOS women: A prospective randomized trial

    Directory of Open Access Journals (Sweden)

    Sujata Kar

    2012-01-01

    Full Text Available Objective: To compare Letrozole (5 mg and clomiphene citrate (100 mg as first line ovulation induction drug in infertile PCOS women. Study Design: Prospective Randomised trial. Setting: A Tertiary level infertility centre. Patients: 103 infertile PCOS women Intervention(S: Treatment naοve infertile PCOS women were randomised to treatment with 5 mg letrozole (51 patients or 100 mg clomiphene citrate (52 patients daily starting day 2 to day 6 of menstrual cycle. Timed intercourse or Intra Uterine Insemination (IUI was advised 24 to 36 hours after Human Chorionic Gonadotropin (HCG injection. Main Outcome Measures: Ovulation rate, mono or multi follicular rate, days to ovulation, endometrial thickness, serum progesterone, serum estrogen, pregnancy rate, miscarriage rate. Results: The mean age, Body Mass Index (BMI, duration of infertility in both Clomiphene Citrate (CC and Letrozole groups were similar.Ovulation rate was 73.08% in letrozole group and 60.78% in CC, which was not statistically significant (P=0.398. There was no statistically significant difference between Endometrial thickness (CC 7.61 ±1.96, Let 7.65 ± 2.10, Sr E 2 on day of HCG (CC 178.3 ± 94.15, Let 162.09 ± 73.24, Days to ovulation (CC 14.2 ± 3.41; Let 13.13 ± 2.99 and Sr P 4 on D 21 (CC 10.58 ± 6.65; Let 11.86 ± 6.51. Monofolliculo genesis (CC 54.84, Let 79.49 %, P=0.027 and Pregnancy rate (CC 7.84%, Let 21.56% P=0.0125 were statistically significantly higher in letrozole group. Conclusion: Our study shows that letrozole has excellent pregnancy rates compared to clomiphene citrate. Letrozole should be considered at par with clomiphene citrate as first line drug for ovulation induction in infertile PCOS women.

  10. Comparative Evaluation of Efficacy of Physics Forceps versus Conventional Forceps in Orthodontic Extractions: A Prospective Randomized Split Mouth Study.

    Science.gov (United States)

    Patel, Harsh S; Managutti, Anil M; Menat, Shailesh; Agarwal, Arvind; Shah, Dishan; Patel, Jigar

    2016-07-01

    Tooth extraction is one of the most commonly performed procedures in dentistry. It is usually a traumatic procedure often resulting in immediate destruction and loss of alveolar bone and surrounding soft tissues. Various instruments have been described to perform atraumatic extractions which can prevent damage to the paradental structures. Recently developed physics forceps is one of the instruments which is claimed to perform atraumatic extractions. The aim of the present study was to compare the efficacy of physics forceps with conventional forceps in terms of operating time, prevention of marginal bone loss & soft tissue loss, postoperative pain and postoperative complications following bilateral premolar extractions for orthodontic purpose. In this prospective split-mouth study, outcomes of the 2 groups (n = 42 premolars) requiring extraction of premolars for orthodontic treatment purpose using Physics forceps and Conventional forceps were compared. Clinical outcomes in form of time taken, loss of buccal soft tissue and buccal cortical plate based on extraction defect classification system, postoperative pain and other complication associated with extraction were recorded and compared. Statistically significant reduction in the operating time was noted in physics forceps group. Marginal bone loss and soft tissue loss was also significantly lesser in physics forceps group when compared to conventional forceps group. However, there was no statistically significant difference in severity of postoperative pain between both groups. The results of the present study suggest that physics forceps was more efficient in reducing operating time and prevention of marginal bone loss & soft tissue loss when compared to conventional forceps in orthodontically indicated premolar extractions.

  11. Two icodextrin exchanges per day in peritoneal dialysis patients with ultrafiltration failure: one center's experience and review of the literature.

    Science.gov (United States)

    Dousdampanis, Periklis; Trigka, Konstantza; Chu, Maggie; Khan, Saimah; Venturoli, Daniele; Oreopoulos, Dimitrios G; Bargman, Joanne M

    2011-03-01

    At present, only one exchange of an icodextrin-based solution is recommended to increase peritoneal ultrafiltration (UF) during long-dwell exchanges in peritoneal dialysis (PD) patients with impaired UF. To review our experience with two icodextrin exchanges per day on net UF and body weight in PD patients with poor UF. Data were analyzed on nine patients with poor UF on chronic PD who were given two icodextrin exchanges per day for 6 months and had various clinical and biochemical parameters assessed monthly. Administration of icodextrin twice daily reduced the body weight in six of nine patients by an average of 2.9 ± 1.2 kg, a reduction that was maintained throughout the study; two patients gained 0.5 kg; and, in one patient, the measurements were inadequate. Mean blood pressure was reduced. Mean serum creatinine increased slightly. Serum sodium levels decreased from a mean baseline level of 134 ± 3 to 132 ± 4 mmol/L at three and six months. Among the diabetics in this group, average daily insulin requirements were 44 ± 35 units/day at baseline and 40 ± 23 units/day after 6 months. Hb1Ac levels remained stable throughout the study period. The use of two icodextrin exchanges per day reduced body weight in six of the nine patients and appeared to be safe. Long-term prospective studies are needed to assess the contribution of twice-daily icodextrin to the management of peritoneal dialysis patients with ultrafiltration failure and its long-term safety.

  12. Prospective randomized clinical trial comparing phytotherapy with potassium citrate in management of minimal burden (≤8 mm nephrolithiasis

    Directory of Open Access Journals (Sweden)

    Iqbal Singh

    2011-01-01

    Full Text Available Aim : To compare efficacy and tolerability of phytotherapy (PT vs. potassium citrate (KC in patients with minimal nephrolithiasis. To compare and assess changes in value of certain serum (Ca 2 +, PO4 3- , uric acid [UA] and urinary (24-hr Ca 2+ , PO4 3- , UA, citrate, oxalate, and urine pH parameters in patients being treated with PT or KC. Materials and Methods : After clearance by the local institutional ethics committee, 60 patients of nephrolithiasis who had consented for the study, were enrolled (as per entry criteria and randomized into citrate therapy (group-I or PT (group-II. PT was administered as a nutritional supplement, using a lupeol-based extract (Tablet Calcury™, two tablets twice a day. They were monitored for the changes in the serum and urinary biochemical, radiological, and clinical parameters (efficacy and tolerability as per protocol. Results : Group-I patients demonstrated favorable changes in certain biochemical parameters (decreased serum calcium, urinary UA/oxalate, increased urinary citrate and pH along with significant symptomatic improvement (decrease in visual analogue pain score with increased stone clearance/reduction in stone size. Four (13.3% patients of group-I had mild upper gastrointestinal discomfort which was controlled with antacids. Group-II patients had favorable changes in biochemical parameters (decreased serum UA and increased urinary citrate along with significant symptomatic improvement (reduction/clearance in the stone size, but without any noticeable side effects. Conclusions : Medical therapies with both KC and PT (with lupeol extract using Calcury™ were effective in reducing the stone size and symptoms of nephrolithiasis. It appeared that KC was biochemically efficacious in producing some favorable biochemical changes with some side effects, whereas PT was probably clinically efficacious in hastening stone expulsion (<8 mm without any observed adverse events. Although both the medical

  13. Virtual reality robotic surgery warm-up improves task performance in a dry laboratory environment: a prospective randomized controlled study.

    Science.gov (United States)

    Lendvay, Thomas S; Brand, Timothy C; White, Lee; Kowalewski, Timothy; Jonnadula, Saikiran; Mercer, Laina D; Khorsand, Derek; Andros, Justin; Hannaford, Blake; Satava, Richard M

    2013-06-01

    Preoperative 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 that a brief virtual reality (VR) robotic warm-up would enhance robotic task performance and reduce errors. In a 2-center randomized trial, 51 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 (Intuitive Surgical Inc). Once they successfully achieved performance benchmarks, surgeons were randomized to either receive a 3- to 5-minute VR simulator warm-up or read a leisure book for 10 minutes before 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. Task time (-29.29 seconds, p = 0.001; 95% CI, -47.03 to -11.56), path length (-79.87 mm; p = 0.014; 95% CI, -144.48 to -15.25), and cognitive errors were reduced in the warm-up group compared with 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 earlier robotic and laparoscopic clinical experience, the more experienced surgeons (n = 17) demonstrated significant improvements from warm-up in task time (-53.5 seconds; p = 0.001; 95% CI, -83.9 to -23.0) and economy of motion (0.63 mm/s; p = 0.007; 95% CI, 0.18-1.09), and improvement in these metrics was not statistically significantly appreciated in the less-experienced cohort (n = 34). We observed significant performance improvement and error reduction rates among surgeons of varying experience after VR warm-up for basic robotic surgery tasks. In addition, the VR warm-up reduced errors on

  14. Anticoagulation therapy in Chinese patients with non-valvular atrial fibrillation: a prospective, multi-center, randomized,controlled study

    Institute of Scientific and Technical Information of China (English)

    CHEN Ke-ping; HUANG Cong-xin; HUANG De-jia; CAO Ke-jiang; MA Chang-sheng; WANG Fang-zheng; ZHANG Shu

    2012-01-01

    Background Non-valvular atrial fibrillation is associated with an increased risk of ischemic stroke; however,the appropriate intensity of anticoagulation therapy for Chinese patients has not been determined.The purpose of this study was to compare the safety and the efficacy of standard-intensity warfarin therapy,low-intensity warfarin therapy,and aspirin therapy for the prevention of ischemic events in Chinese patients with non-valvular atrial fibrillation (NVAF).Methods A total of 786 patients from 75 Chinese hospitals were enrolled in this study and randomized into three therapy groups:standard-intensity warfarin (international normalized ratio (INR) 2.1 to 2.5) group,low-intensity warfarin (INR 1.6 to 2.0) group and aspirin (200 mg per day) group.All patients were evaluated by physicians at 1,3,6,9,12,15,18,21 and 24 months after randomization to obtain a patient questionnaire,physical examination and related laboratory tests.Results The annual event rates of ischemic stroke,transient ischemic attack (TIA) or systemic thromboembolism were 2.6%,3.1% and 6.9% in the standard-intensity warfarin,low-intensity warfarin and aspirin groups,respectively (P=0.027).Thromboembolic event rates in both warfarin groups were significantly lower than that in the aspirin group (P=0.018,P=0.044),and there was no significant difference between the two warfarin groups.Severe hemorrhagic events occurred in 15 patients,7 (2.6%) in the standard-intensity warfarin group,7 (2.4%) in the low-intensity warfarin group and 1 (0.4%)in the aspirin group.The severe hemorrhagic event rates in the warfarin groups were higher than that in the aspirin group,but the difference did not reach statistical significance (P=0.101).The mild hemorrhagic and total hemorrhagic event rates in the warfarin groups (whether in the standard-intensity warfarin group or low-intensity warfarin group) were much higher than that in the aspirin group with the annual event rates of total hemorrhages of 10

  15. Posterior lumbar interbody fusion using nonresorbable poly-ether-ether-ketone versus resorbable poly-L-lactide-co-D,L-lactide fusion devices: a prospective, randomized study to assess fusion and clinical outcome

    NARCIS (Netherlands)

    Jiya, T.U.; Smit, T.H.; Deddens, J.; Mullender, M.G.

    2009-01-01

    STUDY DESIGN: A prospective randomized clinical study. OBJECTIVE.: To assess fusion, clinical outcome, and complications. SUMMARY OF BACKGROUND DATA: Resorbable poly-L- lactide-co-D,L-lactide (PLDLLA) cages intended to aid spinal interbody fusion have been introduced into clinical practice within th

  16. Efficacy and safety of Changfu peritoneal dialysis solution:a multi-center prospective randomized controlled trial

    Institute of Scientific and Technical Information of China (English)

    ZHOU Jian-hui; NI Zhao-hui; MEI Chang-lin; YU Xue-qing; LIU Fu-you; MIAO Li-ning; LIU Zhi-hong

    2013-01-01

    Background A multi-center large scale study is needed to confirm the efficacy and safety of domestic peritoneal dialysis (PD) solutions.Some researchers believe that 6 L/d is enough for adequate dialysis,but there is no multi-center prospective study on Chinese population to confirm this.In this study,we evaluated the efficacy and safety of domestic PD solution (Changfu) and its difference between 6 L and 8 L dosage.Methods Adult PD patients who had taken PD therapy for at least one month were selected and divided into four groups according to two dialysis solution brands and two dialysis dosages,i.e.,6 L dose with Changfu dialysis solution,6 L dose with Baxter dialysis solution,8 L dose with Changfu dialysis solution,and 8 L dose with Baxter dialysis solution.After 48 weeks,the changes of primary and secondary efficacy indices were compared between different types and different dosages.We also analyzed the changes of safety indices.Results Changes of KW from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of creatinine clearance rate (Ccr).Normalized protein catabolic rate (nPCR) from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of net ultrafiltration volume (nUF) and estimated glomerular filtration rate (eGFR).Changes of nPCR from baseline to 48 weeks between 6 L and 8 L showed no statistical differences; so did those of nUF and eGFR.The decline of KW from baseline to 48 weeks in 6 L group was more than that in 8 L group.Change of Ccr was similar.During the 48-week period,the mean Kt/V was above 1.7/w,and mean Ccr was above 50 L·1.73 m-2·w-1.More adverse events were found in Changfu group before Changfu Corporation commenced technology optimization,and the statistical differences disappeared after that.Conclusions The domestic PD solution (Changfu) was proven to be as effective as Baxter dialysis solution.During 48-week period,a dosage of 6 L/d was enough for

  17. INTRAMUSCULAR VERSUS INTRADERMAL HEPATITIS B REVACCINATION IN HEALTHY NON-RESPONDER CHILDREN:A 5-YEAR PROSPECTIVE RANDOMIZED STUDY

    Institute of Scientific and Technical Information of China (English)

    Zhuang Guihua; Yan Hong; Wang Xueliang; Wu Qian; Wang Lirong; Gao Haiyan

    2005-01-01

    Objective With the same times of injection to compare low-dose intradermal regimen with routine-dose intramuscular inoculation in revaccination of non-responders to hepatitis B vaccine. Methods 40 healthy non-responder children collected by screening were administrated a three-dose revaccination randomly by intramuscular or intradermal route (10 vs 2 g per dose), and regularly tested for serologic markers up to five years. By the end of follow-up, a booster dose (5 μg) was given to those who had lost anti-HBs of ≥10 mIU/mL (seroprotection) and anamnestic response was estimated thereafter. Results All 17 intramuscular and 22 of 23 intradermal children effected seroprotection after revaccination. Intradermal children lost seroprotection over time significantly rapider compared with intramuscular children (Log Rank test, P= 0.029). In year 5, 50% of intramuscular but only 18.2% of intradermal children still maintained seroprotection (P=0.075). 12-14 days after the booster dose, all the eight intramuscular children developed an anamnestic response with anti-HBs titer increasing greater, but two of the 18 intradermal children failed to mount seroprotective level. Conclusion Three-routine-dose intramuscular revaccination was significantly effective than low-dose intradermal one with the same times of injection, especially in long-term immunity. We recommend routine-dose intramuscular protocol in revaccination of non-responders.

  18. Are postoperative intravenous antibiotics necessary after bimaxillary orthognathic surgery? A prospective, randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Tan, S K; Lo, J; Zwahlen, R A

    2011-12-01

    Postoperative antibiotic prophylaxis is often administered intravenously, despite an increased morbidity rate compared with oral application. This study investigates whether a postoperative oral antibiotic regimen is as effective as incorporation of intravenous antibiotics after bimaxillary orthognathic surgery. 42 patients who underwent bimaxillary orthognathic surgery between December 2008 and May 2010 were randomly allocated to 2 placebo-controlled postoperative antibiotic prophylaxis groups. Group 1 received oral amoxicillin 500mg three times daily; group 2 received intravenous ampicillin 1g four times daily, during the first two postoperative days. Both groups subsequently took oral amoxicillin for three more days. Clinically, the infection rate was assessed in both study groups for a period of 6 weeks after the surgery. 9 patients (21.4%) developed infection. No adverse drug event was detected. No significant difference (p=0.45) was detected in the infection rate between group 1 (3/21) and group 2 (6/21). Age, type of surgical procedures, duration of the operative procedure, surgical procedure-related events, blood loss, and blood transfusion were all found not related to infection (p>0.05). Administration of more cost-effective oral antibiotic prophylaxis, which causes less comorbidity, can be considered to be safe in bimaxillary orthognathic surgery with segmentalizations. Copyright © 2011 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  19. Doxazosin oral intake therapy to relieve stent - related urinary symptoms and pain: a prospective, randomized, controlled study

    Directory of Open Access Journals (Sweden)

    Long Zhang

    Full Text Available ABSTRACT Objective: To assess the impact of Doxazosin Oral Intake Therapy on urinary symptoms and pain in patients with indwelling ureteral stents Patients and Methods: A total of 239 patients with ureteral stone-related hydronephrosis who underwent a double-J stent insertion after ureteroscopic lithotripsy were enrolled. Patients were randomized to receive doxazosin cotrolled release 4 mg once daily for 4 weeks or matching placebo. Patients completed the brief-form Chinese version Ureteric Stent Symptom Questionnaire (USSQ and quality of life (QoL score 2 weeks and 4 weeks after stent placement and 4 weeks after stent withdrawal. The analgesic use was also recorded during the stenting period. Results: Patients in Doxazosin Oral Intake Therapy group, in the first 2 weeks and second 2 weeks with the stent in situ, expressed significant lower daytime frequency (p=0.028 and p=0.038, nocturia (p=0.021 and p=0.008 and urgency (p=0.012 and p=0.014, respectively. Similarly, flank pain score, QoL score and analgesic use were also significant less in the stenting period. There was no significant difference in scores of urinary symptoms, pain and QoL during the post-stent period between two cohorts. Conclusions: Doxazosin Oral Intake Therapy reduced stent-related urinary symptoms, pain and the negative impact on QoL.

  20. Tenoxicam 20 mg or 40 mg after thoracotomy: a prospective, randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Merry, A F; Sidebotham, D A; Middleton, N G; Calder, M V; Webster, C S

    2002-04-01

    Forty-five adults undergoing thoracotomy were randomized to receive placebo, tenoxicam 20 mg or tenoxicam 40 mg IV during chest wall closure. All patients received intraoperative fentanyl and intercostal blocks followed by morphine by patient-controlled analgesia. Patient numbers 13 to 45 also received thoracic epidural analgesia by continuous infusion of bupivacaine 0.125%, patient numbers 25 to 45 having fentanyl 2 microg/ml added to the epidural infusion. Efficacy parameters and adverse reactions were assessed over the first 24 hours postoperatively. On a 100 mm visual analogue scale, mean (SD) pain at rest (adjusted area under curve for hours 1 to 24) was 25.8 (12.5), 17.4 (14.8) and 16.5 (13.3) mm for groups receiving placebo, 20 mg and 40 mg tenoxicam, respectively (ANOVA: P<0.05). There were no significant differences between study groups postoperatively in pain on coughing, opioid consumption, blood gas measurements, nausea, vomiting, sedation, blood loss, haemoglobin or serum creatinine. One patient in each tenoxicam group reported epigastric pain, rated moderate. These data support the inclusion of tenoxicam 20 mg IV in the management of pain at rest for patients undergoing thoracotomy, but do not show additional benefit for a higher dose.

  1. [Postoperative analgesic effect after intra-articular morphine or ropivacaine following knee arthroscopy - a prospective randomized, doubleblinded study].

    Science.gov (United States)

    Müller, M; Burkhardt, J; Borchardt, E; Büttner-Janz, K

    2001-02-01

    Recent studies for postoperative pain relief after arthroscopy by intraarticular morphine or bupivacaine showed controversial results. The aim of the study was to evaluate the analgesic effect of intraarticular morphine and ropivacaine. 135 patients were randomized into 9 groups (n=15) after standardized knee-arthroscopy. They received either 1 mg or 5 mg morphine or 150 mg ropivacaine or a combination of 5 mg morphine and 75 mg ropivacaine. Drains were opened either after 10 or 30 minutes. A control-group received isotonic saline. Pain was assesed 1 h and 4 h after surgery, at 8 pm on the day of the operation and at 8am and 4 pm the following two days by a VAS scale. Tramadol consumption as rescue medication was registred. Ropivacaine showed the best pain relief after surgery. After 24 h the pain intensity approximated in all groups and after 48 h there was no difference. Tramadol consumption was highest in the control group and lowest in the ropivacaine group (p<0,05). Ropivacaine showed better pain reduction than morphine. An influence of the time, when drains were opened, could only be demostrated for the 75 mg ropivacain combination group. Intraarticular ropivacaine following elective knee-arthroscopy reduces postoperative analgetic consumption significantly and improves patient comfort.

  2. Treatment of chronic pain associated with nocturnal bruxism with botulinum toxin. A prospective and randomized clinical study

    Science.gov (United States)

    Al-Wayli, Hessa

    2017-01-01

    Background To evaluate the role of botulinum toxin type A (BTX-A) in the treatment of pain associated with nocturnal bruxism. Material and Methods Fifty subjects reporting nocturnal bruxism were recruited for a randomized clinical trial. Twenty five bruxers were injected with botulinum toxin in both masseters, and twenty five were treated with traditional methods of treating bruxism. Patients were evaluated at 3rd week, 2nd and 6th month and one year after injection and then used to calculate bruxism events. Bruxism symptoms were investigated using questionnaires. Results Mean pain score due to Bruxism events in the masseter muscle decreased significantly in the botulinum toxin injection group A (P =0.000, highly significant). However, in the conventional treatment group, mean pain score does not show improvement with time (p>0.05). Conclusions Our results suggest that botulinum toxin injection reduced the mean pain score and number of bruxism events, most likely by decreasing the muscle activity of masseter rather than affecting the central nervous system. Key words:Temporomandibular pain, nocturnal bruxism, botulinum toxin.

  3. Effects of nutritional intervention in head and neck cancer patients undergoing radiotherapy: A prospective randomized clinical trial.

    Science.gov (United States)

    Kang, Wen-Xing; Li, Wentao; Huang, Shi-Gao; Dang, Yazhang; Gao, Hongxiang

    2016-09-01

    Head and neck malignant tumors have numerous locations of the disease. After patients receive radiotherapy, their nutritional status is very poor, thus the curative effect is unsatisfactory. The aims of the present study were to investigate and analyze the nutritional status of patients with head and neck cancer undergoing radiotherapy (RT) in order to provide positive nutrition intervention for assisting the radiotherapy effect. A total of 40 patients with head and neck cancer were selected using a method of subjective global assessment (SGA) to assess nutritional status, including calorie intake and energy expenditure. In a randomized, controlled study, 20 patients received intensive dietary counseling and nutritional therapy (G1) and 20 received regular dietary as controls (G0) preradiotherapy and postradiotherapy. The primary endpoint was calorie intake and energy expenditure. The secondary endpoint was SGA rating with nutritional therapy. At the end of RT, energy intake showed a net increase in G1 (1,691±301 kcal) compared with that in G0 (1,066±312 kcal) (Pnutritional intervention can effectively prevent weight loss and muscle wasting. Additionally, it may improve quality of life by decreasing the frequency of severe malnutrition.

  4. The effectiveness of low laser therapy in subacromial impingement syndrome: a randomized placebo controlled double-blind prospective study

    Directory of Open Access Journals (Sweden)

    Sebnem Koldas Dogan

    2010-01-01

    Full Text Available OBJECTIVES: Conflicting results were reported about the effectiveness of Low level laser therapy on musculoskeletal disorders. The aim of this study was to investigate the effectiveness of 850-nm gallium arsenide aluminum (Ga-As-Al laser therapy on pain, range of motion and disability in subacromial impingement syndrome. METHODS: A total of 52 patients (33 females and 19 males with a mean age of 53.59±11.34 years with subacromial impingement syndrome were included. The patients were randomly assigned into two groups. Group I (n = 30, laser group received laser therapy (5 joule/cm² at each point over maximum 5-6 painful points for 1 minute. Group II (n = 22, placebo laser group received placebo laser therapy. Initially cold pack (10 minutes was applied to all of the patients. Also patients were given an exercise program including range of motion, stretching and progressive resistive exercises. The therapy program was applied 5 times a week for 14 sessions. Pain severity was assessed by using visual analogue scale. Range of motion was measured by goniometer. Disability was evaluated by using Shoulder Pain and Disability Index. RESULTS: In group I, statistically significant improvements in pain severity, range of motion except internal and external rotation and SPADI scores were observed compared to baseline scores after the therapy (p0.05. CONCLUSIONS: The Low level laser therapy seems to have no superiority over placebo laser therapy in reducing pain severity, range of motion and functional disability.

  5. A Prospective Randomized Trial of Diltiazem Gel and Glyceryl Trinitrate Ointment on Treatment of Chronic Anal Fissure

    Directory of Open Access Journals (Sweden)

    M Akhondi-Meybodi

    2014-12-01

    Methods: This semi-experimental study consisted of sixty six outpatients (34 females and 32 males with chronic anal fissure, who referred to the gastroenterology clinic. Patients were randomly classified into two groups. Group A received GTN ointment (0.03%, whereas group B was treated with Diltiazem gel (2%. The treatment was administered twice daily for 8 weeks. Healing and side-effects were recorded to be compared after 8 weeks. Results: In group A, the anal fissure was thoroughly healed within 53.3% of patients, moderately healed for 6.7% of patients and not healed in 25.8% of patients. Moreover, side-effects were noted in 15(46.9% patients (P= 0.482. Two (6.2% patients had intolerable headache and discontinued the study, 11 (34.3% patients suffered from headache and 2 patients (6.2% were reported to have orthostatic hypotension. In group B, healing occurred in 21(67.7% out of 31 patients and 1 (3.2% case of headache was noted(P= 0.0001. Conclusion: The present study has demonstrated that topical diltiazem can be preferable to GTN owing to the absence of side-effects.

  6. Children with dry skin and atopic predisposition: daily use of emollients in a participant-blinded, randomized, prospective trial.

    Science.gov (United States)

    Schario, Marianne; Lünnemann, Lena; Stroux, Andrea; Reisshauer, Anett; Zuberbier, Torsten; Blume-Peytavi, Ulrike; Garcia Bartels, Natalie

    2014-01-01

    Dry skin reflects a skin barrier defect which can lead to atopic dermatitis. Little is known about the distinct effects of emollient use in children with dry skin and atopic predisposition. We investigated the effects of daily application of pressed ice plant juice (PIPJ)-based emollients and petrolatum-based emollients. Children aged 2-6 years with dry skin and atopic predisposition were randomized into 2 groups: group 1 received emollients containing PIPJ and natural lipids, while group 2 received petrolatum-based emollients. Skin condition and biophysical properties of the skin barrier were assessed at inclusion and weeks 4, 12 and 16. Skin condition improved significantly in all children. Comparing the groups, children treated with emollients containing PIPJ showed significantly higher stratum corneum hydration values and significantly lower transepidermal water loss values at week 16 on the forearm and forehead. A significant decrease in skin pH was noted in group 2 on the forearm and forehead; group 1 showed a stable course. Early intervention with emollients in children with dry skin condition and atopic predisposition may improve their skin condition during daily emollient application. PIPJ-based formulations may be helpful to maintain skin barrier integrity.

  7. Combined modality treatment of localized small-cell lung carcinoma. A randomized prospective study of the Southeastern Cancer Study Group.

    Science.gov (United States)

    Krauss, S; Perez, C; Lowenbraun, S; Sonoda, T; Bartolucci, A; Buchanan, R

    1980-01-01

    Seventy patients with small-cell lung carcinoma limited to the thorax +/- ipsilateral supraclavicular lymph nodes were randomized to either of two study arms: 33 patients received radiation therapy (RT) alone consisting of 4500 rads in 5-6 weeks to primary tumor and regional lymph nodes, and 3500 rads in 2 1/2 weeks to brain as prophylaxis; 37 patients received, in addition to the RT above, chemotherapy (CT) with cyclophosphamide (500 mg/m2), Adriamycin (50 mg/m2), and DTIC (250 mg/m2) every 3 weeks given in two cycles before RT and seven cycles post-RT. Patients receiving RT alone who showed recurrence were crossed over to receive CT as above. Of 23 patients receiving RT alone who were evaluable 17 or 74% were responders; seven of these responses were complete (30%). On the RT and CT arm, of 24 evaluable cases, the response rate was 75%, of which 12 (50%) were complete. The median duration of disease-free survival of patients receiving RT + CT was 27 weeks, which ws superior to that of patients receiving RT alone (9.9 weeks, p = 0.019). The median survival of responders was essentially the same on both treatment arms; RT + CT, 47.7 weeks vs. RT alone, 50 weeks (p = N.S.).

  8. Comparison of two different doses of magnesium sulphate for spinal anaesthesia.- A prospective, randomized double blind study

    Directory of Open Access Journals (Sweden)

    Hemalatha P

    2017-01-01

    Full Text Available Background: The present study aim was designed to compare and evaluate the efficacy of adding two different doses of magnesium sulphate to 0.5% hyperbaric levobupivacaine for spinal anaesthesia in terms of block characteristics, haemodynamic and safety profile. Methods: Ninety American Society of Anaesthesiologist (ASA grade I–II patients undergoing elective infra-umbilical surgeries under spinal anaesthesia were randomly allocated into three groups. Group C (n=30, control group received 3 mL (15 mg of 0.5% hyperbaric levobupivacaine; Group M50 (n=30: received 3 mL (15 mg of 0.5% hyperbaric levobupivacaine + 50 mg of magnesium sulphate. Group M100 (n=30 received 3 mL (15 mg of 0.5% hyperbaric levobupivacaine + 100 mg of magnesium sulphate.A standard protocol was followed after which a blinded observer assessed the sensory and motor blocks. The onset and duration of sensory (pin-prick block, onset, intensity and duration of motor block were recorded. Results: All the subarachnoid blocks were adequate. The addition of magnesium sulphate to intrathecal levobupivacaine had not only increased the time to onset of sensory block (p=0.007 but also prolonged the duration of sensory (p<0.001 and motor block (p<0.001 to statistically significant level in a dose dependent manner. Conclusions: Addition of magnesium sulphate does not offer any further advantage in terms of haemodynamic stability. However, it certainly increases the duration of sensory block to a significant level.

  9. The Effect of Aromatherapy Abdominal Massage on Alleviating Menstrual Pain in Nursing Students: A Prospective Randomized Cross-Over Study

    Directory of Open Access Journals (Sweden)

    Tyseer M. F. Marzouk

    2013-01-01

    Full Text Available Dysmenorrhea is a common cause of sickness absenteeism from both classes and work. This study investigated the effect of aromatherapy massage on a group of nursing students who are suffering of primary dysmenorrhea. A randomized blind clinical trial of crossover design was used. In the first treatment phase, group 1 ( received aromatherapy abdominal massage once daily for seven days prior to menstruation using the essential oils (cinnamon, clove, rose, and lavender in a base of almond oil. Group 2 ( received the same intervention but with placebo oil (almond oil. In the second treatment phase, the two groups switched to alternate regimen. Level and duration of pain and the amount of menstrual bleeding were evaluated at the baseline and after each treatment phase. During both treatment phases, the level and duration of menstrual pain and the amount of menstrual bleeding were significantly lower in the aromatherapy group than in the placebo group. These results suggests that aromatherapy is effective in alleviating menstrual pain, its duration and excessive menstrual bleeding. Aromatherapy can be provided as a nonpharmacological pain relief measure and as a part of nursing care given to girls suffering of dysmenorrhea, or excessive menstrual bleeding.

  10. Endoscopic versus transcranial procurement of allograft tympano-ossicular systems: a prospective double-blind randomized controlled audit.

    Science.gov (United States)

    Caremans, Jeroen; Hamans, Evert; Muylle, Ludo; Van de Heyning, Paul; Van Rompaey, Vincent

    2016-06-01

    Allograft tympano-ossicular systems (ATOS) have proven their use over many decades in tympanoplasty and reconstruction after resection of cholesteatoma. The transcranial bone plug technique has been used in the past 50 years to procure en bloc ATOS (tympanic membrane with malleus, incus and stapes attached). Recently, our group reported the feasibility of the endoscopic procurement technique. The aim of this study was to assess whether clinical outcome is equivalent in ATOS acquired by using the endoscopic procurement technique compared to ATOS acquired by using the transcranial technique. A double-blind randomized controlled audit was performed in a tertiary referral center in patients that underwent allograft tympanoplasty because of chronic otitis media with and without cholesteatoma. Allograft epithelialisation was evaluated at the short-term postoperative visit by microscopic examination. Failures were reported if reperforation was observed. Fifty patients underwent allograft tympanoplasty: 34 received endoscopically procured ATOS and 16 received transcranially procured ATOS. One failed case was observed, in the endoscopic procurement group. We did not observe a statistically significant difference between the two groups in failure rate. This study demonstrates equivalence of the clinical outcome of allograft tympanoplasty using either endoscopic or transcranial procured ATOS and therefore indicates that the endoscopic technique can be considered the new standard procurement technique. Especially because the endoscopic procurement technique has several advantages compared to the former transcranial procurement technique: it avoids risk of prion transmission and it is faster while lacking any noticeable incision.

  11. Cardiovascular function during the first 24 hours after off pump coronary artery bypass grafting--a prospective, randomized study.

    Science.gov (United States)

    Vedin, Jenny; Jensen, Ulf; Ericsson, Anders; Bitkover, Catarina; Samuelsson, Sten; Bredin, Fredrik; Vaage, Jarle

    2003-12-01

    We hypothesized that cardiovascular performance during the first 24 postoperative hours would be better in patients after off pump coronary artery bypass grafting compared to conventional on pump surgery. Fifty-nine patients were randomized to on or off pump coronary artery bypass grafting. Hemodynamic parameters, including cardiac index and systemic vascular resistance index were measured before and at 1, 4, and 20 h after surgery. Troponin T and creatine kinase-MB (CK-MB) were measured before and at 1, 6, and 20 h after surgery. There was no difference in age, sex, ejection fraction or number of grafts between groups. Cardiac index was higher (p=0.05) and systemic vascular resistance index was lower (p=0.007) in the off pump group 1 h after arrival in the intensive care unit. CK-MB and troponin T were significantly lower in the off pump group after 1 h (CK-MB p<0.001, troponin T p<0.001) and after 6 h (CK-MB p=0.02, troponin T p<0.001). After 24 h there was no difference between the two groups. In conclusion, immediately after surgery there was better cardiovascular performance and less release of markers of myocardial damage after off pump coronary surgery. After 24 h all differences were eliminated.

  12. ULTRAPRO Hernia System versus lichtenstein repair in treatment of primary inguinal hernias: a prospective randomized controlled study.

    Science.gov (United States)

    Karateke, Faruk; Ozyazici, Sefa; Menekse, Ebru; Özdogan, Hatice; Kunt, Mevlüt; Bozkurt, Hilmi; Bali, İlhan; Özdogan, Mehmet

    2014-01-01

    The Lichtenstein repair has been recommended as the gold standard for inguinal hernia repair. However, postoperative discomfort still constitutes a concern and an area for improvement. New mesh materials have been continuously introduced to achieve this goal. The goal of the present study was to investigate the outcomes of ULTRAPRO Hernia System (UHS) compared with Lichtenstein mesh repair. A total of 99 male patients with primary unilateral inguinal hernia were included in the study during the period of September 2010-January 2012. Patients with body mass index>30, comorbid diseases, and anesthetic risk of ASA-III and ASA-IV were excluded. The patients were randomly allocated to operation with the Lichtenstein technique (group L) or UHS. Demographics, operative and postoperative/recovery data, and short- and medium-term outcomes of the patients were recorded. A total of 50 patients in group L and 49 patients in group UHS were analyzed. The median follow-up time for the study was 33 months. There were no significant differences regarding demographics, complications, and rehabilitation between the groups. Overall, there was a prolonged operation time in the UHS group compared with the L group (UHS: 53.7±5.7 minutes; L: 44.5±5.5 minutes; Phernias regarding perioperative course, complications, recovery, and recurrence rates. However, because of reduced costs and the lack of need for the exploration of the preperitoneal space, we conclude that the Lichtenstein technique should be recommended as the first choice.

  13. A prospective randomized controlled study comparing two doses of gestodene in cyclic combined HRT preparations on endometrial physiology.

    Science.gov (United States)

    Okon, M A; Lee, S; Laird, S M; Li, T C

    2001-06-01

    Postmenopausal women taking oestradiol 17-beta 2 mg daily were randomized to receive either 25 or 50 microg gestodene from day 17 to 28 of the cycle in a double-blind study. Placental protein P14 (PP14) and CA 125 concentrations in uterine flushing, endometrial morphology and irregular bleeding after 12 cycles of study were observed. Eleven and 12 women in the 25 and 50 microg groups respectively completed the study. There were no significant differences in pre-treatment biochemical and morphological indices between the groups. The median PP14 concentration increased from 332 to 5800 ng/ml (P gestodene groups respectively. No between-group significant rise of PP14 was observed. Similarly, no significant change was seen between the initial and post-treatment concentrations of CA 125 for either group. All biopsies were atrophic at inception of the study, and both regimens produced secretory endometrial transformation in the majority of biopsies. No between-group difference was observed in the morphometric indices measured, or any significant correlation between the concentrations of PP14 or CA 125 and morphology. The mean number of days of withdrawal bleeding (3.8 and 4.2 days for 25 and 50 microg respectively) were similar. In conclusion, both regimens produced a significant rise in uterine flushing concentrations of PP14, but not CA 125. PP14 is a sensitive biochemical marker in the assessment of endometrial response to hormone replacement therapy.

  14. High-dose dexamethasone vs prednisone for treatment of adult immune thrombocytopenia: a prospective multicenter randomized trial.

    Science.gov (United States)

    Wei, Yu; Ji, Xue-bin; Wang, Ya-wen; Wang, Jing-xia; Yang, En-qin; Wang, Zheng-cheng; Sang, Yu-qi; Bi, Zuo-mu; Ren, Cui-ai; Zhou, Fang; Liu, Guo-qiang; Peng, Jun; Hou, Ming

    2016-01-21

    This study compared the efficacy and safety of high-dose dexamethasone (HD-DXM) and conventional prednisone (PDN) on the largest cohort to date as first-line strategies for newly diagnosed adult primary immune thrombocytopenia (ITP). Patients enrolled were randomized to receive DXM 40 mg/d for 4 days (n = 95, nonresponders received an additional 4-day course of DXM) or prednisone 1.0 mg/kg daily for 4 weeks and then tapered (n = 97). One or 2 courses of HD-DXM resulted in a higher incidence of overall initial response (82.1% vs 67.4%, P = .044) and complete response (50.5% vs 26.8%, P = .001) compared with prednisone. Time to response was shorter in the HD-DXM arm (P < .001), and a baseline bleeding score ≥8 was associated with a decreased likelihood of initial response. Sustained response was achieved by 40.0% of patients in the HD-DXM arm and 41.2% in the PDN arm (P = .884). Initial complete response was a positive indicator of sustained response, whereas presence of antiplatelet autoantibodies was a negative indicator. HD-DXM was generally tolerated better. We concluded that HD-DXM could be a preferred corticosteroid strategy for first-line management of adult primary ITP. This study is registered at www.clinicaltrials.gov as #NCT01356511.

  15. Teaching basic life support: a prospective randomized study on low-cost training strategies in secondary schools.

    Science.gov (United States)

    Van Raemdonck, Veerle; Monsieurs, Koenraad G; Aerenhouts, Dirk; De Martelaer, Kristine

    2014-08-01

    Cardiopulmonary resuscitation (CPR) training at school is recommended. Limited school resources prevent implementation. The learning efficacy of low-cost training strategies is unknown. To evaluate the efficacy of different CPR learning strategies using low-cost didactic tools. Children (n=593, 15-16 years) were randomized to four training conditions: (1) manikin+teacher instruction (control group), (2) manikin+video instruction, (3) foam dice+plastic bag+peer training+teacher instruction, and (4) foam dice+plastic bag+peer training+video instruction. After a 50 min training, a 3 min CPR test on a manikin was performed using SkillReporting Software (Laerdal, Norway), and repeated after 6 months. The data of children without previous CPR training were analysed. Analysis of variance and the χ-test assessed differences between groups. Complete data sets were available for 165 pupils. Initially, group 3 scored lower on the mean ventilation volume (Pstrategies was suboptimal. The basics of CPR can be taught with alternative equipment if manikins are not available.

  16. [Value of exact focusing of extracorporeal shock waves (ESWT) in therapy of tendinitis calcarea. A prospective randomized study].

    Science.gov (United States)

    Haake, M; Deike, B; Thon, A; Schmitt, J

    2001-03-01

    A controlled randomized study was designed to analyse the effect of extracorporeal shockwave therapy (ESWT) focussed on either the calcified region or the insertion of the supraspinatus tendon. The study included 50 patients who were treated with a Storz Minilith SI-1 prototype shockwave generator. In the treated group, 4000 impulses (ED+ 0.78 ml/mm2) were applied, under local anaesthesia to the insertion of the supraspinatus in 2 treatment sessions. Control patients received ESWT focussed on the calcified region. Follow-up examinations were carried out 12 weeks after treatment by an independent observer. We found functional improvement and pain reduction in both groups. Statistical analyses showed significant superiority of ESWT focussed on the calcified region for the parameters constant-score (primary endpoint, p < 0.001) and pain intensity (p = 0.001). For the treatment of calcific tendinitis affecting the supraspinatus, we recommend accurate fluoroscopy-controlled focussing of ESWT on the calcification. Focussing on the calcification rather than on the insertion of the supraspinatus tendon is significantly more effective. On the basis of our results, ESWT requires the use of suitable shockwave generators that permit accurate focussing.

  17. Adverse drug reaction monitoring with angiotensin converting enzyme inhibitors: A prospective, randomized, open-label, comparative study.

    Science.gov (United States)

    Sangole, Nishant V; Dadkar, Vaishali N

    2010-02-01

    Angiotensin converting enzyme inhibitors (ACEIs) are known to possess different chemical structures, and change in structure of a drug can bring about change in its adverse drug reaction (ADR) profile. The study aims to observe the incidence and severity of ADRs between the di-carboxyl group containing ACEIs (d-ACEIs) versus phosphonate group containing ACEIs (p-ACEIs), in patients suffering from essential hypertension. One hundred and twenty patients with essential hypertension were randomized into four groups receiving enalapril, lisinopril, ramipril, and fosinopril. They were followed up for four months, to observe the clinical efficacy along with the associated ADRs. Mild, dry brassy cough (% incidence; 95% CI) was observed with d-ACEIs (6.6%; 0 to 15.6) versus p-ACEI (20%; 5.7 to 34.3), in which the cough observed was moderate-to-severe in intensity and two patients required treatment discontinuation (P ACEIs, whereas, two patients on p-ACEI (6.6%; 0 to15.6) had hypotension (P ACEIs had nausea, which was not observed with p-ACEI treatment (0%) (P ACEIs may have a probable relationship with increase in the incidence and severity of ADRs such as dry brassy cough and hypotension. The di-carboxyl group in d-ACEIs may have a probable relationship with increase in the incidence of ADRs like nausea.

  18. Efficacy of tramadol as a preincisional infiltration anesthetic in children undergoing inguinal hernia repair: a prospective randomized study

    Science.gov (United States)

    Numanoğlu, Kemal Varım; Ayoğlu, Hilal; Er, Duygu TatlıEbubekir

    2014-01-01

    Background Preincisional local anesthetic infiltration at the surgical site is a therapeutic option for postoperative pain relief for pediatric inguinal hernia. Additionally, tramadol has been used as an analgesic for postoperative pain in children. Recently, the local anesthetic effects of tramadol have been reported. The aim of this study was to determine both the systemic analgesic and the local anesthetic effects of tramadol and to determine how it differs from bupivacaine when administered preincisionally. Methods Fifty-two healthy children, aged 2–7 years, who were scheduled for elective herniorrhaphy were randomly allocated to receive either preincisional infiltration at the surgical site with 2 mg/kg tramadol (Group T, n=26) or 0.25 mL/kg 0.5% bupivacaine (Group B, n=26). At the time of anesthetic administration, perioperative hemodynamic parameters were recorded. The pain assessments were performed 10 minutes after the end of anesthesia and during the first 6-hour period, using pain scores. The time of first dose of analgesia and need for additional analgesia were recorded. Results Between T and B groups, the anesthesia time, perioperative hemodynamic changes, and pain scores were not statistically different. However, in group B, the postoperative analgesic requirement was higher than in group T. Conclusion Tramadol shows equal analgesic effect to bupivacaine and decreases additional analgesic requirement, when used for preincisional infiltration anesthesia in children undergoing inguinal herniorrhaphy. PMID:25285011

  19. Effectiveness of acupuncture on chronic prostatitis-chronic pelvic pain syndrome category IIIB patients: a prospective, randomized, nonblinded, clinical trial.

    Science.gov (United States)

    Küçük, Eyüp Veli; Suçeken, Ferhat Yakup; Bindayı, Ahmet; Boylu, Ugur; Onol, Fikret Fatih; Gümüş, Eyüp

    2015-03-01

    To compare the acupuncture treatment and the medical treatment with antibiotics and nonsteroidal anti-inflammatory drugs (NSAIDs) on pain control, urinary symptoms, and quality of life of category IIIB chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS). From November 2008 to May 2009, 54 male patients with category IIIB CP-CPPS were randomly divided into 2 groups: the medical treatment group (group 1, n = 28) and the acupuncture treatment group (group 2, n = 26). Group 1 took levofloxacin 500 mg daily and ibuprofen 200 mg twice a day for 6 weeks. In the acupuncture group (group 2), bilateral BL32 (Ciliao) and BL33 (Zhongliao) acupoints were used to stimulate the sacral nerve using an electrical pulse generator, twice a week for 7 weeks. The change in National Institutes of Health Chronic Prostatitis Symptom Index scores from the baseline to the end of the treatment was observed. The mean follow-up was 28 weeks from the baseline (range, 20-43 weeks). In acupuncture group, reduction of pain, urinary symptoms, quality of life, and total National Institutes of Health Chronic Prostatitis Symptom Index score was higher compared with the medical group. However the treatment of CP-CPPS is challenging and difficult for the urologists. This clinical study showed that the acupuncture treatment is a safe and effective treatment of category IIIB CP-CPPS. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Comparison of low-dose oxytocin and dinoprostone for labor induction in postterm pregnancies: a randomized controlled prospective study.

    Science.gov (United States)

    Akay, Nezahat Öztürk; Hızlı, Deniz; Yılmaz, Saynur Sarıcı; Yalvaç, Serdar; Kandemir, Omer

    2012-01-01

    The aim of this study was to compare the efficacy of oxytocin and dinoprostone in achieving successful labor induction and vaginal delivery in postterm women with an unfavorable cervix. Postterm women with an uncomplicated pregnancy and a Bishop score of ≤6 were randomized to receive either dinoprostone vaginal pessary (Propess®) or low-dose oxytocin. The primary outcomes were the length of the induction-to-delivery period and the incidence of vaginal delivery. A total of 144 women were available for the analysis. The overall vaginal delivery rates were 75% (54/72) for the dinoprostone group and 80.6% (58/72; p = 0.35) for the oxytocin group; the mean induction-to-vaginal delivery interval was 13.3 and 10.3 h in the dinoprostone and the oxytocin group, respectively (p = 0.003). Uterine hyperstimulation was 7.4% compared with 6.8% (p = 0.8), and abnormal fetal heart rate was 26.4% compared with 18% (p = 0.2), respectively. Both oxytocin and dinoprostone seem to have similar obstetric outcomes in postterm pregnancies with an unfavorable cervix, except for a significant superiority of oxytocin for delivery in a shorter period. Copyright © 2012 S. Karger AG, Basel.

  1. Auricular acupressure reduces anxiety levels and improves outcomes of in vitro fertilization: a prospective, randomized and controlled study.

    Science.gov (United States)

    Qu, Fan; Zhang, Dan; Chen, Lu-Ting; Wang, Fang-Fang; Pan, Jie-Xue; Zhu, Yi-Min; Ma, Chun-Mei; Huang, Yi-Ting; Ye, Xiao-Qun; Sun, Sai-Jun; Zheng, Wen-Jun; Zhang, Run-Ju; Xu, Jian; Xing, Lan-Feng; Huang, He-Feng

    2014-05-22

    The study was to explore whether auricular acupressure (AA) can relieve anxiety during the period from trans-vaginal oocyte retrieval to the embryo transfer in IVF treatment and whether AA can improve the outcomes of IVF. 305 infertile patients with tubal blockage who were referred for IVF were included. The women were randomized into a control group with 102 cases, a Sham-AA group with 102 cases and an AA group with 101 cases. The anxiety levels were rated with Spielberger's State Trait Anxiety Inventory and the Amsterdam Preoperative Anxiety and Information Scale. Data of clinical pregnancy rate (CPR), implantation rate (IR) and live birth rate (LBR) were obtained. The levels of neuropeptide Y (NPY) and transforming growth factor alpha (TGF-alpha) in the follicular fluids were detected with ELISA. After treatment, in AA group, the levels of state anxiety, preoperative anxiety and need-for-information were significantly lower, whereas CPR, IR, LBR and NPY levels in the follicular fluids were markedly higher than Sham-AA group and control group. We concluded that AA could help to reduce anxiety levels associated with IVF and improves the outcomes of IVF partly through increasing the levels of NPY in the follicular fluids.

  2. Analgesic Efficacy of Intrarectal Instillation of Lidocaine Gel prior to Transrectal Ultrasound Guided Prostate Biopsy: A Prospective Randomized Trial

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    Yun, Tae Jin; Kim, Seung Hyup; Cho, Jeong Yeon [Seoul National University Hospital, Seoul (Korea, Republic of); Lee, Hak Jong; Lee, Sang Eun; Byun, Seok Soo [Seoul National University Bundang Hospital, Seongnam (Korea, Republic of); Seong, Chang Kyu [Seoul National University Borame Hospital, Seoul (Korea, Republic of)

    2006-06-15

    To assess the analgesic efficacy of intrarectal lidocaine gel instillation prior to periprostatic nerve block during transrectal, ultrasound-guided prostate biopsies. Between March 2004 and October 2004, 203 consecutive patients for prostate biopsies were randomized into two groups. In 90 patients of group A, 10ml of 2% lidocaine gel was instilled intrarectally 10 minutes prior to periprostatic neurovascular bundle block, while 113 patients of group B received only periprostatic neurovascular bundle block without lidocaine gel instillation. Pain was assessed with the visual analogue pain scale, during periprostatic neurovascular bundle block (VAS 1), during the biopsy procedures (VAS 2) and 20 minutes after the procedure (VAS 3). The difference in VAS scores between patients in the two groups was evaluated with the unpaired t-test, with p < 0.05 considered significant. Patients in group A experienced statistically less pain during transrectal ultrasound guided prostate biopsy (VAS 2, 2.994 versus 3.903, p < 0.01). However, no significant difference in VAS values could be demonstrated during periprostatic neurovascular bundle block (VAS 1, 4.761 versus 5.133, p > 0.05) or at after 20 minutes after the procedure (VAS 3, 0.9778 versus 1.257, p > 0.05). Intrarectal instillation of lidocaine gel leads to significant additional analgesic efficacy during the biopsy procedure. It is a simple, safe and rapid technique that should be considered in all patients undergoing TRUS guided prostate biopsy

  3. Quality of life assessment with different radiotherapy schedules in palliative management of advanced carcinoma esophagus: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Shaveta Mehta

    2008-01-01

    Full Text Available Aim: To investigate the quality of life (QOL of patients with advanced carcinoma esophagus treated with different palliative radiation schedules. Methods: Sixty-two consecutive patients with inoperable, non-metastatic carcinoma of the esophagus were randomly allocated to Arm-A (external radiotherapy 30 Gy/10 fractions + brachytherapy 12 Gy/two sessions, Arm-B (external radiotherapy 30 Gy /10 fractions and Arm-C (external radiotherapy 20Gy /five fractions. The QOL was assessed using the European Organization for Research and Treatment of Cancer questionnaire at presentation, after treatment and at 3 months follow-up. Results: The mean QOL score improved, in arm-A from 38 to 52 after treatment and 56 at 3 months, in arm-B from 30 to 44 after treatment and 55 at 3 months and in arm-C from 24 to 40 after treatment but decreased to 37 at 3 months. Improvement in dysphagia scores at the first follow-up was 46.1% in arm-A, 25.0% in arm-B and 22.6% in arm-C. The difference was maintained at 3 months, with maximum improvement in arm-A (57.6%. No significant differences were found between the three arms with regard to complications and additional procedures needed for relief of dysphagia. Conclusion: In comparison with external radiotherapy alone, external radiotherapy with intraluminal brachytherapy has shown a trend toward better QOL and consistent dysphagia relief without significant difference in adverse effects.

  4. Optimizing prostate cancer screening; prospective randomized controlled study of the role of PSA and PCA3 testing in a sequential manner in an opportunistic screening program.

    Science.gov (United States)

    Rubio-Briones, J; Casanova, J; Dumont, R; Rubio, L; Fernandez-Serra, A; Casanova-Salas, I; Domínguez-Escrig, J; Ramírez-Backhaus, M; Collado, A; Gómez-Ferrer, A; Iborra, I; Monrós, J L; Ricós, J V; Solsona, E; Salas, D; Martínez, F; Lopez-Guerrero, J A

    2014-05-01

    To reduce unnecessary biopsies (Bx) in an opportunistic screening programme of prostate cancer. We perform a prospective evaluation of PCA3 as a second line biomarker in an opportunistic screening for prostate cancer (PCa). From September-2010 until September-2012, 2,366 men, aged 40-74 years and with >10 years life expectancy, were initially screened with PSA/digital rectal examination (DRE). Men with previous Bx or with recent urine infections were excluded. Men with abnormal DRE and/or PSA >3 ng/ml were submitted for PCA3. All men with PCA3 ≥ 35 underwent an initial biopsy (IBx) -12cores-. Men with PCA3 .5 ng/ml at 4-6 months or PSAv > .75 ng/ml/year. With median follow-up (FU) of 10.1 months, PCA3 was performed in 321/2366 men (13.57%), 289 at first visit and 32 during FU. All 110 PCA3+ men (34.3%) were biopsied and PCa was identified in 43 men in IBx (39.1%). In the randomized arm, 110 were observed and 101 underwent biopsy, finding 12 PCa (11.9%), showing a statistically significant reduction of PCa detection rate in this cohort (P<.001). Global PCa detection rates were 40.9% and 9.5% for the PCA3+ and PCA3- branches, respectively (P<.001). Area under the curve for PSA and PCA3 were .601 and .74, respectively. This is an ongoing prospective study limited by its short follow-up period and still limited enrolment. PCA3 as a second line biomarker within an opportunistic dual screening protocol, can potentially avoid 65.7% and 50.1% biopsies at first round and at median FU of 10.1 months, respectively, just missing around 3.2% of high grade PCa. Copyright © 2013 AEU. Published by Elsevier Espana. All rights reserved.

  5. Repair versus shaving of partial-thickness articular-sided tears of the upper subscapularis tendon. A prospective randomized controlled trial

    Science.gov (United States)

    RANDELLI, PIETRO; ARRIGONI, PAOLO; ALIPRANDI, ALBERTO; SDAO, SILVANA; RAGONE, VINCENZA; D’AMBROSI, RICCARDO; RANDELLI, FILIPPO; CABITZA, PAOLO; BANFI, GIUSEPPE

    2015-01-01

    Purpose the purpose of this study was to evaluate whether treating partial-thickness articular-sided tears of the upper subscapularis (SSC) tendon with a dedicated suture anchor would result in an internal rotation strength improvement compared with simple shaving of the SSC tendon and footprint. Methods twenty-six patients with a limited SSC tendon tear (equal or inferior to the most superior centimeter) in association with a posterosuperior cuff lesion were prospectively randomized to two treatments: repair with a dedicated suture anchor versus shaving of the tendon and footprint. The patients also underwent long head of the biceps (LHB) treatment and posterosuperior cuff tear repair. In each patient the following parameters were measured both preoperatively and at a minimum follow-up of 2.5 years: strength in internal rotation in the bear-hug testing position (using a digital tensiometer), DASH score and Constant scores. MRI assessment of tendon healing was performed at the final follow-up. Results twenty of the 26 patients (76%) were reviewed after a mean follow-up time of 42 months: 11 patients had undergone SSC tendon repair and nine simple shaving. At final follow-up no significant differences were found between the repaired and shaving group in strength in internal rotation (9.5 ± 3.8 kg versus 10.3±5.4 kg; p=0.7). The DASH score and Constant score also failed to show significant differences between the two groups. Furthermore, no significant difference in SSC tendon healing rate was observed on MRI evaluation. Conclusions partial-thickness articular-sided tear of the upper SSC tendon in association with a posterosuperior rotator cuff repair and LHB treatment, when limited to the superior centimeter of the SSC tendon, shows a comparable performance in terms of strength in internal rotation either after simple shaving or a tendon-to-bone repair. Level of evidence Level II, prospective comparative study. PMID:26889466

  6. Prospective randomized trial of iliohypogastric-ilioinguinal nerve block on post-operative morphine use after inpatient surgery of the female reproductive tract

    Directory of Open Access Journals (Sweden)

    Saltzman Steven L

    2008-11-01

    Full Text Available Abstract Objective To determine the impact of pre-operative and intra-operative ilioinguinal and iliohypogastric nerve block on post-operative analgesic utilization and length of stay (LOS. Methods We conducted a prospective randomized double-blind placebo controlled trial to assess effectiveness of ilioinguinal-iliohypogastric nerve block (IINB on post-operative morphine consumption in female study patients (n = 60. Patients undergoing laparotomy via Pfannenstiel incision received injection of either 0.5% bupivacaine + 5 mcg/ml epinephrine for IINB (Group I, n = 28 or saline of equivalent volume given to the same site (Group II, n = 32. All injections were placed before the skin incision and after closure of rectus fascia via direct infiltration. Measured outcomes were post-operative morphine consumption (and associated side-effects, visual analogue pain scores, and hospital length of stay (LOS. Results No difference in morphine use was observed between the two groups (47.3 mg in Group I vs. 45.9 mg in Group II; p = 0.85. There was a trend toward lower pain scores after surgery in Group I, but this was not statistically significant. The mean time to initiate oral narcotics was also similar, 23.3 h in Group I and 22.8 h in Group II (p = 0.7. LOS was somewhat shorter in Group I compared to Group II, but this difference was not statistically significant (p = 0.8. Side-effects occurred with similar frequency in both study groups. Conclusion In this population of patients undergoing inpatient surgery of the female reproductive tract, utilization of post-operative narcotics was not significantly influenced by IINB. Pain scores and LOS were also apparently unaffected by IINB, indicating a need for additional properly controlled prospective studies to identify alternative methods to optimize post-surgical pain management and reduce LOS.

  7. A prospective randomized controlled study of erythromycin on gastric and small intestinal distention: Implications for MR enterography

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    Bharucha, Adil E., E-mail: bharucha.adil@mayo.edu [Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.) Program, Division of Gastroenterology and Hepatology, College of Medicine, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905 (United States); Fidler, Jeff L., E-mail: fidler.jeff@mayo.edu [Department of Radiology, College of Medicine, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905 (United States); Huprich, James E., E-mail: huprich@mayo.edu [Department of Radiology, College of Medicine, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905 (United States); Ratuapli, Shiva K., E-mail: ratuapli.shiva@mayo.edu [Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.) Program, Division of Gastroenterology and Hepatology, College of Medicine, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905 (United States); Holmes, David R., E-mail: holmes.david3@mayo.edu [Biomedical Imaging Resource, College of Medicine, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905 (United States); Riederer, Stephen J., E-mail: riederer@mayo.edu [MR Research Laboratory, College of Medicine, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905 (United States); Zinsmeister, Alan R., E-mail: zinsmeis@mayo.edu [Division of Biomedical Statistics and Informatics, College of Medicine, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905 (United States)

    2014-11-15

    Highlights: • Suboptimal small intestinal distention limits jejunal visualization during MRI. • In this controlled study, erythromycin increased gastric emptying measured with MRI. • However, effects on small intestinal dimensions were variable. - Abstract: Objectives: To assess if erythromycin increases gastric emptying and hence improves small intestinal distention during MR enterography. Methods: Gastric, small intestinal, and large intestinal volumes were assessed with MR after neutral oral contrast (1350 ml in 45 min) and balanced randomization to erythromycin (200 mg i.v., age 31 ± 3y, 13 females), or placebo (37 ± 3y, 13 females) in 40 healthy asymptomatic volunteers. Fat-suppressed T2-weighted MR images of the abdomen were acquired on a 1.5 T magnet at standard delay times for enterography. Gastric, small, and large intestinal volumes were measured by specialized software. In addition, two radiologists manually measured diameters and percentage distention of jejunal and ileal loops. Treatment effects were evaluated by an ITT analysis based on ANCOVA models. Results: All subjects tolerated erythromycin. MRI scans of the stomach and intestine were obtained at 62 ± 2 (mean ± SEM) and 74 ± 2 min respectively after starting oral contrast. Gastric volumes were lower (P < 0.0001) after erythromycin (260 ± 49 ml) than placebo (688 ± 63 ml) but jejunal, ileal, and colonic volumes were not significantly different. However, maximum (76–100%) jejunal distention was more frequently observed (P = 0.03) after erythromycin (8/20 subjects [40%]) than placebo (2/20 subjects [10%]). The diameter of a representative ileal loop was greater (P = 0.001) after erythromycin (18.8 ± 4.3 mm) than placebo (17.3 ± 2.8 mm) infusion. Conclusions: After ingestion of oral contrast, erythromycin accelerated gastric emptying but effects on small intestinal dimensions were variable. In balance, erythromycin did not substantially enhance small intestinal distention during

  8. Influence of premedication with alprazolam on the occurence of obstructive apneas. A prospective randomized double-blind study.

    Science.gov (United States)

    Deflandre, E; Bonhomme, V; Courtois, A-C; Degey, S; Poirrier, R; Brichant, J-F

    2016-08-01

    Postoperative development or worsening of obstructive sleep apnea is a potential complication of anesthesia. The objective of this study was to study the effects of a premedication with alprazolam on the occurrence of apneas during the immediate postoperative period. Fifty ASA 1 - 2 patients undergoing a colonoscopy were recruited. Patients with a history of obstructive sleep apnea (OSA) were excluded. Recruited patients were randomly assigned to one of two groups: in Group A, they received 0.5 mg of alprazolam orally one hour before the procedure; and in Group C, they received placebo. Anesthesia technique was identical in both groups. Patients were monitored during the first two postoperative hours to establish their AHI (apnea hypopnea index, the number of apneas and hypopneas per hour). Nine patients were excluded (4 in group A and 5 in group C) due to technical problems or refusal. Interestingly, premedication by alprazolam did not change intra-operative propofol requirements. During the first two postoperative hours, the AHI was significantly higher in group A than in group C (Group A: 20.33 ± 10.97 h(-1), C: 9.63 ± 4.67 h(-1)). These apneas did not induce significant arterial oxygen desaturation, or mandibular instability. Our study demonstrates that a premedication with 0.5 mg of alprazolam doesn't modify intra-operative anesthetic requirements during colonoscopy, but is associated with a higher rate of obstructive apneas during at least three and a half hours after ingestion. No severe side effects were observed in our non-obese population. Our results must be confirmed on a larger scale.

  9. Effect of Bhramari pranayama and OM chanting on pulmonary function in healthy individuals: A prospective randomized control trial

    Science.gov (United States)

    Mooventhan, A; Khode, Vitthal

    2014-01-01

    Background/Aim: Yoga is an ancient Indian science as well as the way of life. Pranayama is a part of yoga, which improves pulmonary function in combination of many pranayama, but the aim of our study is to evaluate the effect of only Bhramari pranayama and OM chanting on pulmonary function in healthy individuals. Materials and Methods: A total of 82 subjects were randomized into the study group (SG) (n = 41) and control group (CG) (n = 41). Baseline assessment was performed before intervention for both groups. SG practiced Bhramari pranayama and OM chanting for the duration of 10 min (5 min for each practice)/day for the period of 6 days/week for 2 weeks and CG did not practice so. After intervention post-assessment was performed for SG (n = 40) and CG (n = 39). Statistical analysis was performed by Independent samples t-test and Student's paired t-test with the use of Statistical Package for the Social Sciences version 16 (2007, USA). Results: The result showed a significant improvement in peak expiratory flow (PEF), forced expiratory flow (FEF)25% and maximal voluntary ventilation (MVV) along with a significant reduction in weight in SG compared with CG in independent samples t-test. Significant improvement in slow vital capacity (SVC), forced expired volume in 1 s (FEV1) along with PEF, FEF25% and MVV; Significant reduction in weight and body mass index were observed in SG unlike in CG in Student's paired t-test. No significant changes were found in forced vital capacity, FEV1 /SVC and FEF50% , between and within the group analysis of SG and CG. Conclusion: Bhramari pranayama and OM chanting are effective in improving pulmonary function in healthy individuals. PMID:25035619

  10. Treatment of anterior vaginal wall prolapse with and without polypropylene mesh: a prospective, randomized and controlled trial - Part I

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    Jose Tadeu Nunes Tamanini

    2013-07-01

    Full Text Available Objective To compare the use of polypropylene mesh (PM and the traditional anterior vaginal wall colporraphy in women with anterior vaginal wall prolapse (AVWP using objective and subjective tests and evaluation of quality of life (QoL. Materials and Methods One hundred women were randomly distributed in two preoperatory groups. The first group (mesh (n = 45 received a PM implant and the control group (n = 55 was submitted to traditional colporraphy. Postoperatory follow-up was done after 12 months. The primary objective was the correction of the Ba point ≤ -2 POP-Q (Pelvic Organ Prolapse Quantification System and the secondary objective was the improvement of vaginal symptoms and QoL through ICIQ-VS (International Consultation on Incontinence Questionnaire - Vaginal Symptoms. Complications related to the use of PM or not were also described. Results There was a significant difference between all POP-Q measures of pre- and postoperatory periods of each group in particular. There was a significant difference of the Ba point of the postoperatory period between the Mesh and Control group. The mean of Ba point in the Mesh group was statistically lower than of the Control group, depicting the better anatomical result of the first group. Both techniques improved vaginal symptoms and QoL. The most frequent complication of the Mesh group was prepubic hematoma in the perioperative period. In 9.3% of the cases treated with mesh it was observed PM exposition at the anterior vaginal wall after 12 months, being most of them treated clinically. Conclusion The treatment of AVWP significantly improved the Ba point in the Mesh group in comparison to the Control group. There were no differences of the vaginal symptoms and QoL between the two groups after 12 months. There were few and low grade complications on both groups.

  11. The analgesic efficacy of intravenous lidocaine infusion after laparoscopic fundoplication: a prospective, randomized, double-blind, placebo-controlled trial

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    Dale GJ

    2016-12-01

    Full Text Available Gregory J Dale,1 Stephanie Phillips,2 Gregory L Falk3 1Westmead Hospital Clinical School, The University of Sydney, 2Sydney Adventist Hospital Clinical School, The University of Sydney, 3Concord Clinical School, The University of Sydney, Sydney, Australia Abstract: This study aimed to determine if intravenous lidocaine infusion reduces postoperative pain intensity following laparoscopic fundoplication surgery and to also validate the safety of intravenous lidocaine at the dose tested. This was an equally randomized, double-blind, placebo-controlled, parallel-group, single center trial. Adult patients undergoing laparoscopic fundoplication were recruited. The intervention group received 1 mg/kg intravenous lidocaine bolus prior to induction of anesthesia, then an intravenous infusion at 2 mg/kg/h for 24 hours. The primary outcome was pain, measured using a numeric rating scale for 30 hours postoperatively. Secondary outcomes were nausea and vomiting, opioid requirements, adverse events, serum lidocaine concentration, and length of hospital stay. The study was terminated after an interim analysis of 24 patients showed evidence of futility. There was no difference in postoperative pain scores (lidocaine versus control, mean ± standard deviation at rest (2.0 ± 2.7 vs 2.1 ± 2.4, P=0.286 or with movement (2.0 ± 2.6 vs 2.6 ± 2.7, P=0.487. Three adverse events occurred in the lidocaine group (25% of patients. Intravenous lidocaine did not provide clinically significant analgesia to patients undergoing laparoscopic fundoplication. The serum lidocaine concentration of patients who experienced adverse events were within the therapeutic range. This trial cannot confirm the safety of intravenous lidocaine at the dose tested. Keywords: analgesia, local anesthetics, intravenous infusions, pharmacokinetics

  12. Reconstituting factor concentrates: Defining Evidence of Coaching Non-Experts (DEVICE) in haemophilia--a prospective randomized feasibility study.

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    Bidlingmaier, C; Kurnik, K; Hölscher, G; Kappler, M

    2007-09-01

    The introduction of new needleless devices as demanded by the US Department of Labor Occupational Safety and Health Administration (OSHA) has caused problems with the reconstitution of antihaemophilic factor in emergency situations. Our aim therefore was to evaluate the feasibility of a needleless device for reconstitution of antihaemophilic factor for non-haemophilia experts and to define evidence of the need for coaching these physicians via providing two additional photographs illustrating the two key points of the factor reconstitution process. Twenty-eight physicians of a tertiary care university children's hospital were randomized into two groups, either with no further explanation of the reconstitution device or with two additional photographs, showing the two key steps of the procedure. Reconstitution of dummy-factor concentrate was video-taped and evaluated by a blinded helper. Main outcome measure was the successful reconstitution of dummy-factor concentrate and procedure failure respectively. Of the group without explanation of the reconstitution device, only two of 14 physicians were able to reconstitute the dummy-factor concentrate. Of the group receiving two photographs, nine of 14 completed the task successfully (P = 0.0068). The needleless device is not self explaining to non-haemophilia physicians involved in emergency services. Coaching via short to the point instructions as provided by simple visual educational material therefore is crucial to enable these physicians to resolve the expensive emergency drug quickly and correctly. Companies concerned with the production of any devices to dissolve drugs, especially for treatment of rare diseases as haemophilia, therefore should take measures to simplify therapy.

  13. Tramadol vs dexmedetomidine for emergence agitation control in pediatric patients undergoing adenotonsillectomy with sevoflurane anesthesia: prospective randomized controlled clinical study.

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    Bedirli, Nurdan; Akçabay, Mehmet; Emik, Ulku

    2017-03-11

    This study was designed to compare the efficacy of an intraoperative single dose administration of tramadol and dexmedetomidine on hemodynamics and postoperative recovery profile including pain, sedation, emerge reactions in pediatric patients undergoing adenotonsillectomy with sevoflurane anesthesia. Seventy-seven patient, aged 2-12, undergoing adenotonsillectomy with sevoflurane anesthesia was enrolled in this study. Patients were randomly assigned to receive either intravenous 2 mg/kg tramadol (Group T; n = 39) or 1 μg/kg dexmedetomidine (Group D; n = 38) after intubation. Heart rates (HR), mean arterial pressure (MAP) were recorded before induction, at induction and every 5 min after induction. Observational pain scores (OPS), pediatric anesthesia emergence delirium (PAED) scores, percentage of patients with OPS ≥ 4 or PAED scale items 4 or 5 with an intensity of 3 or 4, and Ramsay sedation scores (RSS) were recorded on arrival to the postoperative care unit (PACU) and at 5, 10, 15, 30, 45, 60 min. Extubation time and time to reach Alderete score > 9 were recorded. Dexmedetomidine significantly decreased the HR and MAP 10 and 15 min after induction; increased the RSS 15, 30 and 45 min after arrival to PACU. OPS and PAED scores and percentage of patients with OPS ≥ 4 or PAED scale items 4 or 5 with an intensity of 3 or 4 in both groups did not show any significant difference. Extubation time and time to have Alderete score > 9 was significantly longer in Group D. Both tramadol and dexmedetomidine were effective for controlling pain and emergence agitation. When compared with tramadol intraoperative hypotension, bradycardia and prolonged sedation were problems related with dexmedetomidine administration. Retrospectively registered, registration number: ISRCTN89326952 registration date: 14.07.2016.

  14. Minimally invasive lumbar interbody fusion via MAST Quadrant retractor versus open surgery: a prospective randomized clinical trial

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    WANG Hong-li; L(U) Fei-zhou; JIANG Jian-yuan; MA Xin; XIA Xin-lei; WANG Li-xun

    2011-01-01

    Background In recent years,a variety of minimally invasive lumbar surgery techniques have achieved desirable efficacy,but some dispute remains regarding the advantages over open surgery.This study aimed to compare minimally invasive lumbar interbody fusion via MAST Quadrant retractor with open surgery in terms of perioperative factors,postoperative back muscle function,and 24-month postoperative follow-up results.Methods From September 2006 to June 2008,patients with single-level degenerative lumbar spine disease who were not responsive to conservative treatment were enrolled in this study.Patients were randomized to undergo either minimally invasive surgery (MIS,transforaminal lumbar interbody fusion via MAST Quadrant retractor,41 cases) or open surgery (improved transforaminal lumbar interbody fusion,38 cases).Results The MIS group had longer intraoperative fluoroscopy time than the open surgery group,and the open surgery group had significantly increased postoperative drainage volume and significantly prolonged postoperative recovery time compared with the MIS group (P <0.05 for all).MRI scanning showed that the T2 relaxation time in the multifidus muscle was significantly shorter in the MIS group than in the open surgery group at 3 months after surgery (P <0.01).Surface electromyography of the sacrospinalis muscle showed that the average discharge amplitude and frequency were significantly higher in the MIS group than in the open surgery group (P <0.01).The Oswestry disability index and visual analog scale scores were better at 3,6,12 and 24 months postoperatively than preoperatively in both groups.Both groups of patients met the imaging convergence criteria at the last follow-up.Conclusions MIS can effectively reduce sacrospinalis muscle injury compared with open surgery,which is conducive to early functional recovery.In the short term,MIS is superior to open surgery,but in the long term there is no significant difference between the two procedures.

  15. Carbon Dioxide-Based versus Saline Tissue Expansion for Breast Reconstruction: Results of the XPAND Prospective, Randomized Clinical Trial.

    Science.gov (United States)

    Ascherman, Jeffrey A; Zeidler, Kamakshi; Morrison, Kerry A; Appel, James Z; Berkowitz, R L; Castle, John; Colwell, Amy; Chun, Yoon; Johnson, Debra; Mohebali, Khashayar

    2016-12-01

    AeroForm is a new type of remote-controlled, needle-free, carbon dioxide-based expander involving a potentially faster method of tissue expansion. Results are presented here from the AirXpanders Patient Activated Controlled Tissue Expander pivotal trial comparing AeroForm to saline tissue expanders. Women undergoing two-stage breast reconstruction were randomized at 17 U.S. sites in this U.S. Food and Drug Administration-approved investigational device exemption trial. Expansion in the investigational arm was performed by the patient in 10-cc increments up to 30 cc/day of carbon dioxide and in the control arm by the physician with periodic bolus injections of saline. Safety endpoints, expansion and reconstruction times, pain, and satisfaction were assessed. One hundred fifty women were treated: 98 with carbon dioxide expanders (n = 168) and 52 with saline expanders (n = 88). The treatment success rate (all breasts exchanged successfully excluding non-device-related failures) was 96.1 percent for carbon dioxide and 98.8 percent for saline. Median time to full expansion and completion of the second-stage operation was 21.0 and 108.5 days (carbon dioxide) versus 46.0 and 136.5 days (saline), respectively, with a similar rate of overall complications. Ease of use for the carbon dioxide expander was rated high by patients (98 percent) and physicians (90 percent). The AirXpanders Patient Activated Controlled Tissue Expander trial results demonstrate that a carbon dioxide-based expander is an effective method of tissue expansion with a similar overall adverse event rate compared to saline expanders, and provides a more convenient and expedient expansion. Therapeutic, I.

  16. Topical permethrin and oral ivermectin in the management of scabies: A prospective, randomized, double blind, controlled study

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    Reena Sharma

    2011-01-01

    Full Text Available Background: Scabies is a highly contagious and intensely pruritic parasitic infestation. It is a re-emerging infection in the new millennium especially with HIV pandemic and a significant health problem in developing countries. Various treatment modalities have been used since time immemorial but the search for an ideal scabicide is ongoing. Aims: In this study, we compared the therapeutic efficacy of single application of topical 5% permethrin with oral ivermectin (200 μg/kg/dose in a single-dose and a two-dose regimen in patients with scabies. Methods: 120 clinically diagnosed cases of scabies (>5 years of age and/or >15 kg were randomized into three treatment groups A, B, C of 40 patients each; receiving either topical 5% permethrin (group A or oral ivermectin (200 μg/kg/dose in a single dose (group B or double dose regimen (group C repeated at 2 weeks interval. Patients were followed up at 1, 2, and 4 weeks interval. At each visit, cure rate (>50% improvement in lesion count and pruritus and negative microscopy was assessed and compared. Results: Cure rate in three treatment groups at the end of 4 weeks was 94.7% (A, 90% (B, 89.7%(C, and thus all three treatment modalities were equally efficacious. However, at 1 week follow up, group A patients reported better improvement in both lesion count and pruritus. Conclusions: Both permethrin and ivermectin in both single and two dose regimen are equally efficacious and well tolerated in scabies. However, permethrin has a rapid onset of action.

  17. A randomized prospective study of rehabilitation therapy in the treatment of radiation-induced dysphagia and trismus

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    Tang, Y.; Shen, Q.; Lu, K.; Peng, Y. [Sun Yat-sen Univ., Guangzhou (China). Dept. of Neurology; Wang, Y. [Sun Yat-sen Univ., Guangzhou (China). Dept. of Internal Medicine; Wang, Y. [Sun Yat-sen Univ., Guangzhou (China). Dept. of Neurosurgery

    2011-01-15

    Purpose: To evaluate the therapeutic effect of rehabilitation therapy on radiation-induced dysphagia and trismus in nasopharyngeal carcinoma (NPC) patients after radiotherapy. Patients and Methods: 43 NPC patients after radiotherapy were included. Patients were randomly assigned to either the rehabilitation group or a control group. Both groups were subjected to routine treatment, while the rehabilitation group also received rehabilitation therapy for 3 months. The severity of dysphagia was assessed using the water swallow test, while trismus was evaluated with the LENT/SOMA score and the interincisor distance (IID). The water swallow test, the LENT/SOMA score, as well as IID for both groups before and after treatment were analyzed and compared. Results: After treatment, the rehabilitation group displayed a significant improvement in swallowing function, while the control group did not. The efficacy rate (percentage of patients with excellent or effective results) of rehabilitation group was higher than that of control group (77% vs. 43%), and the difference was statistically significant ({chi}{sup 2} = 5.32, p = 0.02). IID pretreatment and posttreatment did not show much difference in the rehabilitation group, while in the control group IID significantly decreased posttreatment (1.1 {+-} 0.36 cm vs.1.8 {+-} 0.56 cm, p = 0.001). Although the mean IID in patients of both groups decreased after the 3 month follow-up, the decrease in the rehabilitation group was less than that of the control group (0.19 {+-} 0.5 cm vs. 0.69 {+-} 0.56 cm, p = 0.004). The efficacy rate of trismus in the rehabilitation group was significantly higher than that of the control group (64% vs. 28%, {chi}{sup 2} = 5.31, p = 0.02). Conclusions: Rehabilitation training can improve swallow function and slow down the progress of trismus in NPC patients following radiotherapy. (orig.)

  18. A randomized prospective study of rehabilitation therapy in the treatment of radiation-induced dysphagia and trismus.

    Science.gov (United States)

    Tang, Y; Shen, Q; Wang, Y; Lu, K; Wang, Y; Peng, Y

    2011-01-01

    To evaluate the therapeutic effect of rehabilitation therapy on radiation-induced dysphagia and trismus in nasopharyngeal carcinoma (NPC) patients after radiotherapy. 43 NPC patients after radiotherapy were included. Patients were randomly assigned to either the rehabilitation group or a control group. Both groups were subjected to routine treatment, while the rehabilitation group also received rehabilitation therapy for 3 months. The severity of dysphagia was assessed using the water swallow test, while trismus was evaluated with the LENT/SOMA score and the interincisor distance (IID). The water swallow test, the LENT/SOMA score, as well as IID for both groups before and after treatment were analyzed and compared. After treatment, the rehabilitation group displayed a significant improvement in swallowing function, while the control group did not. The efficacy rate (percentage of patients with excellent or effective results) of rehabilitation group was higher than that of control group (77% vs. 43%), and the difference was statistically significant (ϰ(2) = 5.32, p = 0.02). IID pretreatment and posttreatment did not show much difference in the rehabilitation group, while in the control group IID significantly decreased posttreatment (1.1 ± 0.36 cm vs.1.8 ± 0.56 cm, p = 0.001). Although the mean IID in patients of both groups decreased after the 3 month follow-up, the decrease in the rehabilitation group was less than that of the control group (0.19 ± 0.5 cm vs. 0.69 ± 0.56 cm, p = 0.004 ). The efficacy rate of trismus in the rehabilitation group was significantly higher than that of the control group (64% vs. 28%, ϰ(2) = 5.31, p = 0.02). Rehabilitation training can improve swallow function and slow down the progress of trismus in NPC patients following radiotherapy.

  19. Influence of bladder neck suspension stitches on early continence after radical prostatectomy: a prospective randomized study of 180 patients

    Institute of Scientific and Technical Information of China (English)

    Jens-Uwe Stolzenburg; Evangelos Liatsikos; Martin Nicolaus; Panagiotis Kallidonis; Minh Do; Anja Dietel; Tim H(a)fner; George Sakellaropoulos; James Hicks; David Nikoleishvili

    2011-01-01

    Several techniques have been introduced to improve early postoperative continence.In this study,we evaluated the impact of bladder neck (vesicourethral anastomosis) suspension on the outcome of extraperitoneal endoscopic radical prostatectomy (EERPE).In this research,a total of 180 patients underwent EERPE.Group 1 included patients who underwent nerve-sparing EERPE (nsEERPE) (n=45),and Group 2 included patients who underwent nsEERPE with bladder neck suspension (BNS,n=45).Groups 3 (n=45) and 4 (n=45) included patients who received EERPE and EERPE with BNS,respectively.Patients were randomly assigned to receive BNS with their nsEERPE or EERPE procedure.Perioperative parameters were recorded,and continence was evaluated by determining the number and weight of absorbent pads (pad weighing test) on the second day after catheter removal and by a questionnaire 3 months postoperatively.Two days after catheter removal,11.1% of Group 1,11.1% of Group 2,4.4% of Group 3 and 8.9% of Group 4 were continent.The average urine loss was 80.4,70.1,325.0 and 291.3 g for the each of these groups,respectively.At 3 months,76.5% of Group 1 and 81.3% of Group 2 were continent.The continence figures for Group 3 and 4 were 48.5% and 43.8%,respectively.Similar overall rates were observed in all groups.In conclusion,although there are controversial reports in the literature,early continence was never observed to be significantly higher in the BNS groups when compared with the non-BNS groups,regardless of the EERPE technique performed.

  20. Evidence Suggesting That Obesity Prevention Measures May Improve Prostate Cancer Outcomes Using Data from a Prospective Randomized Trial

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    Ravi A. Chandra

    2014-01-01

    Full Text Available Purpose. Increasing body mass index (BMI is associated with higher risk prostate cancer (PC at presentation. Whether increasing BMI also prompts earlier salvage androgen suppression therapy (sAST is unknown. Materials and Methods. Between 1995 and 2001, 206 men with unfavorable risk PC were treated with radiation therapy (RT or RT and six months of androgen suppression therapy in a randomized controlled trial (RCT. 108 sustained PSA failure; 51 received sAST for PSA approaching 10 ng/mL; 49 with BMI data comprised the study cohort. A multivariable Cox regression analysis identified pretreatment factors associated with earlier sAST receipt. Results. Increasing BMI prompted earlier sAST (median years: 3.7 for overweight/obese, 6.9 for normal weight; adjusted hazard ratio (AHR: 1.11; 95% CI: 1.04, 1.18; P=0.002 as did high versus other risk PC (median: 3.2 versus 5.2 years; AHR: 2.01; 95% CI: 1.05, 3.83; P=0.03. Increasing median time to sAST was observed for overweight/obese men with high versus other risk PC and for normal-weight men with any risk PC being 2.3, 4.6, and 6.9 years, respectively (P<0.001 for trend. Conclusion. Increasing BMI was associated with earlier sAST. A RCT evaluating whether BMI reduction delays or eliminates need for sAST is warranted.

  1. A Prospective Randomized Study of Adjuvant Chemotherapy in Completely Resected Stage Ⅲ-N2 Non Small Cell Lung Cancer

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    Objective: To evaluate the effect of postoperative adjuvant chemotherapy on survival after complete resection of stage Ⅲ-N2 non-small-cell lung cancer. Methods: From Jan. 1999 to Dec. 2003, one-hundred and fifty patients, who were diagnosed as stage Ⅲ-N2 non-small cell lung cancer after operation, were randomly devided into chemotherapy group and control group. The former received four cycles of chemotherapy with NVB (25 mg/m2,D1, D5)/paclitaxel (175 mg/m2, DI) and Carboplatin (AUC=5, D1). Results: In chemotherapy group, 75.8% (68/79) of patients had finished the 4 cycles of chemotherapy and no one died of toxic effects of chemotherapy.Twenty-five percent of the patients had grade 3-4 neutropenia and 2% had febrile neutropenia. The median survival for the entire 150 patients was 879 d, with 1-year survival rate of 81%, 2-year survival rate of 59% and 3-year survival rate of 43%. There was no significant difference in median survival between chemotherapy and control group (897 d vs 821 d, P=0.0527), but there was significant difference in the 1-year and 2-year overall survival (94.71%, 76.28% vs 512 d, P=0.122), but there