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Sample records for surgery randomized clinical

  1. Diode laser surgery versus scalpel surgery in the treatment of fibrous hyperplasia: a randomized clinical trial.

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    Amaral, M B F; de Ávila, J M S; Abreu, M H G; Mesquita, R A

    2015-11-01

    Fibrous hyperplasia is treated by surgical incision using a scalpel, together with removal of the source of chronic trauma. However, scalpel techniques do not provide the haemostasis that is necessary when dealing with highly vascular tissues. Diode laser surgery can be used in the management of oral tissues due to its high absorption by water and haemoglobin, and has provided good results in both periodontal surgery and oral lesions. The aim of the present study was to compare the effects of diode laser surgery to those of the conventional technique in patients with fibrous hyperplasia. A randomized clinical trial was performed in which surgical and postoperative evaluations were analyzed. On comparison of the laser-treated (study group) patients to those treated with a scalpel (control group), significant differences were observed in the duration of surgery and the use of analgesic medications. Over a 3-week period, clinical healing of the postoperative wound was significantly faster in the control group as compared to the study group. In conclusion, diode laser surgery proved to be more effective and less invasive when compared to scalpel surgery in the management of fibrous hyperplasia. However, wound healing proved to be faster when using scalpel surgery. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  2. Preoperative lifestyle intervention in bariatric surgery: a randomized clinical trial.

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    Kalarchian, Melissa A; Marcus, Marsha D; Courcoulas, Anita P; Cheng, Yu; Levine, Michele D

    2016-01-01

    Studies on the impact of presurgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed. To evaluate whether a presurgery behavioral lifestyle intervention improves weight loss through a 24-month postsurgery period. Bariatric Center of Excellence at a large, urban medical center. Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of usual presurgical care. The lifestyle intervention consisted of 8 weekly face-to-face sessions, followed by 16 weeks of face-to-face and telephone sessions before surgery; the intervention also included 3 monthly telephone contacts after surgery. Assessments were conducted 6, 12, and 24 months after surgery. Participants who underwent surgery (n = 143) were 90.2% female and 86.7% White. Average age was 44.9 years, and average body mass index was 47.5 kg/m(2) at study enrollment. At follow-up, 131 (91.6%), 126 (88.1%), 117 (81.8%) patients participated in the 6-, 12-, and 24-month assessments, respectively. Percent weight loss from study enrollment to 6 and 12 months after surgery was comparable for both groups, but at 24 months after surgery, the lifestyle group had significantly smaller percent weight loss compared with the usual care group (26.5% versus 29.5%, respectively, P = .02). Presurgery lifestyle intervention did not improve weight loss at 24 months after surgery. The findings from this study raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients. Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  3. Cyanoacrylate Skin Microsealant for Preventing Surgical Site Infection after Vascular Surgery : A Discontinued Randomized Clinical Trial

    NARCIS (Netherlands)

    Vierhout, Bastiaan P.; Ott, Alewijn; Reijnen, Michel M. P. J.; Oskam, Jacques; Ott, Alewijn; van den Dungen, Jan J. A. M.; Zeebregts, Clark J.

    Background: Surgical site infections (SSI) after vascular surgery are related to substantial morbidity. Restriction of bacterial access to the site of surgery with a cyanoacrylate sealant is a new concept. We performed a randomized clinical trial to assess the effect of the sealing of skin with a

  4. Oral nutrition or water loading before hip replacement surgery; a randomized clinical trial

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    Ljunggren Stefan

    2012-07-01

    Full Text Available Abstract Background Surgery induces insulin resistance that might be alleviated by a nutritional drink given preoperatively. The authors hypothesized that some of the beneficial effects of the drink could be attributed to the volume component (approximately 1 L rather than to the nutrients. Methods Sixty patients scheduled for elective total hip replacement under spinal anesthesia were recruited to a clinical trial, and randomly allocated to preoperative fasting, to oral ingestion of tap water, or to oral ingestion of a carbohydrate drink. An intravenous glucose tolerance test calculated glucose clearance and insulin sensitivity on the day before surgery, in the postoperative ward, and on the day after surgery. Other parameters were stress (cortisol in plasma and urine, muscle catabolism (urinary 3-methylhistidine, and wellbeing. Results Fifty-seven patients completed the study. In the postoperative ward, the glucose clearance and the insulin response had decreased from the previous day by 23% and 36%, respectively. Insulin sensitivity did not decrease until the next morning (−48% and was due to an increased insulin response (+51%. Cortisol excretion was highest on the day of surgery, while 3-methylhistidine increased 1 day later. Follow-up on the third postoperative day showed an average of 1.5 complications per patient. Wellbeing was better 2 weeks after than before the surgery. None of the measured parameters differed significantly between the study groups. Conclusions Preoperative ingestion of tap water or a nutritional drink had no statistically significant effect on glucose clearance, insulin sensitivity, postoperative complications, or wellbeing in patients undergoing elective hip surgery. Trial registration Registration number: NCT 01211184 (http://www.clinicaltrials.gov

  5. Oral nutrition or water loading before hip replacement surgery; a randomized clinical trial.

    Science.gov (United States)

    Ljunggren, Stefan; Hahn, Robert G

    2012-07-02

    Surgery induces insulin resistance that might be alleviated by a nutritional drink given preoperatively. The authors hypothesized that some of the beneficial effects of the drink could be attributed to the volume component (approximately 1 L) rather than to the nutrients. Sixty patients scheduled for elective total hip replacement under spinal anesthesia were recruited to a clinical trial, and randomly allocated to preoperative fasting, to oral ingestion of tap water, or to oral ingestion of a carbohydrate drink. An intravenous glucose tolerance test calculated glucose clearance and insulin sensitivity on the day before surgery, in the postoperative ward, and on the day after surgery. Other parameters were stress (cortisol in plasma and urine), muscle catabolism (urinary 3-methylhistidine), and wellbeing. Fifty-seven patients completed the study. In the postoperative ward, the glucose clearance and the insulin response had decreased from the previous day by 23% and 36%, respectively. Insulin sensitivity did not decrease until the next morning (-48%) and was due to an increased insulin response (+51%). Cortisol excretion was highest on the day of surgery, while 3-methylhistidine increased 1 day later. Follow-up on the third postoperative day showed an average of 1.5 complications per patient. Wellbeing was better 2 weeks after than before the surgery. None of the measured parameters differed significantly between the study groups. Preoperative ingestion of tap water or a nutritional drink had no statistically significant effect on glucose clearance, insulin sensitivity, postoperative complications, or wellbeing in patients undergoing elective hip surgery.

  6. [Comparison of two antimicrobial prophylaxis regimens in biliary tract surgery: a randomized controlled clinical trial].

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    Orozco, H; Sifuentes Osornio, J; Prado, E; Takahashi, T; López Graniel, C M; Anaya, E; Canto, J

    1993-01-01

    The aim of this study was to analyze the efficacy in prophylaxis during biliary tract and gallbladder surgery with amoxicillin/clavulanate and to compare it with the combination of cephalothin and clindamycin. A randomized nonblinded clinical trial with a blind independent observer. Tertiary-care center. Forty-two patients were included. All had undergone biliary tract and/or gallbladder surgery. They were divided in two groups: 22 in group A (cephalothin and clindamycin), and 20 in group B (amoxicillin/clavulanate). Patients from group A were intravenously treated with three doses of cephalothin (2 g at anesthetic induction and two additional doses of 1 g at six-hour intervals), and three of clindamycin (600 mg every six hours). Patients from group B received three doses of amoxicillin/clavulanate (1000/200 mg IV, one during the induction of the anesthesia followed by two more at six-hour intervals). In group A six wound infections were recorded, one of them with secondary bacteremia. In group B we did not record any infection (Fisher p clindamycin.

  7. A randomized clinical trial of continuous aspiration of subglottic secretions in cardiac surgery patients.

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    Kollef, M H; Skubas, N J; Sundt, T M

    1999-11-01

    To determine whether the application of continuous aspiration of subglottic secretions (CASS) is associated with a decreased incidence of ventilator-associated pneumonia (VAP). Prospective clinical trial. Cardiothoracic ICU (CTICU) of Barnes-Jewish Hospital, St. Louis, a university-affiliated teaching hospital. Three hundred forty-three patients undergoing cardiac surgery and requiring mechanical ventilation in the CTICU. Patients were assigned to receive either CASS, using a specially designed endotracheal tube (Hi-Lo Evac; Mallinckrodt Inc; Athlone, Ireland), or routine postoperative medical care without CASS. One hundred sixty patients were assigned to receive CASS, and 183 were assigned to receive routine postoperative medical care without CASS. The two groups were similar at the time of randomization with regard to demographic characteristics, surgical procedures performed, and severity of illness. Risk factors for the development of VAP were also similar during the study period for both treatment groups. VAP was seen in 8 patients (5.0%) receiving CASS and in 15 patients (8. 2%) receiving routine postoperative medical care without CASS (relative risk, 0.61%; 95% confidence interval, 0.27 to 1.40; p = 0. 238). Episodes of VAP occurred statistically later among patients receiving CASS ([mean +/- SD] 5.6 +/- 2.3 days) than among patients who did not receive CASS (2.9 +/- 1.2 days); (p = 0.006). No statistically significant differences for hospital mortality, overall duration of mechanical ventilation, lengths of stay in the hospital or CTICU, or acquired organ system derangements were found between the two treatment groups. No complications related to CASS were observed in the intervention group. Our findings suggest that CASS can be safely administered to patients undergoing cardiac surgery. The occurrence of VAP can be significantly delayed among patients undergoing cardiac surgery using this simple-to-apply technique.

  8. Neuraxial anesthesia for orthopedic surgery: systematic review and meta-analysis of randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Fabiano Timbó Barbosa

    Full Text Available CONTEXT AND OBJECTIVE: Taking the outcome of mortality into consideration, there is controversy about the beneficial effects of neuraxial anesthesia for orthopedic surgery. The aim of this study was to compare the effectiveness and safety of neuraxial anesthesia versus general anesthesia for orthopedic surgery. DESIGN AND SETTING: Systematic review at Universidade Federal de Alagoas. METHODS: We searched the Cochrane Central Register of Controlled Trials (Issue 10, 2012, PubMed (1966 to November 2012, Lilacs (1982 to November 2012, SciELO, EMBASE (1974 to November 2012 and reference lists of the studies included. Only randomized controlled trials were included. RESULTS: Out of 5,032 titles and abstracts, 17 studies were included. There were no statistically significant differences in mortality (risk difference, RD: -0.01; 95% confidence interval, CI: -0.04 to 0.01; n = 1903, stroke (RD: 0.02; 95% CI: -0.04 to 0.08; n = 259, myocardial infarction (RD: -0.01; 95% CI: -0.04 to 0.02; n = 291, length of hospitalization (mean difference, -0.05; 95% CI: -0.69 to 0.58; n = 870, postoperative cognitive dysfunction (RD: 0.00; 95% CI: -0.04 to 0.05; n = 479 or pneumonia (odds ratio, 0.61; 95% CI: 0.25 to 1.49; n = 167. CONCLUSION: So far, the evidence available from the studies included is insufficient to prove that neuraxial anesthesia is more effective and safer than general anesthesia for orthopedic surgery. However, this systematic review does not rule out clinically important differences with regard to mortality, stroke, myocardial infarction, length of hospitalization, postoperative cognitive dysfunction or pneumonia.

  9. Randomized Controlled Trial of Antiseptic Hand Hygiene Methods in an Outpatient Surgery Clinic.

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    Therattil, Paul J; Yueh, Janet H; Kordahi, Anthony M; Cherla, Deepa V; Lee, Edward S; Granick, Mark S

    2015-12-01

    Outpatient wound care plays an integral part in any plastic surgery practice. However, compliance with hand hygiene measures has shown to be low, due to skin irritation and lack of time. The objective of this trial was to determine whether single-use, long-acting antiseptics can be as effective as standard multiple-use hand hygiene methods in an outpatient surgical setting. A prospective, randomized controlled trial was performed in the authors' outpatient plastic surgery clinic at Rutgers New Jersey Medical School, Newark, NJ to compare the efficacy of an ethyl alcohol-based sanitizer (Avagard D Instant Hand Aniseptic, 3M Health Care, St. Paul, MN), a benzalkonium chloride-based sanitizer (Soft & Shield, Bioderm Technologies, Inc, Trenton, NJ, distributed by NAPP Technologies, Hackensack, NJ ), and soap and- water handwashing. Subjects included clinic personnel, who were followed throughout the course of a 3-hour clinic session with hourly hand bacterial counts taken. During the course of the trial, 95 subjects completed the clinic session utilizing 1 of the hand hygiene methods (36 ethyl alcohol-based sanitizer, 38 benzalkonium chloride-based sanitizer, and 21 soap-and-water handwashing). There was no difference between hand bacterial counts using the different methods at 4 hourly time points (P greater than 0.05). Hand bacterial counts increased significantly over the 3-hour clinic session with the ethyl alcohol-based sanitizer (9.24 to 21.90 CFU, P less than 0.05), benzalkonium chloride-based sanitizer (6.69 to 21.59 CFU, P less than 0.05), and soap-and-water handwashing (8.43 to 22.75 CFU, P less than 0.05). There does not appear to be any difference in efficacy between single-use, long-acting sanitizer, and standard multiple-use hand hygiene methods. Hand bacterial counts increased significantly over the course of the 3-hour clinic session regardless of the hand hygiene measure used. Hand condition of subjects was improved with the ethyl alcohol

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

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

    2018-01-01

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

  11. Randomized clinical study comparing piezosurgery and conventional rotatory surgery in mandibular cyst enucleation.

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    Pappalardo, Sabrina; Guarnieri, Renzo

    2014-07-01

    The aim of the present study is to compare piezoelectric surgery to the conventional rotatory surgery in mandibular cyst enucleation, and to determine the 2 method's suitability and the postoperative outcomes. Eighty patients were included in the study. 35 male and 45 female, which showed cystic mandibular lesions, compared with the inferior alveolar nerve or the mental nerve. The patients were randomly divided into two groups. In the test group, cystectomy was performed using conventional rotatory instrumentation (rotatory-group), and in the other one piezoelectric surgery (piezo-group). The swelling was documented 24/48/72 h and 1 week post-surgery and the patients recorded their subjective postoperative pain daily for 7 days using a Visual Analog Scale (VAS). Patients treated with piezoelectric technique have presented a lower VAS, minor swelling and less recovery time compared to the rotatory-group. No lesions of the mandible nerve were detected with piezosurgery whereas surgery with rotary instruments resulted in 8% hypesthesia at least up to one week. The results of this study suggest that piezosurgery may be considered effective in cyst enucleation compared to traditional procedures with burs, since it grants the patients significantly less post-surgical pain and swelling. Copyright © 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  12. Analgesia with interfascial continuous wound infiltration after laparoscopic colon surgery: A randomized clinical trial.

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    Telletxea, S; Gonzalez, J; Portugal, V; Alvarez, R; Aguirre, U; Anton, A; Arizaga, A

    2016-04-01

    For major laparoscopic surgery, as with open surgery, a multimodal analgesia plan can help to control postoperative pain. Placing a wound catheter intraoperatively following colon surgery could optimize the control of acute pain with less consumption of opioids and few adverse effects. We conducted a prospective, randomized, study of patients scheduled to undergo laparoscopic colon surgery for cancer in Galdakao-Usansolo Hospital from January 2012 to January 2013. Patients were recruited and randomly allocated to wound catheter placement plus standard postoperative analgesia or standard postoperative analgesia alone. A physician from the acute pain management unit monitored all patients for pain at multiple points over the first 48 hours after surgery. The primary outcome variables were verbal numeric pain scale scores and amount of intravenous morphine used via patient controlled infusion. 92 patients were included in the study, 43 had a wound catheter implanted and 49 did not. Statistically significant differences in morphine consumption were observed between groups throughout the course of the treatment period. The mean total morphine consumption at the end of the study was 5.63±5.02mg among wound catheter patients and 21. 86±17.88mg among control patients (P=.0001). Wound catheter patients had lower pain scale scores than control patients throughout the observation period. No adverse effects associated with the wound catheter technique were observed. The wound catheter group showed lower hospital stays with statistically significant difference (P=.02). In patients undergoing laparoscopic colon surgery, continuous infusion of local anaesthetics through interfascial wound catheters during the first 48h aftersurgery reduced the level of perceived pain and also reduced parenteral morphine consumption with no associated adverse effects and lower hospital stays. Copyright © 2015 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor

  13. Bemiparin for thromboprophylaxis after benign gynecologic surgery: a randomized clinical trial.

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    Alalaf, S K; Jawad, A K; Jawad, R K; Ali, M S; Al Tawil, N G

    2015-12-01

    Venous thromboembolism (VTE) is the leading cause of mortality and morbidity in women following gynecologic surgery. To determine the efficacy of a second-generation low molecular weight heparin (bemiparin) for thromboprophylaxis after benign gynecologic surgery. We performed a single-blind randomized controlled trial including women in the moderate-risk, high-risk and highest-risk groups for developing VTE after benign gynecologic surgery. Participants were randomized at a 1 : 1 ratio into parallel groups to receive either seven daily doses of 3500 IU of subcutaneous bemiparin or to a non-intervention group receiving standard rehydration and advice on ambulation. Participants were followed up for 7 days and 30 days postoperatively for symptomatic VTE, which was confirmed by compression Doppler ultrasound, magnetic resonance imaging, or computed tomographic pulmonary angiography, according to the type of VTE. In total, 387 participants were randomized to the bemiparin group and 387 to the non-intervention group. The incidence of symptomatic VTE (deep vein thrombosis and pulmonary embolism) events was lower (0/377) in participants who received bemiparin than in those who received no pharmacologic intervention (12/380, 3.2%; 95% confidence interval [CI] 0.002-0.6). Logistic regression analysis showed significant associations between VTE and immobility (odds ratio [OR] 7.1; 95% CI 1.3-36.2), varicose veins (OR 16.8; 95% CI 3.1-76.2), and thrombophilia (OR 39.3; 95% CI 1.5-1006.7). There were no major bleeding events or side effects related to the use of bemiparin. Bemiparin was an effective thromboprophylactic agent for preventing venous thrombosis after benign gynecologic surgery. © 2015 International Society on Thrombosis and Haemostasis.

  14. Randomized clinical trial of expressive writing on wound healing following bariatric surgery.

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    Koschwanez, Heidi; Robinson, Hayley; Beban, Grant; MacCormick, Andrew; Hill, Andrew; Windsor, John; Booth, Roger; Jüllig, Mia; Broadbent, Elizabeth

    2017-07-01

    Writing emotionally about upsetting life events (expressive writing) has been shown to speed healing of punch-biopsy wounds compared to writing objectively about daily activities. We aimed to investigate whether a presurgical expressive writing intervention could improve surgical wound healing. Seventy-six patients undergoing elective laparoscopic bariatric surgery were randomized either to write emotionally about traumatic life events (expressive writing) or to write objectively about how they spent their time (daily activities writing) for 20 min a day for 3 consecutive days beginning 2 weeks prior to surgery. A wound drain was inserted into a laparoscopic port site and wound fluid analyzed for proinflammatory cytokines collected over 24 hr postoperatively. Expanded polytetrafluoroethylene tubes were inserted into separate laparoscopic port sites during surgery and removed after 14 days. Tubes were analyzed for hydroxyproline deposition (the primary outcome), a major component of collagen and marker of healing. Fifty-four patients completed the study. Patients who wrote about daily activities had significantly more hydroxyproline than did expressive writing patients, t(34) = -2.43, p = .020, 95% confidence interval [-4.61, -0.41], and higher tumor necrosis factor-alpha, t(29) = -2.42, p = .022, 95% confidence interval [-0.42, -0.04]. Perceived stress significantly reduced in both groups after surgery. Expressive writing prior to bariatric surgery was not effective at increasing hydroxyproline at the wound site 14 days after surgery. However, writing about daily activities did predict such an increase. Future research needs to replicate these findings and investigate generalizability to other surgical groups. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  15. A randomized-clinical trial examining a neoprene abdominal binder in gynecologic surgery patients

    Science.gov (United States)

    Szender, J.B.; Hall, K.L.; Kost, E.R.

    2016-01-01

    Summary Purpose of Investigation Pain control and early ambulation are two important postoperative goals. Strategies that decrease morphine use while increasing ambulation have the potential to decrease postoperative complications. In this study the authors sought to determine the effect of an abdominopelvic binder on postoperative morphine use, pain, and ambulation in the first day after surgery. Materials and Methods The authors randomly assigned 75 patients undergoing abdominal gynecologic surgery to either binder or not after surgery. Demographic data and surgical characteristics were collected. Outcome variables included morphine use, pain score, time to ambulation, and number of ambulations. Results A group at high risk for decreased mobility was identified and the binder increased the number of ambulatory events by 300%, 260%, and 240% in patients with vertical incisions, age over 50 years, and complex surgeries, respectively. Morphine use and pain scores were not significantly different. Conclusion The binder increased ambulations in the subset of patients at the highest risk for postoperative complications: elderly, cancer patients, and vertical incisions. Routine use of the binder may benefit particularly high-risk gynecologic surgical patients. PMID:25864252

  16. Sensory retraining: burden in daily life related to altered sensation after orthognathic surgery, a randomized clinical trial.

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    Phillips, C; Kim, S H; Tucker, M; Turvey, T A

    2010-08-01

    Assess the long-term effect of sensory retraining exercises, age, gender, type of surgery, and pre-surgical psychological distress on patients' perception of the interference related to altered sensation 2 years after orthognathic surgery. A total of 186 subjects with a developmental dentofacial disharmony were enrolled in a multicenter randomized clinical trial: one center was a community-based practice and the other a university-based center. Subjects were randomly allocated to two groups: standard of care mouth opening exercises after BSSO or a progressive series of sensory retraining facial exercises in addition to the opening exercises. At 1, 3, 6, 12, and 24 months after surgery, subjects scored unusual feelings on the face, numbness, and loss of lip sensitivity from 'no problem (1)' to 'serious problem (7)'. A marginal proportional odds model was fit for each of the ordinal outcomes. Up to 2 years after surgery, the opening exercise only group had a higher likelihood of reporting interference in daily activities related to numbness and loss of lip sensitivity than the sensory retraining exercise group. The difference between the two groups was relatively constant. Older subjects and those with elevated psychological distress before surgery reported higher burdens related to unusual facial feelings, numbness, and loss of lip sensitivity (p pre-surgical counseling regarding the impact on daily life of persistent altered sensation following a mandibular osteotomy.

  17. A Randomized Clinical Trial of Red Blood Cell Transfusion Triggers in Cardiac Surgery.

    Science.gov (United States)

    Koch, Colleen G; Sessler, Daniel I; Mascha, Edward J; Sabik, Joseph F; Li, Liang; Duncan, Andra I; Zimmerman, Nicole M; Blackstone, Eugene H

    2017-10-01

    Class I evidence supporting a threshold for transfusion in the cardiac surgical setting is scarce. We randomly allocated patients to a transfusion hematocrit trigger of 24% versus 28% to compare morbidity, mortality, and resource use. From March 2007 to August 2014, two centers randomly assigned 722 adults undergoing coronary artery bypass graft surgery or valve procedures to a 24% hematocrit trigger (n = 363, low group) or 28% trigger (n = 354, high group). One unit of red blood cells was transfused if the hematocrit fell below the designated threshold. The primary endpoint was a composite of postoperative morbidities and mortality. Treatment effect was primarily assessed using an average relative effect generalized estimating equation model. At the second planned interim analysis, the a priori futility boundary was crossed, and the study was stopped. There was no detected treatment effect on the composite outcome (average relative effect odds ratio, low versus high, 0.86, 95% confidence interval: 0.29 to 2.54, p = 0.71). However, the low group received fewer red blood cell transfusions than the high group (54% versus 75%, p < 0.001), mostly administered in the operating room (low group, 112 [31%]; high group, 208 [59%]), followed by intensive care unit (low, 105 [31%]; high, 115 [34%]) and floor (low, 41 [12%]; high, 42 [13%]). The low group was exposed to lower hematocrits: median before transfusion, 22% (Q1 = 21%, Q3 = 23%) versus 24% (Q1 = 22%, Q3 = 25%). Negative exposures differed between treatment groups, with lower hematocrit in the 24% trigger group and more red blood cells used in the 28% group, but adverse outcomes did not differ. Because red blood cell use was less with a 24% trigger without adverse effects, our randomized trial results support aggressive blood conservation efforts in cardiac surgery. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  18. Comparison of the analgesic efficacy of preoperative/postoperative oral dexketoprofen trometamol in third molar surgery: A randomized clinical trial.

    Science.gov (United States)

    Esparza-Villalpando, Vicente; Chavarria-Bolaños, Daniel; Gordillo-Moscoso, Antonio; Masuoka-Ito, David; Martinez-Rider, Ricardo; Isiordia-Espinoza, Mario; Pozos-Guillen, Amaury

    2016-09-01

    The aim of this study was to compare the efficacy of preoperative and postoperative dexketoprofen trometamol for pain control after third molar surgery. Sixty subjects indicated for impacted mandibular third molar surgery were randomly assigned to two groups: preoperative (group 1, n = 30) and postoperative (group 2, n = 30) administration. Group 1 received 25 mg of dexketoprofen trometamol 30 min before surgery and 1 placebo capsule (same color and size with active drug) immediately after surgery. Group 2 received the placebo capsule 30 min before surgery and 25 mg of dexketoprofen trometamol immediately after surgery. Pain intensity was assessed using a numeric rating scale (NRS) during the first 8 h. The time of the need for a second dose of dexketoprofen trometamol, after the first administration, was recorded. The data were analyzed using mixed-model repeated-measures (MMRM), Wilcoxon rank-sum, and Kaplan-Meier analysis. After the 8 h period, no statistically significant difference was observed in the intensity of pain (MMRM, p = 0.41); and no significant difference in the time for a second dose (p = 0.956). In conclusion, preoperative administration of dexketoprofen trometamol is a reasonable clinical approach that is as effective as conventional postoperative pharmacological treatment, with the advantage of allowing early analgesia before pain develops. (ClinicalTrials.gov: NCT02380001). Copyright © 2016 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  19. Diathermy vs. scalpel skin incisions in general surgery: double-blind, randomized, clinical trial.

    Science.gov (United States)

    Shamim, Muhammad

    2009-08-01

    This prospective, double-blind, randomized, controlled trial was designed to compare the outcome of diathermy incisions versus scalpel incisions in general surgery. A total of 369 patients who underwent diathermy incision (group A: 185 patients) or scalpel incision (group B: 184 patients) were analyzed. Variables analyzed were: surgical wound classification, length and depth of incision, incision time, duration of operation, incisional blood loss, postoperative pain, duration of hospital stay, duration of healing, and postoperative complications. The inclusion criteria were all patients who underwent elective or emergency general surgery. The exclusion criteria were only cases with incomplete patients' data and patients who were lost to follow-up. This study was conducted at Fatima Hospital-Baqai Medical University and Shamsi Hospital (Karachi), from January 2006 to December 2007. Incision time was significantly longer for patients in group B (p = 0.001). Incisional blood loss also was more for patients in group B (p = 0.000). Pain perception was found to be markedly reduced during the first 48 h in group A (p = 0.000). Total period of hospital stay (p = 0.129) and time for complete wound healing (p = 0.683) were almost the same for both groups. Postoperative complication rate by wound classification did not differ markedly between the two groups (p = 0.002 vs. p = 0.000). Diathermy incision has significant advantages compared with the scalpel because of reduced incision time, less blood loss, & reduced early postoperative pain.

  20. Effects of dexmedetomidine on heart arrhythmia prevention in off-pump coronary artery bypass surgery: A randomized clinical trial.

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    Soltani, Ghasem; Jahanbakhsh, Saeed; Tashnizi, Mohammad Abbasi; Fathi, Mehdi; Amini, Shahram; Zirak, Nahid; Sheybani, Shima

    2017-10-01

    Arrhythmia occurring during and after surgery is one of the major complications in open-heart surgery. Dexmedetomidine is an intravenous alpha-2 agonist and very specific short-acting drug to protect the various organs against ischemic injuries and blood reflow. However, the effect of dexmedetomidine for preventing intraoperative heart arrhythmias has not been recognized. This study aimed to determine the effect of dexmedetomidine on the incidence rate of heart arrhythmias and anesthetic required in off-pump coronary artery bypass surgery. This randomized clinical trial was conducted on patients who were candidates for off-pump coronary artery bypass referring to Imam Reza Hospital of Mashhad, Iran, from July 2016 through January 2017. The patients were randomly assigned to two groups of intervention (infusion of 0.5 mcg/kg/h dexmedetomidine together with induction followed by infusion of 0.5 mcg/kg/h by the end of the surgery) or control (saline infusion). Mean arterial pressure (MAP) and heart rate (HR) were measured before induction, during surgery operation and ICU admission. Data were analyzed by SPSS version 18 using Chi Square and independent-samples t-test. A total of 76 patients with a mean age of 59.8 ± 8.2 years (in two groups of 38) were studied. The two groups had no statistically significant difference in terms of background variables. The MAP and HR values before induction, during surgery and ICU admission were significantly higher in the control group than in the intervention group (p=0.001). Out of the studied arrhythmias, the values of PAC (55.2% vs. 15.7%), PVC (81.5% vs. 21.0%), AF (26.3% vs. 7.8%), VTAC (21.0% vs. 2.6%) were significantly lower in dexmedetomidine group (p=0.001). It seems that dexmedetomidine administration during induction and surgery can cause significant reduction in most of the common arrhythmias in off-pump coronary bypass surgery. The use of dexmedetomidine maintains MAP and HR at significantly lower values, and changes

  1. Effectiveness of manual therapy versus surgery in pain processing due to carpal tunnel syndrome: A randomized clinical trial.

    Science.gov (United States)

    Fernández-de-Las-Peñas, C; Cleland, J; Palacios-Ceña, M; Fuensalida-Novo, S; Alonso-Blanco, C; Pareja, J A; Alburquerque-Sendín, F

    2017-08-01

    People with carpal tunnel syndrome (CTS) exhibit widespread pressure pain and thermal pain hypersensitivity as a manifestation of central sensitization. The aim of our study was to compare the effectiveness of manual therapy versus surgery for improving pain and nociceptive gain processing in people with CTS. The trial was conducted at a local regional Hospital in Madrid, Spain from August 2014 to February 2015. In this randomized parallel-group, blinded, clinical trial, 100 women with CTS were randomly allocated to either manual therapy (n = 50), who received three sessions (once/week) of manual therapies including desensitization manoeuvres of the central nervous system, or surgical intervention (n = 50) group. Outcomes including pressure pain thresholds (PPT), thermal pain thresholds (HPT or CPT), and pain intensity which were assessed at baseline, and 3, 6, 9 and 12 months after the intervention by an assessor unaware of group assignment. Analysis was by intention to treat with mixed ANCOVAs adjusted for baseline scores. At 12 months, 95 women completed the follow-up. Patients receiving manual therapy exhibited higher increases in PPT over the carpal tunnel at 3, 6 and 9 months (all, p < 0.01) and higher decrease of pain intensity at 3 month follow-up (p < 0.001) than those receiving surgery. No significant differences were observed between groups for the remaining outcomes. Manual therapy and surgery have similar effects on decreasing widespread pressure pain sensitivity and pain intensity in women with CTS. Neither manual therapy nor surgery resulted in changes in thermal pain sensitivity. The current study found that manual therapy and surgery exhibited similar effects on decreasing widespread pressure pain sensitivity and pain intensity in women with carpal tunnel syndrome at medium- and long-term follow-ups investigating changes in nociceptive gain processing after treatment in carpal tunnel syndrome. © 2017 European Pain Federation - EFIC®.

  2. 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.

  3. Effect of tranexamic acid irrigation on perioperative blood loss during orthognathic surgery: a double-blind, randomized controlled clinical trial.

    Science.gov (United States)

    Eftekharian, Hamidreza; Vahedi, Ruhollah; Karagah, Tuba; Tabrizi, Reza

    2015-01-01

    Perioperative hemorrhage is an important concern during orthognathic surgery. The purpose of this study was to assess the effect of tranexamic acid (TXA) irrigation on perioperative hemorrhage during orthognathic surgery. In this double-blind, randomized controlled clinical trial, 56 participants who underwent orthognathic surgery were divided into 2 groups. The patients in the first group received TXA irrigation with normal saline (1 mg/mL), and the patients in the second group had normal saline for irrigation during orthognathic surgery. Age, gender, operation duration, the amount of irrigation solution used, and preoperative hemoglobin, hematocrit, and weight were the variables that were studied. The use of TXA solution for irrigation was the predictive factor of the study. Each group consisted of 28 patients. Group 1 consisted of 15 male patients (53.6%) and 13 female patients (46.4%) and group 2 consisted of 14 male patients (50%) and 14 female patients (50%). There was no difference in the distributions of the variables between the 2 groups, except for the duration of the operation. The mean duration of the operation was 3.94 ± 0.61 hours in group 1 and 4.17 ± 0.98 hours in group 2, and the difference in this respect between the 2 groups was statistically significant (P .05). TXA is effective in reducing intraoperative blood loss in patients for whom substantial blood loss is anticipated. Copyright © 2015 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  4. Close Contact Casting vs Surgery for Initial Treatment of Unstable Ankle Fractures in Older Adults: A Randomized Clinical Trial.

    Science.gov (United States)

    Willett, Keith; Keene, David J; Mistry, Dipesh; Nam, Julian; Tutton, Elizabeth; Handley, Robert; Morgan, Lesley; Roberts, Emma; Briggs, Andrew; Lall, Ranjit; Chesser, Timothy J S; Pallister, Ian; Lamb, Sarah E

    2016-10-11

    Ankle fractures cause substantial morbidity in older persons. Surgical fixation is the contemporary intervention but is associated with infection and other healing complications. To determine whether initial fracture treatment with close contact casting, a molded below-knee cast with minimal padding, offers outcome equivalent to that with immediate surgery, with fewer complications and less health resource use. This was a pragmatic, equivalence, randomized clinical trial with blinded outcome assessors. A pilot study commenced in May 2004, followed by multicenter recruitment from July 2010 to November 2013; follow-up was completed May 2014. Recruitment was from 24 UK major trauma centers and general hospitals. Participants were 620 adults older than 60 years with acute, overtly unstable ankle fracture. Exclusions were serious limb or concomitant disease or substantial cognitive impairment. Participants were randomly assigned to surgery (n = 309) or casting (n = 311). Casts were applied in the operating room under general or spinal anesthesia by a trained surgeon. The primary 6-month, per-protocol outcome was the Olerud-Molander Ankle Score at 6 months (OMAS; range, 0-100; higher scores indicate better outcomes and fewer symptoms), equivalence prespecified as ±6 points. Secondary outcomes were quality of life, pain, ankle motion, mobility, complications, health resource use, and patient satisfaction. Among 620 adults (mean age, 71 years; 460 [74%] women) who were randomized, 593 (96%) completed the study. Nearly all participants (579/620; 93%) received allocated treatment; 52 of 275 (19%) who initially received casting later converted to surgery, which was allowable in the casting treatment pathway to manage early loss of fracture reduction. At 6 months, casting resulted in ankle function equivalent to that with surgery (OMAS score, 66.0 [95% CI, 63.6-68.5] for surgery vs 64.5 [95% CI, 61.8-67.2] for casting; mean difference, -0.6 [95% CI, -3.9 to 2.6]; P

  5. Low-level laser therapy for treatment of neurosensory disorders after orthognathic surgery: A systematic review of randomized clinical trials.

    Science.gov (United States)

    Bittencourt, M-A-V; Paranhos, L-R; Martins-Filho, P-R-S

    2017-11-01

    Low-level laser has been widely used in Dentistry and many studies have focused on its application in oral surgeries. This study was conducted with the aim of searching for scientific evidence concerning the effectiveness of laser to reduce pain or paresthesia related to orthognathic surgery. An electronic search was performed in PubMed, Scopus, Science Direct, LILACS, SciELO, CENTRAL, Google Scholar, OpenGrey, and ClinicalTrials.gov, up to November 2016, with no restrictions on language or year of publication. Additionally, a hand search of the reference list of the selected studies was carried out. The PICOS strategy was used to define the eligibility criteria and only randomized clinical trials were selected. Out of 1,257 identified citations, three papers fulfilled the criteria and were included in the systematic review. The risk of bias was assessed according to the Cochrane Guidelines for Clinical Trials and results were exposed based on a descriptive analysis. One study showed that laser therapy was effective to reduce postoperative pain 24 hours (P=0.007) and 72 hours (P=0.007) after surgery. Other study revealed the positive effect of laser to improve neurosensory recovery 60 days after surgery, evaluated also by the two-point discrimination (P=0.005) and sensory (P=0.008) tests. The third study reported an improvement for general sensibility of 68.75% for laser group, compared with 21.43% for placebo (P=0.0095), six months after surgery. Individual studies suggested a positive effect of low-level laser therapy on reduction of postoperative pain and acceleration of improvement of paresthesia related to orthognathic surgery. However, due to the insufficient number and heterogeneity of studies, a meta-analysis evaluating the outcomes of interest was not performed, and a pragmatic recommendation about the use of laser therapy is not possible. This systematic review was conducted according to the statements of PRISMA and was registered at PROSPERO under the

  6. Preoperative antibiotic prophylaxis in orthognathic surgery: a randomized, double-blind, and placebo-controlled clinical study

    NARCIS (Netherlands)

    Zijderveld, S. A.; Smeele, L. E.; Kostense, P. J.; Tuinzing, D. B.

    1999-01-01

    This study evaluated the need for antibiotic prophylaxis in orthognathic surgery. Fifty-four patients (age range, 18 to 40 years) underwent bimaxillary orthognatic surgery. After randomization, a placebo (n = 19), 2,200 mg amoxicillin-clavulanic acid (n = 18), or 1,500 mg cefuroxime (n = 17) was

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

    Science.gov (United States)

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

    2012-12-01

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

  8. Open-Lung Ventilation Improves Clinical Outcomes in Off-Pump Coronary Artery Bypass Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Bolzan, Douglas W; Trimer, Renata; Begot, Isis; Nasrala, Mara L S; Forestieri, Patricia; Mendez, Vanessa M F; Arena, Ross; Gomes, Walter J; Guizilini, Solange

    2016-06-01

    To compare pulmonary function, functional capacity, and clinical outcomes among conventional mechanical ventilation (CMV), early open-lung (EOL), and late open-lung (LOL) strategies after off-pump coronary artery bypass surgery (OPCAB). Prospective, randomized, and double-blinded study. Two hospitals of the Federal University of Sao Paulo, Brazil. Ninety-three patients undergoing elective first-time OPCAB. Patients were randomized into 3 groups: CMV (n=31); LOL (n=32) initiated upon intensive care unit (ICU) arrival; EOL (n = 30) initiated after intubation. Spirometry was performed at bedside preoperatively and on postoperative days (PODs) 1, 3, and 5. Partial pressure of arterial oxygen (PaO2) and pulmonary shunt fraction were evaluated presurgically and on POD 1; 6-minute walk test (6MWT) was performed presurgically and on POD 5. Both open-lung groups demonstrated higher forced vital capacity and forced expiratory volume in 1 second on PODs 1, 3 and 5 compared to the CMV group (pLOL groups were compared. Both open-lung strategies were able to promote higher pulmonary function preservation and greater recovery of functional capacity with better clinical outcomes after OPCAB. No difference in outcome was found when comparing initiation of OLS intraoperatively or after ICU arrival. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Sugammadex by ideal body weight versus 20% and 40% corrected weight in bariatric surgery - double-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Nádia Maria da Conceição Duarte

    Full Text Available Abstract Background and objectives: The weight parameters for use of sugammadex in morbidly obese patients still need to be defined. Methods: A prospective clinical trial was conducted with sixty participants with body mass index ≥ 40 kg.m-2 during bariatric surgery, randomized into three groups: ideal weight (IW, 20% corrected body weight (CW20 and 40% corrected body weight (CW40. All patients received total intravenous anesthesia. Rocuronium was administered at dose of 0.6 mg.kg-1 of Ideal weight for tracheal intubation, followed by infusion of 0.3-0.6 mg.kg-1.h-1. Train of four (TOF was used to monitor depth of blockade. After spontaneous recovery TOF-count 2 at the end of surgery, 2 mg.kg-1 of sugammadex was administered. Primary outcome was neuromuscular blockade reversal time to TOF ≥ 0.9. Secondary outcome was the occurrence of postoperative residual curarization in post-anesthesia recovery room, searching the patient's ability to pass from the surgical bed to the transport, adequacy of oxygenation, respiratory pattern, ability to swallow saliva and clarity of vision. Results: Groups were homogenous in gender, age, total body weight, ideal body weight, body mass index, type and time of surgery. The reversal times (s were (mean ± standard deviation 225.2 ± 81.2, 173.9 ± 86.8 and 174.1 ± 74.9 respectively, in the IW, CW20 and CW40 groups (p = 0.087. Conclusions: No differences were observed between groups with neuromuscular blockade reversal time and frequency of postoperative residual curarization. We concluded that ideal body weight can be used to calculate sugammadex dose to reverse moderate neuromuscular blockade in morbidly obese patients.

  10. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Buunen, M; Bonjer, H J; Hop, W C J

    2009-01-01

    clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...... analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal...

  11. Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control

    DEFF Research Database (Denmark)

    Sibilitz, Kirstine Laerum; Berg, Selina Kikkenborg; Hansen, Tina Birgitte

    2015-01-01

    , either valve replacement or repair, remains the treatment of choice. However, post-surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesize that a comprehensive cardiac rehabilitation program can improve physical capacity and self-assessed mental health...... and reduce hospitalization and healthcare costs after heart valve surgery. METHODS: This randomized clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210...... patients 1:1 to an intervention or a control group, using central randomization, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise and a psycho-educational intervention comprising five consultations. The primary outcome is peak oxygen uptake...

  12. Sub-xyphoid pleural drain as a determinant of functional capacity and clinical results after off-pump coronary artery bypass surgery: a randomized clinical trial.

    Science.gov (United States)

    Guizilini, Solange; Alves, Daniel F; Bolzan, Douglas W; Cancio, Andreia S A; Regenga, Marisa M; Moreira, Rita S L; Trimer, Renata; Gomes, Walter J

    2014-09-01

    The aim of this trial was to compare functional capacity, pulmonary shunt fraction and clinical outcomes between patients undergoing pleurotomy with a pleural drain inserted in the sub-xyphoid position and patients with a pleural drain placed in the intercostal position after off-pump coronary artery bypass surgery. Patients were randomized into two groups according to the pleural drain site: Group II (n = 33 intercostal pleural drain); and Group SI (n = 35 sub-xyphoid pleural drain). Functional capacity was assessed by the distance covered on the 6-min walking test performed preoperatively and on postoperative day (POD) 5; in addition, pulmonary function test was determined preoperatively and on POD 1 and 5. Pulmonary shunt fraction was evaluated preoperatively and on POD 1, and clinical outcomes were recorded throughout the study. Group SI had better preservation of lung volumes and capacities in POD compared with Group II (P Pulmonary shunt fraction increased in both groups postoperatively; however, Group SI showed a smaller pulmonary shunt fraction (0.26 ± 0.04 vs 0.21 ± 0.04%; P = 0.0014). Functional capacity was significantly reduced in both groups on POD 5; however, Group SI showed better preservation of functional capacity (P = 0.0001). Group SI had better postoperative clinical results, with lower incidence of atelectasis and pleural effusion (P capacity and exercise tolerance with a smaller pulmonary shunt fraction and improved clinical outcomes compared with intercostal pleural drainage after off-pump coronary artery bypass surgery. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  13. Attenuation of Hemodynamic Responses to Intubation by Gabapentin in Coronary Artery Bypass Surgery: a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Seyed Mojtaba Marashi

    2015-12-01

    Full Text Available A varieties of medications have been suggested to prevent hemodynamic instabilities following laryngoscopy and endotracheal intubation. This study was conducted to determine the beneficial effects of gabapentin on preventing hemodynamic instabilities associated with intubation in patients who were a candidate for coronary artery bypass surgery (CABG. This double blinded randomized, parallel group clinical trial was carried out on 58 normotensive patients scheduled for elective CABG under general anesthesia with endotracheal intubation in Shariati Hospital. Patients were randomly allocated to two groups of 29 patients that received 1200 mg of gabapentin in two dosages (600 mg, 8 hours before anesthesia induction and 600 mg, 2 hours before anesthesia induction as gabapentin group or received talc powder as placebo (placebo group. Heart rate, mean arterial pressure, systolic and diastolic blood pressure were measured immediately before intubation, during intubation, immediately after intubation, 1 and 2 minutes after tracheal intubation. Inter-group comparisons significantly showed higher systolic and diastolic blood pressure, mean arterial pressure and heart rate immediately before intubation, during intubation, immediately after intubation, 1 and 2 minutes after tracheal intubation in the placebo group in comparison to gabapentin group. The median of anxiety  verbal analog scale (VAS at the pre-induction room in gabapentin and placebo groups were 2 and 4,  respectively that was significantly lower in the former group (P. value =0.04 ; however, regarding median of pain score no difference was observed between them (P. value =0.07. Gabapentin (1200mg given preoperatively can effectively attenuate the hemodynamic response to laryngoscopy, intubation and also reduce preoperative related anxiety in patients who were a candidate for CABG.

  14. Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial.

    Science.gov (United States)

    Courcoulas, Anita P; Belle, Steven H; Neiberg, Rebecca H; Pierson, Sheila K; Eagleton, Jessie K; Kalarchian, Melissa A; DeLany, James P; Lang, Wei; Jakicic, John M

    2015-10-01

    Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM). To compare the remission of T2DM following surgical and nonsurgical treatments. In this 3-arm randomized clinical trial conducted at the University of Pittsburgh Medical Center from October 1, 2009, to June 26, 2014, in Pittsburgh, Pennsylvania, outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM. Analysis was conducted with an intent-to-treat population. Participants were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3. Primary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change. Body mass index (calculated as weight in kilograms divided by height in meters squared) was less than 35 for 26 participants (43%), 50 (82%) were women, and 13 (21%) were African American. Mean (SD) values were 100.5 (13.7) kg for weight, 47.3 (6.6) years for age, 7.8% (1.9%) for hemoglobin A1c level, and 171.3 (72.5) mg/dL for fasting plasma glucose level. Partial or complete T2DM remission was achieved by 40% (n = 8) of RYGB, 29% (n = 6) of LAGB, and no intensive lifestyle weight loss intervention participants (P = .004). The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention-alone group, with 65% of RYGB, 33% of LAGB, and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 (P lifestyle treatment at 5.7% (2.4%) (P lifestyle intervention resulted in more disease remission than did lifestyle intervention alone. clinicaltrials.gov Identifier: NCT

  15. Randomized clinical trial comparing manual suture and different models of mechanical suture in the mimicking of bariatric surgery in swine

    Directory of Open Access Journals (Sweden)

    Fernandes MA

    2014-02-01

    analysis included the formation of foreign body granuloma in the gastroenteroanastomosis and enteroanastomosis in 88.9% of the swine that underwent manual suture and in none of the swine that underwent stapling. There was also a significant statistical difference among swine from Group A, and those from groups B, C and D regarding the degree of inflammation, being more intense in those swine that underwent manual suture. Conclusion: This study shows that both types of suture promoted proper healing of gastroenteroanastomosis and enteroanastomosis, although there was a higher degree of inflammation and an increased occurrence of foreign body granuloma in swine subjected to manual suture, although there have been similarities in safety, efficiency, and effectiveness between the models of linear mechanical staplers tested during the performance of these anastomoses on swine. Keywords: linear mechanical stapler, stapler, manual suture, surgery, gastroenteroanastomosis, enteroanastomosis, swine, randomized clinical trial

  16. Beneficial Effects of Early Enteral Nutrition After Major Rectal Surgery: A Possible Role for Conditionally Essential Amino Acids? Results of a Randomized Clinical Trial.

    Science.gov (United States)

    van Barneveld, Kevin W Y; Smeets, Boudewijn J J; Heesakkers, Fanny F B M; Bosmans, Joanna W A M; Luyer, Misha D; Wasowicz, Dareczka; Bakker, Jaap A; Roos, Arnout N; Rutten, Harm J T; Bouvy, Nicole D; Boelens, Petra G

    2016-06-01

    To investigate direct postoperative outcome and plasma amino acid concentrations in a study comparing early enteral nutrition versus early parenteral nutrition after major rectal surgery. Previously, it was shown that a low plasma glutamine concentration represents poor prognosis in ICU patients. A preplanned substudy of a previous prospective, randomized, open-label, single-centre study, comparing early enteral nutrition versus early parenteral nutrition in patients at high risk of postoperative ileus after surgery for locally advanced or locally recurrent rectal cancer. Early enteral nutrition reduced postoperative ileus, anastomotic leakage, and hospital stay. Tertiary referral centre for locally advanced and recurrent rectal cancer. A total of 123 patients with locally advanced or recurrent rectal carcinoma requiring major rectal surgery. Patients were randomized (ALEA web-based external randomization) preoperatively into two groups: early enteral nutrition (early enteral nutrition, intervention) by nasojejunal tube (n = 61) or early parenteral nutrition (early parenteral nutrition, control) by jugular vein catheter (n = 62). Eight hours after the surgical procedure artificial nutrition was started in hemodynamically stable patients, stimulating oral intake in both groups. Blood samples were collected to measure plasma glutamine, citrulline, and arginine concentrations using a validated ultra performance liquid chromatography-tandem mass spectrometric method. Baseline concentrations were comparable for both groups. Directly after rectal surgery, a decrease in plasma amino acids was observed. Plasma glutamine concentrations were higher in the parenteral group than in the enteral group on postoperative day 1 (p = 0.027) and day 5 (p = 0.008). Arginine concentrations were also significantly increased in the parenteral group at day 1 (p < 0.001) and day 5 (p = 0.001). Lower plasma glutamine and arginine concentrations were measured in the enteral group, whereas a

  17. Evaluation of Preemptive Use of Analgesia of The Skin, Before and After Lower Abdominal Surgery: A Prospective, Double-Blind, Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    P Kashefi

    2005-03-01

    Full Text Available Background: Perioperative pain is prevalent and poorly treated. Apart from that it makes the recovery from surgery unpleasent, pain often remains as a residual side effect of surgery, even though the tissue healing is complete. An essential observation is that tissue injury and the resulting nociceptor barrage initiates a cascade of events that can indelibly alter pain perception. Preemptive analgesia is the concept of initiating analgesic therapy before the onset of the noxious stimulus so as to prevent the nociceptor barrage and its consequences. However, anticipated clinical potency of preemptive analgesia, though has firmly grounded in the neurobiology of pain, has not been yet realized. As data accumulates, it has become clear that clinical studies emulating those from the laboratory and designed around a relatively narrow definition of preemptive analgesia have been largely unsupportive of its use. Nevertheless, preemptive analgesic interventions that recognize the intensity, duration, and somatotopic extent of major surgery can help reduce perioperative pain and its longer-term sequelae. surgeons spend a lot of time treating the pain of lower abdominal surgery. Methods: A total number of 48 consecutive patients who were going to undergo elective lower abdominal surgery. Were randomly assigned in two groups of 24 each. In one group the patients received an injection of 0.5 % bupivacaine in the planned skin for incision just before lower abdominal surgery, and in the other group, they received an equal amount of 0.5% bupivacaine after the surgery had been done. Pain was objectified by a numerical visual pain score, in the 24 hours following the lower abdominal surgery. Results: There were no differences in postoperative pain scores on the visual analog scale (VAS: In groups 1and 2, VAS at hour 4 were 6.37±1.13 versus 6.29±1.19; At hour 8 were 5.54 ± 1.17 versus 5.37±1.09; and at hour 12 were 4.5 ± 1.31 versus 4.45 ± 1

  18. A randomized clinical evaluation of the safety of Systane® Lubricant Eye Drops for the relief of dry eye symptoms following LASIK refractive surgery

    Directory of Open Access Journals (Sweden)

    Daniel Durrie

    2008-12-01

    Full Text Available Daniel Durrie, Jason StahlDurrie Vision, Overland Park, Kansas, USAPurpose: To evaluate the safety of Systane® Lubricant Eye Drops in relieving the symptoms of dry eye following laser-assisted in situ keratomileusis (LASIK surgery.Methods: This was a randomized, double-masked, single-center, placebo-controlled, contralateral eye study of 30 patients undergoing LASIK surgery. The mean age of patients was 42.4 ± 10.7 years, and the mean spherical equivalent was −3.29 (range, +1.75 to −7.38. Patients’ right and left eyes were randomized to receive either Systane® or placebo – a preserved, thimerosal-free saline solution – beginning from the day of surgery and ending 30 days following surgery. Outcome measures included tear film break up time (TFBUT, visual acuity, degree of corneal and conjunctival staining, and treatment-related adverse events.Results: Preoperatively, placebo-treated eyes had statistically significantly higher sum corneal staining score than Systane®-treated eyes (p = 0.0464; however, the difference was clinically insignificant (p = 0.27. Two weeks post operatively, the average TFBUT in the Systane®-treated eyes was 1.23 seconds longer than that of the placebo-treated eyes (p = 0.028. All other evaluated variables were comparable between the two treatments. No adverse events were reported in the study.Conclusion: Systane® Lubricant Eye Drops are safe for use following LASIK surgery to relieve the discomfort symptoms of dry eye associated with the procedure.Keywords: Systane®, safety, dry eye, LASIK

  19. Early Versus Delayed Postoperative Feeding After Major Gynaecological Surgery and its Effects on Clinical Outcomes, Patient Satisfaction, and Length of Stay: A Randomized Controlled Trial.

    Science.gov (United States)

    Balayla, Jacques; Bujold, Emmanuel; Lapensée, Louise; Mayrand, Marie-Hélène; Sansregret, Andrée

    2015-12-01

    To compare early versus delayed postoperative feeding in women undergoing major gynaecological surgery with regard to clinical outcomes, duration of postoperative stay, and patient satisfaction. We conducted a parallel-randomized controlled trial at a tertiary care centre in Montreal, Quebec, between June 2000 and July 2001. Patients undergoing major gynaecological surgery were randomized following a 1:1 allocation ratio to receive either early postoperative feeding in which oral clear fluids were begun up to six hours after surgery followed by solid foods as tolerated, or delayed postoperative feeding, in which clear fluids were begun on the first postoperative day and solid foods on the second or third day as tolerated. The primary outcomes analyzed were duration of postoperative stay and patient satisfaction. Secondary outcomes included mean time to appetite, passage of flatus, and bowel movement, as well as the presence of symptoms of paralytic ileus. A total of 119 patients were randomized; 61 patients were assigned to the early feeding group and 58 to the delayed feeding group. Demographic characteristics, including age, weight, smoking status, and prior surgical history were comparable between both groups. There was no difference in length of postoperative stay between the two groups (86.4 ± 21.0 hours in the early feeding group vs. 85.6 ± 26.2 hours in the delayed feeding group; P > 0.05). No significant difference was noted in patient satisfaction (P > 0.05). No difference was found in the frequency of postoperative ileus, mean time to appetite, passage of flatus, or first bowel movement. The introduction of early postoperative feeding appears to be safe and well tolerated by patients undergoing major gynaecological surgery. The duration of postoperative stay, patient satisfaction, and gastrointestinal symptoms are comparable between patients undergoing early or delayed postoperative feeding.

  20. Adjuvant therapy for melanoma in dogs: results of randomized clinical trials using surgery, liposome-encapsulated muramyl tripeptide, and granulocyte macrophage colony-stimulating factor.

    Science.gov (United States)

    MacEwen, E G; Kurzman, I D; Vail, D M; Dubielzig, R R; Everlith, K; Madewell, B R; Rodriguez, C O; Phillips, B; Zwahlen, C H; Obradovich, J; Rosenthal, R C; Fox, L E; Rosenberg, M; Henry, C; Fidel, J

    1999-12-01

    Spontaneous canine oral melanoma (COM) is a highly metastatic cancer, resistant to chemotherapy, and can serve as a model for cancer immunotherapy. Liposome-encapsulated muramyl tripeptide-phosphatidylethanolamine (L-MTP-PE) can activate the tumoricidal activity of the monocyte-macrophage system following i.v. injection. The objective of these studies was to evaluate the therapeutic effectiveness of L-MTP-PE administered alone and combined with recombinant canine granulocyte macrophage colony-stimulating factor (rcGM-CSF) in dogs undergoing surgery for oral melanoma. Ninety-eight dogs with histologically confirmed, clinically staged, oral melanoma were entered into two randomized, double-blind, surgical adjuvant trials. In trial 1, 50 dogs were stratified based on clinical stage and randomized to once a week L-MTP-PE or lipid equivalent (control). When all of the clinical stages were combined, no difference in disease-free survival or in survival time (ST) were detected. However, within stage I, dogs receiving L-MTP-PE had a significant increase in ST compared with control, with 80% of the dogs treated with L-MTP-PE still alive at >2 years. Within each stage II and stage III, there was no difference detected between the treatment groups. In trial 2, 48 dogs were stratified on the basis of clinical stage and extent of surgery (simple resection or radical excision), treated with L-MTP-PE two times a week, and randomized to rcGM-CSF or saline (placebo) given s.c. daily for 9 weeks. Within each stage and when all of the stages were combined, there was no difference between the treatment groups. In both studies, stage I COM is associated with a better prognosis. No effect on survival was observed with regard to tumor location in the oral cavity, sex, type/extent of surgery, or age. In a subset of dogs tested, pulmonary alveolar macrophage cytotoxicity was enhanced with combined rcGM-CSF and L-MTP-PE but not in dogs treated with L-MTP-PE alone. The present study

  1. Marginal Bone Remodeling around healing Abutment vs Final Abutment Placement at Second Stage Implant Surgery: A 12-month Randomized Clinical Trial.

    Science.gov (United States)

    Nader, Nabih; Aboulhosn, Maissa; Berberi, Antoine; Manal, Cordahi; Younes, Ronald

    2016-01-01

    The periimplant bone level has been used as one of the criteria to assess the success of dental implants. It has been documented that the bone supporting two-piece implants undergoes resorption first following the second-stage surgery and later on further to abutment connection and delivery of the final prosthesis. The aim of this multicentric randomized clinical trial was to evaluate the crestal bone resorption around internal connection dental implants using a new surgical protocol that aims to respect the biological distance, relying on the benefit of a friction fit connection abutment (test group) compared with implants receiving conventional healing abutments at second-stage surgery (control group). A total of partially edentulous patients were consecutively treated at two private clinics, with two adjacent two-stage implants. Three months after the first surgery, one of the implants was randomly allocated to the control group and was uncovered using a healing abutment, while the other implant received a standard final abutment and was seated and tightened to 30 Ncm. At each step of the prosthetic try-in, the abutment in the test group was removed and then retightened to 30 Ncm. Horizontal bone changes were assessed using periapical radiographs immediately after implant placement and at 3 (second-stage surgery), 6, 9 and 12 months follow-up examinations. At 12 months follow-up, no implant failure was reported in both groups. In the control group, the mean periimplant bone resorption was 0.249 ± 0.362 at M3, 0.773 ± 0.413 at M6, 0.904 ± 0.36 at M9 and 1.047 ± 0.395 at M12. The test group revealed a statistically significant lower marginal bone loss of 20.88% at M3 (0.197 ± 0.262), 22.25% at M6 (0.601 ± 0.386), 24.23% at M9 (0.685 ± 0.341) and 19.2% at M9 (0.846 ± 0.454). The results revealed that bone loss increased over time, with the greatest change in bone loss occurring between 3 and 6 months. Alveolar bone loss was significantly greater in the

  2. Comparing the effect of a desensitizing material and a self-etch adhesive on dentin sensitivity after periodontal surgery: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Hila Hajizadeh

    2017-07-01

    Full Text Available Objectives This double-blind randomized placebo-controlled clinical trial evaluated the ability of a desensitizing agent and a self-etch adhesive on cervical dentin sensitivity (CDS after periodontal surgery. Materials and Methods Ninety hypersensitive teeth of 13 subjects were included in the study. After periodontal surgery, the teeth of each posterior sextant treated with one of the following materials: G1: Clearfil S3 Bond (Kuraray Dental, G2: Gluma Desensitizer (Heraeus Kulzer, and G3: placebo (water. The sensitivity was assessed using evaporative stimuli before treatment (baseline, T0, 1 day after treatment (T1, after 1 week (T2, and after 1 month (T3 according to visual analog scale (VAS. Results Following the treatment, all the 3 groups showed significant reduction of CDS in T1 compared to T0. Reduction of CDS between T1 and T2 was observed only in G1 but there was no significant difference between T2 and T3 in this group. Although we observed a significant difference in T3 compared to T1 and T2 in G2 and G3, comparison of treatment groups in each assessment time showed a significant difference only in T3. According to paired comparison, this was due to the difference between G2 and G3. Conclusions Dentin sensitivity following periodontal surgery will decrease spontaneously over time, but treating the sensitive teeth with Gluma Desensitizer and Clearfil S3 Bond can have some benefits.

  3. Clinical Trials in Surgery

    African Journals Online (AJOL)

    The ANNALS of AFRICAN SURGERY | www.sskenya.org/journal. The ANNALS of ... by two different experiments on small pox by Lady. Mary Wortley Montagu and ... through their 'animal magnetism' were nothing more than an expensive ...

  4. A preliminary randomized clinical trial comparing diode laser and scalpel periosteal incision during implant surgery: impact on postoperative morbidity and implant survival.

    Science.gov (United States)

    Shahnaz, Aysan; Jamali, Raika; Mohammadi, Farnush; Khorsand, Afshin; Moslemi, Neda; Fekrazad, Reza

    2018-01-01

    The aim of this preliminary randomized clinical trial was to compare: (1) post-operative morbidity after application of laser or scalpel incision for flap advancement during implant surgery and bone grafting and (2) implant survival rate following flap advancement with laser or scalpel incision after 6 months of loading. Eighteen patients who were scheduled for dental implant placement and simultaneous bone grafting were randomly assigned to test or control groups. Diode laser (810 nm, 2 W, pulse interval 200 μs; pulse length 100 μs, 400-μm initiated fiber tip), or scalpel (control) was used to sever the periosteum to create a tension-free flap. Visual analogue scale (VAS) pain score, rate of nonsteroid anti-inflammatory drug (NSAID) consumption, intensity of swelling, and ecchymosis were measured for the six postsurgical days. Six months after loading, implant survival was assessed. VAS pain score (during the first four postoperative days), rate of NSAID consumption (during the first three postoperative days), and intensity of swelling (during the first five postoperative days) were significantly lower in the test group compared to the control group (All P values laser for performing periosteal releasing incision reduced the incidence and severity of postoperative morbidity of the patients undergone implant surgery in conjunction with bone augmentation procedure. We did not find any detrimental effect of laser incision on the implant survival within 6 months of loading.

  5. Adjustable Gastric Band Surgery or Medical Management in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

    Science.gov (United States)

    Ding, Su-Ann; Simonson, Donald C; Wewalka, Marlene; Halperin, Florencia; Foster, Kathleen; Goebel-Fabbri, Ann; Hamdy, Osama; Clancy, Kerri; Lautz, David; Vernon, Ashley; Goldfine, Allison B

    2015-07-01

    Recommendations for surgical, compared with lifestyle and pharmacologically based, approaches for type 2 diabetes (T2D) management remain controversial. The objective was to compare laparoscopic adjustable gastric band (LAGB) to an intensive medical diabetes and weight management (IMWM) program for T2D. This was designed as a prospective, randomized clinical trial. The setting was two Harvard Medical School-affiliated academic institutions. INTERVENTIONS AND PARTICIPANTS: A 12-month randomized trial comparing LAGB (n = 23) vs IMWM (n = 22) in persons aged 21-65 years with body mass index of 30-45 kg/m(2), T2D diagnosed more than 1 year earlier, and glycated hemoglobin (HbA(1c)) ≥ 6.5% on antihyperglycemic medication(s). The proportion meeting the prespecified primary glycemic endpoint, defined as HbA(1c) medication. After randomization, five participants did not undergo the surgical intervention. Of the 40 initiating intervention (22 males/18 females; age, 51 ± 10 y; body mass index, 36.5 ± 3.7 kg/m(2); diabetes duration, 9 ± 5 y; HbA(1c), 8.2 ± 1.2%; 40% on insulin), the proportion meeting the primary glycemic endpoint was achieved in 33% of the LAGB patients and 23% of the IMWM patients (P = .457). HbA(1c) reduction was similar between groups at both 3 and 12 months (-1.2 ± 0.3 vs -1.0 ± 0.3%; P = .496). Weight loss was similar at 3 months but greater 12 months after LAGB (-13.5 ± 1.7 vs -8.5 ± 1.6 kg; P = .027). Systolic blood pressure reduction was greater after IMWM than LAGB, whereas changes in diastolic blood pressure, lipids, fitness, and cardiovascular risk scores were similar between groups. Patient-reported health status, assessed using the Short Form-36, Impact of Weight on Quality of Life, and Problem Areas in Diabetes, all improved similarly between groups. LAGB and a multidisciplinary IMWM program have similar 1-year benefits on diabetes control, cardiometabolic risk, and patient satisfaction, which should be considered in the context of

  6. Intravenous sufentanil and morphine for post-cardiac surgery pain relief using patient-controlled analgesia (pca) device: a randomized double-blind clinical trial

    International Nuclear Information System (INIS)

    Alavi, S.M.; Kish, R.F.; Farsad, F.; Imani, F.; Sheikhvatan, M.

    2010-01-01

    Selection of the best analgesic technique in patients undergoing major surgeries can result in lower morbidity and satisfactory postoperative pain relief. In the present study, we tried to compare the effect of morphine and sufentanil on postoperative pain severity and hemodynamic changes by using patient-controlled analgesia (PCA) device in patients who were candidate for coronary artery bypass surgery (CABG). It was a randomized double-blinded clinical trial in which 120 patients aged 30-65 years, ASA physical status I-III, candidate for CABG in Shahid Rajaee hospital in Tehran were included. Before anesthesia, patients were randomly assigned to one of three groups to receive sufentanil (n=40), morphine (n=40) or normal saline (n=40). After tracheal extubation at intensive care unit, PCA was started by, sufentanil 4mg for the first group, morphine 2mg for the second group and normal saline, at same volume for the third group, intravenously with 10 minute lockout interval. Postoperative pain was evaluated by VAS scale, 1, 6, 12, 18 and 24 hours after extubation and systolic blood pressure, arterial oxygen saturation, PCO2 and PO2 were recorded 24 hours after extubation. VAS scores at rest revealed significantly less pain for patients in sufentanil and morphine groups than normal saline group, throughout the twenty-four hours after operation (P<0.001). However, there were no significant differences in the means of VAS scores between sufentanil and morphine groups. Among studied hemodynamic parameters, only systolic blood pressure was reduced more in morphine than sufentanil group (P<0.001). After CABG surgery, administration of intravenous sufentanil and morphine using PCA can lead to similar reduction of postoperative pain severity. (author)

  7. A comparison of the fascia iliaca block to the lumbar plexus block in providing analgesia following arthroscopic hip surgery: A randomized controlled clinical trial.

    Science.gov (United States)

    Badiola, Ignacio; Liu, Jiabin; Huang, Stephanie; Kelly, John D; Elkassabany, Nabil

    2018-05-31

    This randomized controlled single blinded clinical trial compared the fascia iliaca block (FIB) and the lumbar plexus block (LPB) in patients with moderate to severe pain following hip arthroscopic surgery. Single blinded randomized trial. Postoperative recovery area, postoperative days 0 and 1. Fifty patients undergoing hip arthroscopy were approached in the Post Anesthesia Care Unit (PACU) if they had moderate to severe pain (defined as > or equal 4/10 on the numeric rating scale). Twenty-five patients were allocated to the FIB and twenty-five patients to the LPB. Fascia iliaca block or lumbar plexus block. A blinded observer recorded pain scores just prior to the block, 15 min following the block (primary endpoint), and then every 15 min for 2 h (or until the patient was discharged). Total PACU time and opioid use were recorded. Pain scores and analgesic use on postoperative day (POD) 0, and POD 1 were recorded. At 24 h post block the Quality of Recovery 9 questionnaire was administered. The mean pre-block pain scores were comparable between the two groups (P = 0.689). There was no difference in mean post block pain scores between the two groups at 15 min (P = 0.054). In the PACU patients who underwent a LPB consumed less opioids compared to FIB patients (P = 0.02), however no differences were noted between the two groups in PACU length of stay, or POD 0 or 1 opioid use. A fascia iliaca block is not inferior to a lumbar plexus block in reducing PACU pain scores in patients with moderate to severe pain following hip arthroscopic surgery and is a viable option to help manage postoperative pain following hip arthroscopic surgery. Copyright © 2018. Published by Elsevier Inc.

  8. Intravenous lidocaine for post-operative pain relief after hand-assisted laparoscopic colon surgery: a randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Tikuišis, R; Miliauskas, P; Samalavičius, N E; Žurauskas, A; Samalavičius, R; Zabulis, V

    2014-04-01

    Perioperative intravenous (IV) infusion of lidocaine has been shown to decrease post-operative pain, shorten time to return of bowel function, and reduce the length of hospital stay. This randomized, prospective, double-blinded, placebo-controlled clinical trial evaluated the impact of IV lidocaine on the quality of post-operative analgesia and other outcomes after hand-assisted laparoscopic colon surgery. Sixty four patients with colon cancer scheduled for elective colon resection were involved in this study. Patients were randomized to receive either lidocaine infusion [lidocaine group (LG)] or normal 0.9 % saline infusion [placebo group (PG)] for a period of 24 h. Anaesthetic and surgical techniques were standardized. Twenty-four-hour post-operative analgesia in the recovery area was maintained by continuous infusion of 0.1 μg/kg/h fentanyl. The primary outcome of the study was post-operative pain control. Pain was assessed using visual analogue scale (VAS) scores at 2, 4, 8, 12, and 24 h after surgery. Patients with a VAS score >3 were treated with ketorolac 30 mg as needed. Secondary outcomes included time to resumption of bowel function and length of hospital stay. Data in the two groups were compared using the two-tailed Student's t test. All statistical tests were two-tailed at a significance level of 0.05. Demographic characteristics and clinical features of both groups were similar. Intensity of pain at rest in LG compared with PG was significantly lower during the first 24 h post-operatively. LG patients reported significantly less pain during movements at 2-, 12-, and 24-h post-surgery than PG patients. The study showed that ketorolac consumption was significantly higher in PG: mean ketorolac consumption in LG was 43.77 ± 13.86 mg and in PG 51.67 ± 13.16 mg (p = 0.047). Compared with placebo, lidocaine infusion produced a 32 % reduction in time to the first drink (Cohen's d = 3.85), 16 % reduction in time to the first full diet

  9. Randomized clinical trial of arginine-supplemented enteral nutrition versus standard enteral nutrition in patients undergoing gastric cancer surgery.

    Science.gov (United States)

    Zhao, Hongyan; Zhao, Hongying; Wang, Yu; Jing, Huang; Ding, Qian; Xue, Jun

    2013-09-01

    Significant malnutrition exists in a high percentage of patients with gastric cancer. It is, therefore, crucial to establish an effective means to provide nutrition for these patients. This prospective, randomized, double-blinded clinical trial aims to assess the long-term survival of arginine-supplementation enteral nutrition versus standard enteral nutrition in malnourished patients with gastric cancer. The control group (36 cases) received postoperative standard enteral nutrition. Meanwhile, the arginine-supplementation group (37 cases) adopted the same nutrition product but enriched with arginine (9.0 g/L). The primary study objective was overall survival (OS). Secondary endpoints were progression-free survival (PFS); serum parameters including total protein, albumin, proalbumin, and transferrin obtained on preoperative day 1, postoperative day 2, and day 12; CD4(+) and CD8(+) T cells, natural killer (NK) cells, immunoglobulin M (IgM), and immunoglobulin G (IgG) obtained on preoperative day 1 and postoperative day 7. No significant differences in baseline characteristics were observed between groups. The group receiving arginine-enriched nutrition had a significantly better OS (P = 0.03, 41 vs. 30.5 months) and better PFS (P = 0.02, 18 vs. 11.5 months). On postoperative day 7, CD4(+) T cells, NK cells, IgM and IgG levels of the arginine-supplemented group increased prominently and were significantly higher than those of the control group and those on preoperative day 1. There is no significant difference in the serum total protein, albumin, proalbumin, and transferrin levels between the two arms. Arginine-supplemented enteral nutrition significantly improves long-term survival and restores immunity in malnourished gastric cancer.

  10. Improvement of nutritional support strategies after surgery for benign liver tumor through nutritional risk screening: a prospective, randomized, controlled, single-blind clinical study.

    Science.gov (United States)

    Lu, Xin; Li, Ying; Yang, Huayu; Sang, Xinting; Zhao, Haitao; Xu, Haifeng; Du, Shunda; Xu, Yiyao; Chi, Tianyi; Zhong, Shouxian; Yu, Kang; Mao, Yilei

    2013-02-01

    The rising of individualized therapy requires nutritional risk screening has become a major topic for each particular disease, yet most of the screenings were for malignancies, less for benign diseases. There is no report on the screening of patients with benign liver tumors postoperatively. We aim to evaluate the nutritional support strategies post operation for benign liver tumors through nutritional risk screening. In this prospective, randomized, controlled study, 95 patients who underwent hepatectomy for benign tumors were divided into two groups. Fifty patients in the control group were given routine permissive underfeeding nutritional supply (75 kJ/kg/d), and 45 patients in the experimental group were given lower energy (42 kJ/kg/d) in accordance of their surgical trauma. Routine blood tests, liver/kidney function were monitored before surgery and at the day 1, 3, 5, 9 after surgery, patients were observed for the time of flatus, complications, length of hospitalization (LOH), nutrition-related costs, and other clinical parameters. This completed study is registered with Clinicaltrials.gov, number NCT01292330. The nutrition-related expenses (494.0±181.0 vs. 1,514.4±348.4 RMB, Pgroup were significantly lower than those in the control group. Meanwhile, the lowered energy supply after the surgeries did not have adverse effects on clinical parameters, complications, and LOH. Patient with benign liver tumors can adopt an even lower postoperative nutritional supply that close to that for mild non-surgical conditions, and lower than the postoperative permissive underfeeding standard.

  11. Comparison of the effects of magnesium sulphate and dexmedetomidine on surgical vision quality in endoscopic sinus surgery: randomized clinical study

    Directory of Open Access Journals (Sweden)

    Akcan Akkaya

    2014-12-01

    Full Text Available Background and objectives: Even a small amount of bleeding during endoscopic sinus surgery can corrupt the endoscopic field and complicate the procedure. Various techniques, including induced hypotension, can minimize bleeding during endoscopic sinus surgery. The aim of this study was to compare the surgical vision quality, haemodynamic parameters, postoperative pain, and other effects of magnesium, a hypotensive agent, with that of dexmedetomidine, which was initially developed for short-term sedation in the intensive care unit but also is an alpha 2 agonist sedative. Method: 60 patients between the ages of 18 and 45 years were divided into either the magnesium group (Group M or the dexmedetomidine group (Group D. In Group M, magnesium sulphate was given at a pre-induction loading dose of 50 mg kg−1 over 10 min and maintained at 15 mg kg−1 h−1; in Group D, dexmedetomidine was given at 1 mcg kg−1 10 min before induction and maintained at 0.6 mcg kg−1 h−1. Intraoperatively, the haemodynamic and respiratory parameters and 6-point intraoperative surgical field evaluation scale were recorded. During the postoperative period, an 11-point numerical pain scale, the Ramsay sedation scale, the nausea/vomiting scale, the adverse effects profile, and itching parameters were noted. Results: Group D showed a significant decrease in intraoperative surgical field evaluation scale scale score and heart rate. The average operation time was 50 min, and Group M had a higher number of prolonged surgeries. No significant difference was found in the other parameters. Conclusions: Due to its reduction of bleeding and heart rate in endoscopic sinus surgery and its positive impacts on the duration of surgery, we consider dexmedetomidine to be a good alternative to magnesium.

  12. Comparison of Flow and Volume Incentive Spirometry on Pulmonary Function and Exercise Tolerance in Open Abdominal Surgery: A Randomized Clinical Trial

    Science.gov (United States)

    Kumar, Amaravadi Sampath; Augustine, Alfred Joseph; Pazhyaottayil, Zulfeequer Chundaanveetil; Ramakrishna, Anand; Krishnakumar, Shyam Krishnan

    2016-01-01

    Introduction Surgical procedures in abdominal area lead to changes in pulmonary function, respiratory mechanics and impaired physical capacity leading to postoperative pulmonary complications, which can affect up to 80% of upper abdominal surgery. Aim To evaluate the effects of flow and volume incentive spirometry on pulmonary function and exercise tolerance in patients undergoing open abdominal surgery. Materials and Methods A randomized clinical trial was conducted in a hospital of Mangalore city in Southern India. Thirty-seven males and thirteen females who were undergoing abdominal surgeries were included and allocated into flow and volume incentive spirometry groups by block randomization. All subjects underwent evaluations of pulmonary function with measurement of Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV1), Peak Expiratory Flow (PEF). Preoperative and postoperative measurements were taken up to day 5 for both groups. Exercise tolerance measured by Six- Minute Walk Test during preoperative period and measured again at the time of discharge for both groups. Pulmonary function was analysed by post-hoc analysis and carried out using Bonferroni’s ‘t’-test. Exercise tolerance was analysed by Paired ‘T’-test. Results Pulmonary function (FVC, FEV1, and PEFR) was found to be significantly decreased in 1st, 2nd and 3rd postoperative day when compared with preoperative day. On 4th and 5th postoperative day the pulmonary function (FVC, FEV1, and PEFR) was found to be better preserved in both flow and volume incentive spirometry groups. The Six-Minute Walk Test showed a statistically significant improvement in pulmonary function on the day of discharge than in the preoperative period. In terms of distance covered, the volume- incentive spirometry group showed a greater statistically significant improvement from the preoperative period to the time of discharge than was exhibited by the flow incentive spirometry group

  13. Randomized clinical trial of new intravenous lipid (SMOFlipid 20%) versus medium-chain triglycerides/long-chain triglycerides in adult patients undergoing gastrointestinal surgery.

    Science.gov (United States)

    Wu, Ming-Hsun; Wang, Ming-Yang; Yang, Chin-Yao; Kuo, Min-Liang; Lin, Ming-Tsan

    2014-09-01

    SMOFlipid 20% is intravenous lipid emulsion (ILE) containing long-chain triglycerides (LCT), medium-chain triglycerides (MCT), olive oil, and fish oil as a mixed emulsion containing α-tocopherol. The aim was to assess the efficacy of this new ILE in gastrointestinal surgery compared with MCT/LCT. In this prospective study, 40 patients were randomized to SMOFlipid 20% or MCT/LCT (Lipovenoes 20%) group. Clinical and biochemistry data were collected. Inflammatory markers (CRP, IL-6, IL-10, TNF-α, TGF-β1) and oxidative stress (ROS and superoxide) were measured. Thirty-five patients (17 males and 18 females) with a mean age of 57 years completed the study. The patients' demographic characteristics (age, gender, height, body weight, and BMI) were similar without significant differences between groups. The increment of triglyceride on day 6 from baseline was significantly lower in SMOFlipid group than in Lipovenoes MCT/LCT group. Inflammatory markers, as well as superoxide radical and total oxygen radical were not different between groups. Despite the comparable effect on inflammatory response, because of its well-balanced fatty acid pattern, relatively low n-6:n-3 ratio, and high vitamin E content, SMOFlipid had a better triglyceride-lowering effect as compared with MCT/LCT in adult patients undergoing gastrointestinal surgery. © 2013 American Society for Parenteral and Enteral Nutrition.

  14. Prophylactic furosemide infusion decreasing early major postoperative renal dysfunction in on-pump adult cardiac surgery: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Fakhari S

    2017-01-01

    Full Text Available Solmaz Fakhari,1 Fariba Mirzaei Bavil,2 Eissa Bilehjani,1 Sona Abolhasani,3 Moussa Mirinazhad,2 Bahman Naghipour2 1Department of Anesthesiology, 2Department of Physiology, 3Tabriz University of Medical Sciences, Tabriz, Iran Introduction: Acute renal dysfunction is a common complication of cardiac surgery. Furosemide is used in prevention, or treatment, of acute renal dysfunction. This study was conducted to evaluate the protective effects of intra- and early postoperative furosemide infusion on preventing acute renal dysfunction in elective adult cardiac surgery. Methods: Eighty-one patients, candidates of elective cardiac surgery, were enrolled in this study in either the furosemide (n=41 or placebo (n=40 group. Furosemide (2 mg/h or 0.9% saline was administered and continued up to 12 hours postoperatively. We measured serum creatinine (Scr at preoperative and on the second and fifth postoperative days. Then calculated estimated glomerular filtration rate (eGFR at these times. An increase in Scr of >0.5 mg/dL and/or >25%–50%, compared to preoperative values, was considered as acute kidney injury (AKI. In contrast, an increase in Scr by >50% and/or the need for hemodialysis was regarded as acute renal failure (ARF. At the end we compared the AKI or ARF incidence between the two groups. Results: On the second and fifth postoperative days, Scr was lower, and the eGFR was higher in the furosemide group. AKI incidence was similar in the two groups (11 vs 12 cases; P-value 0.622; however, ARF rate was lower in furosemide group (1 vs 6 cases; P-value 0.044. During the study period, Scr was more stable in the furosemide group, however in the placebo group, Scr initially increased and then decreased to its preoperative value after a few days. Conclusion: This study showed that intra- and early postoperative furosemide infusion has a renal protective effect in adult cardiac surgery with cardiopulmonary bypass. Although this protective effect cannot

  15. Comparison of the changes in blood glucose level during sedation with midazolam and propofol in implant surgery: a prospective randomized clinical trial.

    Science.gov (United States)

    Kaviani, Nasser; Koosha, Farzad; Shahtusi, Mina

    2014-09-01

    Reducing the patients' stress can prevent, or at least, limit the increase in blood glucose level. The study compares the effect of propofol and midazolam on blood glucose level in the patients undergoing dental implant surgery. The effect of pre-operational stress on blood glucose level during the surgery is also evaluated. This prospective randomized clinical trial recruited 33 patients undergoing dental implant surgery and divided into two groups. Conscious sedation was performed by midazolam in one group and with propofol in another group. The pre-operational stress was scored and the blood glucose level was measured in 4 different stages; before the operation, two minutes after the local anesthetic injection; thirty minutes after the onset of operation and at the end of the operation. The results were analyzed by employing ANOVA and Pearson test. The p Value was adopted 0.05 and the confidence coefficient was assumed 95%. The average levels of the blood glucose in midazolam and propofol group were 93.82 mg/dl and 94 mg/dl before the operation which displayed a meaningful increase of blood glucose level in both groups as the operation went on. The values were 103.76 mg/dl for midazolam and 108.56 mg/dl for the propofol group (pblood glucose level between two groups in the different stages of the operation (p= 0.466). The Pearson correlation coefficient test revealed a higher increase in the blood glucose level in the patients with a higher pre-operational stress score (r= 0.756, pblood glucose level while undergoing an operation. No statistically significant difference was detected between midazolam and propofol.

  16. Early rehabilitation after total knee replacement surgery: a multicenter, noninferiority, randomized clinical trial comparing a home exercise program with usual outpatient care.

    Science.gov (United States)

    Han, Annie S Y; Nairn, Lillias; Harmer, Alison R; Crosbie, Jack; March, Lyn; Parker, David; Crawford, Ross; Fransen, Marlene

    2015-02-01

    To determine, at 6 weeks postsurgery, if a monitored home exercise program (HEP) is not inferior to usual care rehabilitation for patients undergoing primary unilateral total knee replacement (TKR) surgery for osteoarthritis. We conducted a multicenter, randomized clinical trial. Patients ages 45-75 years were allocated at the time of hospital discharge to usual care rehabilitation (n = 196) or the HEP (n = 194). Outcomes assessed 6 weeks after surgery included the Western Ontario and McMaster Universities Osteoarthritis Index pain and physical function subscales, knee range of motion, and the 50-foot walk time. The upper bound of the 95% confidence interval (95% CI) mean difference favoring usual care was used to determine noninferiority. At 6 weeks after surgery there were no significant differences between usual care and HEP, respectively, for pain (7.4 and 7.2; 95% CI mean difference [MD] -0.7, 0.9), physical function (22.5 and 22.4; 95% CI MD -2.5, 2.6), knee flexion (96° and 97°; 95% CI MD -4°, 2°), knee extension (-7° and -6°; 95% CI MD -2°, 1°), or the 50-foot walk time (12.9 and 12.9 seconds; 95% CI MD -0.8, 0.7 seconds). At 6 weeks, 18 patients (9%) allocated to usual care and 11 (6%) to the HEP did not achieve 80° knee flexion. There was no difference between the treatment allocations in the number of hospital readmissions. The HEP was not inferior to usual care as an early rehabilitation protocol after primary TKR. Copyright © 2015 by the American College of Rheumatology.

  17. Comparing minimally supervised home-based and closely supervised gym-based exercise programs in weight reduction and insulin resistance after bariatric surgery: A randomized clinical trial.

    Science.gov (United States)

    Kaviani, Sara; Dadgostar, Haleh; Mazaherinezhad, Ali; Adib, Hanie; Solaymani-Dodaran, Masoud; Soheilipour, Fahimeh; Hakiminezhad, Mahdi

    2017-01-01

    Background: Effectiveness of various exercise protocols in weight reduction after bariatric surgery has not been sufficiently explored in the literature. Thus, in the present study, we aimed at comparing the effect of minimally supervised home-based and closely supervised gym-based exercise programs on weight reduction and insulin resistance after bariatric surgery. Methods: Females undergoing gastric bypass surgery were invited to participate in an exercise program and were randomly allocated into 2 groups using a random number generator in Excel. They were either offered a minimally supervised home-based (MSHB) or closely supervised gym-based (CSGB) exercise program. The CSGB protocol constitutes 2 weekly training sessions under ACSM guidelines. In the MSHB protocol, the participants received a notebook containing a list of recommended aerobic and resistance exercises, a log to record their activity, and a schedule of follow-up phone calls and clinic visits. Both groups received a pedometer. We measured their weight, BMI, lipid profile, FBS, and insulin level at baseline and at 20 weeks after the exercises, the results of which were compared using t test or Mann-Whitney U test at the end of the study. All the processes were observed by 1 senior resident in sport medicine. Results: A total of 80 patients were recruited who were all able to complete our study (MSHB= 38 and CSGB= 42). The baseline comparison revealed that the 2 groups were similar. The mean change (reduction) in BMI was slightly better in CSGB (8.61 95% CI 7.76-9.45) compared with the MSHB (5.18 95% CI 3.91-6.46); p< 0.01. However, the 2 groups did not have a statistically significant difference in the amount of change in the other factors including FBS and Homa.ir. Conclusion: As we expected a non-inferiority result, our results showed that both MSHB and CSGB exercise methods are somewhat equally effective in improving lipid profile and insulin resistance in the 2 groups, but a slightly better

  18. Diabetic Macular Edema at the time of Cataract Surgery trial: a prospective, randomized clinical trial of intravitreous bevacizumab versus triamcinolone in patients with diabetic macular oedema at the time of cataract surgery - preliminary 6 month results.

    Science.gov (United States)

    Lim, Lyndell L; Morrison, Julie L; Constantinou, Marios; Rogers, Sophie; Sandhu, Sukhpal S; Wickremasinghe, Sanjeewa S; Kawasaki, Ryo; Al-Qureshi, Salmaan

    2016-05-01

    To compare visual and anatomical outcomes between intravitreous bevacizumab (BVB, Avastin) and triamcinolone (TA, Triesence) when administered at the time of cataract surgery in patients with diabetic macular oedema (DME). Prospective, single-masked, randomized clinical trial at The Royal Victorian Eye and Ear Hospital, Melbourne. Patients with clinically significant cataract and either centre-involving DME or DME treated within the previous 24 months. Participants were randomized 1:1 to receive intravitreous BVB 1.25 mg or TA 4 mg during cataract surgery, and at subsequent review if required over 6 months. Change in central macular thickness (CMT) and best corrected visual acuity at 6 months. Forty-one patients (mean age 66.4 years, 73.2% male) were recruited. Visual acuity and CMT were similar between groups at baseline (P > 0.2).After six months, both groups gained vision (mean +21.4 letters in TA group P < 0.0001, +12.5 letters in BVB, P = 0.002), with no significant difference between groups (P = 0.085). In addition, 60.9% of eyes receiving TA achieved a VA of ≥6/12 compared to 73.3% in the BVB group (P = 0.501). However, only TA was associated with a sustained reduction in CMT (-43.8-µm reduction TA vs. +37.3-µm increase BVB, P = 0.006 over 6 months). Following surgery, additional injections were required in 70.6% of participants in the BVB group, compared to 16.7% in the TA group (P < 0.0001). Three patients in the TA group experienced a rise of IOP over 21 mmHg (12.5%) during the 6-month follow-up; BVB had no cases (P = 0.130). There were no cases of endophthalmitis in either group. When administered at the time of cataract surgery in patients with DME, at 6 months both TA and BVB improve visual acuity; however, only TA results in a sustained reduction in CMT. Further follow-up will determine whether this translates into better long-term visual outcomes in the TA group. © 2016 Royal Australian and New

  19. Does high-dose metformin cause lactic acidosis in type 2 diabetic patients after CABG surgery? A double blind randomized clinical trial

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    Rahman Ghafari

    2011-06-01

    Full Text Available Metformin is a dimethyl biguanide oral anti-hyperglycemic agent. Lactic acidosis due to metformin is a fatal metabolic condition that limits its use in patients in poor clinical condition, consequently reducing the number of patients who benefit from this medication. In a double blind randomized clinical trial, we investigated 200 type 2 diabetic patients after coronary artery bypass surgery in the open heart ICU of the Mazandaran Heart Center, and randomly assigned them to equal intervention and control groups. The intervention group received regular insulin infusion along with 2 metformin 500 mg tablets every twelve hours, while the control group received only intravenous insulin with 2 placebo tablets every twelve hours. Lactate level, pH, base excess, blood glucose and serum creatinine were measured over five 12 h periods, with data averaged for each period. The primary outcome in this study was high lactate levels. Comparison between the 2 groups was made by independent Student’s t-test. To compare changes in multiple measures in each group and analysis of group interaction, a repeated measurement ANOVA test was used. There was no significant difference between the 2 groups regarding pH, base excess, or bicarbonate intake (P>0.05. No patient showed lactic acidosis in either group. Lactate levels were 23.0 vs 23.4 in the insulin-metformin and insulin only groups when the study was started, respectively. At the end of the study, those levels were 18.7 vs 18.9, respectively. In addition, the ANOVA repeated measurement test did not show a significant difference in terms of changes in the amount of lactate level between the 2 groups during the five measurement tests of the study period (P>0.05. High-dose metformin (1,000 mg twice daily with insulin does not cause lactic acidosis in type 2 diabetic patients after coronary artery

  20. Methodology for Speech Assessment in the Scandcleft Project-An International Randomized Clinical Trial on Palatal Surgery

    DEFF Research Database (Denmark)

    Willadsen, Elisabeth

    2009-01-01

    Objective: To present the methodology for speech assessment in the Scandcleft project and discuss issues from a pilot study. Design: Description of methodology and blinded test for speech assessment. Speech samples and instructions for data collection and analysis for comparisons of speech outcomes...... across five included languages were developed and tested. Participants and Materials: Randomly selected video recordings of 10 5-year-old children from each language (n = 50) were included in the project. Speech material consisted of test consonants in single words, connected speech, and syllable chains......-sum and the overall rating of VPC was 78%. Conclusions: Pooling data of speakers of different languages in the same trial and comparing speech outcome across trials seems possible if the assessment of speech concerns consonants and is confined to speech units that are phonetically similar across languages. Agreed...

  1. Positive regulatory effects of perioperative probiotic treatment on postoperative liver complications after colorectal liver metastases surgery: a double-center and double-blind randomized clinical trial.

    Science.gov (United States)

    Liu, Zhihua; Li, Chao; Huang, Meijin; Tong, Chao; Zhang, Xingwei; Wang, Lei; Peng, Hui; Lan, Ping; Zhang, Peng; Huang, Nanqi; Peng, Junsheng; Wu, Xiaojian; Luo, Yanxing; Qin, Huanlong; Kang, Liang; Wang, Jianping

    2015-03-20

    Colorectal liver metastases (CLM) occur frequently and postoperative intestinal infection is a common complication. Our previous study showed that probiotics could decrease the rate of infectious complications after colectomy for colorectal cancer. To determine the effects of the perioperative administration of probiotics on serum zonulin levels which is a marker of intestinal permeability and the subsequent impact on postoperative infectious complications in patients with CLM. 150 patients with CLM were randomly divided into control group (n = 68) and probiotics group (n = 66). Probiotics and placebo were given orally for 6 days preoperatively and 10 days postoperatively to control group and probiotics group respectively. We used the local resection for metastatic tumor ,while for large tumor, the segmental hepatectomy. Postoperative outcome were recorded. Furthermore, complications in patients with normal intestinal barrier function and the relation with serum zonulin were analyzed to evaluate the impact on the liver barrier dysfunction. The incidence of infectious complications in the probiotics group was lower than control group. Analysis of CLM patients with normal postoperative intestinal barrier function paralleled with the serum zonulin level. And probiotics could also reduce the concentration of serum zonulin (P = 0.004) and plasma endotoxin (P zonulin level, the rate of postoperative septicemia and maintain the liver barrier in patients undergoing CLM surgery. we propose a new model about the regulation of probiotics to liver barrier via clinical regulatory pathway. We recommend the preoperative oral intake of probiotics combined with postoperative continued probiotics treatment in patients who undergo CLM surgery. ChiCTR-TRC- 12002841 . 2012/12/21.

  2. Cardioprotection of Electroacupuncture for Enhanced Recovery after Surgery on Patients Undergoing Heart Valve Replacement with Cardiopulmonary Bypass: A Randomized Control Clinical Trial

    Directory of Open Access Journals (Sweden)

    Fangxiang Zhang

    2017-01-01

    Full Text Available We attempted to investigate cardioprotection of electroacupuncture (EA for enhanced recovery after surgery on patients undergoing heart valve replacement with cardiopulmonary bypass. Forty-four patients with acquired heart valve replacement were randomly allocated to the EA group or the control group. Patients in the EA group received EA stimulus at bilateral Neiguan (PC6, Ximen (PC4, Shenting (GV24, and Baihui (GV20 acupoints twenty minutes before anesthesia induction to the end of surgery. The primary end point was cardioprotection effect of electroacupuncture postoperatively and the secondary endpoints were quality of recovery and cognitive functioning postoperatively. The present study demonstrated that electroacupuncture reduced the occurrence of complications and played a role of cardioprotective effect on patients after heart valve replacement surgery with cardiopulmonary bypass, and it benefits patients more comfortable and contributes to recovery after surgery. This trial is registered with ChiCTR-IOC-16009123.

  3. Soft tissue changes from maxillary distraction osteogenesis versus orthognathic surgery in patients with cleft lip and palate--a randomized controlled clinical trial.

    Science.gov (United States)

    Chua, Hannah Daile P; Cheung, Lim Kwong

    2012-07-01

    The objective of this randomized controlled clinical trial was to compare the soft tissue changes after maxillary advancement using conventional orthognathic surgery (CO) and distraction osteogenesis (DO) in patients with cleft lip and palate (CLP). The study group of 39 CLP patients with maxillary hypoplasia underwent either CO or DO with 4 to 10 mm of maxillary advancement. Lateral cephalographs were taken preoperatively and postoperatively at regular intervals. A series of skeletal, dental, and soft tissue landmarks was used to evaluate the changes in the soft tissue and the correlation of hard and soft tissue changes and ratios. Significant differences were found between the CO and DO patients at A point in both maxillary advancement and downgrafting in the early follow-up period. On soft tissue landmarks of pronasale, subnasale, and labial superius, significant differences were found between the 2 groups at 6 months postoperatively only with maxillary advancement. There was better correlation of hard and soft tissue changes with maxillary advancement. The nasal projection was significantly different between the 2 groups at the early and intermediate period. There was much more consistent hard to soft tissue ratios in maxillary advancement with DO than with CO. Both CO and DO can induce significant soft tissue changes of the upper lip and nose, particularly with maxillary advancement. DO generates more consistent hard to soft tissue ratios. Copyright © 2012 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  4. The effect of continuous low dose methylprednisolone infusion on inflammatory parameters in patients undergoing coronary artery bypass graft surgery: a randomized-controlled clinical trial.

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    Abbas Ghiasi

    2015-02-01

    Full Text Available This trial was performed to determine if a continuous low-dose infusion of methylprednisolone is as effective as its bolus of high-dose in reducing inflammatory response. The study was single-center, double-blinded randomized clinical trial and performed in a surgical intensive care unit of an academic hospital. In this study, 72 consecutive patients undergoing elective coronary artery bypass grafting (CABG were assigned to receive either a methylprednisolone loading dose (1mg/kg followed by continuous infusion (2mg/Kg/24 hours for 1 day (low-dose regime or a single dose of methylprednisolone (15 mg/kg before cardiopulmonary bypass (high dose regime. Serum concentrations of IL-6 and C- reactive protein (CRP were measured preoperatively and 6, 24 and 48 hours after surgery, and serum creatinine was measured before the operation and 24, 48 and 72 hours postoperatively. The measurements were then compared between the groups to evaluate the efficacy of each regimen. The basic characteristics and measurements were not different between the study groups. There was no significant difference in IL-6 and CRP elevation (P=0.52 and P=0.46, respectively. Early outcomes such as the length of stay in the intensive care unit, intubation time, changes in serum creatinine and blood glucose levels, inotropic support, insulin requirements, and rate of infection were also similar in both groups. A continuous low dose infusion of methylprednisolone was as effective as a single high dose methylprednisolone in reducing the inflammatory response after CABG with extracorporeal circulation with no significant difference in the postoperative measurements and outcomes.

  5. A prospective randomized clinical study of the influence of primary closure or dressing on post-operative morbidity after mandibular third molar surgery

    Directory of Open Access Journals (Sweden)

    Peter E Egbor

    2014-01-01

    Full Text Available Objective: The aim of the following study is to determine the effect of primary closure or dressing on post-operative morbidity after impacted lower third molar surgery. Materials and Methods: This was a randomized clinical study of 72 patients who had surgical extraction of impacted mandibular third molars. The subjects were divided into two groups of A and B. Group A had total closure (primary closure and Group B had whitehead varnish dressing of the socket. Pain, swelling and trismus were evaluated pre-operatively using visual analogue scale, flexible tape measuring method and inter-incisal distance measurement with Vernier Callipers respectively as well as post-operatively on 1 st , 2 nd , 3 rd , 5 th and 7 th day. Results: The study participants consisted of 27 males and 45 females in a ratio 1:1.7. With a mean age of 24.7 ± 4.9 years (range 19-33 years for Group A and 25.5 ± 4.3 years (range 20-39 years for Group B. Post-operative pain was not significantly affected by the closure techniques (P > 0.05. Dressing was found to significantly reduce the degree of swelling and trismus peaking on the 2 nd day (P = 0.0207 and P = 0.010 respectively. Conclusion: The use of dressing was more effective than primary closure to reduce the degree of swelling and trismus though its effect on post-operative pain reduction was not significant.

  6. Clinical Effects and Safety of 3% Diquafosol Ophthalmic Solution for Patients With Dry Eye After Cataract Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Park, Dae Hyun; Chung, Jin Kwon; Seo, Du Ri; Lee, Sung Jin

    2016-03-01

    To compare the efficacies and safety profiles of 3% diquafosol and 0.1% sodium hyaluronate in patients with dry eye after cataract surgery. Randomized controlled trial. setting: Soonchunhyang University Hospital, Seoul, South Korea. In all, 130 eyes of 86 dry eye patients who had undergone cataract surgery between January 2014 and January 2015 were enrolled and randomly divided into a diquafosol group and a sodium hyaluronate group. The diquafosol group used diquafosol 6 times a day and the hyaluronate group used sodium hyaluronate 6 times a day after cataract surgery. Evaluations of efficacy were conducted based on an Ocular Surface Disease Index questionnaire, tear breakup time (TBUT), Schirmer I test, corneal fluorescein and conjunctival lissamine green staining scores, serial measurement of ocular higher-order aberrations (HOAs), corneal HOAs, and uncorrected distance visual acuity test. Safety evaluations were based on anterior chamber inflammation and discontinuation of the eye drops. Objective signs and subjective symptoms were aggravated at 1 week postoperatively and began to recover significantly 4 weeks after surgery. The diquafosol group showed significantly superior TBUT (P < .001), corneal fluorescein (P = .045), and conjunctival staining (P = .001) compared to the sodium hyaluronate group throughout the study period. TBUT (P < .001) and the change in HOAs (P = .018) recovered significantly more quickly in the diquafosol group. The safety evaluations showed no intergroup differences. Eye drops of 3% diquafosol may be an effective and safe treatment for the management of cataract surgery-induced dry eye aggravation in patients with preexisting dry eye. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. [Clinical pharmacy and surgery: Review].

    Science.gov (United States)

    Jarfaut, A; Nivoix, Y; Vigouroux, D; Kehrli, P; Gaudias, J; Kempf, J-F; Levêque, D; Gourieux, B

    2014-05-01

    Clinical pharmacy has been developed and evaluated in various medical hospital activities. Reviews conducted in this area reported a higher value of this discipline. In surgical services, evenly adverse drug events may occur, so clinical pharmacy activities must also help to optimize the management of drug's patient. The objectives of this literature review is to determine the profile of clinical pharmacy activities developed in surgical services and identify indicators. The research was conducted on Pubmed(®) database with the following keywords (2000-2013), "surgery", "pharmacy", "pharmacist", "pharmaceutical care", "impact" and limited to French or English papers. Studies dealing on simultaneously medical and surgical areas were excluded. Twenty-one papers were selected. The most frequently developed clinical pharmacy activities were history and therapeutic drug monitoring (antibiotics or anticoagulants). Two types of indicators were identified: activity indicators with the number of pharmaceutical interventions, their description and clinical signification, the acceptance rate and workload. Impact indicators were mostly clinical and economic impacts. The development of clinical pharmacy related to surgical patients is documented and appears to have, as for medical patients, a clinical and economical value. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  8. Effect of inhalation aromatherapy with lavender essential oil on stress and vital signs in patients undergoing coronary artery bypass surgery: A single-blinded randomized clinical trial.

    Science.gov (United States)

    Bikmoradi, Ali; Seifi, Zahra; Poorolajal, Jalal; Araghchian, Malihe; Safiaryan, Reza; Oshvandi, Khodayar

    2015-06-01

    At present, aromatherapy is used widely in medical research. This study aimed to investigate the effects of inhalation aromatherapy using lavender essential oil to reduce mental stress and improve the vital signs of patients after coronary artery bypass surgery (CABG). A single-blinded randomized controlled trial was conducted with 60 patients who had undergone CABG in a 2-day intervention that targeted stress reduction. Sixty subjects following coronary artery bypass surgery in two aromatherapy and control groups. The study was conducted in Ekbatan Therapeutic and Educational Center, Hamadan, Iran, in 2013. On the second and third days after surgery, the aromatherapy group patients received two drops of 2% lavender essential oil for 20min and the control group received two drops of distilled water as a placebo. The primary outcome was mental stress, which was measured before and after the intervention using the DASS-21 questionnaire. The secondary outcomes were vital signs, including the heart rate, respiratory rate, and systolic and diastolic blood pressure, which were measured before and after the intervention. The individual characteristics of the aromatherapy and control groups were the same. There were no significant difference in the mean mental stress scores and vital signs of the aromatherapy and control groups on the second or third days after surgery. Inhalation aromatherapy with lavender essential oil had no significant effects on mental stress and vital signs in patients following CABG, except the systolic blood pressure. Copyright © 2014 Elsevier Ltd. All rights reserved.

  9. Geranisetron versus gabapentin in preventing postoperative nausea and vomiting after middle ear surgery in adults: A double-blinded randomized clinical trial study

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    Morteza Heidari

    2015-01-01

    Full Text Available Background: The incidence of postoperative nausea and vomiting (PONV after middle ear surgery is high. In this study we want to compare the effects of intravenous granisetron and oral gabapentin as a premedication before surgery on the incidence and severity of PONV after middle ear surgery in adult patents. Materials and Methods: We enrolled 90 patients that were randomly divided into the three groups of 30 in each. Group I received granisetron 3 mg iv 2 minutes before induction of anesthesia; Group II received oral gabapentin 300 mg 1 hour before anesthesia and Group III received placebo. The incidence and severity of PONV were recorded each 15 minutes in the post-anesthesia care unit (PACU and each 8 hours until 24 hours after discharge from the PACU. Result: The incidence and severity of nausea and vomiting at different time intervals in Groups I and Group II was significantly lower compared with Group III (P < 0.05. There was no significant difference in the incidence of side effects of study drug administration including respiratory depression, apnea, extra pyramidal disorders, drowsiness, dizziness, vertigo and headache in three groups. Conclusion: The study was shown that using gabapentin and granisetron have equal anti-emetic effects, but significant differences were seen between these two groups compared to the control group. These submit the efficiency of these drugs in preventing PONV.

  10. Effect of lung-protective ventilation with lower tidal volumes on clinical outcomes among patients undergoing surgery: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Gu, Wan-Jie; Wang, Fei; Liu, Jing-Chen

    2015-02-17

    In anesthetized patients undergoing surgery, the role of lung-protective ventilation with lower tidal volumes is unclear. We performed a meta-analysis of randomized controlled trials (RCTs) to evaluate the effect of this ventilation strategy on postoperative outcomes. We searched electronic databases from inception through September 2014. We included RCTs that compared protective ventilation with lower tidal volumes and conventional ventilation with higher tidal volumes in anesthetized adults undergoing surgery. We pooled outcomes using a random-effects model. The primary outcome measures were lung injury and pulmonary infection. We included 19 trials (n=1348). Compared with patients in the control group, those who received lung-protective ventilation had a decreased risk of lung injury (risk ratio [RR] 0.36, 95% confidence interval [CI] 0.17 to 0.78; I2=0%) and pulmonary infection (RR 0.46, 95% CI 0.26 to 0.83; I2=8%), and higher levels of arterial partial pressure of carbon dioxide (standardized mean difference 0.47, 95% CI 0.18 to 0.75; I2=65%). No significant differences were observed between the patient groups in atelectasis, mortality, length of hospital stay, length of stay in the intensive care unit or the ratio of arterial partial pressure of oxygen to fraction of inspired oxygen. Anesthetized patients who received ventilation with lower tidal volumes during surgery had a lower risk of lung injury and pulmonary infection than those given conventional ventilation with higher tidal volumes. Implementation of a lung-protective ventilation strategy with lower tidal volumes may lower the incidence of these outcomes. © 2015 Canadian Medical Association or its licensors.

  11. Sugammadex by ideal body weight versus 20% and 40% corrected weight in bariatric surgery – double-blind randomized clinical trial

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    Nádia Maria da Conceição Duarte

    2018-05-01

    Full Text Available Background and objectives: The weight parameters for use of sugammadex in morbidly obese patients still need to be defined. Methods: A prospective clinical trial was conducted with sixty participants with body mass index ≥ 40 kg.m−2 during bariatric surgery, randomized into three groups: ideal weight (IW, 20% corrected body weight (CW20 and 40% corrected body weight (CW40. All patients received total intravenous anesthesia. Rocuronium was administered at dose of 0.6 mg.kg−1 of Ideal weight for tracheal intubation, followed by infusion of 0.3–0.6 mg.kg−1.h−1. Train of four (TOF was used to monitor depth of blockade. After spontaneous recovery TOF-count 2 at the end of surgery, 2 mg.kg−1 of sugammadex was administered. Primary outcome was neuromuscular blockade reversal time to TOF ≥ 0.9. Secondary outcome was the occurrence of postoperative residual curarization in post-anesthesia recovery room, searching the patient's ability to pass from the surgical bed to the transport, adequacy of oxygenation, respiratory pattern, ability to swallow saliva and clarity of vision. Results: Groups were homogenous in gender, age, total body weight, ideal body weight, body mass index, type and time of surgery. The reversal times (s were (mean ± standard deviation 225.2 ± 81.2, 173.9 ± 86.8 and 174.1 ± 74.9 respectively, in the IW, CW20 and CW40 groups (p = 0.087. Conclusions: No differences were observed between groups with neuromuscular blockade reversal time and frequency of postoperative residual curarization. We concluded that ideal body weight can be used to calculate sugammadex dose to reverse moderate neuromuscular blockade in morbidly obese patients. Resumo: Justificativa e objetivos: Os parâmetros de peso para o uso de sugamadex em pacientes com obesidade mórbida ainda precisam ser definidos. Métodos: Um ensaio clínico prospectivo foi realizado com sessenta participantes com índice de massa corporal ≥ 40

  12. Prevention of hypothermia in patients undergoing orthotopic liver transplantation using the humigard® open surgery humidification system: a prospective randomized pilot and feasibility clinical trial.

    Science.gov (United States)

    Weinberg, Laurence; Huang, Andrew; Alban, Daniel; Jones, Robert; Story, David; McNicol, Larry; Pearce, Brett

    2017-01-23

    Perioperative thermal disturbances during orthotopic liver transplantation (OLT) are common. We hypothesized that in patients undergoing OLT the use of a humidified high flow CO 2 warming system maintains higher intraoperative temperatures when compared to standardized multimodal strategies to maintain thermoregulatory homeostasis. We performed a randomized pilot study in adult patients undergoing primary OLT. Participants were randomized to receive either open wound humidification with a high flow CO 2 warming system in addition to standard care (Humidification group) or to standard care alone (Control group). The primary end point was nasopharyngeal core temperature measured 5 min immediately prior to reperfusion of the donor liver (Stage 3 - 5 min). Secondary endpoints included intraoperative PaCO 2 , minute ventilation and the use of vasoconstrictors. Eleven patients were randomized to each group. Both groups were similar for age, body mass index, MELD, SOFA and APACHE II scores, baseline temperature, and duration of surgery. Immediately prior to reperfusion (Stage 3 - 5 min) the mean (SD) core temperature was higher in the Humidification Group compared to the Control Group: 36.0 °C (0.13) vs. 35.4 °C (0.22), p = 0.028. Repeated measured ANOVA showed that core temperatures over time during the stages of the transplant were higher in the Humidification Group compared to the Control Group (p < 0.0001). There were no significant differences in the ETCO 2 , PaCO 2 , minute ventilation, or inotropic support. The humidified high flow CO 2 warming system was superior to standardized multimodal strategies in maintaining normothermia in patients undergoing OLT. Use of the device was feasible and did not interfere with any aspects of surgery. A larger study is needed to investigate if the improved thermoregulation observed is associated with improved patient outcomes. ACTRN12616001631493 . Retrospectively registered 25 November 2016.

  13. Counterbalancing risks and gains from extended resections in malignant glioma surgery: a supplemental analysis from the randomized 5-aminolevulinic acid glioma resection study. Clinical article.

    Science.gov (United States)

    Stummer, Walter; Tonn, Jörg-Christian; Mehdorn, Hubertus Maximilian; Nestler, Ulf; Franz, Kea; Goetz, Claudia; Bink, Andrea; Pichlmeier, Uwe

    2011-03-01

    Accumulating data suggest more aggressive surgery in patients with malignant glioma to improve outcome. However, extended surgery may increase morbidity. The randomized Phase III 5-aminolevulinic acid (ALA) study investigated 5-ALA-induced fluorescence as a tool for improving resections. An interim analysis demonstrated more frequent complete resections with longer progression-free survival (PFS). However, marginal differences were found regarding neurological deterioration and the frequency of additional therapies. Presently, the authors focus on the latter aspects in the final study population, and attempt to determine how safety might be affected by cytoreductive surgery. Patients with malignant gliomas were randomized for fluorescence-guided (ALA group) or conventional white light (WL) (WL group) microsurgery. The final intent-to-treat population consisted of 176 patients in the ALA and 173 in the WL group. Primary efficacy variables were contrast-enhancing tumor on early MR imaging and 6-month PFS. Among secondary outcome measures, the National Institutes of Health Stroke Scale (NIH-SS) score and the Karnofsky Performance Scale (KPS) score were used for assessing neurological function. More frequent complete resections and improved PFS were confirmed, with higher median residual tumor volumes in the WL group (0.5 vs 0 cm(3), p = 0.001). Patients in the ALA group had more frequent deterioration on the NIH-SS at 48 hours. Patients at risk were those with deficits unresponsive to steroids. No differences were found in the KPS score. Regarding outcome, a combined end point of risks and neurological deficits was attempted, which demonstrated results in patients in the ALA group to be superior to those in participants in the WL group. Interestingly, the cumulative incidence of repeat surgery was significantly reduced in ALA patients. When stratified by completeness of resection, patients with incomplete resections were quicker to deteriorate neurologically (p = 0

  14. Adjuvant radiation therapy versus surgery alone in operable breast cancer: long-term follow-up of a randomized clinical trial.

    Science.gov (United States)

    Rutqvist, L E; Pettersson, D; Johansson, H

    1993-02-01

    This paper presents long-term results from a randomized trial of pre- or postoperative megavoltage radiation therapy versus surgery alone in pre- and postmenopausal women with operable breast cancer. Treatment outcome after relapse among patients who developed loco-regional recurrences was also analyzed. A total of 960 patients were included in the trial. The mean follow-up was 16 years (range: 13-19 years). The radiation therapy was individually planned. It included the chest wall (and the breast in the preoperative cases) and the regional lymph nodes. The tumor dose was 45 Gy/5 weeks. No adjuvant systemic therapy was used. The results showed a significant benefit with radiation therapy in terms of recurrence-free survival during the entire follow-up period. There was also an overall survival difference-corresponding to a 16% reduction of deaths-in favor of the irradiated patients which, however, was not statistically significant (p = 0.09). Among those 169 patients who developed locoregional recurrences long-term control was only achieved in about one-third of the cases. This figure was similar among those who had received adjuvant radiation therapy (34%) compared to those initially treated with surgery alone (32%). This implied that the overall proportion of patients who eventually developed uncontrolled local disease was significantly higher among those initially allocated to surgery alone (16%) compared to those allocated to pre- or postoperative radiation therapy (6%, p < 0.01). These results suggest that local undertreatment may be deleterious in subgroups of patients.

  15. Effectiveness of a New Exercise Program after Lower Limb Arterial Blood Flow Surgery in Patients with Peripheral Arterial Disease: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Edita Jakubsevičienė

    2014-08-01

    Full Text Available Objective: The aim of this study was to evaluate the effectiveness of a supervised exercise program (SEP plus at home nonsupervised exercise therapy (non-SET on functional status, quality of life (QoL and hemodynamic response in post-lower-limb bypass surgery patients. Results: One hundred and seventeen patients were randomized to an intervention (n = 57 or a control group (n = 60. A new individual SEP was designed for patients with peripheral arterial disease (PAD and applied to the studied subjects of the intervention group who also continued non-SET at home, whereas those assigned to the control group received just usual SEP according to a common cardiovascular program. The participants of the study were assessed by a 6-min walking test (6 MWT, an ankle-brachial index (ABI, and the Medical Outcomes Study Short Form-36 (SF-36 of QoL at baseline, at 1 and 6 months after surgery. A significant improvement was observed in the walked distance in the intervention group after 6 months compared with the control group (p < 0.001. The intervention group had significantly higher QoL score in the physical and mental component of SF-36 (p < 0.05. Conclusions: A 6-month application of the new SEP and non-SET at home has yielded significantly better results in walking distance and QoL in the intervention group than in the controls.

  16. A randomized clinical trial to compare the efficacy of submucosal aprotinin injection and intravenous dexamethasone in reducing pain and swelling after third molar surgery: a prospective study.

    Science.gov (United States)

    Arakeri, Gururaj; Rai, Kirthi Kumar; Shivakumar, H R; Jayade, Bhushan

    2013-03-01

    The purpose of this study was to compare two different groups of drugs, aprotinin and dexamethasone for its efficacy in reducing post operative swelling and pain after third molar surgery. Fifty consecutive patients requiring surgical removal of single mandibular third molar (class II position B) under local anesthesia were randomly divided into two groups, each group consisting of 25 patients. One group was administered 8 mg dexamethasone through intravenous route pre-operatively. The other group received 1 ml of Aprotinin through submucosal route in operating area after the onset of local anesthesia. Swelling was assessed by measuring facial contours at baseline and at 1st, 3rd and 7th post-operative days. Pain was measured on the 1st, 3rd and 7th post-operative days using visual analog scale. Based on statistical analysis (paired t test and Wilcoxon's signed ranking test), the results showed statistically significant difference in post operative swelling and pain on 3rd postoperative day in dexamethasone group as compared to aprotinin group. The results of present study showed a similar reduction in the severity of pain and swelling at the aprotinin and dexamethasone sites on 1st and 7th postoperative day. It was also noticed that the aprotinin promoted a greater reduction of swelling and pain on 3rd postoperative day. It appeared that, benefits of aprotinin against the risks of dexamethasone and its efficacy in controlling pain and swelling after third molar surgery makes aprotinin to be a valuable alternative to dexamethasone.

  17. Increase in Periodontal Interleukin-1β Gene Expression Following Osseous Resective Surgery Using Conventional Rotary Instruments Compared with Piezosurgery: A Split-Mouth Randomized Clinical Trial.

    Science.gov (United States)

    Aimetti, Mario; Ferrarotti, Francesco; Bergandi, Loredana; Saksing, Laura; Parducci, Francesca; Romano, Federica

    2016-01-01

    The purpose of this study was to evaluate the early inflammatory response following osseous resective surgery (ORS) with Piezosurgery compared to commonly used diamond burs. A sample was selected of 24 bilateral posterior sextants requiring ORS in 12 chronic periodontitis patients in a split-mouth design. In 12 sextants, bone recontouring was performed using a piezoelectric device. In the contralateral sextants, rotary instruments were used. Sextants treated with Piezosurgery obtained similar 12-month clinical results but lower postsurgical gene expression of interleukin-1β (IL-1β), a well-known proinflammatory cytokine, and lower patient morbidity compared with sextants treated with rotary instruments. In spite of the longer surgical time, the use of Piezosurgery for ORS seems to promote more favorable wound healing compared with rotary instruments, as the lower pain and the low levels of IL-1β mRNA at the surgical sites suggest a milder underlying inflammatory response.

  18. The impact of an hematocrit of 20% during normothermic cardiopulmonary bypass for elective low risk coronary artery bypass graft surgery on oxygen delivery and clinical outcome – a randomized controlled study [ISRCTN35655335

    Science.gov (United States)

    von Heymann, Christian; Sander, Michael; Foer, Achim; Heinemann, Anja; Spiess, Bruce; Braun, Jan; Krämer, Michael; Grosse, Joachim; Dohmen, Pascal; Dushe, Simon; Halle, Jürgen; Konertz, Wolfgang F; Wernecke, Klaus-Dieter; Spies, Claudia

    2006-01-01

    Introduction Cardiopulmonary bypass (CPB) induces hemodilutional anemia, which frequently requires the transfusion of blood products. The objective of this study was to evaluate oxygen delivery and consumption and clinical outcome in low risk patients who were allocated to an hematocrit (Hct) of 20% versus 25% during normothermic CPB for elective coronary artery bypass graft (CABG) surgery. Methods This study was a prospective, randomized and controlled trial. Patients were subjected to normothermic CPB (35 to 36°C) and were observed until discharge from the intensive care unit (ICU). Outcome measures were calculated whole body oxygen delivery, oxygen consumption and clinical outcome. A nonparametric multivariate analysis of variance for repeated measurements and small sample sizes was performed. Results In a total of 54 patients (25% Hct, n = 28; 20% Hct, n = 26), calculated oxygen delivery (p = 0.11), oxygen consumption (p = 0.06) and blood lactate (p = 0.60) were not significantly different between groups. Clinical outcomes were not different between groups. Conclusion These data indicate that an Hct of 20% during normothermic CPB maintained calculated whole body oxygen delivery above a critical level after elective CABG surgery in low risk patients. The question of whether a transfusion trigger in excess of 20% Hct during normothermic CPB is still supported requires a larger prospective and randomized trial. PMID:16606474

  19. Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study)

    NARCIS (Netherlands)

    Vlug, Malaika S.; Wind, Jan; Hollmann, Markus W.; Ubbink, Dirk T.; Cense, Huib A.; Engel, Alexander F.; Gerhards, Michael F.; van Wagensveld, Bart A.; van der Zaag, Edwin S.; van Geloven, Anna A. W.; Sprangers, Mirjam A. G.; Cuesta, Miguel A.; Bemelman, Willem A.; Preckel, Benedikt; Bossuyt, Patrick; Gouma, Dirk; van Berge Henegouwen, Mark; Fuhring, Jan; van Lenthe, Ineke Picard; Bakker, Chris; King-Kalimanis, Bellinda; Hofland, Jan; Dejong, Cornelis; van Dam, Ronald; van der Peet, Donald; van Zalingen, Edith; Noordhuis, Astrid; de Jong, Dick; Goei, T. Hauwy; de Stoppelaar, Erica; van den Dongen, Marjon; van Tets, Willem; van den Elsen, Maarten; Swart, Annemiek; deWit, Laurens; Siepel, Muriel; Molly, Glaresa; Juttmann, Jan; Clevers, Wilfred; Bieleman, Andrea; Coenen, Ludo; Bonekamp, Elly; van Abeelen, Jacobus; van Iterson-de Jong, Diana; Krombeen, Margriet

    2011-01-01

    To investigate which perioperative treatment, ie, laparoscopic or open surgery combined with fast track (FT) or standard care, is the optimal approach for patients undergoing segmental resection for colon cancer. Important developments in elective colorectal surgery are the introduction of

  20. Evaluation of diode laser and stannous fluoride in the treatment of root sensitivity after access flap surgery: Randomized controlled clinical trial.

    Science.gov (United States)

    Raut, Chetan Purushottam; Sethi, Kunal Sunder; Kohale, Bhagyashree; Mamajiwala, Alefiya; Warang, Ayushya

    2018-01-01

    Postsurgical root sensitivity has always been an enigma to the periodontists. There is a plethora of evidence suggesting the presence of root sensitivity following periodontal flap surgical procedures. Thus, the aim of the present study was to compare and evaluate the effect of low-power diode lasers with and without topical application of stannous fluoride (SnF 2 ) gel in the treatment of root sensitivity and also evaluate whether laser creates any placebo effect in the control group or not. Thirty patients participated in this study and 99 teeth were included. Root sensitivity was assessed for all groups with a Verbal Rating Scale (VRS). For each patient, the teeth were randomized into three groups. In the test Group I, sensitive teeth were treated with SnF 2 and diode laser. In the test Group II, sensitive teeth were irradiated with laser only. In the control group, no treatment was performed. The mean ± standard deviation (SD) score for VRS and Visual Analog Scale at baseline was not statistically significant ( P > 0.05) between the three groups. After 15 min, statistical significant difference was seen in test Group I and test Group II, although no difference was found in the control group. At 15 th day and 30 th day, the mean ± SD scores were statistically significant ( P diode lasers alone and in combination with 0.4% SnF 2 was effective in the treatment of root sensitivity after access flap surgery.

  1. Effectiveness of a nursing intervention in decreasing the anxiety levels of family members of patients undergoing cardiac surgery: a randomized clinical trial.

    Science.gov (United States)

    Hamester, Letícia; Souza, Emiliane Nogueira de; Cielo, Cibele; Moraes, Maria Antonieta; Pellanda, Lúcia Campos

    2016-08-15

    to verify the effectiveness of nursing orientation provided to families of patients in the immediate post-operative following cardiac surgery before the first visit to the post-anesthesia care unit, in decreasing anxiety levels, compared to the unit's routine orientation. open randomized clinical trial addressing family members in the waiting room before the first visit in the immediate post-operative period. The family members assigned to the intervention group received audiovisual orientation concerning the patients' conditions at the time and the control group received the unit's routine orientation. Outcome anxiety was assessed using the STAI-State. 210 individuals were included, 105 in each group, aged 46.4 years old on average (±14.5); 69% were female and 41% were the patients' children. The mean score obtained on the anxiety assessment in the intervention group was 41.3±8.6, while the control group scored 50.6±9.4 (pde enfermagem a familiares de pacientes em pós-operatório imediato de cirurgia cardíaca, antes da primeira visita na sala de recuperação pós-anestésica, nos níveis de ansiedade, comparados com a orientação de rotina da unidade. ensaio clínico randomizado, realizado com familiares abordados na sala de espera, antes da primeira visita no pós-operatório imediato. Familiares alocados no grupo intervenção receberam orientações audiovisuais sobre as condições em que o paciente se encontrava naquele momento, e o grupo controle recebeu as orientações de rotina da unidade. O desfecho ansiedade foi avaliado pelo inventário IDATE. foram incluídos 210 sujeitos, 105 em cada grupo, com idade média de 46,4±14,5 anos, sendo 69% do sexo feminino e 41% filhos dos pacientes. Na avaliação da ansiedade, o escore médio para o grupo intervenção foi de 41,3±8,6 pontos e, para o grupo controle, 50,6±9,4 pontos (pde enfermagem voltada à orientação de familiares, no momento que antecede a primeira visita no pós-operatório imediato de

  2. Efficacy of local dexmedetomidine add-on for spermatic cord block anesthesia in patients undergoing intrascrotal surgeries: randomized controlled multicenter clinical trial

    Directory of Open Access Journals (Sweden)

    Hetta DF

    2017-11-01

    Full Text Available Diab Fuad Hetta,1 Emad E Kamal,2 Ali M Mahran,2 Doaa G Ahmed,1 Abdelraheem Elawamy,3 Abdelraouf MS Abdelraouf3 1Department of Anesthesiology and Pain Management, South Egypt Cancer Institute, 2Department of Dermatology and Andrology, 3Department of Anesthesiology and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt Study objective: The objective of this study was to evaluate the effect of adding dexmedetomidine (DEX to bupivacaine on the quality of spermatic cord block anesthesia and postoperative analgesia. Design: This is a randomized, double-blind study. Setting: This study was performed in an educational and research hospital. Patients: One hundred twenty adult males were scheduled for intrascrotal surgeries. Interventions: Patients were divided into two groups: group B received 10 mL of bupivacaine 0.25% for spermatic cord block and intravenous 50 µg of DEX and group BD received 10 mL of bupivacaine 0.25% added to 50 µg of DEX (9.5 mL bupivacaine 0. 25% + 0.5 mL [50 µg] DEX for spermatic cord block, and for masking purposes, the patients received isotonic saline intravenously. Measurements: Time to first analgesic request, analgesic consumption, and visual analog scale (VAS pain score in the first 24 hours postoperatively were assessed. Main results: Time to first rescue analgesic was significantly delayed in group BD in comparison with group B, median (interquartile range, 7 (6–12 hours versus 6 (5–7 hours, (p=0.000, the mean cumulative morphine consumption (mg in the first postoperative 24 hours was significantly lower in group BD compared with group B, 8.13±4.45 versus 12.7±3.79, with a mean difference (95% CI of −4.57 (−6.06 to −3.07 (p=0.000; also, there was a significant reduction of VAS pain score in group BD in comparison with group B at all measured time points, VAS 2 hours (1.28±0.9 vs 1.92±0.8, VAS 6 hours (2.62±1.5 vs 3.93±1.2, VAS 12 hours (2.40±1.1 vs 3.57±0.65, VAS 24 hours (1.90±0

  3. Evaluation of diode laser and stannous fluoride in the treatment of root sensitivity after access flap surgery: Randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Chetan Purushottam Raut

    2018-01-01

    Full Text Available Background: Postsurgical root sensitivity has always been an enigma to the periodontists. There is a plethora of evidence suggesting the presence of root sensitivity following periodontal flap surgical procedures. Thus, the aim of the present study was to compare and evaluate the effect of low-power diode lasers with and without topical application of stannous fluoride (SnF2 gel in the treatment of root sensitivity and also evaluate whether laser creates any placebo effect in the control group or not. Materials and Methods: Thirty patients participated in this study and 99 teeth were included. Root sensitivity was assessed for all groups with a Verbal Rating Scale (VRS. For each patient, the teeth were randomized into three groups. In the test Group I, sensitive teeth were treated with SnF2and diode laser. In the test Group II, sensitive teeth were irradiated with laser only. In the control group, no treatment was performed. Results: The mean ± standard deviation (SD score for VRS and Visual Analog Scale at baseline was not statistically significant (P > 0.05 between the three groups. After 15 min, statistical significant difference was seen in test Group I and test Group II, although no difference was found in the control group. At 15th day and 30th day, the mean ± SD scores were statistically significant (P < 0.05. Conclusion: Within the limitations of the study, it can be concluded that diode lasers alone and in combination with 0.4% SnF2was effective in the treatment of root sensitivity after access flap surgery.

  4. Outpatient Surgery In Day Clinics*

    African Journals Online (AJOL)

    1971-12-18

    Dec 18, 1971 ... over-supplied with hospital beds and nursing staff that we can afford such ... disposing to sepsis and deep-vein thrombosis? Finally, must we put our .... patients for surgery; by the same token, extra care was probably taken in.

  5. Probiotic Supplementation in Morbid Obese Patients Undergoing One Anastomosis Gastric Bypass-Mini Gastric Bypass (OAGB-MGB) Surgery: a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial.

    Science.gov (United States)

    Karbaschian, Zohreh; Mokhtari, Zeinab; Pazouki, Abdolreza; Kabir, Ali; Hedayati, Mahdi; Moghadam, Somayeh Soleymanzadeh; Mirmiran, Parvin; Hekmatdoost, Azita

    2018-05-03

    Bariatric surgery is known as one of the most effective treatments for sustainable weight loss; however, it may be associated with some complications. This study was designed to examine the effects of probiotic supplementation on some morbidities related to this surgery. This was a placebo-controlled, double-blind, randomized clinical trial on morbid obese patients referred for One Anastomosis Gastric Bypass- Mini Gastric Bypass (OAGB-MGB) surgery to a tertiary referral center. Patients were assigned to receive a probiotic supplement (Familact®) or placebo from 4 weeks prior to surgery to 12 weeks after surgery. Anthropometric, biochemical, and inflammatory indices were evaluated at the beginning and the end of the study. At the end of study, significant improvements in some serum inflammatory markers, vitamin D status, and anthropometric measurements were observed (p < 0.05), which were significantly more in probiotic group rather than placebo group (p < 0.05). Moreover, significant improvements in glycemic indices and lipid profile were observed in both groups; however, these changes were not significantly different between the groups. There was no significant difference in serum levels of vitamin B 12 , folate, and homocysteine between groups at week 16 of the study. Our results indicate that probiotic supplementation promotes inflammatory markers, body weight loss, and status of vitamin D in patients undergoing OAGB-MGB bypass. Whether these findings will sustain in longer treatment duration remained to be elucidated in future studies. This study has been registered at Clinicaltrial.gov with registration number NCT02708589.

  6. Trends in Mortality After Primary Cytoreductive Surgery for Ovarian Cancer: A Systematic Review and Metaregression of Randomized Clinical Trials and Observational Studies.

    Science.gov (United States)

    Di Donato, Violante; Kontopantelis, Evangelos; Aletti, Giovanni; Casorelli, Assunta; Piacenti, Ilaria; Bogani, Giorgio; Lecce, Francesca; Benedetti Panici, Pierluigi

    2017-06-01

    Primary cytoreductive surgery (PDS) followed by platinum-based chemotherapy is the cornerstone of treatment and the absence of residual tumor after PDS is universally considered the most important prognostic factor. The aim of the present analysis was to evaluate trend and predictors of 30-day mortality in patients undergoing primary cytoreduction for ovarian cancer. Literature was searched for records reporting 30-day mortality after PDS. All cohorts were rated for quality. Simple and multiple Poisson regression models were used to quantify the association between 30-day mortality and the following: overall or severe complications, proportion of patients with stage IV disease, median age, year of publication, and weighted surgical complexity index. Using the multiple regression model, we calculated the risk of perioperative mortality at different levels for statistically significant covariates of interest. Simple regression identified median age and proportion of patients with stage IV disease as statistically significant predictors of 30-day mortality. When included in the multiple Poisson regression model, both remained statistically significant, with an incidence rate ratio of 1.087 for median age and 1.017 for stage IV disease. Disease stage was a strong predictor, with the risk estimated to increase from 2.8% (95% confidence interval 2.02-3.66) for stage III to 16.1% (95% confidence interval 6.18-25.93) for stage IV, for a cohort with a median age of 65 years. Metaregression demonstrated that increased age and advanced clinical stage were independently associated with an increased risk of mortality, and the combined effects of both factors greatly increased the risk.

  7. CROSS and beyond: a clinical perspective on the results of the randomized ChemoRadiotherapy for Oesophageal cancer followed by Surgery Study.

    Science.gov (United States)

    van der Woude, Stephanie O; Hulshof, Maarten C C M; van Laarhoven, Hanneke W M

    2016-02-01

    Despite extensive research efforts oesophageal cancer remains a malignancy with a poor prognosis. Improvement of treatment is urgently needed. Although multimodality treatment for resectable oesophageal cancer has established it place in standard practice, there are still many differences worldwide in the preferred treatment. The Dutch ChemoRadiotherapy for Oesophageal cancer followed by Surgery Study (CROSS) trial has contributed significantly to the current use of neoadjuvant chemoradiation. This study compared neoadjuvant chemoradiotherapy (CRT) using a moderate radiation dose weekly combined with carboplatin and paclitaxel followed by surgery versus surgery alone. Median overall survival in the CRT group is 49.4 months compared to 24.0 months in the surgery alone group, resulting in an overall survival benefit of 13% in favor of the CRT group (HR, 0.81; 95% CI: 0.70-0.93; P=0.002). Recently the results after long-term follow-up (median 60 months) have been published and confirm the benefit of neoadjuvant CRT to surgery alone. Perioperative mortality rates are low and did not increase by adding CRT (4%) and the CROSS scheme has a favorable toxicity profile. Recurrence patterns in patients treated according to the CROSS protocol report significantly reduced loco regional recurrence in the CRT group (34% to 14%; P<0.001) and less peritoneal carcinomatosis (14% to 4%; P<0.001). With the contemporary focus of research on tumor tailored therapy, the effective and safe CROSS protocol serves as a backbone in many ongoing trials.

  8. Clinical privileges for laparoscopic surgery.

    Science.gov (United States)

    Albrink, M H; Rosemurgy, A S

    1993-06-01

    Laparoscopic cholecystectomy has undergone an explosive growth. Its benefits to patients--shortened recovery time and less pain--became immediately obvious. The procedure's development and adaptation have largely been devised and implemented by ingenious and creative private practitioners, not the typical mode of introduction. Most or many new procedures in the past evolved from academic institutions after laboratory and then clinical trials. With rapid development and acceptance has come an additional new burden among medical practitioners: credentialing and granting clinical privileges.

  9. Comparison between paracetamol, piroxicam, their combination, and placebo in postoperative pain management of upper limb orthopedic surgery (a randomized double blind clinical trial

    Directory of Open Access Journals (Sweden)

    Gholamreza Khalili

    2016-01-01

    Conclusion: IV infusion of 15 mg/kg Paracetamol used as a preventive may provide effective analgesia in comparison with IM 0.4 mg/kg Piroxicam or placebo. Addition of Piroxicam to Paracetamol has not much more benefit than Paracetamol alone, in reducing pain after upper limb orthopedic surgery.

  10. Efficacy of Preoperative Administration of Paracetamol-Codeine on Pain following Impacted Mandibular Third Molar Surgery: A Randomized, Split-Mouth, Placebo-Controlled, Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Maria Paola Cristalli

    2017-01-01

    Full Text Available Objectives. The aim of this study was to determine the effectiveness of preoperative administration of single-dose of paracetamol-codeine, in the relieving of acute postoperative pain after the surgical removal of an impacted mandibular third molar. Materials and Methods. The study cohort consisted of 32 Caucasian outpatients, giving a total of 64 bilateral symmetrical impacted mandibles. Patients were randomized in two experimental groups to receive a preoperative oral dose of paracetamol-codeine (analgesic group or a placebo (placebo group at the first and second surgeries. Study participants were asked to record pain intensity scores during the operation and the next 2 days, the time of the first request for rescue analgesic, and the total number of postoperative-supplement paracetamol-codeine tablets. Results. The pain intensity score on the first day was significantly lower in the analgesic group than in the placebo group (p<0.001. The time to using rescue therapy was significantly longer in the analgesic group than in the placebo group (p=0.004. The number of paracetamol-codeine tablets used postoperatively did not differ between the analgesic and placebo groups (p=0.104. Conclusions. Preoperative paracetamol-codeine is effective in providing immediate postoperative pain control after third molar surgery and in delaying the initial onset of pain. This trial is registered with ClinicalTrials.gov Identifier (Registration Number: NCT03049878.

  11. The efficacy of preventive parasternal single injection of bupivacaine on intubation time, blood gas parameters, narcotic requirement, and pain relief after open heart surgery: A randomized clinical trial study

    Directory of Open Access Journals (Sweden)

    Mahmoud Saeidi

    2011-01-01

    Full Text Available Background: Postsurgical pain usually results in some complications in the patients. This study has tried to investigate the effects of parasternal single injection of bupivacaine on postoperative pulmonary and pain consequences in patients after open heart surgery. Methods: : In a prospective double blind clinical study, 100 consenting patients undergoing elective open heart surgery were randomized into two groups. In case group, bupivacaine was injected at both sides of sternum, immediately before sternal closure. In the control group, no intervention was performed. Then, the patients were investigated regarding intubation period, length of ICU stay, arterial blood gas (ABG parameters, morphine requirement, and their severity of postoperative pain using a visual analogue scale (VAS device. Results: No differences were found between the two groups regarding to age, sex, pump time, operation time, and body mass index and preoperative cardiac ejection fraction. Mean intubation length in case group was much shorter than that in control group. Mean PaO 2 in case group was lower in different checking times in postoperative period. The patients in the case group needed less morphine compared to those in the control group during the 24-hour observation period in the ICU. Finally, mean VAS scores of pain in case group were significantly lower than those in control group at 6, 12, and 24 hours postoperatively. Conclusions: Patients′ pain relief by parasternal single injection of bupivacaine in early postoperative period can facilitate earlier ventilator weaning and tracheal extubation after open heart surgery as well as achieving lower pain scores and narcotic requirements.

  12. Evaluation of the Efficacy of Tranexamic Acid on the Surgical Field in Primary Cleft Palate Surgery on Children-A Prospective, Randomized Clinical Study.

    Science.gov (United States)

    Durga, Padmaja; Raavula, Parvathi; Gurajala, Indira; Gunnam, Poojita; Veerabathula, Prardhana; Reddy, Mukund; Upputuri, Omkar; Ramachandran, Gopinath

    2015-09-01

    To assess the effect of tranexamic acid on the quality of the surgical field. Prospective, randomized, double-blind study. Institutional, tertiary referral hospital. American Society of Anesthesiologists physical status class I patients, aged 8 to 60 months with Group II or III (Balakrishnan's classification) clefts scheduled for cleft palate repair. Children were randomized into two groups. The control group received saline, and the tranexamic acid group received tranexamic acid 10 mg/kg as a bolus, 15 minutes before incision. Grade of surgical field on a 10-point scale, surgeon satisfaction, and primary hemorrhage. Significant improvements were noted in surgeon satisfaction and median grade of assessment of the surgical field (4 [interquartile range, 4 to 6] in the control group vs. 3 [interquartile range, 2 to 4] in the test group; P = .003) in the tranexamic acid group compared to the control group. Preincision administration of 10 mg/kg of tranexamic acid significantly improved the surgical field during cleft palate repair.

  13. Allgöwer-Donati Versus Vertical Mattress Suture Technique Impact on Perfusion in Ankle Fracture Surgery: A Randomized Clinical Trial Using Intraoperative Angiography.

    Science.gov (United States)

    Shannon, Steven F; Houdek, Matthew T; Wyles, Cody C; Yuan, Brandon J; Cross, William W; Cass, Joseph R; Sems, Stephen A

    2017-02-01

    The purpose of this study was to evaluate which primary wound closure technique for ankle fractures affords the most robust perfusion as measured by laser-assisted indocyanine green angiography: Allgöwer-Donati or vertical mattress. Prospective, randomized. Level 1 Academic Trauma Center. Thirty patients undergoing open reduction internal fixation for ankle fractures were prospectively randomized to Allgöwer-Donati (n = 15) or vertical mattress (n = 15) closure. Demographics were similar for both cohorts with respect to age, sex, body mass index, surgical timing, and OTA/AO fracture classification. Skin perfusion (mean incision perfusion and mean perfusion impairment) was quantified in fluorescence units with laser-assisted indocyanine green angiography along the lateral incision as well as anterior and posterior to the incision at 30 separate locations. Minimum follow-up was 3 months with a mean follow-up 4.7 months. Allgöwer-Donati enabled superior perfusion compared with the vertical mattress suture technique. Mean incision perfusion for Allgöwer-Donati was 51 (SD = 13) and for vertical mattress was 28 (SD = 10, P ankle fractures. Theoretically, this may enhance soft tissue healing and decrease the risk of wound complications. Surgeons may take this into consideration when deciding closure techniques for ankle fractures. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  14. Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery : A multicenter randomized controlled trial

    NARCIS (Netherlands)

    Gareb, B.; van Bakelen, N. B.; Buijs, G. J.; Jansma, J.; de Visscher, J. G. A. M.; Hoppenreijs, Th. J. M.; Bergsma, J. E.; van Minnen, B.; Stegenga, B.; Bos, R. R. M.

    2017-01-01

    Background Biodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation. Aim The aim of this study was to compare the long-term (i.e. >5 years postoperatively) clinical performance of a titanium and a biodegradable system in

  15. 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.

  16. The effects of perioperative probiotic treatment on serum zonulin concentration and subsequent postoperative infectious complications after colorectal cancer surgery: a double-center and double-blind randomized clinical trial.

    Science.gov (United States)

    Liu, Zhi-Hua; Huang, Mei-Jin; Zhang, Xing-Wei; Wang, Lei; Huang, Nan-Qi; Peng, Hui; Lan, Pin; Peng, Jun-Sheng; Yang, Zhen; Xia, Yang; Liu, Wei-Jie; Yang, Jun; Qin, Huan-Long; Wang, Jian-Ping

    2013-01-01

    Zonulin is a newly discovered protein that has an important role in the regulation of intestinal permeability. Our previous study showed that probiotics can decrease the rate of infectious complications in patients undergoing colectomy for colorectal cancer. The objective was to determine the effects of the perioperative administration of probiotics on serum zonulin concentrations and the subsequent effect on postoperative infectious complications in patients undergoing colorectal surgery. A total of 150 patients with colorectal carcinoma were randomly assigned to the control group (n = 75), which received placebo, or the probiotics group (n = 75). Both the probiotics and placebo were given orally for 6 d preoperatively and 10 d postoperatively. Outcomes were measured by assessing bacterial translocation, postoperative intestinal permeability, serum zonulin concentrations, duration of postoperative pyrexia, and cumulative duration of antibiotic therapy. The postoperative infection rate, the positive rate of blood microbial DNA, and the incidence of postoperative infectious complications-including septicemia, central line infection, pneumonia, urinary tract infection, and diarrhea-were also assessed. The infection rate was lower in the probiotics group than in the control group (P zonulin concentration (P zonulin concentrations in patients undergoing colectomy. We propose a clinical regulatory model that might explain this association. This trial was registered at http://www.chictr.org/en/ as ChiCTR-TRC-00000423.

  17. The effect of massage therapy by patients' companions on severity of pain in the patients undergoing post coronary artery bypass graft surgery: a single-blind randomized clinical trial.

    Science.gov (United States)

    Najafi, Sied Saeed; Rast, Fazlola; Momennasab, Marzieh; Ghazinoor, Mahmood; Dehghanrad, Fereshteh; Mousavizadeh, Sied Ali

    2014-07-01

    Pain on mid sternotomy incision site after Coronary Artery Bypass  Graft  Surgery (CABG) is a common problem that causes sleep disturbance, delayed wound healing, and increased use of analgesic drugs. Massage therapy which is mostly performed by healthcare providers is a non-pharmacological approach for managing this pain. The present study aimed to determine the effect of massage therapy by patient's companion on the severity of pain in post CABG patients. In this randomized single-blind clinical trial, 70 post CABG patients were randomly divided into an intervention and a control group. The intervention group received massage by one of their relatives who was trained by an expert nurse. The control group, on the other hand, received routine care. The pain intensity was assessed by Visual Analogue Scale (VAS) before and immediately, 30, 60, and 120 minutes after the intervention. Then, the data were entered into the SPSS statistical software (version 16) and analyzed using repeated measures ANOVA and post-hoc test (Scheffe). At the beginning of the study, no significant difference was found between the two groups regarding the pain severity. In the intervention group, the pain severity significantly decreased in all the four time points after the intervention (P=0.001). However, no significant difference was observed in this regard in the control group. Massage therapy by patient's companion trained by a nurse was an effective strategy for pain management in post CABG patients. This could also promote the patient's family participation in the process of care. IRCT201208218505N3.

  18. [Impact of digital technology on clinical practices: perspectives from surgery].

    Science.gov (United States)

    Zhang, Y; Liu, X J

    2016-04-09

    Digital medical technologies or computer aided medical procedures, refer to imaging, 3D reconstruction, virtual design, 3D printing, navigation guided surgery and robotic assisted surgery techniques. These techniques are integrated into conventional surgical procedures to create new clinical protocols that are known as "digital surgical techniques". Conventional health care is characterized by subjective experiences, while digital medical technologies bring quantifiable information, transferable data, repeatable methods and predictable outcomes into clinical practices. Being integrated into clinical practice, digital techniques facilitate surgical care by improving outcomes and reducing risks. Digital techniques are becoming increasingly popular in trauma surgery, orthopedics, neurosurgery, plastic and reconstructive surgery, imaging and anatomic sciences. Robotic assisted surgery is also evolving and being applied in general surgery, cardiovascular surgery and orthopedic surgery. Rapid development of digital medical technologies is changing healthcare and clinical practices. It is therefore important for all clinicians to purposefully adapt to these technologies and improve their clinical outcomes.

  19. Effect of low-level laser therapy on the healing process of donor site in patients with grade 3 burn ulcer after skin graft surgery (a randomized clinical trial).

    Science.gov (United States)

    Vaghardoost, Reza; Momeni, Mahnoush; Kazemikhoo, Nooshafarin; Mokmeli, Soheila; Dahmardehei, Mostafa; Ansari, Fereshteh; Nilforoushzadeh, Mohammad Ali; Sabr Joo, Parisa; Mey Abadi, Sara; Naderi Gharagheshlagh, Soheila; Sassani, Saeed

    2018-04-01

    Skin graft is a standard therapeutic technique in patients with deep ulcers, but managing donor site after grafting is very important. Although several modern dressings are available to enhance the comfort of donor site, using techniques that accelerate wound healing may enhance patient satisfaction. Low-level laser therapy (LLLT) has been used in several medical fields, including healing of diabetic, surgical, and pressure ulcers, but there is not any report of using this method for healing of donor site in burn patients. The protocols and informed consent were reviewed according to Medical Ethics Board of Shahid Beheshti University of Medical Sciences (IR.SBMU.REC.1394.363) and Iranian Registry of Clinical Trials (IRCT2016020226069N2). Eighteen donor sites in 11 patients with grade 3 burn ulcer were selected. Donor areas were divided into 2 parts, for laser irradiation and control randomly. Laser area was irradiated by a red, 655-nm laser light, 150 mW, 2 J/cm 2 , on days 0 (immediately after surgery), 3, 5, and 7. Dressing and other therapeutic care for both sites were the same. The patients and the person who analyzed the results were blinded. The size of donor site reduced in both groups during the 7-day study period (P < 0.01) and this reduction was significantly greater in the laser group (P = 0.01). In the present study, for the first time, we evaluate the effects of LLLT on the healing process of donor site in burn patients. The results showed that local irradiation of red laser accelerates wound healing process significantly.

  20. Clinical results of Trabectome surgery for open-angle glaucoma

    Directory of Open Access Journals (Sweden)

    Mizoguchi T

    2015-10-01

    Full Text Available Takanori Mizoguchi,1 Shiro Nishigaki,2 Tomoki Sato,3 Harumi Wakiyama,4 Nobuchika Ogino2 1Mizoguchi Eye Clinic, Ophthalmology, Sasebo, 2Nishigaki Eye Clinic, Ophthalmology, Nagoya, 3Sato Eye Clinic, Ophthalmology, Arao, 4Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan Background: The purpose of this study was to determine outcomes when using Trabectome surgery and to evaluate factors associated with its effects in primary open-angle glaucoma (POAG and exfoliation glaucoma (EXG. Methods: This was a prospective, non-randomized, observational, comparative cohort study in which Trabectome surgery was used alone in patients with POAG or EXG. Trabectome surgery was considered to have failed when at least one of the following three criteria was fulfilled: intraocular pressure (IOP ≥21 mmHg and a <20% reduction below the baseline IOP on two consecutive follow-up visits 3 months or more after surgery; need for additional glaucoma surgery; and an increase in number of medications compared with baseline. Results: The subjects were 32 males (34 eyes and 46 females (48 eyes. POAG was observed in 43 eyes and EXG in 39 eyes. IOP after Trabectome surgery decreased significantly from 22.3±6.8 mmHg at baseline to 14.0±3.9 mmHg (23.0% reduction at month 24 in all cases (P<0.0000. The success rate at 2 years was 51.2% for all cases (POAG, 50.9%; EXG, 49.2%. There was no significant difference in success rate between POAG and EXG (P=0.91. Preoperative IOP (P=0.033 and number of medications (P=0.041 were significant factors for surgical success/failure in multivariate logistic regression. No serious complications were observed. Conclusion: Trabectome surgery achieved favorable IOP control and was equally effective in patients with POAG and those with EXG. Its effects were influenced by preoperative IOP and number of preoperative medications. Keywords: Trabectome, primary open-angle glaucoma, exfoliation glaucoma, success rate, risk factors 

  1. Clinical application of thoracic paravertebral anesthetic block in breast surgeries

    Directory of Open Access Journals (Sweden)

    Sara Socorro Faria

    2015-04-01

    Full Text Available INTRODUCTION: Optimum treatment for postoperative pain has been of fundamental importance in surgical patient care. Among the analgesic techniques aimed at this group of patients, thoracic paravertebral block combined with general anesthesia stands out for the good results and favorable risk-benefit ratio. Many local anesthetics and other adjuvant drugs are being investigated for use in this technique, in order to improve the quality of analgesia and reduce adverse effects. OBJECTIVE: Evaluate the effectiveness and safety of paravertebral block compared to other analgesic and anesthetic regimens in women undergoing breast cancer surgeries. METHODS: Integrative literature review from 1966 to 2012, using specific terms in computerized databases of articles investigating the clinical characteristics, adverse effects, and beneficial effects of thoracic paravertebral block. RESULTS: On the selected date, 16 randomized studies that met the selection criteria established for this literature review were identified. Thoracic paravertebral block showed a significant reduction of postoperative pain, as well as decreased pain during arm movement after surgery. CONCLUSION: Thoracic paravertebral block reduced postoperative analgesic requirement compared to placebo group, markedly within the first 24 h. The use of this technique could ensure postoperative analgesia of clinical relevance. Further studies with larger populations are necessary, as paravertebral block seems to be promising for preemptive analgesia in breast cancer surgery.

  2. Interscalene plexus block versus general anaesthesia for shoulder surgery: a randomized controlled study.

    Science.gov (United States)

    Lehmann, Lars J; Loosen, Gregor; Weiss, Christel; Schmittner, Marc D

    2015-02-01

    This randomized clinical trial evaluates interscalene brachial plexus block (ISB), general anaesthesia (GA) and the combination of both anaesthetic methods (GA + ISB) in patients undergoing shoulder arthroscopy. From July 2011 until May 2012, 120 patients (male/female), aged 20-80 years, were allocated randomly to receive ISB (10 ml mepivacaine 1 % and 20 ml ropivacaine 0.375%), GA (propofol, sunfentanil, desflurane) or ISB + GA. The primary outcome variable was opioid consumption at the day of surgery. Anaesthesia times were analysed as secondary endpoints. After surgery, 27 of 40 patients with a single ISB bypassed the recovery room (p surgery [GA: n = 25 vs. GA + ISB: n = 10 vs. ISB: n = 10, p = 0.0037]. ISB is superior to GA and GA + ISB in patients undergoing shoulder arthroscopy in terms of faster recovery and analgesics consumption.

  3. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

  4. Conjunctival Goblet Cell Density Following Cataract Surgery With Diclofenac Versus Diclofenac and Rebamipide: A Randomized Trial.

    Science.gov (United States)

    Kato, Kumiko; Miyake, Kensaku; Kondo, Nagako; Asano, Sayaka; Takeda, Junko; Takahashi, Akiko; Takashima, Yuko; Kondo, Mineo

    2017-09-01

    To determine the effects of topical diclofenac or betamethasone with concomitant application of topical rebamipide on the conjunctival goblet cell density in eyes after cataract surgery. Randomized clinical trial. Eighty patients who were scheduled for cataract surgery. Patients were randomized into 4 groups according to the postoperative topical drugs to be given; Group A, diclofenac alone; Group B, diclofenac and rebamipide; Group C, betamethasone alone; and Group D, betamethasone and rebamipide. Impression cytology was performed before and at 1 month after the surgery, and the mean density of goblet cells was determined. The mean (± SD) density of goblet cells before the surgery in Group A was 257.0 ± 188.7 cells/mm 2 , and it decreased significantly to 86.5 ± 76.7 cells/mm 2 at 1 month after the surgery (P = .002). In Group B, the goblet cell density was not statistically different between before (238.5 ± 116.6 cells/mm 2 ) and at 1 month after the surgery (211.3 ± 184.4 cells/mm 2 , P = .55). In Groups C and D, the mean density of goblet cells was decreased at 1 month after the surgery, but the decreases were not significant (P = .11 and P = .52, respectively). After cataract surgery with postoperative topical diclofenac, the conjunctival goblet cell density was significantly reduced, and this reduction was blocked by the concomitant use of topical rebamipide. These results suggest that the concomitant use of topical rebamipide with nonsteroidal anti-inflammatory drugs is beneficial, especially in cases with postoperative dry eyes. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

  5. [Vitreoretinal outpatient surgery: clinical and financial considerations].

    Science.gov (United States)

    Creuzot-Garcher, C; Aubé, H; Candé, F; Dupont, G; Guillaubey, A; Malvitte, L; Arnavielle, S; Bron, A

    2008-11-01

    Vitreoretinal surgery has benefited from great advances opening the opportunity for outpatient management. We report on the 6-month experience of outpatient surgery for vitreoretinal diseases. From November 2007 to April 2008, 270 patients benefited from a vitreoretinal surgery, with 173 retinal detachments, 63 epiretinal membranes, and 34 other procedures. Only 8.5% (n=23) of the patients had to stay at the hospital one or two nights. The main reasons were the distance from the hospital and surgery on a single-eye patient. The questionnaire given after the surgery showed that almost all the patients were satisfied with the outpatient setting. In contrast, the financial results showed a loss of income of around 400,000 euros due to the low level of payment of outpatient surgery in France by the national health insurance system. Vitreoretinal surgery can be achieved in outpatient surgery with an improvement in the information given to the patients and the overall organization of the hospitalization. However, the current income provided with vitreoretinal outpatient surgery is highly disadvantageous in France, preventing this method from being generalized.

  6. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly vari...

  7. [Clinical trials of laparoscopic gastric cancer surgery in South Korea: review and prospect].

    Science.gov (United States)

    Zhu, Chunchao; Zhao, Gang; Cao, Hui

    2018-02-25

    Laparoscopic technology is gradually accepted in gastric cancer surgery, whose efficacy has been demonstrated by some clinical researches. Randomized controlled trials (RCT) are considered as the most important evidence to prove clinical outcomes of laparoscopic surgery for gastric cancer. Korean gastric surgeons have made great contributions to RCT in laparoscopic gastric cancer surgery. KLASS (Korean Laparoscopic Gastrointestinal Surgery Study Group) is one of the most important forerunner and global leader of clinical trials of gastric cancer treatment. KLASS series clinical trials are attracting global attention because of the significant value of surgical treatment for gastric cancer. The RCTs in Korea involve in many aspects of laparoscopic gastrectomy for gastric cancer, including laparoscopy application in early gastric cancer (KLASS-01, KLASS-03 and KLASS-07), advanced gastric cancer (KLASS-02 and KLASS-06), function-preserving gastrectomy (KLASS-04,KLASS-05) and sentinel node navigation surgery (SENORITA trial). In order to share some informations of these RCTs, we review and prospect some important clinical trials of laparoscopic gastric cancer surgery in Korea. With the experience of Korean gastric surgeons, we can make more progress in our own clinical trials of laparoscopic gastric cancer surgery.

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

    Directory of Open Access Journals (Sweden)

    Dariusz Timler

    2015-06-01

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

  9. Randomized controlled trials in children's heart surgery in the 21st century: a systematic review.

    Science.gov (United States)

    Drury, Nigel E; Patel, Akshay J; Oswald, Nicola K; Chong, Cher-Rin; Stickley, John; Barron, David J; Jones, Timothy J

    2018-04-01

    Randomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children's heart surgery. We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature. We searched MEDLINE, CENTRAL and LILACS, and manually screened retrieved references and systematic reviews to identify all randomized controlled trials reporting the effect of any intervention on the conduct or outcomes of heart surgery in children published in any language since January 2000; secondary publications and those reporting inseparable adult data were excluded. Two reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases. We identified 333 trials from 34 countries randomizing 23 902 children. Most were early phase (313, 94.0%), recruiting few patients (median 45, interquartile range 28-82), and only 11 (3.3%) directly evaluated a surgical intervention. One hundred and nine (32.7%) trials calculated a sample size, 52 (15.6%) reported a CONSORT diagram, 51 (15.3%) were publicly registered and 25 (7.5%) had a Data Monitoring Committee. The overall risk of bias was low in 22 (6.6%), high in 69 (20.7%) and unclear in 242 (72.7%). The recent literature in children's heart surgery contains few late-phase clinical trials. Most trials did not conform to the accepted standards of reporting, and the overall risk of bias was low in few studies. There is a need for high-quality, multicentre clinical trials to provide a robust evidence base for contemporary paediatric cardiac surgical practice.

  10. 2D vs. 3D imaging in laparoscopic surgery-results of a prospective randomized trial.

    Science.gov (United States)

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

    2017-12-01

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

  11. The impact of cataract surgery on visual functioning, vision-related disability and psychological distress: a randomized controlled trial.

    Science.gov (United States)

    Walker, Janine G; Anstey, Kaarin J; Hennessy, Michael P; Lord, Stephen R; von Sanden, Chwee

    2006-11-01

    Determine whether there are changes in visual functioning, vision-related disability, health status and mood after cataract surgery. 45 adults (mean age = 73.7 years) with bilateral cataract needing surgery for the first eye were recruited from public ophthalmology clinics. The Visual Functioning-14 survey assessed visual disability. Minimal angle of resolution tested visual acuity, and the Melbourne Edge Test examined contrast sensitivity. Demographic, psychological, health and medication use variables were examined. Participants were randomized to either an intervention or control arm. Controls were assessed on two occasions at a 3-month interval before having surgery. The intervention group was assessed 1-2 weeks before surgery and then reassessed 3 months after surgery. Visual functioning improved for those who had cataract surgery with better visual acuity in the better (P = 0.010) and worse (P = 0.028) eye compared with controls. The intervention group reported fewer difficulties with overall vision-related disability (P = 0.0001), reading (P = 0.004) and instrumental activities of daily living (P = 0.010) post-surgery compared with controls. People with improved depression scores (P = 0.048) after surgery had less difficulty with reading compared with those with unchanged or worsened depression scores. Cataract surgery did not improve health status. First eye cataract surgery is effective in improving outcomes in visual functioning and disability. Improved mood after surgery was related to less vision-related disability compared with unchanged or worse depression.

  12. A randomized, double blind trial of prophylactic fibrinogen to reduce bleeding in cardiac surgery

    Directory of Open Access Journals (Sweden)

    Mostafa Sadeghi

    2014-07-01

    Full Text Available BACKGROUND AND OBJECTIVES: Postoperative bleeding has a great clinical importance and can contribute to increased mortality and morbidity in patients undergoing coronary artery bypass graft surgery. In this prospective, randomized, double-blind study, we evaluated the effect of prophylactic administration of fibrinogen concentrate on post-coronary artery bypass graft surgery bleeding. METHODS: A total of 60 patients undergoing coronary artery bypass surgery were randomly divided into two groups. Patients in the fibrinogen group received 1 g of fibrinogen concentrate 30 min prior to the operation, while patients in the control group received placebo. Post-operative bleeding volumes, prothrombin time, partial thromboplastin time, INR, hemoglobin and transfused blood products in both groups were recorded. A strict red blood cell transfusion protocol was used in all patients. RESULTS: There were no significant differences between intra-operative packed red blood cells infusion in the studied groups (1.0 ± 1.4 in fibrinogen group, and 1.3 ± 1.1 in control group. Less postoperative bleeding was observed in the fibrinogen group (477 ± 143 versus 703 ± 179, p = 0.0001. Fifteen patients in the fibrinogen group and 21 in the control group required post-op packed red blood cells infusion (p = 0.094. No thrombotic event was observed through 72 h after surgery. CONCLUSION: Prophylactic fibrinogen reduces post-operative bleeding in patients undergoing coronary artery bypass graft.

  13. Adding left atrial appendage closure to open heart surgery provides protection from ischemic brain injury six years after surgery independently of atrial fibrillation history: the LAACS randomized study.

    Science.gov (United States)

    Park-Hansen, Jesper; Holme, Susanne J V; Irmukhamedov, Akhmadjon; Carranza, Christian L; Greve, Anders M; Al-Farra, Gina; Riis, Robert G C; Nilsson, Brian; Clausen, Johan S R; Nørskov, Anne S; Kruuse, Christina R; Rostrup, Egill; Dominguez, Helena

    2018-05-23

    Open heart surgery is associated with high occurrence of atrial fibrillation (AF), subsequently increasing the risk of post-operative ischemic stroke. Concomitant with open heart surgery, a cardiac ablation procedure is commonly performed in patients with known AF, often followed by left atrial appendage closure with surgery (LAACS). However, the protective effect of LAACS on the risk of cerebral ischemia following cardiac surgery remains controversial. We have studied whether LAACS in addition to open heart surgery protects against post-operative ischemic brain injury regardless of a previous AF diagnosis. One hundred eighty-seven patients scheduled for open heart surgery were enrolled in a prospective, open-label clinical trial and randomized to concomitant LAACS vs. standard care. Randomization was stratified by usage of oral anticoagulation (OAC) planned to last at least 3 months after surgery. The primary endpoint was a composite of post-operative symptomatic ischemic stroke, transient ischemic attack or imaging findings of silent cerebral ischemic (SCI) lesions. During a mean follow-up of 3.7 years, 14 (16%) primary events occurred among patients receiving standard surgery vs. 5 (5%) in the group randomized to additional LAACS (hazard ratio 0.3; 95% CI: 0.1-0.8, p = 0.02). In per protocol analysis (n = 141), 14 (18%) primary events occurred in the control group vs. 4 (6%) in the LAACS group (hazard ratio 0.3; 95% CI: 0.1-1.0, p = 0.05). In a real-world setting, LAACS in addition to elective open-heart surgery was associated with lower risk of post-operative ischemic brain injury. The protective effect was not conditional on AF/OAC status at baseline. LAACS study, clinicaltrials.gov NCT02378116 , March 4th 2015, retrospectively registered.

  14. A randomized trial of preoperative oral carbohydrates in abdominal surgery

    OpenAIRE

    Sada, Fatos; Krasniqi, Avdyl; Hamza, Astrit; Gecaj-Gashi, Agreta; Bicaj, Besnik; Kavaja, Floren

    2014-01-01

    Background Carbohydrate-rich liquid drinks (CRLDs) have been recommended to attenuate insulin resistance by shortening the preoperative fasting interval. The aim of our study the effect of preoperative oral administration of CRLDs on the well-being and clinical status of patients. Methods A randomized, double blind, prospective study of patients undergoing open colorectal operations (CR) and open cholecyctectomy (CH) was conducted. Patients were divided into three groups: study, placebo, and ...

  15. Laparoscopic surgery for chronic groin pain in athletes is more effective than nonoperative treatment: a randomized clinical trial with magnetic resonance imaging of 60 patients with sportsman's hernia (athletic pubalgia).

    Science.gov (United States)

    Paajanen, Hannu; Brinck, Tuomas; Hermunen, Heikki; Airo, Ilari

    2011-07-01

    Chronic groin pain in athletes presents often a diagnostic and therapeutic challenge. Sportsman's hernia (also called "athletic pubalgia") is a deficiency of the posterior wall of the inguinal canal, which is often repaired by laparoscopic mesh placement. Endoscopic mesh repair may offer a faster recovery for athletes with sportsman's hernia than nonoperative therapy. A randomized, prospective study was conducted on 60 patients with a diagnosis of chronic groin pain and suspected sportsman's hernia. Clinical data and MRI were collected on all patients. After 3 to 6 months of groin symptoms, the patients were randomized into an operative or a physiotherapy group (n = 30 patients in each group). Operation was performed using a totally extraperitoneal repair in which mesh was placed behind the symphysis and painful groin area. Conservative treatment included at least 2 months of active physiotherapy, including corticosteroid injections and oral anti-inflammatory analgesics. The outcome measures were pre- and postoperative pain using a visual analogue scale and partial or full recovery to sports activity at 1, 3, 6, and 12 months after randomization. The athletes in both treatment groups had similar characteristics and pain scores. Operative repair was more effective than nonoperative treatment to decrease chronic groin pain after 1 month and up to 12 months of follow-up (P pubalgia). Copyright © 2011 Mosby, Inc. All rights reserved.

  16. Piezoelectric surgery in implant dentistry: clinical applications

    Directory of Open Access Journals (Sweden)

    Lydia Masako Ferreira

    2009-01-01

    Full Text Available Pizosurgery has therapeutic characteristics in osteotomies, such as extremely precise, selective and millimetric cuts and a clear operating field. Piezoelectricity uses ultrasonic frequencies, which cause the points specially designed for osteotomy to vibrate. The points of the instrument oscillate, allowing effective osteotomy with minimal or no injury to the adjacent soft tissues, membranes and nerve tissues. This article presents the various applications of piezoelectricity in oral implant surgery such as: removal of autogenous bone; bone window during elevation of the sinus membrane and removal of fractured implants. The cavitational effect caused by the vibration of the point and the spray of physiological solution, provided a field free of bleeding and easy to visualize. The study showed that the piezoelectric surgery is a new surgical procedurethat presents advantages for bone cutting in many situations in implant dentistry, with great advantages in comparison with conventional instrumentation. Operating time is longer when compared with that of conventional cutters.

  17. A systematic review of the quality of randomized controlled trials in head and neck oncology surgery.

    Science.gov (United States)

    Carlton, Daniel A; Kocherginsky, Masha; Langerman, Alexander J

    2015-01-01

    To determine the quality of randomized controlled trials (RCTs) in head and neck surgery in which surgery was a primary intervention. Potential articles were identified in PubMed without publication date restrictions. Articles were scored using the CONSORT checklist and the relationship between the checklist score and whether the first and/or last authors were surgeons was investigated. Differences in the checklist score based on how many surgeons were among the first and last authors of the study were analyzed using the Kruskal-Wallis test. Fisher's exact test was used to examine if there was a significant difference of the reporting of individual items from the checklist between surgeons and nonsurgeons. A nonparametric trend test was used to determine whether there was a difference in the reporting of individual items based on whether there were none, one, or two surgeons among first and last authors. A total of 38 publications satisfied the inclusion criteria. There was a trend toward lower quality for studies in which surgeons were either first, last, or both first and last authors compared to studies that were first-authored and last-authored by nonsurgeons (P = 0.068). Nonsurgeons were more likely to report on critical elements regarding hypothesis, sample size determination, randomization, and eligibility of centers (P = 0.023-0.058). The quality of RCTs in head and neck surgery is poor. Improved training in conducting and reporting clinical research is needed in otolaryngology residencies. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

  18. Can evidence change the rate of back surgery? A randomized trial of community-based education.

    Science.gov (United States)

    Goldberg, H I; Deyo, R A; Taylor, V M; Cheadle, A D; Conrad, D A; Loeser, J D; Heagerty, P J; Diehr, P

    2001-01-01

    Timely adoption of clinical practice guidelines is more likely to happen when the guidelines are used in combination with adjuvant educational strategies that address social as well as rational influences. To implement the conservative, evidence-based approach to low-back pain recommended in national guidelines, with the anticipated effect of reducing population-based rates of surgery. A randomized, controlled trial. Ten communities in western Washington State with annual rates of back surgery above the 1990 national average (158 operations per 100,000 adults). Spine surgeons, primary care physicians, patients who were surgical candidates, and hospital administrators. The five communities randomized to the intervention group received a package of six educational activities tailored to local needs by community planning groups. Surgeon study groups, primary care continuing medical education conferences, administrative consensus processes, videodisc-aided patient decision making, surgical outcomes management, and generalist academic detailing were serially implemented over a 30-month intervention period. Quarterly observations of surgical rates. After implementation of the intervention, surgery rates declined in the intervention communities but increased slightly in the control communities. The net effect of the intervention is estimated to be a decline of 20.9 operations per 100,000, a relative reduction of 8.9% (P = 0.01). We were able to use scientific evidence to engender voluntary change in back pain practice patterns across entire communities.

  19. Predictors of clinical outcome following lumbar disc surgery

    DEFF Research Database (Denmark)

    Hebert, Jeffrey J; Fritz, Julie; Koppenhaver, S.L.

    2016-01-01

    scheduled for first time, single-level lumbar discectomy. Participants underwent a standardized preoperative evaluation including real-time ultrasound imaging assessment of lumbar multifidus function, and an 8-week postoperative rehabilitation programme. Clinical outcome was defined by change in disability....... CONCLUSIONS: Information gleaned from the clinical history and physical examination helps to identify patients more likely to succeed with lumbar disc surgery. While this study helps to inform clinical practice, additional research confirming these results is required prior to confident clinical...

  20. NBME subject examination in surgery scores correlate with surgery clerkship clinical experience.

    Science.gov (United States)

    Myers, Jonathan A; Vigneswaran, Yalini; Gabryszak, Beth; Fogg, Louis F; Francescatti, Amanda B; Golner, Christine; Bines, Steven D

    2014-01-01

    Most medical schools in the United States use the National Board of Medical Examiners Subject Examinations as a method of at least partial assessment of student performance, yet there is still uncertainty of how well these examination scores correlate with clinical proficiency. Thus, we investigated which factors in a surgery clerkship curriculum have a positive effect on academic achievement on the National Board of Medical Examiners Subject Examination in Surgery. A retrospective analysis of 83 third-year medical students at our institution with 4 unique clinical experiences on the general surgery clerkship for the 2007-2008 academic year was conducted. Records of the United States Medical Licensing Examination Step 1 scores, National Board of Medical Examiners Subject Examination in Surgery scores, and essay examination scores for the groups were compared using 1-way analysis of variance testing. Rush University Medical Center, Chicago IL, an academic institution and tertiary care center. Our data demonstrated National Board of Medical Examiners Subject Examination in Surgery scores from the group with the heavier clinical loads and least time for self-study were statistically higher than the group with lighter clinical services and higher rated self-study time (p = 0.036). However, there was no statistical difference of National Board of Medical Examiners Subject Examination in Surgery scores between the groups with equal clinical loads (p = 0.751). Students experiencing higher clinical volumes on surgical services, but less self-study time demonstrated statistically higher academic performance on objective evaluation, suggesting clinical experience may be of higher value than self-study and reading. Copyright © 2014 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  1. Robotic-assisted versus laparoscopic colorectal surgery: a meta-analysis of four randomized controlled trials

    Science.gov (United States)

    2014-01-01

    Background Robotic-assisted laparoscopy is popularly performed for colorectal disease. The objective of this meta-analysis was to compare the safety and efficacy of robotic-assisted colorectal surgery (RCS) and laparoscopic colorectal surgery (LCS) for colorectal disease based on randomized controlled trial studies. Methods Literature searches of electronic databases (Pubmed, Web of Science, and Cochrane Library) were performed to identify randomized controlled trial studies that compared the clinical or oncologic outcomes of RCS and LCS. This meta-analysis was performed using the Review Manager (RevMan) software (version 5.2) that is provided by the Cochrane Collaboration. The data used were mean differences and odds ratios for continuous and dichotomous variables, respectively. Fixed-effects or random-effects models were adopted according to heterogeneity. Results Four randomized controlled trial studies were identified for this meta-analysis. In total, 110 patients underwent RCS, and 116 patients underwent LCS. The results revealed that estimated blood losses (EBLs), conversion rates and times to the recovery of bowel function were significantly reduced following RCS compared with LCS. There were no significant differences in complication rates, lengths of hospital stays, proximal margins, distal margins or harvested lymph nodes between the two techniques. Conclusions RCS is a promising technique and is a safe and effective alternative to LCS for colorectal surgery. The advantages of RCS include reduced EBLs, lower conversion rates and shorter times to the recovery of bowel function. Further studies are required to define the financial effects of RCS and the effects of RCS on long-term oncologic outcomes. PMID:24767102

  2. Comparative Efficacy of Amoxicillin/Clavulanic Acid and Levofloxacin in the Reduction of Postsurgical Sequelae After Third Molar Surgery: A Randomized, Double-Blind, Clinical Trial in a Nigerian University Teaching Hospital.

    Science.gov (United States)

    Ndukwe, Kizito Chioma; Braimah, Ramat Oyebunmi; Owotade, John Foluso; Aregbesola, Stephen Babatunde

    2016-01-01

    The most common sequelae after surgical removal of mandibular third molar are pain, trismus, swelling, and dysphagia. However, these symptoms can also signal the onset of surgical site infection and alveoli osteitis. The aim of this study was to evaluate the efficacy of prophylactic amoxicillin/clavulanic acid and levofloxacin and preemptive therapy of amoxicillin/clavulanic acid in the reduction of postinflammatory complications, surgical site infection, and alveolar osteitis following the third molar surgery. A total of 135 patients were randomized into three equal groups: Group A (preemptive therapy of amoxicillin/clavulanic acid) with preoperative dose of 875/125 mg amoxicillin/clavulanic acid followed by 500/125 mg amoxicillin/clavulanic acid 12 hourly for 5 days, Group B (amoxicillin/clavulanic acid prophylaxis) with a single preoperative dose of amoxicillin/clavulanic acid 875/125 mg tablets, and Group C (levofloxacin prophylaxis) with a single preoperative dose of levofloxacin 1000 mg tablets. All patients had ostectomy using surgical handpiece and burs and received same analgesics (tabs ibuprofen 400 mg 8 hourly for 3 days). No case of surgical site infection or alveoli osteitis was recorded in the study groups. There were no statistically significant differences between the treatment groups with regard to pain, mouth opening, postoperative facial dimension, and body temperature. Amoxicillin/clavulanic acid as a single preoperative bolus should be adequate for the prevention of postoperative wound infection and alveoli osteitis following the third molar extraction as there is no need for an extension of the antibiotic. Moreover, levofloxacin can be utilized as prophylaxis in patients undergoing mandibular third molar extraction if such patients are allergic to penicillins.

  3. Comparative efficacy of amoxicillin/clavulanic acid and levofloxacin in the reduction of postsurgical sequelae after third molar surgery: a randomized, double-blind, clinical trial in a Nigerian university teaching hospital

    Directory of Open Access Journals (Sweden)

    Kizito Chioma Ndukwe

    2016-01-01

    Full Text Available Background: The most common sequelae after surgical removal of mandibular third molar are pain, trismus, swelling, and dysphagia. However, these symptoms can also signal the onset of surgical site infection and alveoli osteitis. The aim of this study was to evaluate the efficacy of prophylactic amoxicillin/clavulanic acid and levofloxacin and preemptive therapy of amoxicillin/clavulanic acid in the reduction of postinflammatory complications, surgical site infection, and alveolar osteitis following the third molar surgery. Patients and Methods: A total of 135 patients were randomized into three equal groups: Group A (preemptive therapy of amoxicillin/clavulanic acid with preoperative dose of 875/125 mg amoxicillin/clavulanic acid followed by 500/125 mg amoxicillin/clavulanic acid 12 hourly for 5 days, Group B (amoxicillin/clavulanic acid prophylaxis with a single preoperative dose of amoxicillin/clavulanic acid 875/125 mg tablets, and Group C (levofloxacin prophylaxis with a single preoperative dose of levofloxacin 1000 mg tablets. All patients had ostectomy using surgical handpiece and burs and received same analgesics (tabs ibuprofen 400 mg 8 hourly for 3 days. Results: No case of surgical site infection or alveoli osteitis was recorded in the study groups. There were no statistically significant differences between the treatment groups with regard to pain, mouth opening, postoperative facial dimension, and body temperature. Conclusion: Amoxicillin/clavulanic acid as a single preoperative bolus should be adequate for the prevention of postoperative wound infection and alveoli osteitis following the third molar extraction as there is no need for an extension of the antibiotic. Moreover, levofloxacin can be utilized as prophylaxis in patients undergoing mandibular third molar extraction if such patients are allergic to penicillins.

  4. Comparison of clinical parameters and environmental noise levels between regular surgery and piezosurgery for extraction of impacted third molars

    OpenAIRE

    Chang, Hao-Hueng; Lee, Ming-Shu; Hsu, You-Chyun; Tsai, Shang-Jye; Lin, Chun-Pin

    2015-01-01

    Impacted third molars can be extracted by regular surgery or piezosurgery. The aim of this study was to compare clinical parameters and device-produced noise levels between regular surgery and piezosurgery for the extraction of impacted third molars. Methods: Twenty patients (18 women and 2 men, 17–29 years of age) with bilateral symmetrical impacted mandibular or maxillary third molars of the same level were included in this randomized crossover clinical trial. The 40 impacted third molar...

  5. Clinical applications of robotic technology in vascular and endovascular surgery.

    Science.gov (United States)

    Antoniou, George A; Riga, Celia V; Mayer, Erik K; Cheshire, Nicholas J W; Bicknell, Colin D

    2011-02-01

    Emerging robotic technologies are increasingly being used by surgical disciplines to facilitate and improve performance of minimally invasive surgery. Robot-assisted intervention has recently been introduced into the field of vascular surgery to potentially enhance laparoscopic vascular and endovascular capabilities. The objective of this study was to review the current status of clinical robotic applications in vascular surgery. A systematic literature search was performed in order to identify all published clinical studies related to robotic implementation in vascular intervention. Web-based search engines were searched using the keywords "surgical robotics," "robotic surgery," "robotics," "computer assisted surgery," and "vascular surgery" or "endovascular" for articles published between January 1990 and November 2009. An evaluation and critical overview of these studies is reported. In addition, an analysis and discussion of supporting evidence for robotic computer-enhanced telemanipulation systems in relation to their applications in laparoscopic vascular and endovascular surgery was undertaken. Seventeen articles reporting on clinical applications of robotics in laparoscopic vascular and endovascular surgery were detected. They were either case reports or retrospective patient series and prospective studies reporting laparoscopic vascular and endovascular treatments for patients using robotic technology. Minimal comparative clinical evidence to evaluate the advantages of robot-assisted vascular procedures was identified. Robot-assisted laparoscopic aortic procedures have been reported by several studies with satisfactory results. Furthermore, the use of robotic technology as a sole modality for abdominal aortic aneurysm repair and expansion of its applications to splenic and renal artery aneurysm reconstruction have been described. Robotically steerable endovascular catheter systems have potential advantages over conventional catheterization systems

  6. Financial management of a large multisite randomized clinical trial.

    Science.gov (United States)

    Sheffet, Alice J; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E; Longbottom, Mary E; Howard, Virginia J; Marler, John R; Brott, Thomas G

    2014-08-01

    The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21 112 866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2500 randomized participants at 40 sites. Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Projections of the original grant's fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant's fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2500 targeted sample size, 138 (5·5%) were randomized during the first five years and 1387 (55·5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13 845) of the projected per-patient costs ($152 992) of the fixed model. Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. © 2014 The Authors. International Journal of Stroke © 2014 World Stroke Organization.

  7. Clinical Outcomes of Penile Prosthesis Implantation Surgery

    Directory of Open Access Journals (Sweden)

    Onur Dede

    2016-06-01

    Full Text Available Objective: We aimed to evaluating the outcomes of in­flatable penile prosthesis implantations and partner sat­isfaction. Methods: Data of 52 patients who underwent penile prosthesis implantation in single center between May 2010 and December 2015 were retrospectively analyzed. Types of prosthesis, complication and satisfaction rates of patients were recorded by EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire was used. Results: The mean age was 49.2±14.7 years for patients. The mean follow-up durations for 34.3±12.5 months. The mean hospital stay was 3.84±1.52 days. Evaluating of the couples satisfaction revealed that 44 (84% of the patient were very satisfied. There was not any complication and no patient need to underwent revision surgery. Conclusion: Inflatable penile prosthesis implants, with high levels of treatment success, patient and partner sat­isfaction, are effective and safe options for treatment of organic erectile dysfunction with acceptable complication and revision rates.

  8. 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.

  9. A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design.

    Science.gov (United States)

    Zangrillo, Alberto; Alvaro, Gabriele; Pisano, Antonio; Guarracino, Fabio; Lobreglio, Rosetta; Bradic, Nikola; Lembo, Rosalba; Gianni, Stefano; Calabrò, Maria Grazia; Likhvantsev, Valery; Grigoryev, Evgeny; Buscaglia, Giuseppe; Pala, Giovanni; Auci, Elisabetta; Amantea, Bruno; Monaco, Fabrizio; De Vuono, Giovanni; Corcione, Antonio; Galdieri, Nicola; Cariello, Claudia; Bove, Tiziana; Fominskiy, Evgeny; Auriemma, Stefano; Baiocchi, Massimo; Bianchi, Alessandro; Frontini, Mario; Paternoster, Gianluca; Sangalli, Fabio; Wang, Chew-Yin; Zucchetti, Maria Chiara; Biondi-Zoccai, Giuseppe; Gemma, Marco; Lipinski, Michael J; Lomivorotov, Vladimir V; Landoni, Giovanni

    2016-07-01

    Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes. Double-blind, placebo-controlled, multicenter randomized trial. Tertiary care hospitals. Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 μg/[kg min]) or placebo for 24-48 hours. The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction. This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. A 1-year videoconferencing-based psychoeducational group intervention following bariatric surgery: results of a randomized controlled study.

    Science.gov (United States)

    Wild, Beate; Hünnemeyer, Katharina; Sauer, Helene; Hain, Bernhard; Mack, Isabelle; Schellberg, Dieter; Müller-Stich, Beat Peter; Weiner, Rudolf; Meile, Tobias; Rudofsky, Gottfried; Königsrainer, Alfred; Zipfel, Stephan; Herzog, Wolfgang; Teufel, Martin

    2015-01-01

    For severely obese patients, bariatric surgery has been recommended as an effective therapy. The Bariataric Surgery and Education (BaSE) study aimed to assess the efficacy of a videoconferencing-based psychoeducational group intervention in patients after bariatric surgery. The BaSE study is a randomized, controlled multicenter clinical trial involving 117 patients undergoing bariatric surgery (mean preoperative body mass index [BMI] 49.9 kg/m(2), SD 6.4). Patients were enrolled between May 2009 and November 2012 and were randomly assigned to receive either conventional postsurgical visits or, in addition, a videoconferencing-based 1-year group program. Primary outcome measures were weight in kilograms, health-related quality of life (HRQOL), and general self-efficacy (GSE). Secondary outcome measures were depression symptoms and eating behavior. 94% of the patients completed the study. Mean weight loss for all patients was 45.9 kg (SD 16.4) 1 year after surgery (mean excess weight loss [EWL] 63%). Intention-to-treat analyses revealed no differences in weight loss, EWL, HRQOL, or self-efficacy between study groups at 1 year after surgery. However, patients with clinically significant depression symptoms (CSD) at baseline assigned to the intervention group (n = 29) had a significantly better HRQOL (P = .03), lower depression scores (P = .02), and a trend for a better EWL (.06) 1 year after surgery compared with the control group (n = 20). We could not prove the efficacy of the group program for the whole study sample. However, results indicate that the intervention is effective for the important subgroup of patients with CSD. Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  11. Femtosecond laser cataract surgery: technology and clinical practice.

    Science.gov (United States)

    Roberts, Timothy V; Lawless, Michael; Chan, Colin Ck; Jacobs, Mark; Ng, David; Bali, Shveta J; Hodge, Chris; Sutton, Gerard

    2013-03-01

    The recent introduction of femtosecond lasers to cataract surgery has generated much interest among ophthalmologists around the world. Laser cataract surgery integrates high-resolution anterior segment imaging systems with a femtosecond laser, allowing key steps of the procedure, including the primary and side-port corneal incisions, the anterior capsulotomy and fragmentation of the lens nucleus, to be performed with computer-guided laser precision. There is emerging evidence of reduced phacoemulsification time, better wound architecture and a more stable refractive result with femtosecond cataract surgery, as well as reports documenting an initial learning curve. This article will review the current state of technology and discuss our clinical experience. © 2012 The Authors. Clinical and Experimental Ophthalmology © 2012 Royal Australian and New Zealand College of Ophthalmologists.

  12. Expert opinion on laparoscopic surgery for colorectal cancer parallels evidence from a cumulative meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Guillaume Martel

    Full Text Available This study sought to synthesize survival outcomes from trials of laparoscopic and open colorectal cancer surgery, and to determine whether expert acceptance of this technology in the literature has parallel cumulative survival evidence.A systematic review of randomized trials was conducted. The primary outcome was survival, and meta-analysis of time-to-event data was conducted. Expert opinion in the literature (published reviews, guidelines, and textbook chapters on the acceptability of laparoscopic colorectal cancer was graded using a 7-point scale. Pooled survival data were correlated in time with accumulating expert opinion scores.A total of 5,800 citations were screened. Of these, 39 publications pertaining to 23 individual trials were retained. As well, 414 reviews were included (28 guidelines, 30 textbook chapters, 20 systematic reviews, 336 narrative reviews. In total, 5,782 patients were randomized to laparoscopic (n = 3,031 and open (n = 2,751 colorectal surgery. Survival data were presented in 16 publications. Laparoscopic surgery was not inferior to open surgery in terms of overall survival (HR = 0.94, 95% CI 0.80, 1.09. Expert opinion in the literature pertaining to the oncologic acceptability of laparoscopic surgery for colon cancer correlated most closely with the publication of large RCTs in 2002-2004. Although increasingly accepted since 2006, laparoscopic surgery for rectal cancer remained controversial.Laparoscopic surgery for colon cancer is non-inferior to open surgery in terms of overall survival, and has been so since 2004. The majority expert opinion in the literature has considered these two techniques to be equivalent since 2002-2004. Laparoscopic surgery for rectal cancer has been increasingly accepted since 2006, but remains controversial. Knowledge translation efforts in this field appear to have paralleled the accumulation of clinical trial evidence.

  13. [Randomized controlled trial on the effectiveness of Corpitolinol 60 in the prevention of pressure sores in patients undergoing surgery].

    Science.gov (United States)

    Chiari, Paolo; Giorgi, Sabina; Ugolini, Daniela; Montanari, Morena; Giudanella, Pietro; Gramantieri, Antonella; Collesi, Franca; Pau, Michelina; Smaldone, Maddalena; Matarasso, Maddalena; Mazzini, Cinzia; Russo, Francesca; Gazineo, Domenica; Fontana, Mirella; Taddia, Patrizia

    2012-01-01

    Randomized controlled trial on the effectiveness of Corpitolinol 60 in the prevention of pressure sores in surgical patients. The risk of pressure sores in surgical patients is widely recognised. The Corpitolinol 60 (Sanyréne®) applied on compressed areas seems to reduce the risk of pressure sores. To assess the efficacy of Corpitolinol 60 in preventing pressure sores in the operatory theatre. The open label randomized clinical trial was conducted in 5 operating theatres of Northen Italy. Patients were randomized to receive Corpitolinol 60 in areas undergoing compression. Experimental group and controls were treated with usual measures for preventing pressure sores. The lesions were staged according to NPUAP up to 24 hours after surgery. Three-hundred-one patients were randomized (155 in the Sanyréne® group and 143 controls). The main variables predictive of pressure sores risk (ASA class, sex, age, duration of the surgery, and BMI) were comparable across groups. At the end of the surgery 71 patients (23.8%) in the experimental group and 47 controls (30.8%) had a pressure sore (p 0.006; RR 1.81 IC95% 1.17-2.79). Twelve and 24 hours after surgery the differences between groups were not significant. The aim of reducing pressure sores was not reached for patients treated with Corpitolinol 60.

  14. A randomized controlled trial evaluating early versus traditional oral feeding after colorectal surgery

    Directory of Open Access Journals (Sweden)

    Ahmet Dag

    2011-01-01

    Full Text Available OBJECTIVE: This prospective randomized clinical study was conducted to evaluate the safety and tolerability of early oral feeding after colorectal operations. METHODS: A total of 199 patients underwent colorectal surgery and were randomly assigned to early feeding (n = 99 or a regular diet (n = 100. Patients’ characteristics, diagnoses, surgical procedures, comorbidity, bowel movements, defecation, nasogastric tube reinsertion, time of tolerance of solid diet, complications, and length of hospitalization were assessed. RESULTS: The two groups were similar in terms of gender, age, diagnosis, surgical procedures, and comorbidity. In the early feeding group, 85.9% of patients tolerated the early feeding schedule. Bowel movements (1.7±0.89 vs. 3.27±1.3, defecation (3.4±0.77 vs. 4.38±1.18 and time of tolerance of solid diet (2.48±0.85 vs. 4.77±1.81 were significantly earlier in the early feeding group. There was no change between the groups in terms of nasogastric tube reinsertion, overall complication or anastomotic leakage. Hospitalization (5.55±2.35 vs. 9.0±6.5 was shorter in the early feeding group. CONCLUSIONS: The present study indicated that early oral feeding after elective colorectal surgery was not only well tolerated by patients but also affected the postoperative outcomes positively. Early postoperative feeding is safe and leads to the early recovery of gastrointestinal functions.

  15. Benign prostatic hyperplasia: clinical treatment can complicate cataract surgery

    Directory of Open Access Journals (Sweden)

    Fernando Facio

    2010-10-01

    Full Text Available PURPOSE: To investigate the effects of alpha-1 adrenergic receptor antagonists for the treatment of benign prostatic hyperplasia (BPH regarding potential risks of complications in the setting of cataract surgery. AIM: To address recommendations, optimal control therapy, voiding symptoms and safety within the setting of cataract surgery. MATERIALS AND METHODS: A comprehensive literature review was performed using MEDLINE with MeSH terms and keywords "benign prostatic hyperplasia", "intraoperative floppy iris syndrome", "adrenergic alpha-antagonist" and "cataract surgery". In addition, reference lists from identified publications were reviewed to identify reports and studies of interest from 2001 to 2009. RESULTS: The first report of intraoperative floppy iris syndrome (IFIS was observed during cataract surgery in patients taking systemic alpha-1 AR antagonists in 2005. It has been most commonly seen related to use of tamsulosin. Changes of medication and washout periods of up to 2 weeks have been attempted to reduce the risk of complications in the setting of cataract surgery. CONCLUSION: Patients under clinical treatment for BPH should be informed about potential risks of this drug class so that it can be discuss with their healthcare providers, in particular urologist and ophthalmologist, prior to cataract surgery.

  16. Celiac Patients: A Randomized, Controlled Clinical Study

    Directory of Open Access Journals (Sweden)

    Giuseppe Mazzarella

    2012-01-01

    Full Text Available A lifelong gluten-free diet (GFD is mandatory for celiac disease (CD but has poor compliance, justifying novel strategies. We found that wheat flour transamidation inhibited IFN-γ secretion by intestinal T cells from CD patients. Herein, the primary endpoint was to evaluate the ability of transamidated gluten to maintain GFD CD patients in clinical remission. Secondary endpoints were efficacy in prevention of the inflammatory response and safety at the kidney level, where reaction products are metabolized. In a randomized single blinded, controlled 90-day trial, 47 GFD CD patients received 3.7 g/day of gluten from nontransamidated (12 or transamidated (35 flour. On day 15, 75% and 37% of patients in the control and experimental groups, respectively, showed clinical relapse (=0.04 whereas intestinal permeability was mainly altered in the control group (50% versus 20%, =0.06. On day 90, 0 controls and 14 patients in the experimental group completed the challenge with no variation of antitransglutaminase IgA (=0.63, Marsh-Oberhuber grading (=0.08, or intestinal IFN-γ mRNA (>0.05. Creatinine clearance did not vary after 90 days of treatment (=0.46. In conclusion, transamidated gluten reduced the number of clinical relapses in challenged patients with no changes of baseline values for serological/mucosal CD markers and an unaltered kidney function.

  17. A Randomized Controlled Trial Study in Abdominal Surgery

    African Journals Online (AJOL)

    ADMIN

    , and finally, greatly improved postoperative recovery 5-7. In recent years, FTS has been applied to several surgical diseases including radical prostatectomy 8, cardiac surgery 9, total knee replacement 10, cesarean section11, coronary artery ...

  18. Can we optimize chemo-radiation and surgery in locally advanced stage III non-small cell lung cancer based on evidence from randomized clinical trials? A hypothesis-generating study

    International Nuclear Information System (INIS)

    De Ruysscher, Dirk; Dehing, Cary; Bentzen, Soren M.; Houben, Ruud; Dekker, Andre; Wanders, Rinus; Borger, Jacques; Hochstenbag, Monique; Boersma, Liesbeth; Geskes, Gijs; Dingemans, Anne-Marie C.; Bootsma, Gerben; Lammering, Guido; Lambin, Philippe

    2009-01-01

    Purpose: Improved local tumor control (LC) improves survival of patients with non-small cell lung cancer (NSCLC). We estimated the capability of surgical and non-surgical options to improve LC further in this disease. Methods: Eligible studies were phase III trials reporting 2-year survival data as well as the incidence of LC and/or distant metastases. Effect estimates, as well as the statistical uncertainty of these, were combined in order to estimate the benefit in terms of LC from combining multiple modalities. Results: It was estimated that the highest rates of LC can be obtained with high-dose concurrent chemo-radiation followed by surgery. In this situation, escalating the pre-operative radiation dose from 45 to 66 Gy, delivered concurrently with chemotherapy, could increase LC from 58% to 76%. Toxicity may also be higher, but could not be estimated. Without surgery, the gain in LC from concurrent chemo-radiation versus sequential, corresponds to a radiation dose increase from 65 to 72 Gy. Conclusions: We hypothesize that high-dose concurrent chemo-radiation followed by surgery could be superior to other current treatment approaches for selected patients with stage III NSCLC, provided toxicity would be low. At present, high-dose concurrent chemo-radiation followed by surgery should be considered experimental.

  19. A randomized trial of preoperative oral carbohydrates in abdominal surgery.

    Science.gov (United States)

    Sada, Fatos; Krasniqi, Avdyl; Hamza, Astrit; Gecaj-Gashi, Agreta; Bicaj, Besnik; Kavaja, Floren

    2014-01-01

    Carbohydrate-rich liquid drinks (CRLDs) have been recommended to attenuate insulin resistance by shortening the preoperative fasting interval. The aim of our study the effect of preoperative oral administration of CRLDs on the well-being and clinical status of patients. A randomized, double blind, prospective study of patients undergoing open colorectal operations (CR) and open cholecyctectomy (CH) was conducted. Patients were divided into three groups: study, placebo, and control. Visual analogue scale (VAS) scores for seven parameters (thirst, hunger, anxiety, mouth dryness, nausea, weakness and sleep quality) were recorded and compared for two different time periods (up to 24 h postoperatively and from 36 to 48 h postoperatively). The Simplified Acute Physiology Score changes (SAPS)-II between the three groups were also studied. There were 142 patients American Society of Anesthesiology (ASA) I or II enrolled in the study (CR = 71 and CH = 71). There were no significant differences in postoperative SAPS-II scores or lengths of hospital stay (LOS) between the groups. However, in CR patients, the degree of thirst was partially improved by drinking CRLDs (P = 0.027). In CH patients, on the other hand, feelings of thirst, hunger, mouth dryness, nausea and weakness showed significant improvement (P < 0.05). Oral administration of carbohydrate-rich liquid drinks (CRLDs) improves the well-being in patients undergoing CH, but the effect is less evident in patients undergoing CR. No significant improvements were seen in clinical status or in length of hospital stay in either group. ANZCTR.org.au: ACTRN12614000995673 (registered on 16/09/2014).

  20. Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery.

    Science.gov (United States)

    Shepherd, Deborah M; Jahnke, Heidi; White, William L; Little, Andrew S

    2018-02-01

    OBJECTIVE Pain control is an important clinical consideration and quality-of-care metric. No studies have examined postoperative pain control following transsphenoidal surgery for pituitary lesions. The study goals were to 1) report postoperative pain scores following transsphenoidal surgery, 2) determine if multimodal opioid-minimizing pain regimens yielded satisfactory postoperative pain control, and 3) determine if intravenous (IV) ibuprofen improved postoperative pain scores and reduced opioid use compared with placebo. METHODS This study was a single-center, randomized, double-blinded, placebo-controlled intervention trial involving adult patients with planned transsphenoidal surgery for pituitary tumors randomized into 2 groups. Group 1 patients were treated with scheduled IV ibuprofen, scheduled oral acetaminophen, and rescue opioids. Group 2 patients were treated with IV placebo, scheduled oral acetaminophen, and rescue opioids. The primary end point was patient pain scores (visual analog scale [VAS], rated 0-10) for 48 hours after surgery. The secondary end point was opioid use as estimated by oral morphine equivalents (OMEs). RESULTS Of 136 patients screened, 62 were enrolled (28 in Group 1, 34 in Group 2). The study was terminated early because the primary and secondary end points were reached. Baseline characteristics between groups were well matched except for age (Group 1, 59.3 ± 14.4 years; Group 2, 49.8 ± 16.2 years; p = 0.02). Mean VAS pain scores were significantly different, with a 43% reduction in Group 1 (1.7 ± 2.2) compared with Group 2 (3.0 ± 2.8; p transsphenoidal surgery. IV ibuprofen resulted in significantly improved pain scores and significantly decreased opioid use compared with placebo. Postoperative multimodal pain management, including a nonsteroidal antiinflammatory medication, should be considered after surgery to improve patient comfort and to limit opioid use. Clinical trial registration no.: NCT02351700 (clinicaltrials

  1. Harmonic scalpel versus electrocautery in breast reduction surgery: a randomized controlled trial.

    Science.gov (United States)

    Burdette, Todd E; Kerrigan, Carolyn L; Homa, Karen; Homa, Karen A

    2011-10-01

    The authors hypothesized that the Harmonic Scalpel (Ethicon Endo-Surgery, Cincinnati, Ohio) might outperform electrocautery in bilateral breast reduction surgery, possibly resulting in (1) shorter operative times, (2) lower postoperative fluid drainage rates, and (3) reduced postoperative pain scores. Thirty-one patients were evaluated in a matched-pair design, with random (blinded) assignment of one side to the Harmonic Scalpel, with the other side defaulting to electrocautery. Main outcome measures were: (1) resection/hemostasis time, (2) drainage volume, and (3) postoperative pain. The authors also compared the learning curves, operative time versus specimen weights, complications, and costs for the devices. There was a statistically significant (but not clinically significant) difference between the median times for the Harmonic Scalpel (33 minutes) and electrocautery (31 minutes) (p=0.02). There was no statistical difference in drainage scores, and pain scores were equivalent. The analysis of specimen weight versus resection/hemostasis time showed no correlation. There were more complications on the breasts reduced with the Harmonic device, but due to the small sample size, the complication results were not statistically significant. Start-up costs for the devices were comparable, but the per-procedure cost for the Harmonic device was considerably higher. The Harmonic Scalpel is roughly equivalent to electrocautery in breast reduction surgery in terms of resection/hemostasis time, serous drainage, and postoperative pain. Though the Harmonic device may be excellent for other surgical procedures, its high cost suggests that surgeons and institutions can confidently forgo its use in breast reduction surgery. Therapeutic, II.

  2. Intensive perioperative glucose control does not improve outcomes of patients submitted to open-heart surgery: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Raquel Pei Chen Chan

    2009-01-01

    Full Text Available BACKGROUND: The objective of this study was to investigate the relationship between different target levels of glucose and the clinical outcomes of patients undergoing cardiac surgery with cardiopulmonary bypass. METHODS: We designed a prospective study in a university hospital where 109 consecutive patients were enrolled during a six-month period. All patients were scheduled for open-heart surgery requiring cardiopulmonary bypass. Patients were randomly allocated into two groups. One group consisted of 55 patients and had a target glucose level of 80-130 mg/dl, while the other contained 54 patients and had a target glucose level of 160-200 mg/dl. These parameters were controlled during surgery and for 36 hours after surgery in the intensive care unit. Primary outcomes were clinical outcomes, including time of mechanical ventilation, length of stay in the intensive care unit, infection, hypoglycemia, renal or neurological dysfunction, blood transfusion and length of stay in the hospital. The secondary outcome was a combined end-point (mortality at 30 days, infection or length of stay in the intensive care unit of more than 3 days. A p-value of 0.05. CONCLUSIONS: In 109 patients undergoing cardiac surgery with cardiopulmonary bypass, both protocols of glycemic control in an intraoperative setting and in the intensive care unit were found to be safe, easily achieved and not to differentially affect clinical outcomes.

  3. Clinical utility of carotid duplex ultrasound prior to cardiac surgery.

    Science.gov (United States)

    Lin, Judith C; Kabbani, Loay S; Peterson, Edward L; Masabni, Khalil; Morgan, Jeffrey A; Brooks, Sara; Wertella, Kathleen P; Paone, Gaetano

    2016-03-01

    Clinical utility and cost-effectiveness of carotid duplex examination prior to cardiac surgery have been questioned by the multidisciplinary committee creating the 2012 Appropriate Use Criteria for Peripheral Vascular Laboratory Testing. We report the clinical outcomes and postoperative neurologic symptoms in patients who underwent carotid duplex ultrasound prior to open heart surgery at a tertiary institution. Using the combined databases from our clinical vascular laboratory and the Society of Thoracic Surgery, a retrospective analysis of all patients who underwent carotid duplex ultrasound within 13 months prior to open heart surgery from March 2005 to March 2013 was performed. The outcomes between those who underwent carotid duplex scanning (group A) and those who did not (group B) were compared. Among 3233 patients in the cohort who underwent cardiac surgery, 515 (15.9%) patients underwent a carotid duplex ultrasound preoperatively, and 2718 patients did not (84.1%). Among the patients who underwent carotid screening vs no screening, there was no statistically significant difference in the risk factors of cerebrovascular disease (10.9% vs 12.7%; P = .26), prior stroke (8.2% vs 7.2%; P = .41), and prior transient ischemic attack (2.9% vs 3.3%; P = .24). For those undergoing isolated coronary artery bypass grafting (CABG), 306 (17.8%) of 1723 patients underwent preoperative carotid duplex ultrasound. Among patients who had carotid screening prior to CABG, the incidence of carotid disease was low: 249 (81.4%) had minimal or mild stenosis (duplex scanning and those who did not. Primary outcomes of patients who underwent open heart surgery also showed no difference in the perioperative mortality (5.1% vs 6.9%; P = .14) and stroke (2.6% vs 2.4%; P = .85) between patients undergoing preoperative duplex scanning and those who did not. Operative intervention of severe carotid stenosis prior to isolated CABG occurred in 2 of the 17 patients (11.8%) identified who

  4. Clinical applications of gamma-detection probes - radioguided surgery

    International Nuclear Information System (INIS)

    Schneebaum, S.; Stadler, J.; Skornick, Y.

    1999-01-01

    Radioguided surgery (RGS) is a surgical technique that enables the surgeon to identify tissue ''marked'' by a radionuclide before surgery, based on the tissue characteristics, the radioactive tracer and its carrying molecule, or the affinity of both. Thus, yet another tool has been added to the inspection and palpation traditionally used by the surgeon. Current clinical applications of radioguided surgery are: radioimmunoguided surgery (RIGS) for colon cancer, sentinel-node mapping for malignant melanoma (which has become state-of-the-art), sentinel-node mapping for breast, vulvar and penile cancer, and detection of parathyroid adenoma and bone tumour (such as osteid osteoma). Although the same gamma-detecting probe (GDP) may be used for all these applications, the carrier substance and the radionuclide differ. MoAb and peptides are used for RIGS, sulphur colloid for sentinel-node mapping, iodine-125 for RIGS, technetium-99m for sentinel node, parathyroid and bone. The mode of injection also differs, but there are some common principles of gamma-guided surgery. RIGS enables the surgeon to corroborate tumour existence, find occult metastases, and assess the margins of resection; this may result in a change on the surgical plan. Sentinel lymph-node (SLN) scintigraphy for melanoma guides the surgeon to find the involved lymph nodes for lymph-node dissection. SLN for breast cancer is being investigated with promising results. This procedure has also changed the outlook of lymph-node pathology by giving the pathologist designated tissue samples for more comprehensive examination. Gamma-guided surgery will result in more accurate and less unnecessary surgery, better pathology and, hopefully, in better patient survival. (orig.)

  5. Effect of Preoperative Warm-up Exercise Before Laparoscopic Gynecological Surgery: A Randomized Trial.

    Science.gov (United States)

    Polterauer, Stephan; Husslein, Heinrich; Kranawetter, Marlene; Schwameis, Richard; Reinthaller, Alexander; Heinze, Georg; Grimm, Christoph

    2016-01-01

    Laparoscopic surgical procedures require a high level of cognitive and psychomotoric skills. Thus, effective training methods to acquire an adequate level of expertise are crucial. The aim of this study was to investigate the effect of preoperative warm up training on surgeon׳s performance during gynecologic laparoscopic surgery. In this randomized controlled trial, surgeons performed a preoperative warm up training using a virtual reality simulator before laparoscopic unilateral salpingo-oophorectomy. Serving as their own controls, each subject performed 2 pairs of laparoscopic cases, each pair consisting of 1 case with and 1 without warm up before surgery. Surgeries were videotaped and psychomotoric skills were rated using objective structured assessment of technical skills (OSATS) and the generic error rating tool by a masked observer. Perioperative complications were assessed. Statistical analysis was performed using a mixed model, and mean OSATS scores were compared between both the groups. In total, data of 10 surgeons and 17 surgeries were available for analysis. No differences between educational level and surgical experiences were observed between the groups. Mean standard error psychomotoric and task-specific OSATS scores of 19.8 (1.7) and 3.7 (0.2) were observed in the warm up group compared with 18.6 (1.7) and 3.8 (0.2) in the no warm up group, respectively (p = 0.51 and p = 0.29). Using generic error rating tool, the total number of errors was 8.75 (2.15) in the warm up group compared with 10.8 (2.18) in the no warm-up group (p = 0.53). Perioperative complications and operating time did not differ between both the groups. The present study suggests that warm-up before laparoscopic salpingo-oophorectomy does not increase psychomotoric skills during surgery. Moreover, it does not influence operating time and complication rates. (Medical University of Vienna-IRB approval number, 1072/2011, ClinicalTrials.gov number, NCT01712607). Copyright © 2016

  6. A randomized study comparing outcomes of stapled and hand-sutured anastomoses in patients undergoing open gastrointestinal surgery.

    Science.gov (United States)

    Chandramohan, S M; Gajbhiye, Raj Narenda; Agwarwal, Anil; Creedon, Erin; Schwiers, Michael L; Waggoner, Jason R; Tatla, Daljit

    2013-08-01

    Although stapling is an alternative to hand-suturing in gastrointestinal surgery, recent trials specifically designed to evaluate differences between the two in surgery time, anastomosis time, and return to bowel activity are lacking. This trial compared the outcomes of the two in subjects undergoing open gastrointestinal surgery. Adult subjects undergoing emergency or elective surgery requiring a single gastric, small, or large bowel anastomosis were enrolled into this open-label, prospective, randomized, interventional, parallel, multicenter, controlled trial. Randomization was assigned in a 1:1 ratio between the hand-sutured group (n = 138) and the stapled group (n = 142). Anastomosis time, surgery time, and time to bowel activity were collected and compared as primary endpoints. A total of 280 subjects were enrolled from April 2009 to September 2010. Only the time of anastomosis was significantly different between the two arms: 17.6 ± 1.90 min (stapled) and 20.6 ± 1.90 min (hand-sutured). This difference was deemed not clinically or economically meaningful. Safety outcomes and other secondary endpoints were similar between the two arms. Mechanical stapling is faster than hand-suturing for the construction of gastrointestinal anastomoses. Apart from this, stapling and hand-suturing are similar with respect to the outcomes measured in this trial.

  7. Vibration for Pain Reduction in a Plastic Surgery Clinic.

    Science.gov (United States)

    Eichhorn, Mitchell George; Karadsheh, Murad Jehad; Krebiehl, Johanna Ruth; Ford, Dawn Marie; Ford, Ronald D

    2016-01-01

    Patients can experience significant pain during routine procedures in the plastic surgery clinic. Methods for clinical pain reduction are often impractical, time-consuming, or ineffective. Vibration is a safe, inexpensive, and highly applicable modality for pain reduction that can be readily utilized for a wide variety of procedures. This study evaluated the use of vibration as a viable pain-reduction strategy in the clinical plastic surgery setting. Patients requiring at least 2 consecutive procedures that are considered painful were enrolled in the study. These included injections, staple removal, and suture removal. In the same patient, one half of the procedures were performed without vibration and the other half with vibration. After completing the procedures, the patients rated their pain with vibration and without vibration. The patient and the researcher also described the experience with a short questionnaire. Twenty-eight patients were enrolled in the study. Patients reported significantly less pain on the Numeric Rating Scale pain scale when vibration was used compared with the control group (p reduction. It significantly reduces the pain experienced by patients during minor office procedures. Given its practicality and ease of use, it is a welcome tool in the plastic surgery clinic.

  8. NSAID Use after Bariatric Surgery : a Randomized Controlled Intervention Study

    NARCIS (Netherlands)

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N.

    2016-01-01

    Background Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. Aim To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID

  9. 3D laparoscopic surgery: a prospective clinical trial.

    Science.gov (United States)

    Agrusa, Antonino; Di Buono, Giuseppe; Buscemi, Salvatore; Cucinella, Gaspare; Romano, Giorgio; Gulotta, Gaspare

    2018-04-03

    Since it's introduction, laparoscopic surgery represented a real revolution in clinical practice. The use of a new generation three-dimensional (3D) HD laparoscopic system can be considered a favorable "hybrid" made by combining two different elements: feasibility and diffusion of laparoscopy and improved quality of vision. In this study we report our clinical experience with use of three-dimensional (3D) HD vision system for laparoscopic surgery. Between 2013 and 2017 a prospective cohort study was conducted at the University Hospital of Palermo. We considered 163 patients underwent to laparoscopic three-dimensional (3D) HD surgery for various indications. This 3D-group was compared to a retrospective-prospective control group of patients who underwent the same surgical procedures. Considerating specific surgical procedures there is no significant difference in term of age and gender. The analysis of all the groups of diseases shows that the laparoscopic procedures performed with 3D technology have a shorter mean operative time than comparable 2D procedures when we consider surgery that require complex tasks. The use of 3D laparoscopic technology is an extraordinary innovation in clinical practice, but the instrumentation is still not widespread. Precisely for this reason the studies in literature are few and mainly limited to the evaluation of the surgical skills to the simulator. This study aims to evaluate the actual benefits of the 3D laparoscopic system integrating it in clinical practice. The three-dimensional view allows advanced performance in particular conditions, such as small and deep spaces and promotes performing complex surgical laparoscopic procedures.

  10. Revision hip preservation surgery with hip arthroscopy: clinical outcomes.

    Science.gov (United States)

    Domb, Benjamin G; Stake, Christine E; Lindner, Dror; El-Bitar, Youseff; Jackson, Timothy J

    2014-05-01

    To analyze and report the clinical outcomes of a cohort of patients who underwent revision hip preservation with arthroscopy and determine predictors of positive and negative outcomes. During the study period from April 2008 to December 2010, all patients who underwent revision hip preservation with arthroscopy were included. This included patients who had previous open surgery and underwent revision with arthroscopy. Patient-reported outcome (PRO) scores were obtained preoperatively and at 3-month, 1-year, 2-year, and 3-year follow-up time points. Any revision surgeries and conversions to total hip arthroplasty were noted. A multiple regression analysis was performed to look for positive and negative predictive factors for improvement in PROs after revision hip arthroscopy. Forty-seven hips in 43 patients had completed 2 years' follow-up or needed total hip arthroplasty. The mean length of follow-up was 29 months (range, 24 to 47 months). Of the hips, 31 (66%) had either unaddressed or incompletely treated femoroacetabular impingement. There was a significant improvement in all PRO scores at a mean of 29 months after revision (P arthroscopy can achieve moderately successful outcomes and remains a viable treatment strategy after failed primary hip preservation surgery. Preoperative predictors of success after revision hip arthroscopy include segmental labral defects, unaddressed or incompletely addressed femoroacetabular impingement, heterotopic ossification, and previous open surgery. Level IV, therapeutic case series. Copyright © 2014 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  11. Humidification during laparoscopic surgery: overview of the clinical benefits of using humidified gas during laparoscopic surgery.

    Science.gov (United States)

    Binda, Maria Mercedes

    2015-11-01

    The peritoneum is the serous membrane that covers the abdominal cavity and most of the intra-abdominal organs. It is a very delicate layer highly susceptible to damage and it is not designed to cope with variable conditions such as the dry and cold carbon dioxide (CO2) during laparoscopic surgery. The aim of this review was to evaluate the effects caused by insufflating dry and cold gas into the abdominal cavity after laparoscopic surgery. A literature search using the Pubmed was carried out. Articles identified focused on the key issues of laparoscopy, peritoneum, morphology, pneumoperitoneum, humidity, body temperature, pain, recovery time, post-operative adhesions and lens fogging. Insufflating dry and cold CO2 into the abdomen causes peritoneal damage, post-operative pain, hypothermia and post-operative adhesions. Using humidified and warm gas prevents pain after surgery. With regard to hypothermia due to desiccation, it can be fully prevented using humidified and warm gas. Results relating to the patient recovery are still controversial. The use of humidified and warm insufflation gas offers a significant clinical benefit to the patient, creating a more physiologic peritoneal environment and reducing the post-operative pain and hypothermia. In animal models, although humidified and warm gas reduces post-operative adhesions, humidified gas at 32 °C reduced them even more. It is clear that humidified gas should be used during laparoscopic surgery; however, a question remains unanswered: to achieve even greater clinical benefit to the patient, at what temperature should the humidified gas be when insufflated into the abdomen? More clinical trials should be performed to resolve this query.

  12. Randomized controlled trials in children’s heart surgery in the 21st century: a systematic review

    Science.gov (United States)

    Drury, Nigel E; Patel, Akshay J; Oswald, Nicola K; Chong, Cher-Rin; Stickley, John; Barron, David J; Jones, Timothy J

    2018-01-01

    Abstract OBJECTIVES Randomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children’s heart surgery. We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature. METHODS We searched MEDLINE, CENTRAL and LILACS, and manually screened retrieved references and systematic reviews to identify all randomized controlled trials reporting the effect of any intervention on the conduct or outcomes of heart surgery in children published in any language since January 2000; secondary publications and those reporting inseparable adult data were excluded. Two reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases. RESULTS We identified 333 trials from 34 countries randomizing 23 902 children. Most were early phase (313, 94.0%), recruiting few patients (median 45, interquartile range 28–82), and only 11 (3.3%) directly evaluated a surgical intervention. One hundred and nine (32.7%) trials calculated a sample size, 52 (15.6%) reported a CONSORT diagram, 51 (15.3%) were publicly registered and 25 (7.5%) had a Data Monitoring Committee. The overall risk of bias was low in 22 (6.6%), high in 69 (20.7%) and unclear in 242 (72.7%). CONCLUSIONS The recent literature in children’s heart surgery contains few late-phase clinical trials. Most trials did not conform to the accepted standards of reporting, and the overall risk of bias was low in few studies. There is a need for high-quality, multicentre clinical trials to provide a robust evidence base for contemporary paediatric cardiac surgical practice. PMID:29186478

  13. Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial.

    Science.gov (United States)

    Kjeken, Ingvild; Eide, Ruth Else Mehl; Klokkeide, Åse; Matre, Karin Hoegh; Olsen, Monika; Mowinckel, Petter; Andreassen, Øyvor; Darre, Siri; Nossum, Randi

    2016-11-15

    In the absence of disease-modifying interventions for hand osteoarthritis (OA), occupational therapy (OT) comprising patient education, hand exercises, assistive devices and orthoses are considered as core treatments, whereas surgery are recommended for those with severe carpometacarpal (CMC1) OA. However, even though CMC1 surgery may reduce pain and improve function, the risk of adverse effects is high, and randomized controlled trials comparing surgery with non-surgical interventions are warranted. This multicentre randomized controlled trial aims to address the following questions: Does OT in the period before surgical consultation reduce the need for surgery in CMC1-OA? What are patients' motivation and reasons for wanting CMC1-surgery? Are there differences between departments of rheumatology concerning the degree of CMC1-OA, pain and functional limitations in patients who are referred for surgical consultation for CMC1 surgery? Is the Measure of Activity Performance of the Hand a reliable measure in patients with CMC1-OA? Do patients with CMC1-OA with and without affection of the distal and proximal interphalangeal finger joints differ with regard to symptoms and function? Do the degree of CMC1-OA, symptoms and functional limitations significantly predict improvement after 2 years following OT or CMC1-surgery? Is OT more cost-effective than surgery in the management of CMC1-OA? All persons referred for surgical consultation due to their CMC1-OA at one of three Norwegian departments of rheumatology are invited to participate. Those who agree attend a clinical assessment and report their symptoms, function and motivation for surgery in validated outcome measures, before they are randomly selected to receive OT in the period before surgical consultation (estimated n = 180). The primary outcome will be the number of participants in each group who have received surgical treatment after 2 years. Secondary and tertiary outcomes are pain, function and

  14. Audit of accuracy of clinical coding in oral surgery.

    Science.gov (United States)

    Naran, S; Hudovsky, A; Antscherl, J; Howells, S; Nouraei, S A R

    2014-10-01

    We aimed to study the accuracy of clinical coding within oral surgery and to identify ways in which it can be improved. We undertook did a multidisciplinary audit of a sample of 646 day case patients who had had oral surgery procedures between 2011 and 2012. We compared the codes given with their case notes and amended any discrepancies. The accuracy of coding was assessed for primary and secondary diagnoses and procedures, and for health resource groupings (HRGs). The financial impact of coding Subjectivity, Variability and Error (SVE) was assessed by reference to national tariffs. The audit resulted in 122 (19%) changes to primary diagnoses. The codes for primary procedures changed in 224 (35%) cases; 310 (48%) morbidities and complications had been missed, and 266 (41%) secondary procedures had been missed or were incorrect. This led to at least one change of coding in 496 (77%) patients, and to the HRG changes in 348 (54%) patients. The financial impact of this was £114 in lost revenue per patient. There is a high incidence of coding errors in oral surgery because of the large number of day cases, a lack of awareness by clinicians of coding issues, and because clinical coders are not always familiar with the large number of highly specialised abbreviations used. Accuracy of coding can be improved through the use of a well-designed proforma, and standards can be maintained by the use of an ongoing data quality assurance programme. Copyright © 2014. Published by Elsevier Ltd.

  15. Clinical implications of medulloblastoma subgroups: incidence of CSF diversion surgery.

    Science.gov (United States)

    Schneider, Christian; Ramaswamy, Vijay; Kulkarni, Abhaya V; Rutka, James T; Remke, Marc; Tabori, Uri; Hawkins, Cynthia; Bouffet, Eric; Taylor, Michael D

    2015-03-01

    While medulloblastoma was initially thought to comprise a single homogeneous entity, it is now accepted that it in fact comprises 4 discrete subgroups, each with its own distinct demographics, clinical presentation, transcriptomics, genetics, and outcome. Hydrocephalus is a common complication of medulloblastoma and not infrequently requires CSF diversion. The authors report the incidence of CSF diversion surgery in each of the subgroups of medulloblastoma (Wnt, Shh, Group 3, and Group 4). The medical and imaging records for patients who underwent surgery for medulloblastoma at The Hospital for Sick Children were retrospectively reviewed. The primary outcome was the requirement for CSF diversion surgery either before or within 60 days of tumor resection. The modified Canadian Preoperative Prediction Rule for Hydrocephalus (mCPPRH) was compared among subgroups. Of 143 medulloblastoma patients, treated from 1991 to 2013, sufficient data were available for 130 patients (15 with Wnt, 30 with Shh, 30 with Group 3, and 55 with Group 4 medulloblastomas). Of these, 28 patients (22%) ultimately underwent CSF diversion surgery: 0% with Wnt, 29% with Shh, 29% with Group 3, and 43% with Group 4 tumors. Patients in the Wnt subgroup had a lower incidence of CSF diversion than all other patients combined (p = 0.04). Wnt patients had a lower mCPPRH score (lower risk of CSF diversion, p = 0.045), were older, had smaller ventricles at diagnosis, and had no leptomeningeal metastases. The overall rate of CSF diversion surgery for Shh, Group 3, and Group 4 medulloblastomas is around 30%, but no patients in the present series with a Wnt medulloblastoma required shunting. The low incidence of hydrocephalus in patients with Wnt medulloblastoma likely reflects both host factors (age) and disease factors (lack of metastases). The absence of hydrocephalus in patients with Wnt medulloblastomas likely contributes to their excellent rate of survival and may also contribute to a higher quality

  16. e-Consultation Improves Efficacy in Thoracic Surgery Outpatient Clinics.

    Science.gov (United States)

    Novoa, Nuria M; Gómez, Maria Teresa; Rodríguez, María; Jiménez López, Marcelo F; Aranda, Jose L; Bollo de Miguel, Elena; Diez, Florentino; Hernández Hernández, Jesús; Varela, Gonzalo

    2016-11-01

    The aim of this study is analysing the impact of the systematic versus occasional videoconferencing discussion of patients with two respiratory referral units along 6 years of time over the efficiency of the in-person outpatient clinics of a thoracic surgery service. Retrospective and comparative study of the evaluated patients through videoconferencing and in-person first visits during two equivalents periods of time: Group A (occasional discussion of cases) between 2008-2010 and Group B (weekly regular discussion) 2011-2013. Data were obtained from two prospective and electronic data bases. The number of cases discussed using e-consultation, in-person outpatient clinics evaluation and finally operated on under general anaesthesia in each period of time are presented. For efficiency criteria, the index: number of operated on cases/number of first visit outpatient clinic patients is created. Non-parametric Wilcoxon test is used for comparison. The mean number of patients evaluated at the outpatient clinics/year on group A was 563 versus 464 on group B. The median number of cases discussed using videoconferencing/year was 42 for group A versus 136 for group B. The mean number of operated cases/first visit at the outpatient clinics was 0.7 versus 0.87 in group B (P=.04). The systematic regular discussion of cases using videoconferencing has a positive impact on the efficacy of the outpatient clinics of a Thoracic Surgery Service measured in terms of operated cases/first outpatient clinics visit. Copyright © 2016 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.

  17. Warming and humidification of insufflation carbon dioxide in laparoscopic colonic surgery: a double-blinded randomized controlled trial.

    Science.gov (United States)

    Sammour, Tarik; Kahokehr, Arman; Hayes, Julian; Hulme-Moir, Mike; Hill, Andrew G

    2010-06-01

    We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced postoperative pain and improved recovery by reducing peritoneal inflammation in laparoscopic colonic surgery. Warming and humidification of insufflation gas is thought be beneficial in laparoscopic surgery, but evidence in prolonged laparoscopic procedures is lacking. We used a multicenter, double-blinded, randomized controlled design. The Study Group received warmed (37 degrees C), humidified (98% RH) insufflation carbon dioxide, and the Control Group received standard gas (19 degrees C, 0% RH). Anesthesia and analgesia were standardized. Intraoperative oesophageal temperature was measured at 15 minutes intervals. At the conclusion of surgery, the primary surgeon was asked to rate camera fogging on a Likert scale. Postoperative opiate usage was determined using Morphine Equivalent Daily Dose (MEDD), and pain was measured using visual analogue scores. Peritoneal and plasma cytokine concentrations were measured at 20 hours postoperatively. Postoperative recovery was measured using defined discharge and complication criteria, and the Surgical Recovery Score. Eighty-two patients were randomized, with 41 in each arm. Groups were well matched at baseline. Intraoperative core temperature was similar in both groups. Median camera fogging score was significantly worse in the Study group (4 vs. 2, P = 0.040). There were marginal differences in pain scores, but no significant differences were detected in MEDD usage, cytokine concentrations, or any recovery parameters measured. Warming and humidification of insufflation CO2 does not attenuate the early inflammatory cytokine response, and confers no clinically significant benefit in laparoscopic colonic surgery.

  18. Causes of Ocular Surgery Cancellation and the Need of Anesthesia Preoperative Medicine Clinic (APMC)

    International Nuclear Information System (INIS)

    Shaikh, Rehan Moinuddin; Al-Yafi, A.; Malak, M.

    2007-01-01

    Objective was to evaluate the causes of cancellation rate of elective ocular surgeries in our tertiary care center and to analyze the need of Anesthesia Preoperative Medicine Clinic (APMC). We conducted a prospective study from January 21, 2006 till 30 June, 2006 at King Fahd Armed Forces Hospital, Jeddah, Saudi Arabia. The selected patients for the surgery have gone through pre operative investigations including CBC, Random blood sugar, coagulation profile, renal function tests, urea and electrolytes, IOL calculation and their medical condition assessment for the chronic disease. Study was conducted on 240 patients from whom 180 were adults and 60 were pediatrics. Out of 240 patients, 45 patients were cancelled in which 40 were adults and 5 were pediatric patients. In 45 patients 23 were male and 22 were female having a ratio of 1:1. Age was ranging from one year to 60+ an average of 58 years. Surgeries include was anterior segment, pediatric, retinal and oculoplastic. All these patients 45/240 were postponed at a percentage of 19%. The causes of cancellation were, improper control of diabetes, poor control of hypertension, cardiac problem, chest infection or influenza in children, overburden list and miscellaneous. All these patients were cancelled by anesthesia (28 patients), by surgeon (9 patients) and medical team (8 patients) in the ward as the patients were at high risk for the surgeries. So the reason in maximum patient was lack of anesthesia preoperative medicine clinic. The number of cancellation of ocular surgery can be minimized by proper assessment of the patient at anesthesia pre-operative medicine clinic (APMC). (author)

  19. Routine clinical application of virtual reality in abdominal surgery.

    Science.gov (United States)

    Sampogna, Gianluca; Pugliese, Raffaele; Elli, Marco; Vanzulli, Angelo; Forgione, Antonello

    2017-06-01

    The advantages of 3D reconstruction, immersive virtual reality (VR) and 3D printing in abdominal surgery have been enunciated for many years, but still today their application in routine clinical practice is almost nil. We investigate their feasibility, user appreciation and clinical impact. Fifteen patients undergoing pancreatic, hepatic or renal surgery were studied realizing a 3D reconstruction of target anatomy. Then, an immersive VR environment was developed to import 3D models, and some details of the 3D scene were printed. All the phases of our workflow employed open-source software and low-cost hardware, easily implementable by other surgical services. A qualitative evaluation of the three approaches was performed by 20 surgeons, who filled in a specific questionnaire regarding a clinical case for each organ considered. Preoperative surgical planning and intraoperative guidance was feasible for all patients included in the study. The vast majority of surgeons interviewed scored their quality and usefulness as very good. Despite extra time, costs and efforts necessary to implement these systems, the benefits shown by the analysis of questionnaires recommend to invest more resources to train physicians to adopt these technologies routinely, even if further and larger studies are still mandatory.

  20. Randomized trials and quality assurance in gastric cancer surgery.

    Science.gov (United States)

    Dikken, Johan L; Cats, Annemieke; Verheij, Marcel; van de Velde, Cornelis J H

    2013-03-01

    A D2 lymphadenectomy can be considered standard of surgical care for advanced resectable gastric cancer. Currently, several multimodality strategies are used, including postoperative monochemotherapy in Asia, postoperative chemoradiotherapy in the United States, and perioperative chemotherapy in Europe. As the majority of gastric cancer patients are treated outside the framework of clinical trials, quality assurance programs, including referral to high-volume centers and clinical auditing are needed to improve gastric cancer care on a nationwide level. Copyright © 2012 Wiley Periodicals, Inc.

  1. Antibiotics in periodontal surgeries: A prospective randomised cross over clinical trial

    Directory of Open Access Journals (Sweden)

    Sheetal Oswal

    2014-01-01

    Full Text Available Aims and Objectives: (1 To evaluate the need of antibiotics in periodontal surgeries in reducing postsurgical infections and explore if antibiotics have any key role in reducing or eliminating inflammatory complications. (2 To establish the incidence of postoperative infections in relation to type of surgery and determine those factors, which may affect infection rates. Materials and Methods: A prospective randomized double-blind cross over clinical study was carried out for a period of 1-year with predefined inclusion and exclusion criteria. All the patients included in the study for any periodontal surgery were randomly divided into three categories: Group A (prophylactic, Group B (therapeutic, and Group C (no antibiotics. Patients were followed up for 1-week after surgery on the day of suture removal and were evaluated for pain, swelling, fever, infection, delayed wound healing and any other significant findings. Appropriate statistical analysis was carried out to evaluate the objectives and P < 0.05 was considered as statistically significant. Results: No infection was reported in any of 90 sites. Patients reported less pain and postoperative discomfort when prophylactic antibiotics were given. However, there were no statistical significant differences between the three groups. Summary and Conclusion: There was no postoperative infection reported in all the 90 sites operated in this study. The prevalence of postoperative infections following periodontal surgery is <1% and this low risk does not justify the routine use of systemic antimicrobials just to prevent infections. Use of prophylactic antibiotics may have role in prevention of inflammatory complication, but again not infection.

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

    Science.gov (United States)

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

    2010-01-01

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

  3. A randomized, controlled trial of an intervention promoting cataract surgery acceptance in rural China: the Guangzhou Uptake of Surgery Trial (GUSTO).

    Science.gov (United States)

    Liu, Tianyu; Congdon, Nathan; Yan, Xixi; Jin, Ling; Wu, Ying; Friedman, David; He, Mingguang

    2012-08-13

    To evaluate an educational intervention promoting acceptance of cataract surgery in rural China using a randomized controlled design. Patients aged 50 years or older with presenting visual acuity (PVA) less than 6/18 in one or both eyes due to cataract were recruited from 26 screening sessions (13 intervention, 13 control) conducted by five rural hospitals in Guangdong, China. At intervention sessions, subjects were shown a 5-minute informational video, and counseled about cataract, surgery, and surgical cost. During screening, all subjects answered questionnaires on knowledge and attitudes about cataract, their finances, and transportation, and were referred for definitive examination if eligible. Study outcomes were acceptance of surgery (principal outcome) and hospital follow-up. Subjects in the intervention group were younger than controls (P = 0.01), but the groups did not otherwise differ. Among 212 intervention patients and 222 controls, no differences in knowledge and attitude regarding cataract were found. Surgery was accepted by 31.1% of intervention patients and 34.2% of controls (P > 0.50). Predictors of acceptance included younger age, worse logMAR PVA, knowing that cataract can be treated surgically only, greater anticipated loss in income from hospitalization, and greater house floor space per person. Membership in the intervention group was not associated with accepting surgery (odds ratio [OR] = 1.11, 95% confidence interval [CI] 0.67-1.84) or hospital follow-up (OR = 1.03, 95% CI = 0.63-1.67). Educational interventions that successfully impart the knowledge that cataract can be only treated surgically may be more effective in increasing uptake in this setting. (ClinicalTrials.gov number, NCT01123928.).

  4. Clinical observation on fibrin glue technique in pterygium surgery performed with limbal autograft transplantation

    Directory of Open Access Journals (Sweden)

    Hui Liu

    2013-07-01

    Full Text Available AIM: To compare the efficiency and safety of fibrin glue to suture technique in pterygium surgery performed with limbal autograft.METHODS: A prospective randomized clinical trial was carried out in 60 eyes of 48 patients operated for primary nasal pterygium. Autologous limbal graft taken from the superotemporal limbus was used to cover the sclera after pterygium excision under local anesthesia with 2% lidocaine. In 22 cases(30 eyes, the transplant was attached to the sclera with a fibrin tissue adhesive(group 1and in 26 cases(30 eyeswith 10-0 Virgin silk sutures(group 2. Patients were followed up at least for 3 months. Time of operation, matching degree of graft and visual analogue scale(VASscore were mainly observed and recorded. RESULTS: Patient symptoms were significantly less and biomicroscopic findings were better in group 1. Pterygium recurrence was seen in 1 case of group 1, and 1 case of group 2. Average surgery time was shorter(PCONCLUSION: Using fibrin glue for graft fixation in pterygium surgery causes significantly less postoperative pain and shortens surgery time significantly.

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

    NARCIS (Netherlands)

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

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

  6. 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

  7. Normothermic versus hypothermic cardiopulmonary bypass in children undergoing open heart surgery (thermic-2): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Baos, Sarah; Sheehan, Karen; Culliford, Lucy; Pike, Katie; Ellis, Lucy; Parry, Andrew J; Stoica, Serban; Ghorbel, Mohamed T; Caputo, Massimo; Rogers, Chris A

    2015-05-25

    During open heart surgery, patients are connected to a heart-lung bypass machine that pumps blood around the body ("perfusion") while the heart is stopped. Typically the blood is cooled during this procedure ("hypothermia") and warmed to normal body temperature once the operation has been completed. The main rationale for "whole body cooling" is to protect organs such as the brain, kidneys, lungs, and heart from injury during bypass by reducing the body's metabolic rate and decreasing oxygen consumption. However, hypothermic perfusion also has disadvantages that can contribute toward an extended postoperative hospital stay. Research in adults and small randomized controlled trials in children suggest some benefits to keeping the blood at normal body temperature throughout surgery ("normothermia"). However, the two techniques have not been extensively compared in children. The Thermic-2 study will test the hypothesis that the whole body inflammatory response to the nonphysiological bypass and its detrimental effects on different organ functions may be attenuated by maintaining the body at 35°C-37°C (normothermic) rather than 28°C (hypothermic) during pediatric complex open heart surgery. This is a single-center, randomized controlled trial comparing the effectiveness and acceptability of normothermic versus hypothermic bypass in 141 children with congenital heart disease undergoing open heart surgery. Children having scheduled surgery to repair a heart defect not requiring deep hypothermic circulatory arrest represent the target study population. The co-primary clinical outcomes are duration of inotropic support, intubation time, and postoperative hospital stay. Secondary outcomes are in-hospital mortality and morbidity, blood loss and transfusion requirements, pre- and post-operative echocardiographic findings, routine blood gas and blood test results, renal function, cerebral function, regional oxygen saturation of blood in the cerebral cortex, assessment of

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

    Science.gov (United States)

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

    2014-07-01

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

  9. Meta-analysis of randomized trials of effect of milrinone on mortality in cardiac surgery: an update.

    Science.gov (United States)

    Majure, David T; Greco, Teresa; Greco, Massimiliano; Ponschab, Martin; Biondi-Zoccai, Giuseppe; Zangrillo, Alberto; Landoni, Giovanni

    2013-04-01

    The long-term use of milrinone is associated with increased mortality in chronic heart failure. A recent meta-analysis suggested that it might increase mortality in patients undergoing cardiac surgery. The authors conducted an updated meta-analysis of randomized trials in patients undergoing cardiac surgery to determine if milrinone impacted survival. A meta-analysis. Hospitals. One thousand thirty-seven patients from 20 randomized trials. None. Biomed, Central, PubMed, EMBASE, the Cochrane central register of clinical trials, and conference proceedings were searched for randomized trials that compared milrinone versus placebo or any other control in adult and pediatric patients undergoing cardiac surgery. Authors of trials that did not include mortality data were contacted. Only trials for which mortality data were available were included. Overall analysis showed no difference in mortality between patients receiving milrinone versus control (12/554 [2.2%] in the milrinone group v 10/483 [2.1%] in the control arm; relative risk [RR] = 1.15; 95% confidence interval [CI], 0.55-2.43; p = 0.7) or in analysis restricted to adults (11/364 [3%] in the milrinone group v 9/371 [2.4%] in the control arm; RR = 1.17; 95% CI, 0.54-2.53; p = 0.7). Sensitivity analyses in trials with a low risk of bias showed a trend toward an increase in mortality with milrinone (8/153 [5.2%] in the milrinone arm v 2/152 [1.3%] in the control arm; RR = 2.71; 95% CI, 0.82-9; p for effect = 0.10). Despite theoretic concerns for increased mortality with intravenous milrinone in patients undergoing cardiac surgery, the authors were unable to confirm an adverse effect on survival. However, sensitivity analysis of high-quality trials showed a trend toward increased mortality with milrinone. Copyright © 2013 Elsevier Inc. All rights reserved.

  10. A randomized controlled trial of cell salvage in routine cardiac surgery.

    Science.gov (United States)

    Klein, Andrew A; Nashef, Samer A M; Sharples, Linda; Bottrill, Fiona; Dyer, Matthew; Armstrong, Johanna; Vuylsteke, Alain

    2008-11-01

    Previous trials have indicated that cell salvage may reduce allogeneic blood transfusion during cardiac surgery, but these studies have limitations, including inconsistent use of other blood transfusion-sparing strategies. We designed a randomized controlled trial to determine whether routine cell salvage for elective uncomplicated cardiac surgery reduces blood transfusion and is cost effective in the setting of a rigorous transfusion protocol and routine administration of antifibrinolytics. Two-hundred-thirteen patients presenting for first-time coronary artery bypass grafting and/or cardiac valve surgery were prospectively randomized to control or cell salvage groups. The latter group had blood aspirate during surgery and mediastinal drainage the first 6 h after surgery processed in a cell saver device and autotransfused. All patients received tranexamic acid and were subjected to an algorithm for red blood cell and hemostatic blood factor transfusion. There was no difference between the two groups in the proportion of patients exposed to allogeneic blood (32% in both groups, relative risk 1.0 P = 0.89). At current blood products and cell saver prices, the use of cell salvage increased the costs per patient by a minimum of $103. When patients who had mediastinal re-exploration for bleeding were excluded (as planned in the protocol), significantly fewer units of allogeneic red blood cells were transfused in the cell salvage compared with the control group (65 vs 100 U, relative risk 0.71 P = 0.04). In patients undergoing routine first-time cardiac surgery in an institution with a rigorous blood conservation program, the routine use of cell salvage does not further reduce the proportion of patients exposed to allogeneic blood transfusion. However, patients who do not have excessive bleeding after surgery receive significantly fewer units of blood with cell salvage. Although the use of cell savage may reduce the demand for blood products during cardiac surgery, this

  11. Evaluation of aesthetic abdominal surgery using a new clinical scale.

    Science.gov (United States)

    Salles, Alessandra Grassi; Ferreira, Marcus Castro; do Nascimento Remigio, Adelina Fatima; Gemperli, Rolf

    2012-02-01

    Evaluation of outcomes after aesthetic surgery still is a challenge in plastic surgery. The evaluation frequently is based on subjective criteria. This study used a new clinical grading scale to evaluate aesthetic results for plastic surgeries to the abdomen. The method scores each of the following five parameters: volume of subcutaneous tissue, contour, excess of skin, aspect of the navel, and quality of the scar on the abdominal wall. The scale options are 0 (poor), 1 (fair), and 2 (good), and the total rate can range from 0 to 10. The study included 40 women ages 18-53 years. Of these 40 women, 20 underwent traditional abdominoplasty, and 20 had liposuction alone. Preoperatively and at least 1 year later, photographic results were analyzed and scored by three independent plastic surgeons. In the abdominoplasty group, the average grade rose from 2.9±0.4 to 6.8±0.4 postoperatively. In the liposuction group, the average grade was 5.3±0.5 preoperatively and 7.7±0.4 postoperatively. In both groups, the average postoperative grade was significantly higher than the preoperative grade. The mean scores for groups A and L were significantly different, demonstrating that the scale was sensitive in identifying different anatomic abnormalities in the abdomen. The rating scale used for the aesthetic evaluation of the abdomen was effective in the analysis of two different procedures: conventional abdominoplasty and liposuction. Abdominoplasty provided the greater gain according to a comparison of the pre- and postoperative scores.

  12. Minimally invasive strabismus surgery versus paralimbal approach: A randomized, parallel design study is minimally invasive strabismus surgery worth the effort?

    Directory of Open Access Journals (Sweden)

    Richa Sharma

    2014-01-01

    Full Text Available Introduction : Minimal access surgery is common in all fields of medicine. We compared a new minimally invasive strabismus surgery (MISS approach with a standard paralimbal strabismus surgery (SPSS approach in terms of post-operative course. Materials and Methods: This parallel design study was done on 28 eyes of 14 patients, in which one eye was randomized to MISS and the other to SPSS. MISS was performed by giving two conjunctival incisions parallel to the horizontal rectus muscles; performing recession or resection below the conjunctival strip so obtained. We compared post-operative redness, congestion, chemosis, foreign body sensation (FBS, and drop intolerance (DI on a graded scale of 0 to 3 on post-operative day 1, at 2-3 weeks, and 6 weeks. In addition, all scores were added to obtain a total inflammatory score (TIS. Statistical Analysis: Inflammatory scores were analyzed using Wilcoxon′s signed rank test. Results: On the first post-operative day, only FBS (P = 0.01 and TIS (P = 0.04 showed significant difference favoring MISS. At 2-3 weeks, redness (P = 0.04, congestion (P = 0.04, FBS (P = 0.02, and TIS (P = 0.04 were significantly less in MISS eye. At 6 weeks, only redness (P = 0.04 and TIS (P = 0.05 were significantly less. Conclusion: MISS is more comfortable in the immediate post-operative period and provides better cosmesis in the intermediate period.

  13. Randomized clinical trial of laparoscopic versus open appendicectomy

    DEFF Research Database (Denmark)

    Pedersen, A G; Petersen, O B; Wara, P

    2001-01-01

    BACKGROUND: Laparoscopy in patients with a clinical suspicion of acute appendicitis has not gained wide acceptance, and its use remains controversial. METHODS: In a randomized controlled trial of laparoscopic versus open appendicectomy, 583 of 828 consecutive patients consented to participate...

  14. Meta-analytic comparison of randomized and nonrandomized studies of breast cancer surgery.

    Science.gov (United States)

    Edwards, Janet P; Kelly, Elizabeth J; Lin, Yongtao; Lenders, Taryn; Ghali, William A; Graham, Andrew J

    2012-06-01

    Randomized controlled trials (RCTs) are thought to provide the most accurate estimation of "true" treatment effect. The relative quality of effect estimates derived from nonrandomized studies (nRCTs) remains unclear, particularly in surgery, where the obstacles to performing high-quality RCTs are compounded. We performed a meta-analysis of effect estimates of RCTs comparing surgical procedures for breast cancer relative to those of corresponding nRCTs. English-language RCTs of breast cancer treatment in human patients published from 2003 to 2008 were identified in MEDLINE, EMBASE and Cochrane databases. We identified nRCTs using the National Library of Medicine's "related articles" function and reference lists. Two reviewers conducted all steps of study selection. We included studies comparing 2 surgical arms for the treatment of breast cancer. Information on treatment efficacy estimates, expressed as relative risk (RR) for outcomes of interest in both the RCTs and nRCTs was extracted. We identified 12 RCTs representing 10 topic/outcome combinations with comparable nRCTs. On visual inspection, 4 of 10 outcomes showed substantial differences in summary RR. The pooled RR estimates for RCTs versus nRCTs differed more than 2-fold in 2 of 10 outcomes and failed to demonstrate consistency of statistical differences in 3 of 10 cases. A statistically significant difference, as assessed by the z score, was not detected for any of the outcomes. Randomized controlled trials comparing surgical procedures for breast cancer may demonstrate clinically relevant differences in effect estimates in 20%-40% of cases relative to those generated by nRCTs, depending on which metric is used.

  15. Fundamentals of randomized clinical trials in wound care

    DEFF Research Database (Denmark)

    Eskes, Anne M; Brölmann, Fleur E; Sumpio, Bauer E

    2012-01-01

    randomization is a necessary feature of a robust comparative study, it is not sufficient to ensure a study at low risk of bias. Randomized clinical trials should also ensure adequate allocation concealment and blinding of outcome assessors, apply intention-to-treat analysis, and use patient-oriented outcomes...

  16. Effect of methylprednisolone on the oxidative burst activity, adhesion molecules and clinical outcome following open heart surgery

    DEFF Research Database (Denmark)

    Toft, P; Christiansen, K; Tønnesen, Else Kirstine

    1997-01-01

    on granulocytes and improve clinical outcome. Sixteen patients undergoing open heart surgery participated in the study. Eight were randomized to receive methylprednisolone (30 mg/kg intravenously) at the start of anaesthesia while eight patients served as a control group. The oxidative burst was measured flow...... not improve the weaning from the ventilator or reduce the stay in the intensive-care unit. In conclusion, treatment with steroids prevented hyperthermia following open heart surgery with CPB and reduced capillary leak during ECC. Methylprednisolone, however, did not reduce the oxidative burst activity...

  17. Random effects models in clinical research

    NARCIS (Netherlands)

    Cleophas, T. J.; Zwinderman, A. H.

    2008-01-01

    BACKGROUND: In clinical trials a fixed effects research model assumes that the patients selected for a specific treatment have the same true quantitative effect and that the differences observed are residual error. If, however, we have reasons to believe that certain patients respond differently

  18. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    , in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  19. The Anxiolytic Effect of Aromatherapy on Patients Awaiting Ambulatory Surgery: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Cheng-Hua Ni

    2013-01-01

    Full Text Available The aim of this study was to determine if aromatherapy could reduce preoperative anxiety in ambulatory surgery patients. A total of 109 preoperative patients were randomly assigned to experimental (bergamot essential oil and control (water vapor conditions and their responses to the State Trait Anxiety Inventory and vital signs were monitored. Patients were stratified by previous surgical experience, but that did not influence the results. All those exposed to bergamot essential oil aromatherapy showed a greater reduction in preoperative anxiety than those in the control groups. Aromatherapy may be a useful part of a holistic approach to reducing preoperative anxiety before ambulatory surgery.

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

    NARCIS (Netherlands)

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

    2017-01-01

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

  1. Comparison between conventional and piezoelectric surgical tools for maxillary sinus floor elevation : a randomized controlled clinical trial

    NARCIS (Netherlands)

    Rickert, Daniela; Vissink, Arjan; Huddleston Slater, James; Meijer, Henny J. A.; Raghoebar, Gerry M.

    Aim: The aim of this study was to assess the performance of conventional rotative instruments and a piezoelectric device for maxillary sinus floor elevation surgery, and to assess whether application of a resorbable membrane reduces resorption of an augmented site in a randomized clinical trial.

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

    Science.gov (United States)

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

    2010-04-30

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

  3. Clinical efficacy of dexmedetomidine in the diminution of fentanyl dosage in pediatric cardiac surgery.

    Science.gov (United States)

    Sun, Yingying; Ye, Hongwu; Xia, Yin; Li, Yuanhai; Yuan, Xianren; Wang, Xing

    2017-06-01

    This study aims to explore the clinical efficacy of dexmedetomidine (DEX) in the diminution of fentanyl dosage in pediatric cardiac surgery based on some clinical and biochemical parameters. Fifty pediatric patients (American Society of Anesthesiologists II), 1-6 years old, were randomly allocated into two groups: group F (control group), in which patients received normal saline and high dosage of fentanyl (30 μg/kg), and group D, in which patients were given DEX and low dosage of fentanyl (15 μg/kg). Some hemodynamic and clinical parameters of the two groups were recorded. Furthermore, stress hormone (serum cortisol, norepinephrine, blood glucose) levels and cytokine (interleukin 6, tumor necrosis factor alpha) levels in the two groups were compared with each other. Stress hormone levels, cytokine levels, hemodynamic parameters and the consumption of sevoflurane did not differ between the two groups. Meanwhile, the extubation time was significantly shorter in Group D than F (Pfentanyl supplemented with DEX almost had the same anesthesia effects and inflammation extent compared with high dose of fentanyl, which suggested that infusion DEX might decrease fentanyl consumption in pediatric cardiac surgery.

  4. Clinics of Oblivion: Makeover Culture and Cosmetic Surgery

    OpenAIRE

    Jones, Meredith

    2011-01-01

    This paper examines cosmetic surgery tourism, arguing that it can be meaningfully analysed as part of makeover culture. It shows that while cosmetic surgery tourism sits at a junction of cosmetic surgery and medical tourism, it also has much in common with contemporary tourism practices. The paper posits cosmetic surgery tourism not only as an economic and globalised phenomenon but also as a set of practices that are experienced, and that take place on the body (see also Cook, 2010; Bell et a...

  5. Risk of Acute Kidney Injury in Patients Randomized to a Restrictive Versus Liberal Approach to Red Blood Cell Transfusion in Cardiac Surgery: A Substudy Protocol of the Transfusion Requirements in Cardiac Surgery III Noninferiority Trial.

    Science.gov (United States)

    Garg, Amit X; Shehata, Nadine; McGuinness, Shay; Whitlock, Richard; Fergusson, Dean; Wald, Ron; Parikh, Chirag; Bagshaw, Sean M; Khanykin, Boris; Gregory, Alex; Syed, Summer; Hare, Gregory M T; Cuerden, Meaghan S; Thorpe, Kevin E; Hall, Judith; Verma, Subodh; Roshanov, Pavel S; Sontrop, Jessica M; Mazer, C David

    2018-01-01

    When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III) trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion. The objective of this substudy is to determine whether the risk of acute kidney injury is no greater with a restrictive versus liberal approach to red blood cell transfusion, and whether this holds true in patients with and without preexisting chronic kidney disease. Multinational noninferiority randomized controlled trial conducted in 73 centers in 19 countries (2014-2017). Patients (~4800) undergoing planned cardiac surgery with cardiopulmonary bypass. The primary outcome of this substudy is perioperative acute kidney injury, defined as an acute rise in serum creatinine from the preoperative value (obtained in the 30-day period before surgery), where an acute rise is defined as ≥26.5 μmol/L in the first 48 hours after surgery or ≥50% in the first 7 days after surgery. We will report the absolute risk difference in acute kidney injury and the 95% confidence interval. We will repeat the primary analysis using alternative definitions of acute kidney injury, including staging definitions, and will examine effect modification by preexisting chronic kidney disease (defined as a preoperative estimated glomerular filtration rate [eGFR] blood cell transfusion in the presence of anemia during cardiac surgery done with cardiopulmonary bypass. www.clinicaltrials.gov; clinical trial registration number NCT 02042898.

  6. The effect of milrinone on induced hypotension in elderly patients during spinal surgery: a randomized controlled trial.

    Science.gov (United States)

    Hwang, Wonjung; Kim, Eunsung

    2014-08-01

    Induced hypotension is widely used intraoperatively to reduce blood loss and to improve the surgical field during spinal surgery. To determine the effect of milrinone on induced hypotension during spinal surgery in elderly patients. Prospective randomized clinical trial. Forty patients, 60 to 70 years old, ASA I-II, who underwent elective lumbar fusion surgery. Intraoperative hemodynamics, blood loss, hourly urine output, and grade of surgical field. All patients were randomized to group M or N. The study drug was infused after perivertebral muscle retraction until complete interbody fusion. In group M, 50 μg/kg/min of milrinone was infused over 10 minutes as a loading dose followed by 0.6 μg/kg/min of milrinone as a continuous dose. In group N, an identical volume of normal saline was infused in the same fashion. This study was not funded by commercial or other sponsorship and the authors confirm no conflicts of interest, financial or otherwise. During infusion of the study drug, the systolic and mean blood pressures were maintained within adequate limits of induced hypotension in group M. Intraoperative blood loss was 445.0±226.5 mL in group M and 765.0±339.2 mL in group N (p=.001). Hourly urine output was 1.4±0.6 mL in group M and 0.8±0.2 mL in group N (pmilrinone is useful for induced hypotension in elderly patients during spinal surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

  7. Cognitive-Behavioral-Based Physical Therapy for Patients With Chronic Pain Undergoing Lumbar Spine Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Archer, Kristin R; Devin, Clinton J; Vanston, Susan W; Koyama, Tatsuki; Phillips, Sharon E; George, Steven Z; McGirt, Matthew J; Spengler, Dan M; Aaronson, Oran S; Cheng, Joseph S; Wegener, Stephen T

    2016-01-01

    The purpose of this study was to determine the efficacy of a cognitive-behavioral-based physical therapy (CBPT) program for improving outcomes in patients after lumbar spine surgery. A randomized controlled trial was conducted on 86 adults undergoing a laminectomy with or without arthrodesis for a lumbar degenerative condition. Patients were screened preoperatively for high fear of movement using the Tampa Scale for Kinesiophobia. Randomization to either CBPT or an education program occurred at 6 weeks after surgery. Assessments were completed pretreatment, posttreatment and at 3-month follow-up. The primary outcomes were pain and disability measured by the Brief Pain Inventory and Oswestry Disability Index. Secondary outcomes included general health (SF-12) and performance-based tests (5-Chair Stand, Timed Up and Go, 10-Meter Walk). Multivariable linear regression analyses found that CBPT participants had significantly greater decreases in pain and disability and increases in general health and physical performance compared with the education group at the 3-month follow-up. Results suggest a targeted CBPT program may result in significant and clinically meaningful improvement in postoperative outcomes. CBPT has the potential to be an evidence-based program that clinicians can recommend for patients at risk for poor recovery after spine surgery. This study investigated a targeted cognitive-behavioral-based physical therapy program for patients after lumbar spine surgery. Findings lend support to the hypothesis that incorporating cognitive-behavioral strategies into postoperative physical therapy may address psychosocial risk factors and improve pain, disability, general health, and physical performance outcomes. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

  8. Postoperative laryngeal symptoms in a general surgery setting. Clinical study.

    Science.gov (United States)

    Geraci, Girolamo; Cupido, Francesco; Lo Nigro, Chiara; Sciuto, Antonio; Sciumè, Carmelo; Modica, Giuseppe

    2013-01-01

    Vocal cord injuries (VI), postoperative hoarseness (PH), dysphonia (DN), dysphagia (DG) and sore throat (ST) are common complications after general anesthesia; there is actually a lack of consensus to support the proper timing for post-operative laryngoscopy that is reliable to support the diagnosis of laryngeal or vocal fold lesions after surgery and there are no valid studies about the entity of laryngeal trauma in oro-tracheal intubation. Aim of our study is to evaluate the statistical relation between anatomic, anesthesiological and surgical variables in the case of PH, DG or impaired voice register. 50 patients (30 thyroidectomies, 8 videolaparoscopic cholecistectomies, 2 right emicolectomies, 2 left emicolectomies, 1 gastrectomy, 1 hemorrhoidectomy, 1 nefrectomy, 1 diagnostic videothoracoscopy, 1 superior right lung lobectomy, 1 appendicectomy, 1 incisional hernia repair, 1 low anterior rectal resection, 1 radical hysterectomy) underwent clinical evaluation and direct laryngoscopy before surgery, within 6 hours, after 72 hours and after 30 days, to evaluate motility and breathing space, phonatory motility, true and false vocal folds and arytenoids oedema. We evaluated also mean age (56.6 ± 3.6 years), male:female ratio (1:1.5), cigarette smoke (20%), atopic comorbidity (17/50 = 34%), Mallampati class (32% 1, 38% 2, 26% 3, 2% 4), mean duration of intubation (159 minutes, range 50 - 405 minutes), Cormack-Lehane score (34% 1, 22% 2, 22% 3, 2% 4), difficult intubation in 9 cases (18%). No complication during the laryngoscopy were registered. We investigated the statistic relationship between pre and intraoperative variables and laryngeal symptoms and lesions. In our experience, statistically significant relations were found in prevalence of vocal folds oedema in smokers (p < 0.005), self limiting DG and DN in younger patients (p < 0.005) and in thyroidectomy (p < 0.01), DG after thyroidectomy (p < 0.01). The short preoperative use of steroids and antihistaminic

  9. Rivaroxaban for venous thromboembolism prevention after major orthopedic surgery: translating trial data into routine clinical practice

    Directory of Open Access Journals (Sweden)

    Beyer-Westendorf J

    2017-01-01

    Full Text Available Jan Beyer-Westendorf,1 Patrick Mouret,2 Alexander GG Turpie3 1Thrombosis Research and Angiology, Dresden University Clinic, Dresden, Germany; 2Orthopedic Clinic, Klinikum Frankfurt Höchst GmbH, Frankfurt, Germany; 3Department of Medicine, General Division, Hamilton Health Sciences, Hamilton, ON, Canada Abstract: An established standard of care for the prevention of venous thromboembolism after major orthopedic surgery has been subcutaneous low-molecular-weight heparin. The non-vitamin K antagonist oral anticoagulant rivaroxaban has demonstrated superior efficacy and similar safety to all tested regimens of enoxaparin in large Phase III clinical studies of venous thromboembolism prevention after elective hip and knee arthroplasty. Despite regulatory approval of rivaroxaban for this indication, concerns remain among physicians regarding its optimal and effective use in routine clinical practice. Real-life studies, such as XAMOS and ORTHO-TEP, are providing physicians with more information on the routine use of rivaroxaban for venous thromboembolism prevention after orthopedic surgery, helping to establish its safety and effectiveness in everyday clinical care. Among the most important issues are the risk of bleeding complications, wound healing, timing of first dose, impact of type of anesthesia on thromboprophylaxis effectiveness, patient comorbidities and comedication use, periprocedural management, associated costs, and clinical outcomes in trauma-related fractures. Many of these issues are difficult to study in randomized, double-blind, Phase III trials, and can be assessed more readily using real-life data. In particular, real-life or noninterventional studies lack many of the strict inclusion and exclusion criteria associated with Phase III trials and involve unselected patients who often present with significant comorbidities or comedication use. Keywords: anticoagulants, arthroplasty, orthopedics, rivaroxaban, thrombosis

  10. Randomized Clinical Trials on Deep Carious Lesions

    DEFF Research Database (Denmark)

    Bjørndal, Lars; Fransson, Helena; Bruun, Gitte

    2017-01-01

    nonselective carious removal to hard dentin with or without pulp exposure. The aim of this article was to report the 5-y outcome on these previously treated patients having radiographically well-defined carious lesions extending into the pulpal quarter of the dentin but with a well-defined radiodense zone...... pulp exposures per se were included as failures. Pulp exposure rate was significantly lower in the stepwise carious removal group (21.2% vs. 35.5%; P = 0.014). Irrespective of pulp exposure status, the difference (13.3%) was still significant when sustained pulp vitality without apical radiolucency......) in deep carious lesions in adults. In conclusion, the stepwise carious removal group had a significantly higher proportion of pulps with sustained vitality without apical radiolucency versus nonselective carious removal of deep carious lesions in adult teeth at 5-y follow-up (ClinicalTrials.gov NCT...

  11. Comparative Effects of Snoring Sound between Two Minimally Invasive Surgeries in the Treatment of Snoring: A Randomized Controlled Trial

    Science.gov (United States)

    Lee, Li-Ang; Yu, Jen-Fang; Lo, Yu-Lun; Chen, Ning-Hung; Fang, Tuan-Jen; Huang, Chung-Guei; Cheng, Wen-Nuan; Li, Hsueh-Yu

    2014-01-01

    Background Minimally invasive surgeries of the soft palate have emerged as a less-invasive treatment for habitual snoring. To date, there is only limited information available comparing the effects of snoring sound between different minimally invasive surgeries in the treatment of habitual snoring. Objective To compare the efficacy of palatal implant and radiofrequency surgery, in the reduction of snoring through subjective evaluation of snoring and objective snoring sound analysis. Patients and Method Thirty patients with habitual snoring due to palatal obstruction (apnea-hypopnea index ≤15, body max index ≤30) were prospectively enrolled and randomized to undergo a single session of palatal implant or temperature-controlled radiofrequency surgery of the soft palate under local anesthesia. Snoring was primarily evaluated by the patient with a 10 cm visual analogue scale (VAS) at baseline and at a 3-month follow-up visit and the change in VAS was the primary outcome. Moreover, life qualities, measured by snore outcomes survey, and full-night snoring sounds, analyzed by a sound analytic program (Snore Map), were also investigated at the same time. Results Twenty-eight patients completed the study; 14 received palatal implant surgery and 14 underwent radiofrequency surgery. The VAS and snore outcomes survey scores were significantly improved in both groups. However, the good response (postoperative VAS ≤3 or postoperative VAS ≤5 plus snore outcomes survey score ≥60) rate of the palatal implant group was significantly higher than that of the radiofrequency group (79% vs. 29%, P = 0.021). The maximal loudness of low-frequency (40–300 Hz) snores was reduced significantly in the palatal implant group. In addition, the snoring index was significantly reduced in the radiofrequency group. Conclusions Both palatal implants and a single-stage radiofrequency surgery improve subjective snoring outcomes, but palatal implants have a greater effect on most measures

  12. Effects of guidelines on adeno-tonsillar surgery on the clinical behaviour of otorhinolaryngologists in Italy

    Directory of Open Access Journals (Sweden)

    Motta Giovanni

    2013-01-01

    Full Text Available Abstract Background Several guidelines on adeno-tonsillar disease have been proposed in recent years and some discrepancies in relation both to clinical manifestations and indications for surgical treatment have emerged. The aim of the study was to verify what influence (adeno-tonsillectomy guidelines have had on the clinical behaviour of ENT specialists in Italy. Our study is a retrospective and multi-centre case series with chart review. Methods The survey involved 14,770 children, aged between the ages of 2 and 11, who had undergone adeno-tonsillar surgery between 2002 and 2008 in fourteen Italian tertiary and secondary referral centres. Anova test was used for the statistical analysis, assuming p Results The frequency of adeno-tonsillar surgeries did not change significantly (p>0.05 during the study period and following the Italian policy document publication. Overall, adeno-tonsillectomy was the most frequent intervention (64.1%, followed by adenoidectomy (31.1% and tonsillectomy (4.8%. The indications for surgery did not change significantly for each of the operations (p>0.05, with the exception of adeno-tonsillectomy in case of feverish episodes due to acute recurrent tonsillitis ≥ 5 without nasal obstruction (decreased p= 0.010 , even when the feverish episodes due to acute recurrent tonsillitis were Conclusions The recommendations first developed in Italy in a 2003 policy document and then resumed in guidelines in 2008, were not implemented by ENT units involved in the survey. The study highlights the fact that the indications for adeno-tonsillar operations are based on the overall clinical presentation (comorbidity rather than on a single symptom. Guidelines are necessary to give coherent recommendations based on both the findings obtained through randomized controlled trials and the data collected from observational studies.

  13. Rain dance: the role of randomization in clinical trials

    Directory of Open Access Journals (Sweden)

    Diniz JB

    2016-07-01

    Full Text Available Juliana Belo Diniz,1 Victor Fossaluza,2 Carlos Alberto de Bragança Pereira,1,2 Sergio Wechsler2 1Institute of Psychiatry, Clinics Hospital University of São Paulo Medical School, 2Department of Statistics, Institute of Mathematics and Statistics, University of São Paulo, São Paulo, Brazil Abstract: Randomized clinical trials are the gold standard for testing efficacy of treatment interventions. However, although randomization protects against deliberately biased samples, it does not guarantee random imbalances will not occur. Methods of intentional allocation that can overcome such deficiency of randomization have been developed, but are less frequently applied than randomization. Initially, we introduce a fictitious case example to revise and discuss the reasons of researchers' resistance to intentionally allocate instead of simply randomizing. We then introduce a real case example to evaluate the performance of an intentional protocol for allocation based on compositional data balance. A real case of allocation of 50 patients in two arms was compared with an optimal allocation of global instead of sequential arrivals. Performance was measured by a weighted average of Aitchison distances, between arms, of prognostic factors. To compare the intentional allocation with simple random allocation, 50,000 arrival orderings of 50 patients were simulated. To each one of the orders, both kinds of allocations into two arms were considered. Intentional allocation performed as well as optimal allocation in the case considered. In addition, out of the 50,000 simulated orders, 61% of them performed better with intentional allocation than random allocation. Hence, we conclude that intentional allocation should be encouraged in the design of future interventional clinical trials as a way to prevent unbalanced samples. Our sequential method is a viable alternative to overcome technical difficulties for study designs that require sequential inclusion of

  14. Acute postoperative digitalization of patients with arteriosclerotic heart disease after major surgery. A randomized haemodynamic study and proposal for therapy.

    Science.gov (United States)

    Bille-Brahe, N E; Engell, H C; Sørensen, M B

    1980-12-01

    Twenty patients with impaired left ventricular function during exercise, who underwent major vascular surgery for arteriosclerotic disease, were randomly digitalized in the immediate postoperative period. All patients had a smooth postoperative course. Haemodynamic measurements showed improved left ventricular function in those who received digitalis, since 60 min after full digitalization the digitalized patients had a highly significant decrease in pulmonary capillary wedge pressure (PCWP) with unchanged stroke volume index (SVI) and left ventricular stroke work index (LVSWI). The same improvement in cardiac function was present the next morning. The present study provides haemodynamic data in support of clinical studies showing a beneficial effect of prophylactic digitalization in surgical patients with clinical signs of arteriosclerotic heart disease, though not in overt failure.

  15. Preoperative clonidine use in trans-sphenoidal pituitary adenoma surgeries - a randomized controlled trial.

    Science.gov (United States)

    Bajaj, Jitin; Mittal, Radhe Shyam; Sharma, Achal

    2017-02-01

    Pituitary masses are common lesions accounting for about 15-20% of all brain tumours. Oozing blood is an annoyance in microscopic sublabial trans-sphenoidal approach for these masses. There have been many ways of reducing the ooze, having their own pros and cons. To find out the efficacy and safety of clonidine in reducing blood loss in pituitary adenoma surgery through a randomized masked trial. It was a prospective randomized controlled trial done. Total 50 patients of pituitary adenomas were randomized into two groups. Group A (25 patients) was given 200 μg clonidine orally, while Group B (25 patients) was given placebo. Surgeon, anaesthesiologist and patient were blinded for the trial. Sublabial trans-septal trans-sphenoidal approach to sella and excision of mass was performed in each patient. Patients were studied for pre-, intra- and post-operative blood pressure and heart rate, pre- and post-operative imaging findings, intra-operative blood loss, bleeding grading by surgeon, surgeon's satisfaction about condition of specific part and quality of surgical field, operative time and extent of resection. Blood loss during the surgery, operative time and bleeding grading by the surgeon were found significantly less in the clonidine group, while quality of surgical field, condition of the specific part and extent of resection were found significantly better in the clonidine group (p value trans-sphenoidal microscopic pituitary adenoma surgeries.

  16. Predictors, Prognosis, and Management of New Clinically Important Atrial Fibrillation After Noncardiac Surgery: A Prospective Cohort Study.

    Science.gov (United States)

    Alonso-Coello, Pablo; Cook, Deborah; Xu, Shou Chun; Sigamani, Alben; Berwanger, Otavio; Sivakumaran, Soori; Yang, Homer; Xavier, Denis; Martinez, Luz Ximena; Ibarra, Pedro; Rao-Melacini, Purnima; Pogue, Janice; Zarnke, Kelly; Paniagua, Pilar; Ostrander, Jack; Yusuf, Salim; Devereaux, P J

    2017-07-01

    Despite the frequency of new clinically important atrial fibrillation (AF) after noncardiac surgery and its increased association with the risk of stroke at 30 days, there are limited data informing their prediction, association with outcomes, and management. We used the data from the PeriOperative ISchemic Evaluation trial to determine, in patients undergoing noncardiac surgery, the association of new clinically important AF with 30-day outcomes, and to assess management of these patients. We also aimed to derive a clinical prediction rule for new clinically important AF in this population. We defined new clinically important AF as new AF that resulted in symptoms or required treatment. We recorded an electrocardiogram 6 to 12 hours postoperatively and on the 1st, 2nd, and 30th days after surgery. A total of 211 (2.5% [8351 patients]; 95% confidence interval, 2.2%-2.9%) patients developed new clinically important AF within 30 days of randomization (8140 did not develop new AF). AF was independently associated with an increased length of hospital stay by 6.0 days (95% confidence interval, 3.5-8.5 days) and vascular complications (eg, stroke or congestive heart failure). The usage of an oral anticoagulant at the time of hospital discharge among patients with new AF and a CHADS2 score of 0, 1, 2, 3, and ≥4 was 6.9%, 10.2%, 23.0%, 9.4%, and 33.3%, respectively. Two independent predictors of patients developing new clinically important AF were identified (ie, age and surgery). The prediction rule included the following factors and assigned weights: age ≥85 years (4 points), age 75 to 84 years (3 points), age 65 to 74 years (2 points), intrathoracic surgery (3 points), major vascular surgery (2 points), and intra-abdominal surgery (1 point). The incidence of new AF based on scores of 0 to 1, 2, 3 to 4, and 5 to 6 was 0.5%, 1.0%, 3.1%, and 5.3%, respectively. Age and surgery are independent predictors of new clinically important AF in the perioperative setting. A

  17. The efficacy of a smoking cessation programme in patients undergoing elective surgery - a randomised clinical trial

    DEFF Research Database (Denmark)

    Azodi, O. Sadr; Lindstrom, D.; Adami, J.

    2009-01-01

    It is known that smokers constitute an important risk group of patients undergoing surgery. It is unknown how smoking cessation intervention initiated 4 weeks prior to elective surgery affects the probability of permanent cessation. We randomly assigned 117 patients, scheduled to undergo elective...

  18. Influence of perioperative oxygen fraction on pulmonary function after abdominal surgery: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Staehr Anne K

    2012-07-01

    Full Text Available Abstract Background A high perioperative inspiratory oxygen fraction (FiO2 may reduce the frequency of surgical site infection. Perioperative atelectasis is caused by absorption, compression and reduced function of surfactant. It is well accepted, that ventilation with 100% oxygen for only a few minutes is associated with significant formation of atelectasis. However, it is still not clear if a longer period of 80% oxygen results in more atelectasis compared to a low FiO2. Our aim was to assess if a high FiO2 is associated with impaired oxygenation and decreased pulmonary functional residual capacity (FRC. Methods Thirty-five patients scheduled for laparotomy for ovarian cancer were randomized to receive either 30% oxygen (n = 15 or 80% oxygen (n = 20 during and for 2 h after surgery. The oxygenation index (PaO2/FiO2 was measured every 30 min during anesthesia and 90 min after extubation. FRC was measured the day before surgery and 2 h after extubation by a rebreathing method using the inert gas SF6. Results Five min after intubation, the median PaO2/FiO2 was 69 kPa [53-71] in the 30%-group vs. 60 kPa [47-69] in the 80%-group (P = 0.25. At the end of anesthesia, the PaO2/FiO2 was 58 kPa [40-70] vs. 57 kPa [46-67] in the 30%- and 80%-group, respectively (P = 0.10. The median FRC was 1993 mL [1610-2240] vs. 1875 mL [1545-2048] at baseline and 1615 mL [1375-2318] vs. 1633 mL [1343-1948] postoperatively in the 30%- and 80%-group, respectively (P = 0.70. Conclusion We found no significant difference in oxygenation index or functional residual capacity between patients given 80% and 30% oxygen for a period of approximately 5 hours. Trial registration ClinicalTrials.gov Identifier: NCT00637936.

  19. [Clinical Practice after Bariatric Surgery: Problems and Complications].

    Science.gov (United States)

    Gebhart, Martina

    2015-12-09

    The number of patients undergoing bariatric surgery because of morbid obesity is increasing rapidly. Therefore, it is an important issue to be aware of outcome and complications after bariatric surgery. This mini-review presents a compilation of important gastrointestinal symptoms, as pain, diarrhea and dumping, and includes treatment options. It characterizes possible micronutrient deficiencies, gives instructions concerning the adaptation of drugs and illustrates possible adverse outcomes, such as excessive weight loss, insufficient weight loss and weight gain after bariatric surgery.

  20. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G

    2014-01-01

    explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial......OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...

  1. Clinical study of salvage surgery after concurrent chemoradiotherapy

    International Nuclear Information System (INIS)

    Shimane, Toshikazu; Nakamura, Taisuke; Shimotatara, Yuko

    2013-01-01

    As the use of concurrent chemoradiotherapy (CCRT) is becoming more widespread, with numerous facilities performing it to maintain function and form, the number of cases requiring salvage surgery is also increasing. We investigated the postoperative prognosis of patients who experienced complications during salvage surgery after CCRT. Subjects were 27 patients who underwent salvage surgery following CCRT at our department during the 7-year period between January 2005 and December 2011. We selected all cases of salvage surgery, comprising neck dissections, total laryngectomies, partial laryngectomies, esophageal resections, and reconstructive surgeries, for analysis. The results were favorable, with a complication rate during salvage surgery after CCRT of 14.8% and a survival rate of 77.8%. Although it is difficult to compare these complications and outcome findings with available reports on salvage surgery without CCRT, it is believed complications can arise in approximately half of the cases. Thus, surgeons should be cognizant of the potential for serious complications, which are sometimes unexpected. Different from our findings, the prognosis following salvage surgery is generally not thought to be favorable and therefore care should be taken to detect recurrence and provide treatment early in salvage surgery cases. (author)

  2. Beta-blocker use and clinical outcomes after primary vascular surgery

    DEFF Research Database (Denmark)

    Høgh, A.; Lindholt, J.S.; Nielsen, Henrik

    2013-01-01

    To explore the associations between beta-blocker use and clinical outcomes (death, hospitalisation with myocardial infarction (MI) or stroke, major amputation and recurrent vascular surgery) after primary vascular reconstruction.......To explore the associations between beta-blocker use and clinical outcomes (death, hospitalisation with myocardial infarction (MI) or stroke, major amputation and recurrent vascular surgery) after primary vascular reconstruction....

  3. Magnetic resonance imaging for cerebral lesions during minimal invasive mitral valve surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Barbero, Cristina; Ricci, Davide; Cura Stura, Erik; Pellegrini, Augusto; Marchetto, Giovanni; ElQarra, Suad; Boffini, Massimo; Passera, Roberto; Valentini, Maria Consuelo; Rinaldi, Mauro

    2017-02-21

    Recent data have highlighted a higher rate of neurological injuries in minimal invasive mitral valve surgery (MIMVS) compared with the standard sternotomy approach; therefore, the role of specific clamping techniques and perfusion strategies on the occurrence of this complication is a matter of discussion in the medical literature. The purpose of this trial is to prospectively evaluate major, minor and silent neurological events in patients undergoing right mini-thoracotomy mitral valve surgery using retrograde perfusion and an endoaortic clamp or a transthoracic clamp. A prospective, blinded, randomized controlled study on the rate of neurological embolizations during MIMVS started at the University of Turin in June 2014. Major, minor and silent neurological events are being investigated through standard neurological evaluation and magnetic resonance imaging assessment. The magnetic resonance imaging protocol includes conventional sequences for the morphological and quantitative assessment and nonconventional sequences for the white matter microstructural evaluation. Imaging studies are performed before surgery as baseline assessment and on the third postoperative day and, in patients who develop postoperative ischemic lesions, after 6 months. Despite recent concerns raised about the endoaortic setting with retrograde perfusion, we expect to show equivalence in terms of neurological events of this technique compared with the transthoracic clamp in a selected cohort of patients. With the first results expected in December 2016 the findings would be of help in confirming the efficacy and safety of MIMVS. ClinicalTrials.gov, Identifier: NCT02818166 . Registered on 8 February 2016 - trial retrospectively registered.

  4. Epidural versus intravenous fentanyl for postoperative analgesia following orthopedic surgery: randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marcelo Soares Privado

    Full Text Available CONTEXT AND OBJECTIVE: Controversy exists regarding the site of action of fentanyl after epidural injection. The objective of this investigation was to compare the efficacy of epidural and intravenous fentanyl for orthopedic surgery. DESIGN AND SETTING: A randomized double-blind study was performed in Hospital São Paulo. METHODS: During the postoperative period, in the presence of pain, 29 patients were divided into two groups: group 1 (n = 14 received 100 µg of fentanyl epidurally and 2 ml of saline intravenously; group 2 (n = 15 received 5 ml of saline epidurally and 100 µg of fentanyl intravenously. The analgesic supplementation consisted of 40 mg of tenoxicam intravenously and, if necessary, 5 ml of 0.25% bupivacaine epidurally. Pain intensity was evaluated on a numerical scale and plasma concentrations of fentanyl were measured simultaneously. RESULTS: The percentage of patients who required supplementary analgesia with tenoxicam was lower in group 1 (71.4% than in group 2 (100%: 95% confidence interval (CI = 0.001-0.4360 (P = 0.001, Fisher's exact test; relative risk, RR = 0.07. Epidural bupivacaine supplementation was also lower in group 1 (14.3% than in group 2 (53.3%: 95% CI = 0.06-1.05 (P = 0.03, Fisher's exact test; RR = 0.26. There was no difference in pain intensity on the numerical scale. Mean fentanyl plasma concentrations were similar in the two groups. CONCLUSION: Intravenous and epidural fentanyl appear to have similar efficacy for reducing pain according to the numerical scale, but supplementary analgesia was needed less frequently when epidural fentanyl was used. CLINICAL TRIAL REGISTRATION NUMBER: NCT00635986

  5. Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction.

    Science.gov (United States)

    Mohtadi, Nicholas; Barber, Rhamona; Chan, Denise; Paolucci, Elizabeth Oddone

    2016-05-01

    Complications/adverse events of anterior cruciate ligament (ACL) surgery are underreported, despite pooled level 1 data in systematic reviews. All adverse events/complications occurring within a 2-year postoperative period after primary ACL reconstruction, as part of a large randomized clinical trial (RCT), were identified and described. Prospective, double-blind randomized clinical trial. Patients and the independent trained examiner were blinded to treatment allocation. University-based orthopedic referral practice. Three hundred thirty patients (14-50 years; 183 males) with isolated ACL deficiency were intraoperatively randomized to ACL reconstruction with 1 autograft type. Graft harvest and arthroscopic portal incisions were identical. Patients were equally distributed to patellar tendon (PT), quadruple-stranded hamstring tendon (HT), and double-bundle (DB) hamstring autograft ACL reconstruction. Adverse events/complications were patient reported, documented, and diagnoses confirmed. Two major complications occurred: pulmonary embolism and septic arthritis. Twenty-four patients (7.3%) required repeat surgery, including 25 separate operations: PT = 7 (6.4%), HT = 9 (8.2%), and DB = 8 (7.3%). Repeat surgery was performed for meniscal tears (3.6%; n = 12), intra-articular scarring (2.7%; n = 9), chondral pathology (0.6%; n = 2), and wound dehiscence (0.3%; n = 1). Other complications included wound problems, sensory nerve damage, muscle tendon injury, tibial periostitis, and suspected meniscal tears and chondral lesions. Overall, more complications occurred in the HT/DB groups (PT = 24; HT = 31; DB = 45), but more PT patients complained of moderate or severe kneeling pain (PT = 17; HT = 9; DB = 4) at 2 years. Overall, ACL reconstructive surgery is safe. Major complications were uncommon. Secondary surgery was necessary 7.3% of the time for complications/adverse events (excluding graft reinjury or revisions) within the first 2 years. Level 1 (therapeutic studies

  6. Effect of methylprednisolone on the oxidative burst activity, adhesion molecules and clinical outcome following open heart surgery

    DEFF Research Database (Denmark)

    Toft, P; Christiansen, K; Tønnesen, Else Kirstine

    1997-01-01

    Following cardiac surgery with cardiopulmonary bypass (CPB), activated granulocytes may be involved with ischaemia/ reperfusion injury. The purpose of this study was to investigate whether steroids could reduce the oxidative burst activity of granulocytes, the expression of adhesion molecules...... on granulocytes and improve clinical outcome. Sixteen patients undergoing open heart surgery participated in the study. Eight were randomized to receive methylprednisolone (30 mg/kg intravenously) at the start of anaesthesia while eight patients served as a control group. The oxidative burst was measured flow...... not improve the weaning from the ventilator or reduce the stay in the intensive-care unit. In conclusion, treatment with steroids prevented hyperthermia following open heart surgery with CPB and reduced capillary leak during ECC. Methylprednisolone, however, did not reduce the oxidative burst activity...

  7. Timing of surgery for sciatica: subgroup analysis alongside a randomized trial

    Science.gov (United States)

    Arts, Mark P.; Brand, Ronald; Koes, Bart W.

    2009-01-01

    Surgery speeds up recovery for sciatica. Prolonged conservative care with surgery for those patients with persistent sciatica however, yields similar results at 1 year. To investigate whether baseline variables modify the difference in recovery rates between these treatment strategies, baseline data of 283 patients enrolled in a randomized trial, comparing early surgery with prolonged conservative care, were used to analyse effect modification of the allotted treatment strategy. For predictors shown to modify the effect of the treatment strategy, repeated measurement analyses with the Roland Disability Questionnaire and visual analogue scale pain as continuous outcomes were performed for every level of that predictor. Presumed predictive variables did not have any interaction with treatment, while “sciatica provoked by sitting” showed to be a significant effect modifier (P = 0.07). In a Cox model we estimated a hazard ratio (HR, surgery versus conservative) of 2.2 (95% CI 1.7–3.0) in favour of surgery when sciatica was provoked by sitting, while the HR was 1.3 (95% CI 0.8–2.2) when this sign was absent. The interaction effect is marginally significant (interactions are usually tested at the 10% level) but the patterns generated by the repeated measurement analyses of all primary outcomes are completely consistent with the inferred pattern from the survival analysis. Classical signs did not show any contribution as decision support tools in deciding when to operate for sciatica, whereas treatment effects of early surgery are emphasized when sciatica is provoked by sitting and negligible when this symptom is absent. PMID:19132412

  8. The efficacy of an intraoperative cell saver during cardiac surgery: a meta-analysis of randomized trials.

    Science.gov (United States)

    Wang, Guyan; Bainbridge, Daniel; Martin, Janet; Cheng, Davy

    2009-08-01

    Cell salvage may be used during cardiac surgery to avoid allogeneic blood transfusion. It has also been claimed to improve patient outcomes by removing debris from shed blood, which may increase the risk of stroke or neurocognitive dysfunction. In this study, we sought to determine the overall safety and efficacy of cell salvage in cardiac surgery by performing a systematic review and meta-analysis of published randomized controlled trials. A comprehensive search was undertaken to identify all randomized trials of cell saver use during cardiac surgery. MEDLINE, Cochrane Library, EMBASE, and abstract databases were searched up to November 2008. All randomized trials comparing cell saver use and no cell saver use in cardiac surgery and reporting at least one predefined clinical outcome were included. The random effects model was used to calculate the odds ratios (OR, 95% confidence intervals [CI]) and the weighted mean differences (WMD, 95% CI) for dichotomous and continuous variables, respectively. Thirty-one randomized trials involving 2282 patients were included in the meta-analysis. During cardiac surgery, the use of an intraoperative cell saver reduced the rate of exposure to any allogeneic blood product (OR 0.63, 95% CI: 0.43-0.94, P = 0.02) and red blood cells (OR 0.60, 95% CI: 0.39-0.92, P = 0.02) and decreased the mean volume of total allogeneic blood products transfused per patient (WMD -256 mL, 95% CI: -416 to -95 mL, P = 0.002). There was no difference in hospital mortality (OR 0.65, 95% CI: 0.25-1.68, P = 0.37), postoperative stroke or transient ischemia attack (OR 0.59, 95% CI: 0.20-1.76, P = 0.34), atrial fibrillation (OR 0.92, 95% CI: 0.69-1.23, P = 0.56), renal dysfunction (OR 0.86, 95% CI: 0.41-1.80, P = 0.70), infection (OR 1.25, 95% CI: 0.75-2.10, P = 0.39), patients requiring fresh frozen plasma (OR 1.16, 95% CI: 0.82-1.66, P = 0.40), and patients requiring platelet transfusions (OR 0.90, 95% CI: 0.63-1.28, P = 0.55) between cell saver and

  9. Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial

    DEFF Research Database (Denmark)

    Andersson, J; Angenete, E; Gellerstedt, M

    2013-01-01

    Previous studies comparing laparoscopic and open surgical techniques have reported improved health-related quality of life (HRQL). This analysis compared HRQL 12¿months after laparoscopic versus open surgery for rectal cancer in a subset of a randomized trial.......Previous studies comparing laparoscopic and open surgical techniques have reported improved health-related quality of life (HRQL). This analysis compared HRQL 12¿months after laparoscopic versus open surgery for rectal cancer in a subset of a randomized trial....

  10. Randomized controlled trial of postoperative belladonna and opium rectal suppositories in vaginal surgery.

    Science.gov (United States)

    Butler, Kristina; Yi, John; Wasson, Megan; Klauschie, Jennifer; Ryan, Debra; Hentz, Joseph; Cornella, Jeffrey; Magtibay, Paul; Kho, Roseanne

    2017-05-01

    After vaginal surgery, oral and parenteral narcotics are used commonly for pain relief, and their use may exacerbate the incidence of sedation, nausea, and vomiting, which ultimately delays convalescence. Previous studies have demonstrated that rectal analgesia after surgery results in lower pain scores and less intravenous morphine consumption. Belladonna and opium rectal suppositories may be used to relieve pain and minimize side effects; however, their efficacy has not been confirmed. We aimed to evaluate the use of belladonna and opium suppositories for pain reduction in vaginal surgery. A prospective, randomized, double-blind, placebo-controlled trial that used belladonna and opium suppositories after inpatient or outpatient vaginal surgery was conducted. Vaginal surgery was defined as (1) vaginal hysterectomy with uterosacral ligament suspension or (2) posthysterectomy prolapse repair that included uterosacral ligament suspension and/or colporrhaphy. Belladonna and opium 16A (16.2/60 mg) or placebo suppositories were administered rectally immediately after surgery and every 8 hours for a total of 3 doses. Patient-reported pain data were collected with the use of a visual analog scale (at 2, 4, 12, and 20 hours postoperatively. Opiate use was measured and converted into parenteral morphine equivalents. The primary outcome was pain, and secondary outcomes included pain medication, antiemetic medication, and a quality of recovery questionnaire. Adverse effects were surveyed at 24 hours and 7 days. Concomitant procedures for urinary incontinence or pelvic organ prolapse did not preclude enrollment. Ninety women were randomly assigned consecutively at a single institution under the care of a fellowship-trained surgeon group. Demographics did not differ among the groups with mean age of 55 years, procedure time of 97 minutes, and prolapse at 51%. Postoperative pain scores were equivalent among both groups at each time interval. The belladonna and opium group used a

  11. The effect of yoga in stress reduction for dental students performing their first periodontal surgery: A randomized controlled study

    Science.gov (United States)

    Shankarapillai, Rajesh; Nair, Manju Anathakrishnan; George, Roy

    2012-01-01

    Context: The dental students experience a lot of stress, which increase when they perform their first surgical procedure. Yoga as an anxiolytic tool in anxiety reduction has been practiced over centuries in India. Aim: To assess the efficacy of yoga in reducing the state trait anxiety of dental students before their first periodontal surgery performance. Settings and Design: A randomized controlled study using a two-way split plot design (pre-post-test) was conducted in the department of periodontics, Pacific Dental College, Udaipur, India. Materials and Methods: One hundred clinical dental students who were ready to perform their first periodontal surgery were selected. Students were randomly assigned to two groups and were given a 60-min session on stress reduction. Group A, yogic intervention group, were instructed to do yoga and their performances were monitored for a period of one week and Group B, control group, were given a lecture on stress reduction without any yoga instructions. The investigator who was unaware of the groups had taken the state trait anxiety score of the students three times a) before assigning them to each group, b) prior to the surgical procedure and c) immediately after the performance of surgery. Statistical Analysis Used: Analyses of variance (ANOVA) by SPSS V.16. Results: The statistical results showed a significant reduction in the VAS and state trait anxiety of Group A compared to Group B (ANOVA; P<0.001). Conclusions: This study concludes that Yogic breathing has a significant effect on the reduction of state trait anxiety level of dental students. PMID:22346066

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

    Science.gov (United States)

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

    2016-09-01

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

  13. A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial.

    Science.gov (United States)

    Chacko, Sara A; Yeh, Gloria Y; Davis, Roger B; Wee, Christina C

    2016-10-01

    This study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery. Randomized, controlled pilot trial. Beth Israel Deaconess Medical Center, Boston, MA, USA. Bariatric patients 1-5 years post-surgery (n=18) were randomized to receive a 10-week MBI or a standard intervention. Primary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted. Attendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (-4.9±13.7 in mindfulness vs. 6.2±28.4 in standard, p for between-group difference=0.03) but not weight. We also observed a significant increase in HbA1C (0.34±0.38 vs. -0.06±0.31, p=0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews. This novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population. ClinicalTrials.gov identifier NCT02603601. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Psychology of plastic and reconstructive surgery: a systematic clinical review.

    Science.gov (United States)

    Shridharani, Sachin M; Magarakis, Michael; Manson, Paul N; Rodriguez, Eduardo D

    2010-12-01

    The authors sought to review the various types of patients with psychological abnormalities who may present to the plastic surgeon and the psychological impact of various plastic surgery procedures on these patients. After systematically searching the Embase and PubMed databases and following further refinement (based on the authors' inclusion and exclusion criteria), the authors identified 65 studies. In addition, the authors felt that important information was contained in four textbooks, two press releases, and one Internet database. The inclusion criteria were studies that investigated the psychological outcomes, background, and personality types of patients seeking specific plastic surgery procedures. In addition, studies that addressed the impact of plastic surgery on patients' psychological status and quality of life were also included. The authors excluded studies with fewer than 30 patients, studies that did not pertain to the particular plastic surgery procedures, and studies that addressed psychological sequelae of revision operations. Narcissistic and histrionic personality disorders and body dysmorphic disorder are the three most common psychiatric conditions encountered in patients seeking cosmetic surgery. Overall, plastic surgery not only restores the appearance and function of the disfigured body unit but also alleviates psychological distress. Identifying the psychologically challenging patient before surgical intervention will allow the patient to obtain the appropriate psychological assistance and may result in a healthier individual with or without associated plastic surgery procedures.

  15. Association of time-to-surgery with outcomes in clinical stage I-II pancreatic adenocarcinoma treated with upfront surgery.

    Science.gov (United States)

    Swords, Douglas S; Zhang, Chong; Presson, Angela P; Firpo, Matthew A; Mulvihill, Sean J; Scaife, Courtney L

    2018-04-01

    Time-to-surgery from cancer diagnosis has increased in the United States. We aimed to determine the association between time-to-surgery and oncologic outcomes in patients with resectable pancreatic ductal adenocarcinoma undergoing upfront surgery. The 2004-2012 National Cancer Database was reviewed for patients undergoing curative-intent surgery without neoadjuvant therapy for clinical stage I-II pancreatic ductal adenocarcinoma. A multivariable Cox model with restricted cubic splines was used to define time-to-surgery as short (1-14 days), medium (15-42), and long (43-120). Overall survival was examined using Cox shared frailty models. Secondary outcomes were examined using mixed-effects logistic regression models. Of 16,763 patients, time-to-surgery was short in 34.4%, medium in 51.6%, and long in 14.0%. More short time-to-surgery patients were young, privately insured, healthy, and treated at low-volume hospitals. Adjusted hazards of mortality were lower for medium (hazard ratio 0.94, 95% confidence interval, .90, 0.97) and long time-to-surgery (hazard ratio 0.91, 95% confidence interval, 0.86, 0.96) than short. There were no differences in adjusted odds of node positivity, clinical to pathologic upstaging, being unresectable or stage IV at exploration, and positive margins. Medium time-to-surgery patients had higher adjusted odds (odds ratio 1.11, 95% confidence interval, 1.03, 1.20) of receiving an adequate lymphadenectomy than short. Ninety-day mortality was lower in medium (odds ratio 0.75, 95% confidence interval, 0.65, 0.85) and long time-to-surgery (odds ratio 0.72, 95% confidence interval, 0.60, 0.88) than short. In this observational analysis, short time-to-surgery was associated with slightly shorter OS and higher perioperative mortality. These results may suggest that delays for medical optimization and referral to high volume surgeons are safe. Published by Elsevier Inc.

  16. Virtual Reality Robotic Surgery Warm-Up Improves Task Performance in a Dry Lab Environment: A Prospective Randomized Controlled Study

    Science.gov (United States)

    Lendvay, Thomas S.; Brand, Timothy C.; White, Lee; Kowalewski, Timothy; Jonnadula, Saikiran; Mercer, Laina; Khorsand, Derek; Andros, Justin; Hannaford, Blake; Satava, Richard M.

    2014-01-01

    Background Pre-operative simulation “warm-up” has been shown to improve performance and reduce errors in novice and experienced surgeons, yet existing studies have only investigated conventional laparoscopy. We hypothesized a brief virtual reality (VR) robotic warm-up would enhance robotic task performance and reduce errors. Study Design In a two-center randomized trial, fifty-one residents and experienced minimally invasive surgery faculty in General Surgery, Urology, and Gynecology underwent a validated robotic surgery proficiency curriculum on a VR robotic simulator and on the da Vinci surgical robot. Once successfully achieving performance benchmarks, surgeons were randomized to either receive a 3-5 minute VR simulator warm-up or read a leisure book for 10 minutes prior to performing similar and dissimilar (intracorporeal suturing) robotic surgery tasks. The primary outcomes compared were task time, tool path length, economy of motion, technical and cognitive errors. Results Task time (-29.29sec, p=0.001, 95%CI-47.03,-11.56), path length (-79.87mm, p=0.014, 95%CI -144.48,-15.25), and cognitive errors were reduced in the warm-up group compared to the control group for similar tasks. Global technical errors in intracorporeal suturing (0.32, p=0.020, 95%CI 0.06,0.59) were reduced after the dissimilar VR task. When surgeons were stratified by prior robotic and laparoscopic clinical experience, the more experienced surgeons(n=17) demonstrated significant improvements from warm-up in task time (-53.5sec, p=0.001, 95%CI -83.9,-23.0) and economy of motion (0.63mm/sec, p=0.007, 95%CI 0.18,1.09), whereas improvement in these metrics was not statistically significantly appreciated in the less experienced cohort(n=34). Conclusions We observed a significant performance improvement and error reduction rate among surgeons of varying experience after VR warm-up for basic robotic surgery tasks. In addition, the VR warm-up reduced errors on a more complex task (robotic

  17. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  18. Comparison of clinical efficacy among remifentanil, nicardipine, and remifentanil plus nicardipine continuous infusion for hypotensive anesthesia during arthroscopic shoulder surgery.

    Science.gov (United States)

    Kim, Joon Yub; Song, Seong Hun; Cho, Jae Ho; Cho, Hyung Rae

    2017-01-01

    Hypotensive anesthesia is crucial during arthroscopic shoulder surgery to reduce bleeding and allow for clear visibility. The aim of this study was to compare the clinical efficacy of continuous infusion of remifentanil, nicardipine, and remifentanil plus nicardipine to control hypotensive anesthesia in arthroscopic shoulder surgery. For this study, we enrolled 45 consecutive patients who were scheduled to have arthroscopic rotator cuff repair surgery and randomly allocated them into remifentanil (group R, n = 15), nicardipine (group N, n = 15), and remifentanil plus nicardipine (group RN, n = 15) groups. During the surgeries, these drugs were administered with continuous infusion. We analyzed the mean arterial pressure (MAP) and heart rate during surgery, stay time in the recovery room, visual analogue scale (VAS) scores, use of antiemetics in the recovery room, and postoperative blood urea nitrogen and creatinine changes. The VAS score in the recovery room was higher for group R (mean 5.6, SD 1.4) than for groups N (mean 3.9, SD 0.9) and RN (mean 4.0, SD 1.1; p = 0.000). There were no statistical differences regarding other clinical variables among the three groups (all p > 0.05) except for MAP at 120 min of surgery between groups N and RN (N: 84.67 (SD 10.7) mmHg, RN: 65.4 (SD 9.2) mmHg, p = 0.027). The continuous infusion of remifentanil plus nicardipine appeared to be advantageous for maintaining hypotensive anesthesia until 120 min of arthroscopic shoulder surgery without rebound pain in a postanesthesia care unit.

  19. Hypnosis in the Perioperative Management of Breast Cancer Surgery: Clinical Benefits and Potential Implications

    Science.gov (United States)

    Roelants, Fabienne; Pospiech, Audrey; Momeni, Mona; Watremez, Christine

    2016-01-01

    The aim of this review is to summarize data published on the use of perioperative hypnosis in patients undergoing breast cancer surgery (BCS). Indeed, the majority of BCS patients experience stress, anxiety, nausea, vomiting, and pain. Correct management of the perioperative period and surgical removal of the primary tumor are clearly essential but can affect patients on different levels and hence have a negative impact on oncological outcomes. This review examines the effect of clinical hypnosis performed during the perioperative period. Thanks to its specific properties and techniques allowing it to be used as complementary treatment preoperatively, hypnosis has an impact most notably on distress and postoperative pain. During surgery, hypnosis may be applied to limit immunosuppression, while, in the postoperative period, it can reduce pain, anxiety, and fatigue and improve wound healing. Moreover, hypnosis is inexpensive, an important consideration given current financial concerns in healthcare. Of course, large randomized prospective studies are now needed to confirm the observed advantages of hypnosis in the field of oncology. PMID:27635132

  20. Clinics of Oblivion: Makeover Culture and Cosmetic Surgery

    Directory of Open Access Journals (Sweden)

    Meredith Jones

    2011-09-01

    Full Text Available This paper examines cosmetic surgery tourism, arguing that it can be meaningfully analysed as part of makeover culture. It shows that while cosmetic surgery tourism sits at a junction of cosmetic surgery and medical tourism, it also has much in common with contemporary tourism practices. The paper posits cosmetic surgery tourism not only as an economic and globalised phenomenon but also as a set of practices that are experienced, and that take place on the body (see also Cook, 2010; Bell et al. 2011. Chris Rojek’s work on contemporary tourist practices is deployed in order to argue that the cosmetic surgery tourist’s body is itself the ‘site’ to be visited and discovered; it is also the souvenir that is brought home. When body and site are brought together in cosmetic surgery tourism, they form a potent nexus that is unique to a contemporary moment tied up with globalisation and consumption, where both identity and self-transformation are managed through the body.

  1. The Effectiveness of Hand Massage on Pain in Critically Ill Patients After Cardiac Surgery: A Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Boitor, Madalina; Martorella, Géraldine; Laizner, Andréa Maria; Maheu, Christine; Gélinas, Céline

    2016-11-07

    Postoperative pain is common in the intensive care unit despite the administration of analgesia. Some trials suggest that massage can be effective at reducing postoperative pain in acute care units; however, its effects on pain relief in the intensive care unit and when pain severity is highest remain unknown. The objective is to evaluate the effectiveness of hand massage on the pain intensity (primary outcome), unpleasantness and interference, muscle tension, anxiety, and vital signs of critically ill patients after cardiac surgery. A 3-arm randomized controlled trial will be conducted. A total of 79 patients who are 18 years or older, able to speak French or English and self-report symptoms, have undergone elective cardiac surgery, and do not have a high risk of postoperative complications and contraindications to hand massage will be recruited. They will be randomly allocated (1:1:1) to standard care plus either 3 20-minute hand massages (experimental), 3 20-minute hand holdings (active control), or 3 20-minute rest periods (passive control). Pain intensity, unpleasantness, anxiety, muscle tension, and vital signs will be evaluated before, immediately after, and 30 minutes later for each intervention administered within 24 hours postoperatively. Peer-reviewed competitive funding was received from the Quebec Nursing Intervention Research Network and McGill University in December 2015, and research ethics approval was obtained February 2016. Recruitment started in April 2016, and data collection is expected to be complete by January 2017. To date, 24 patients were randomized and had data collection done. This study will be one of the first randomized controlled trials to examine the effect of hand massage on the pain levels of critically ill patients after cardiac surgery and to provide empirical evidence for the use of massage among this population. ClinicalTrials.gov NCT02679534; https://clinicaltrials.gov/ct2/show/NCT02679534 (Archived by WebCite at http

  2. Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Björn Stessel, MD

    2014-12-01

    Conclusions: Paracetamol/CR oxycodone and paracetamol/naproxen are equally effective in treatment of acute postoperative pain at home after ambulatory surgery with comparable patient satisfaction level. We suggest paracetamol/CR oxycodone to be a valuable alternative for the current paracetamol/naproxen gold standard, particularly in patients with a contraindication for nonsteroidal anti-inflammatory drugs. ClinicalTrials.gov identifier: NCT02152592.

  3. Deep breathing exercises performed 2 months following cardiac surgery: a randomized controlled trial.

    Science.gov (United States)

    Westerdahl, Elisabeth; Urell, Charlotte; Jonsson, Marcus; Bryngelsson, Ing-Liss; Hedenström, Hans; Emtner, Margareta

    2014-01-01

    Postoperative breathing exercises are recommended to cardiac surgery patients. Instructions concerning how long patients should continue exercises after discharge vary, and the significance of treatment needs to be determined. Our aim was to assess the effects of home-based deep breathing exercises performed with a positive expiratory pressure device for 2 months following cardiac surgery. The study design was a prospective, single-blinded, parallel-group, randomized trial. Patients performing breathing exercises 2 months after cardiac surgery (n = 159) were compared with a control group (n = 154) performing no breathing exercises after discharge. The intervention consisted of 30 slow deep breaths performed with a positive expiratory pressure device (10-15 cm H2O), 5 times a day, during the first 2 months after surgery. The outcomes were lung function measurements, oxygen saturation, thoracic excursion mobility, subjective perception of breathing and pain, patient-perceived quality of recovery (40-Item Quality of Recovery score), health-related quality of life (36-Item Short Form Health Survey), and self-reported respiratory tract infection/pneumonia and antibiotic treatment. Two months postoperatively, the patients had significantly reduced lung function, with a mean decrease in forced expiratory volume in 1 second to 93 ± 12% (P< .001) of preoperative values. Oxygenation had returned to preoperative values, and 5 of 8 aspects in the 36-Item Short Form Health Survey were improved compared with preoperative values (P< .01). There were no significant differences between the groups in any of the measured outcomes. No significant differences in lung function, subjective perceptions, or quality of life were found between patients performing home-based deep breathing exercises and control patients 2 months after cardiac surgery.

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

    Directory of Open Access Journals (Sweden)

    Xu C

    2018-04-01

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

  5. Prospective randomized controlled study on the validity and safety of an absorbable adhesion barrier (Interceed®) made of oxidized regenerated cellulose for laparoscopic colorectal surgery.

    Science.gov (United States)

    Naito, Masanori; Ogura, Naoto; Yamanashi, Takahiro; Sato, Takeo; Nakamura, Takatoshi; Miura, Hirohisa; Tsutsui, Atsuko; Sakamoto, Yasutoshi; Tanaka, Rieko; Kumagai, Yuji; Watanabe, Masahiko

    2017-02-01

    Clinical use of an adhesion barrier made of oxidized, regenerated cellulose, Interceed®, has been reported in the field of obstetrics and gynecology to help prevent adhesions between the peritoneum and the bowel in various types of operations. In gastrointestinal surgery, sodium hyaluronate/carboxymethylcellulose has been reported as an absorbable membrane to reduce postoperative adhesions. The present study was a prospective randomized controlled study to investigate the safety and usefulness of Interceed in laparoscopic colorectal surgery. We analyzed 99 patients who underwent laparoscopic colorectal surgery from 2013 to 2014. The patients were randomly allocated to the group that used Interceed (Interceed group) or the group that did not (Non-Interceed group). Fifty cases used Interceed, and 49 cases did not. The incidence of adverse events was 12.0% in the Interceed group and 16.3% in the Non-Interceed group (P = 0.58). There were no significant differences, and no adhesive bowel obstructions were observed in the Interceed group. We have shown that using Interceed in laparoscopic colorectal surgery is valid and technically safe. © 2016 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and John Wiley & Sons Australia, Ltd.

  6. Impact of smoking on early clinical outcomes in patients undergoing coronary artery bypass grafting surgery

    OpenAIRE

    Ji, Qiang; Zhao, Hang; Mei, YunQing; Shi, YunQing; Ma, RunHua; Ding, WenJun

    2015-01-01

    Background To evaluate the impact of persistent smoking versus smoking cessation over one month prior to surgery on early clinical outcomes in Chinese patients undergoing isolated coronary artery bypass grafting (CABG) surgery in a retrospective study. Methods The peri-operative data of consecutive well-documented patients undergoing isolated CABG surgery from January 2007 to December 2013 were investigated and retrospectively analyzed. All included patients were divided into either a non-smo...

  7. Hospital-level Variation in Utilization of Surgery for Clinical Stage I-II Pancreatic Adenocarcinoma.

    Science.gov (United States)

    Swords, Douglas S; Mulvihill, Sean J; Skarda, David E; Finlayson, Samuel R G; Stoddard, Gregory J; Ott, Mark J; Firpo, Matthew A; Scaife, Courtney L

    2017-07-11

    To (1) evaluate rates of surgery for clinical stage I-II pancreatic ductal adenocarcinoma (PDAC), (2) identify predictors of not undergoing surgery, (3) quantify the degree to which patient- and hospital-level factors explain differences in hospital surgery rates, and (4) evaluate the association between adjusted hospital-specific surgery rates and overall survival (OS) of patients treated at different hospitals. Curative-intent surgery for potentially resectable PDAC is underutilized in the United States. Retrospective cohort study of patients ≤85 years with clinical stage I-II PDAC in the 2004 to 2014 National Cancer Database. Mixed effects multivariable models were used to characterize hospital-level variation across quintiles of hospital surgery rates. Multivariable Cox proportional hazards models were used to estimate the effect of adjusted hospital surgery rates on OS. Of 58,553 patients without contraindications or refusal of surgery, 63.8% underwent surgery, and the rate decreased from 2299/3528 (65.2%) in 2004 to 4412/7092 (62.2%) in 2014 (P < 0.001). Adjusted hospital rates of surgery varied 6-fold (11.4%-70.9%). Patients treated at hospitals with higher rates of surgery had better unadjusted OS (median OS 10.2, 13.3, 14.2, 16.5, and 18.4 months in quintiles 1-5, respectively, P < 0.001, log-rank). Treatment at hospitals in lower surgery rate quintiles 1-3 was independently associated with mortality [Hazard ratio (HR) 1.10 (1.01, 1.21), HR 1.08 (1.02, 1.15), and HR 1.09 (1.04, 1.14) for quintiles 1-3, respectively, compared with quintile 5] after adjusting for patient factors, hospital type, and hospital volume. Quality improvement efforts are needed to help hospitals with low rates of surgery ensure that their patients have access to appropriate surgery.

  8. Adolescent Idiopathic Scoliosis – case report of a patient with clinical deterioration after surgery

    Directory of Open Access Journals (Sweden)

    Weiss Hans-Rudolf

    2007-12-01

    Full Text Available Abstract Background Although there is no evidence that the long-term effects of scoliosis surgery are superior to the long-term effects of Adolescent Idiopathic Scoliosis (AIS itself, patients can fear the consequences of not under going this surgery due to incorrect or insufficient information. The main indication for surgical treatment in patients with AIS, is cosmetic. However spinal surgery may, along with other negative side effects, actually cause postoperative clinical deterioration. This complication of surgery has not yet been described in international literature. Case presentation A 15-year old female patient originally presenting with a well-compensated double curve pattern scoliosis. The patient was advised to undergo surgery due to the long-term negative impact of signs and symptoms of scoliosis upon her health. The patient agreed to surgery, which was performed in one of Germanys leading centres for spinal surgery. The thoracolumbar curve was corrected and fused, while the thoracic curve, clearly showing wedged vertebrae, defined as structural scoliosis, remained untreated. This operation left the patient with an unbalanced appearance, with radiological and clinical imbalance to the right. The clinical appearance of the patient though clearly deteriorated post-surgery. Furthermore, the wedged disc space below the fusion area indicates future problems with possible destabilisation accompanied probably by low back pain. Conclusion Scoliosis surgery for patients with AIS is mainly indicated for cosmetic or psychological reasons. Therefore the treatment leading to the best possible clinical appearance and balance has to be chosen. Patients should be informed that surgery will not necessarily improve their health status. Clinical deterioration after surgery may occur, and such information is crucial for an adequate informed consent.

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

    NARCIS (Netherlands)

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

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

  10. Sequential neoadjuvant chemoradiotherapy (CRT) followed by curative surgery vs. primary surgery alone for resectable, non-metastasized pancreatic adenocarcinoma: NEOPA- a randomized multicenter phase III study (NCT01900327, DRKS00003893, ISRCTN82191749)

    International Nuclear Information System (INIS)

    Tachezy, Michael; Yekebas, Emre; Gebauer, Florian; Petersen, Cordula; Arnold, Dirk; Trepel, Martin; Wegscheider, Karl; Schafhausen, Phillipe; Bockhorn, Maximilian; Izbicki, Jakob Robert

    2014-01-01

    Median OS after surgery in curative intent for non-metastasized pancreas cancer ranges under study conditions from 17.9 months to 23.6 months. Tumor recurrence occurs locally, at distant sites (liver, peritoneum, lungs), or both. Observational and autopsy series report local recurrence rates of up to 87% even after potentially “curative” R0 resection. To achieve better local control, neoadjuvant CRT has been suggested for preoperative tumour downsizing, to elevate the likelihood of curative, margin-negative R0 resection and to increase the OS rate. However, controlled, randomized trials addressing the impact of neoadjuvant CRT survival do not exist. The underlying hypothesis of this randomized, two-armed, open-label, multicenter, phase III trial is that neoadjuvant CRT increases the three-year overall survival by 12% compared to patients undergoing upfront surgery for resectable pancreatic cancer. A rigorous, standardized technique of histopathologically handling Whipple specimens will be applied at all participating centers. Overall, 410 patients (n = 205 in each study arm) will be enrolled in the trial, taking into regard an expected drop out rate of 7% and allocated either to receive neoadjuvant CRT prior to surgery or to undergo surgery alone. Circumferential resection margin status, i.e. R0 and R1 rates, respectively, surgical resectability rate, local and distant disease-free and global survival, and first site of tumor recurrence constitute further essential endpoints of the trial. For the first time, the NEOPA study investigates the impact of neoadjuvant CRT on survival of resectable pancreas head cancer in a prospectively randomized manner. The results of the study have the potential to change substantially the treatment regimen of pancreas cancer. Clinical Trial gov:http://www.clinicaltrials.gov/show/NCT01900327; Clinical Trial gov:http://drks-neu.uniklinik-freiburg.de/drks w eb/navigate.do?navigationId; Clinical Trial gov

  11. Therapeutic effects of flurbiprofen axetil on mesenteric traction syndrome: randomized clinical trial.

    Science.gov (United States)

    Takahashi, Hidemasa; Shida, Dai; Tagawa, Kyoko; Iwamoto, Ryo; Arita, Makoto; Arai, Hiroyuki; Suzuki, Takeo

    2017-08-11

    This study aimed to reveal the appropriate timing for the intravenous administration of flurbiprofen axetil for preventing mesenteric traction syndrome (MTS), caused by prostacyclin release. In this prospective, randomized, clinical study, forty-five patients who were undergoing elective surgery for colorectal cancer via laparotomy were enrolled. Patients were randomly divided into 3 groups: a preoperative group (n = 16) receiving flurbiprofen axetil directly before surgery; a post-MTS group (n = 14) receiving following MTS onset; and a control group (n = 15) who were not administered flurbiprofen axetil. 6-keto-PGF1α, a stable metabolite of prostacyclin, levels were measured and mean blood pressures were recorded. In the preoperative group, 6-keto-PGF1α levels did not increase, blood pressure levels did not decrease, and no facial flushing was observed. In both the post-MTS and control groups, 6-keto-PGF1α levels increased markedly after mesenteric traction and blood pressure decreased significantly. The post-MTS group exhibited a faster decreasing trend in 6-keto-PGF1α levels and quick restore of the mean blood pressure, and the use of vasopressors and phenylephrine were lower than that in the control group. Even therapeutic administration of flurbiprofen axetil after the onset of MTS has also effects on MTS by suppressing prostacyclin production. Clinical trial number: UMIN000009111 . (Registered 14 October 2012).

  12. Weight loss in orthognathic surgery: a clinical study.

    Science.gov (United States)

    Hammond, Douglas; Williams, Rhodri W; Juj, Kiranjit; O'Connell, Susan; Isherwood, Grant; Hammond, Nichola

    2015-09-01

    To analyse weight change, body composition change and Body Mass Index change in patients undergoing orthognathic surgery. A service evaluation was undertaken in orthognathic patients pre-operatively and at 4 weeks post-surgery. Queen Elizabeth Hospital Birmingham outpatient department. Thirty-one patients scheduled for single- or two-jaw orthognathic surgery and rigid internal fixation. Immediately pre-operatively and at 4 weeks post-surgery the following information was gathered: (1) patient height; (2) patient weight (kg); (3) Patient Body Mass Index; and (4) patient body fat percentage. In the 4-week post-operative period, the average weight loss was -4·96 kg (range: -9·6 to +3·0 kg), with a body fat reduction of -3·07% (range: -5·80% to +2·30%) and an average reduction in Body Mass Index of -1·63 (range: -3·4 to +0·8). There was no statistically significant difference in weight loss (P = 0·1562) or body fat composition change (P = 0·2391) between single- or two-jaw surgery. There was no statistically significant difference in weight loss (P = 0·4858) or body fat composition change (P = 0·5321) between male and female patients. Weight loss observed was similar to that reported in studies using inter-maxillary fixation. Closer psychological and dietetic support is needed for patients who have a low normal or underweight Body Mass Index. Better and more bespoke tailored Oral Nutritional Supplementation must be provided for all orthognathic surgery patients to potentially reduce this significant weight loss.

  13. Comparing the outcomes of incisions made by colorado microdissection needle, electrosurgery tip, and surgical blade during periodontal surgery: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rampalli Viswa Chandra

    2016-01-01

    Full Text Available Context: Electrosurgery offers many unique advantages such as hemostasis and precise tissue cutting; however, there are a number of disadvantages including thermal injury and delayed wound healing. Aims: The aim of the present study was to compare the outcomes of incisions made by Colorado® microdissection needle, electrosurgery tip, and surgical blade during periodontal surgery. Settings and Design: Twenty-two individuals participated in this study. Three quadrants in each individual were randomly assigned into each of the following experimental groups: Colorado® microdissection needle (CMD, electrosurgery tip (EC and surgical blade (BP, in which, incisions were given with Colorado® microdissection needle, straight electrocautery tip, and a scalpel blade, respectively. Materials and Methods: Blood loss (BL was measured immediately after surgery, and changes in interdental papilla dimensions were recorded at baseline, 7, 30, 120, and 180 days after surgery. Measures of periodontal disease were recorded at baseline, 120, and 180 days after surgery. Postoperative pain and wound healing were recorded at 1, 7, and 15 days after surgery. Results: The use of CMD for periodontal surgery showed better results over EC in all parameters. CMD resulted in lesser bleeding and less postoperative pain and attained similar results to that of BP in clinical parameters of periodontal disease. Conclusions: Colorado® microdissection needle may be a better choice for incisions as it seems to show less tissue damage than cautery and offers tissue healing comparable to scalpel blade.

  14. Early surgery versus optimal current step-up practice for chronic pancreatitis (ESCAPE): design and rationale of a randomized trial.

    Science.gov (United States)

    Ahmed Ali, Usama; Issa, Yama; Bruno, Marco J; van Goor, Harry; van Santvoort, Hjalmar; Busch, Olivier R C; Dejong, Cornelis H C; Nieuwenhuijs, Vincent B; van Eijck, Casper H; van Dullemen, Hendrik M; Fockens, Paul; Siersema, Peter D; Gouma, Dirk J; van Hooft, Jeanin E; Keulemans, Yolande; Poley, Jan W; Timmer, Robin; Besselink, Marc G; Vleggaar, Frank P; Wilder-Smith, Oliver H; Gooszen, Hein G; Dijkgraaf, Marcel G W; Boermeester, Marja A

    2013-03-18

    In current practice, patients with chronic pancreatitis undergo surgical intervention in a late stage of the disease, when conservative treatment and endoscopic interventions have failed. Recent evidence suggests that surgical intervention early on in the disease benefits patients in terms of better pain control and preservation of pancreatic function. Therefore, we designed a randomized controlled trial to evaluate the benefits, risks and costs of early surgical intervention compared to the current stepwise practice for chronic pancreatitis. The ESCAPE trial is a randomized controlled, parallel, superiority multicenter trial. Patients with chronic pancreatitis, a dilated pancreatic duct (≥5 mm) and moderate pain and/or frequent flare-ups will be registered and followed monthly as potential candidates for the trial. When a registered patient meets the randomization criteria (i.e. need for opioid analgesics) the patient will be randomized to either early surgical intervention (group A) or optimal current step-up practice (group B). An expert panel of chronic pancreatitis specialists will oversee the assessment of eligibility and ensure that allocation to either treatment arm is possible. Patients in group A will undergo pancreaticojejunostomy or a Frey-procedure in case of an enlarged pancreatic head (≥4 cm). Patients in group B will undergo a step-up practice of optimal medical treatment, if needed followed by endoscopic interventions, and if needed followed by surgery, according to predefined criteria. Primary outcome is pain assessed with the Izbicki pain score during a follow-up of 18 months. Secondary outcomes include complications, mortality, total direct and indirect costs, quality of life, pancreatic insufficiency, alternative pain scales, length of hospital admission, number of interventions and pancreatitis flare-ups. For the sample size calculation we defined a minimal clinically relevant difference in the primary endpoint as a difference of at least

  15. A randomized comparison of intraoperative PerfecTemp and forced-air warming during open abdominal surgery.

    Science.gov (United States)

    Egan, Cameron; Bernstein, Ethan; Reddy, Desigen; Ali, Madi; Paul, James; Yang, Dongsheng; Sessler, Daniel I

    2011-11-01

    The PerfecTemp is an underbody resistive warming system that combines servocontrolled underbody warming with viscoelastic foam pressure relief. Clinical efficacy of the system has yet to be formally evaluated. We therefore tested the hypothesis that intraoperative distal esophageal (core) temperatures with the PerfecTemp (underbody resistive) warming system are noninferior to upper-body forced-air warming in patients undergoing major open abdominal surgery under general anesthesia. Adults scheduled for elective major open abdominal surgery (liver, pancreas, gynecological, and colorectal surgery) under general anesthesia were enrolled at 2 centers. Patients were randomly assigned to underbody resistive or forced-air warming. Resistive heating started when patients were transferred to the operating room table; forced-air warming started after patients were draped. The primary outcome was noninferiority of intraoperative time-weighted average core temperature, adjusted for baseline characteristics and using a buffer of 0.5°C. Thirty-six patients were randomly assigned to underbody resistive heating and 34 to forced-air warming. Baseline and surgical characteristics were generally similar. We had sufficient evidence (P=0.018) to conclude that underbody resistive warming is not worse than (i.e., noninferior to) upper-body forced-air warming in the time-weighted average intraoperative temperature, with a mean difference of -0.12°C [95% confidence interval (CI) -0.37 to 0.14]. Core temperatures at the end of surgery averaged 36.3°C [95% CI 36 to 36.5] in the resistive warming patients and 36.6°C [95% CI 36.4 to 36.8] in those assigned to forced-air warming for a mean difference of -0.34°C [95% CI -0.69 to 0.01]. Mean intraoperative time-weighted average core temperatures were no different, and significantly noninferior, with underbody resistive heating in comparison with upper-body forced-air warming. Underbody resistive heating may be an alternative to forced

  16. Effectiveness of a Cognitive Behavioral Therapy for Dysfunctional Eating among Patients Admitted for Bariatric Surgery: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hege Gade

    2014-01-01

    Full Text Available Objective. To examine whether cognitive behavioral therapy (CBT alleviates dysfunctional eating (DE patterns and symptoms of anxiety and depression in morbidly obese patients planned for bariatric surgery. Design and Methods. A total of 98 (68 females patients with a mean (SD age of 43 (10 years and BMI 43.5 (4.9 kg/m2 were randomly assigned to a CBT-group or a control group receiving usual care (i.e., nutritional support and education. The CBT-group received ten weekly intervention sessions. DE, anxiety, and depression were assessed by the TFEQ R-21 and HADS, respectively. Results. Compared with controls, the CBT-patients showed significantly less DE, affective symptoms, and a larger weight loss at follow-up. The effect sizes were large (DE-cognitive restraint, g=-.92, P≤.001; DE-uncontrolled eating, g=-.90, P≤.001, moderate (HADS-depression, g=-.73, P≤.001; DE-emotional eating, g=-.67, P≤.001; HADS-anxiety, g=-.62, P=.003, and low (BMI, g=-.24, P=.004. Conclusion. This study supports the use of CBT in helping patients preparing for bariatric surgery to reduce DE and to improve mental health. This clinical trial is registered with NCT01403558.

  17. Burnout and Work Demands Predict Reduced Job Satisfaction in Health Professionals Working In a Surgery Clinic

    Directory of Open Access Journals (Sweden)

    Dragan Mijakoski

    2015-03-01

    CONCLUSIONS: Adequate management of work demands, particularly excessive workload, time pressure, and lack of staff can lead to prevention of burnout and reduced job satisfaction in surgery clinic HPs, and contribute to better quality of patient care.

  18. Stapes surgery in residency: the UFPR clinical hospital experience.

    Science.gov (United States)

    Caldart, Adriano Ulisses; Terruel, Igor; Enge, Dair Jocely; Kurogi, Adriana Sayuri; Buschle, Maurício; Mocellin, Marcos

    2007-01-01

    Surgery of the stapedius remains the established treatment for otosclerosis. Recent publications have showed that success in surgeries done by residents have decreased and hearing results are worse than those obtained by experienced otologic surgeons. To evaluate the experience of the otorhinolaryngology unit, Parana University, relative to stapes surgery done in the residency training program. A retrospective study of 114 stapes surgeries done in the past 9 years in 96 patients. Audiometric results were analysed according to the Committee on Hearing and Equilibrium guidelines and the Amsterdam Hearing Evaluation Plots. The improvement of the airway postoperative gap and thresholds were taken into account. 96 patients were included, most of them female adults (67.7%) and white (93.7%). Stapedectomy was done in 50.9% of cases, mostly under local anesthesia and sedation (96.5%), using mostly the Teflon prosthesis (37.7%). The surgical success rate was 50.88%, there was an 11.4% complication rate. Postoperative hearing gains considered as surgical success were inferior to published results in the literature, done by experienced surgeons.

  19. Clinical utility and impact of functional neuronavigation for glioma surgery

    International Nuclear Information System (INIS)

    Kamada, Kyousuke; Anei, Ryogo; Ota, Takahiro; Kawai, Kensuke; Saito, Nobuhito

    2010-01-01

    After co-registration of functional MRI with finger tapping tasks for corticospinal tract tractography, the results were imported to a neuronavigation system (functional neuronavigation). Cortical and subcortical stimulation with 5-train electric pulses was then used to identify the motor system. Functional neuronavigation was a reliable and practical technique for preservation of the motor function in glioma surgery. (author)

  20. Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Barone Mark A

    2012-03-01

    Full Text Available Abstract Background A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery. This study will examine whether short-term (7 day urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service. Methods/Design This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT comparing the new proposed short-term (7 day urethral catheterization to longer-term (14 day urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization for medical reasons, catheter blockage, and

  1. Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154

    Science.gov (United States)

    Peul, Wilco C; van Houwelingen, Hans C; van der Hout, Wilbert B; Brand, Ronald; Eekhof, Just AH; Tans, Joseph ThJ; Thomeer, Ralph TWM; Koes, Bart W

    2005-01-01

    Background The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome). Methods/design Patients presenting themselves to their general practitioner with disabling sciatica lasting less than twelve weeks are referred to the neurology outpatient department of one of the participating hospitals. After confirmation of the diagnosis and surgical indication MRI scanning is performed. If a distinct disc herniation is discerned which in addition covers the clinically expected site the patient is eligible for randomization. Depending on the outcome of the randomization scheme the patient will either be submitted to prolonged conservative care or surgery. Surgery will be carried out according to the guidelines and between six and twelve weeks after onset of complaints. The experimental therapy consists of a prolonged conservative treatment under supervision of the general practitioner, which may be followed by surgical intervention in case of persisting or progressive disability. The main primary outcome measure is the disease specific disability of daily functioning. Other primary outcome measures are perceived recovery and intensity of legpain. Secondary outcome measures encompass severity of complaints, quality of life, medical consumption, absenteeism, costs and preference. The main research question will be answered at 12 months after randomization. The total follow-up period covers two years. Discussion Evidence is lacking concerning the optimal treatment of lumbar disc induced sciatica. This pragmatic randomized trial, focusses on the 'timing' of intervention, and will contribute to the decision of the general practictioner and neurologist, regarding referral of patients for surgery. PMID:15707491

  2. Are preoperative experimental pain assessments correlated with clinical pain outcomes after surgery?

    DEFF Research Database (Denmark)

    Sangesland, Anders; Støren, Carl; Vaegter, Henrik B.

    2017-01-01

    of surgery, QST variables, clinical pain outcome measure and main result. Results Most studies showed moderate to high risk of bias. Type of surgery investigated include 7 studies on total knee replacement, 5 studies on caesarean section, 4 studies on thoracic surgery, 2 studies on herniotomy, 2 studies......Background Pain after surgery is not uncommon with 30% of patients reporting moderate to severe postoperative pain. Early identification of patients prone to postoperative pain may be a step forward towards individualized pain medicine providing a basis for improved clinical management through......, and (3) the association between QST and pain after surgery was investigated. Forty-four unique studies were identified, with 30 studies on 2738 subjects meeting inclusion criteria. The methodological quality of the include studies was assessed and data extraction included study population, type...

  3. The Effects of Perioperative Music Interventions in Pediatric Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Marianne J E van der Heijden

    Full Text Available Music interventions are widely used, but have not yet gained a place in guidelines for pediatric surgery or pediatric anesthesia. In this systematic review and meta-analysis we examined the effects of music interventions on pain, anxiety and distress in children undergoing invasive surgery.We searched 25 electronic databases from their first available date until October 2014.Included were all randomized controlled trials with a parallel group, crossover or cluster design that included pediatric patients from 1 month to 18 years old undergoing minimally invasive or invasive surgical procedures, and receiving either live music therapy or recorded music.4846 records were retrieved from the searches, 26 full text reports were evaluated and data was extracted by two independent investigators.Pain was measured with the Visual Analogue Scale, the Coloured Analogue Scale and the Facial Pain Scale. Anxiety and distress were measured with an emotional index scale (not validated, the Spielberger short State Trait Anxiety Inventory and a Facial Affective Scale.Three RCTs were eligible for inclusion encompassing 196 orthopedic, cardiac and day surgery patients (age of 1 day to 18 years receiving either live music therapy or recorded music. Overall a statistically significant positive effect was demonstrated on postoperative pain (SMD -1.07; 95%CI-2.08; -0.07 and on anxiety and distress (SMD -0.34 95% CI -0.66; -0.01 and SMD -0.50; 95% CI -0.84; - 0.16.This systematic review and meta-analysis indicates that music interventions may have a statistically significant effect in reducing post-operative pain, anxiety and distress in children undergoing a surgical procedure. Evidence from this review and other reviews suggests music therapy may be considered for clinical use.

  4. The Effects of Perioperative Music Interventions in Pediatric Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    van der Heijden, Marianne J E; Oliai Araghi, Sadaf; van Dijk, Monique; Jeekel, Johannes; Hunink, M G Myriam

    2015-01-01

    Music interventions are widely used, but have not yet gained a place in guidelines for pediatric surgery or pediatric anesthesia. In this systematic review and meta-analysis we examined the effects of music interventions on pain, anxiety and distress in children undergoing invasive surgery. We searched 25 electronic databases from their first available date until October 2014. Included were all randomized controlled trials with a parallel group, crossover or cluster design that included pediatric patients from 1 month to 18 years old undergoing minimally invasive or invasive surgical procedures, and receiving either live music therapy or recorded music. 4846 records were retrieved from the searches, 26 full text reports were evaluated and data was extracted by two independent investigators. Pain was measured with the Visual Analogue Scale, the Coloured Analogue Scale and the Facial Pain Scale. Anxiety and distress were measured with an emotional index scale (not validated), the Spielberger short State Trait Anxiety Inventory and a Facial Affective Scale. Three RCTs were eligible for inclusion encompassing 196 orthopedic, cardiac and day surgery patients (age of 1 day to 18 years) receiving either live music therapy or recorded music. Overall a statistically significant positive effect was demonstrated on postoperative pain (SMD -1.07; 95%CI-2.08; -0.07) and on anxiety and distress (SMD -0.34 95% CI -0.66; -0.01 and SMD -0.50; 95% CI -0.84; - 0.16. This systematic review and meta-analysis indicates that music interventions may have a statistically significant effect in reducing post-operative pain, anxiety and distress in children undergoing a surgical procedure. Evidence from this review and other reviews suggests music therapy may be considered for clinical use.

  5. Endoscopic outcomes of resorbable nasal packing after functional endoscopic sinus surgery: a multicenter prospective randomized controlled study.

    Science.gov (United States)

    Berlucchi, Marco; Castelnuovo, Paolo; Vincenzi, Andrea; Morra, Bruno; Pasquini, Ernesto

    2009-06-01

    Nasal packings can aid in control of postoperative bleeding and healing following functional endoscopic sinus surgery (FESS), but traditional non-resorbable stents have several inherent drawbacks. We performed a randomized, controlled, multicenter clinical trial to assess efficacy of resorbable nasal packing in patients undergoing FESS for chronic rhinosinusitis. A total of 66 patients for 88 nasal cavities were randomized to receive either hyaluronan resorbable packing (MeroGel) or standard non-resorbable nasal dressing after FESS. All underwent preoperative rhinoscopy, CT of sinuses, and, after surgery, were reassessed by rhinoscopy at 2, 4, and 12 weeks in blinded fashion. A total of 44 nasal cavities (MeroGel-group) received resorbable packing, whereas the remaining 44 were packed with non-resorbable nasal dressing. At follow-up endoscopic visit, the presence of nasal synechia was evaluated as primary outcome. Moreover, the tolerability and surgical handling properties of MeroGel and its comfort were assessed by surgeons and patients. Preoperative severity of rhinosinusitis was similar in both groups. No significant adverse events were observed in all patients. Follow-up endoscopy showed a lower proportion of nasal adhesions in MeroGel-group at both 4 (P = 0.041) and 12 weeks (P appearance of nasal mucosa of nasal cavities after FESS was observed in the MeroGel-group. Tolerability and surgical handling properties of MeroGel were positively rated by clinicians and the overall patient judged comfort of MeroGel was favorable. In conclusion, MeroGel can be considered a valid alternative to standard non-resorbable nasal dressings. It is safe, well-accepted, well-tolerated, and has significant advantage of being resorbable. Moreover, it may favor improved healing in patients undergoing FESS and reduce formation of adhesions.

  6. Randomized trial for superiority of high field strength intra-operative magnetic resonance imaging guided resection in pituitary surgery.

    Science.gov (United States)

    Tandon, Vivek; Raheja, Amol; Suri, Ashish; Chandra, P Sarat; Kale, Shashank S; Kumar, Rajinder; Garg, Ajay; Kalaivani, Mani; Pandey, Ravindra M; Sharma, Bhawani S

    2017-03-01

    Till date there are no randomized trials to suggest the superiority of intra-operative magnetic resonance imaging (IOMRI) guided trans-sphenoidal pituitary resection over two dimensional fluoroscopic (2D-F) guided resections. We conducted this trial to establish the superiority of IOMRI in pituitary surgery. Primary objective was to compare extent of tumor resection between the two study arms. It was a prospective, randomized, outcome assessor and statistician blinded, two arm (A: IOMRI, n=25 and B: 2D-F, n=25), parallel group clinical trial. 4 patients from IOMRI group cross-over to 2D-F group and were consequently analyzed in latter group, based on modified intent to treat method. A total of 50 patients were enrolled till completion of trial (n=25 in each study arm). Demographic profile and baseline parameters were comparable among the two arms (p>0.05) except for higher number of endoscopic procedures and experienced neurosurgeons (>10years) in arm B (p=0.02, 0.002 respectively). Extent of resection was similar in both study arms (A, 94.9% vs B, 93.6%; p=0.78), despite adjusting for experience of operating surgeon and use of microscope/endoscope for surgical resection. We observed that use of IOMRI helped optimize the extent of resection in 5/20 patients (25%) for pituitary tumor resection in-group A. Present study failed to observe superiorty of IOMRI over conventional 2D-F guided resection in pituitary macroadenoma surgery. By use of this technology, younger surgeons could validate their results intra-operatively and hence could increase EOR without causing any increase in complications. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

    DEFF Research Database (Denmark)

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

    2008-01-01

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

  8. Economic impact of clinical variability in preoperative testing for major outpatient surgery.

    Science.gov (United States)

    Gil-Borrelli, Christian Carlo; Agustí, Salomé; Pla, Rosa; Díaz-Redondo, Alicia; Zaballos, Matilde

    2016-05-01

    With the purpose of decreasing the existing variability in the criteria of preoperative evaluation and facilitating the clinical decision-making process, our hospital has a protocol of preoperative tests to use with ASA I and ASA II patients. The aim of the study was to calculate the economic impact caused by clinicians' non-adherence to the protocol for the anaesthesiological evaluation of ASA 1 and ASA II patients. A retrospective study of costs with a random sample of 353 patients that were seen in the consultation for Anesthesiology over a period of one year. Aspects related to the costs, patient's profiles and specialties were analysed, according to the degree of fulfillment of the protocol. The lack of adherence to the the protocol was 70%. 130 chest X-rays and 218 ECG were performed without indication. This generated an excess costs of 34 € per patient. Taking into account the expenses of both tests and the attended population undergoing ambulatory surgery during the one-year period, an excess spending for the hospital of between 69.164 € and 83.312 € was estimated. Clinical variability should be reduced and the creation of synergies between the different departments should be enhanced in order to adjust the request for unnecessary complementary tests to decrease health care and to improve the quality of patient care. Copyright © 2016 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  9. The Healthy Heart-Mind trial: melatonin for prevention of delirium following cardiac surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ford, Andrew H; Flicker, Leon; Passage, Jurgen; Wibrow, Bradley; Anstey, Matthew; Edwards, Mark; Almeida, Osvaldo P

    2016-01-28

    Delirium is a common occurrence in patients undergoing major cardiac surgery and is associated with a number of adverse consequences for the individual, their family and the health system. Current approaches to the prevention of delirium include identifying those at risk together with various non-pharmacological and pharmacological strategies, although the efficacy of these is often modest. Emerging evidence suggests that melatonin may be biologically implicated in the development of delirium and that melatonin supplementation may be beneficial in reducing the incidence of delirium in medical and surgical patients. We designed this trial to determine whether melatonin reduces the incidence of delirium following cardiac surgery compared with placebo. The Healthy Heart-Mind trial is a randomized, double-blind, placebo-controlled clinical trial of 3 mg melatonin or matching placebo administered on seven consecutive days for the prevention of delirium following cardiac surgery. We will recruit 210 adult participants, aged 50 and older, undergoing elective or semi-elective cardiac surgery with the primary outcome of interest for this study being the difference in the incidence of delirium between the groups within 7 days of surgery. Secondary outcomes of interest include the difference between groups in the severity and duration of delirious episodes, hospital length of stay and referrals to mental health services during admission. In addition, we will assess differences in depressive and anxiety symptoms, as well as cognitive performance, at discharge and 3 months after surgery. The results of this trial will clarify whether melatonin reduces the incidence of delirium following cardiac surgery. The trial is registered with the Australian Clinical Trials Registry, trial number ACTRN12615000819527 (10 August 2015).

  10. Risk of Acute Kidney Injury in Patients Randomized to a Restrictive Versus Liberal Approach to Red Blood Cell Transfusion in Cardiac Surgery: A Substudy Protocol of the Transfusion Requirements in Cardiac Surgery III Noninferiority Trial

    Directory of Open Access Journals (Sweden)

    Amit X. Garg

    2018-01-01

    Full Text Available Background: When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion. Objective: The objective of this substudy is to determine whether the risk of acute kidney injury is no greater with a restrictive versus liberal approach to red blood cell transfusion, and whether this holds true in patients with and without preexisting chronic kidney disease. Design and Setting: Multinational noninferiority randomized controlled trial conducted in 73 centers in 19 countries (2014-2017. Patients: Patients (~4800 undergoing planned cardiac surgery with cardiopulmonary bypass. Measurements: The primary outcome of this substudy is perioperative acute kidney injury, defined as an acute rise in serum creatinine from the preoperative value (obtained in the 30-day period before surgery, where an acute rise is defined as ≥26.5 μmol/L in the first 48 hours after surgery or ≥50% in the first 7 days after surgery. Methods: We will report the absolute risk difference in acute kidney injury and the 95% confidence interval. We will repeat the primary analysis using alternative definitions of acute kidney injury, including staging definitions, and will examine effect modification by preexisting chronic kidney disease (defined as a preoperative estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m 2 . Limitations: It is not possible to blind patients or providers to the intervention; however, objective measures will be used to assess

  11. Targeting Prodromal Alzheimer Disease With Avagacestat: A Randomized Clinical Trial.

    Science.gov (United States)

    Coric, Vladimir; Salloway, Stephen; van Dyck, Christopher H; Dubois, Bruno; Andreasen, Niels; Brody, Mark; Curtis, Craig; Soininen, Hilkka; Thein, Stephen; Shiovitz, Thomas; Pilcher, Gary; Ferris, Steven; Colby, Susan; Kerselaers, Wendy; Dockens, Randy; Soares, Holly; Kaplita, Stephen; Luo, Feng; Pachai, Chahin; Bracoud, Luc; Mintun, Mark; Grill, Joshua D; Marek, Ken; Seibyl, John; Cedarbaum, Jesse M; Albright, Charles; Feldman, Howard H; Berman, Robert M

    2015-11-01

    Early identification of Alzheimer disease (AD) is important for clinical management and affords the opportunity to assess potential disease-modifying agents in clinical trials. To our knowledge, this is the first report of a randomized trial to prospectively enrich a study population with prodromal AD (PDAD) defined by cerebrospinal fluid (CSF) biomarker criteria and mild cognitive impairment (MCI) symptoms. To assess the safety of the γ-secretase inhibitor avagacestat in PDAD and to determine whether CSF biomarkers can identify this patient population prior to clinical diagnosis of dementia. A randomized, placebo-controlled phase 2 clinical trial with a parallel, untreated, nonrandomized observational cohort of CSF biomarker-negative participants was conducted May 26, 2009, to July 9, 2013, in a multicenter global population. Of 1358 outpatients screened, 263 met MCI and CSF biomarker criteria for randomization into the treatment phase. One hundred two observational cohort participants who met MCI criteria but were CSF biomarker-negative were observed during the same study period to evaluate biomarker assay sensitivity. Oral avagacestat or placebo daily. Safety and tolerability of avagacestat. Of the 263 participants in the treatment phase, 132 were randomized to avagacestat and 131 to placebo; an additional 102 participants were observed in an untreated observational cohort. Avagacestat was relatively well tolerated with low discontinuation rates (19.6%) at a dose of 50 mg/d, whereas the dose of 125 mg/d had higher discontinuation rates (43%), primarily attributable to gastrointestinal tract adverse events. Increases in nonmelanoma skin cancer and nonprogressive, reversible renal tubule effects were observed with avagacestat. Serious adverse event rates were higher with avagacestat (49 participants [37.1%]) vs placebo (31 [23.7%]), attributable to the higher incidence of nonmelanoma skin cancer. At 2 years, progression to dementia was more frequent in the PDAD

  12. Endoscopic surgery versus conservative treatment for the moderate-volume hematoma in spontaneous basal ganglia hemorrhage (ECMOH: study protocol for a randomized controlled trial

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    Zan Xin

    2012-06-01

    Full Text Available Abstract Background Spontaneous intracerebral hemorrhage is a disease with high morbidity, high disability rate, high mortality, and high economic burden. Whether patients can benefit from surgical evacuation of hematomas is still controversial, especially for those with moderate-volume hematomas in the basal ganglia. This study is designed to compare the efficacy of endoscopic surgery and conservative treatment for the moderate-volume hematoma in spontaneous basal ganglia hemorrhage. Methods Patients meet the criteria will be randomized into the endoscopic surgery group (endoscopic surgery for hematoma evacuation and the best medical treatment or the conservative treatment group (the best medical treatment. Patients will be followed up at 1, 3, and 6 months after initial treatment. The primary outcomes include the Extended Glasgow Outcome Scale and the Modified Rankin Scale. The secondary outcomes consist of the National Institutes of Health Stroke Scale and the mortality. The Barthel Index(BI will also be evaluated. The sample size is 100 patients. Discussion The ECMOH trial is a randomized controlled trial designed to evaluate if endoscopic surgery is better than conservative treatment for patients with moderate-volume hematomas in the basal ganglia. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-11001614 (http://www.chictr.org/en/proj/show.aspx?proj=1618

  13. Clinical course of Crohn's disease first diagnosed at surgery for acute abdomen.

    Science.gov (United States)

    Latella, G; Cocco, A; Angelucci, E; Viscido, A; Bacci, S; Necozione, S; Caprilli, R

    2009-04-01

    The severity of clinical activity of Crohn's disease is high during the first year after diagnosis and decreases thereafter. Approximately 50% of patients require steroids and immunosuppressants and 75% need surgery during their lifetime. The clinical course of patients with Crohn's disease first diagnosed at surgery has never been investigated. To assess the clinical course of Crohn's disease first diagnosed at surgery for acute abdomen and to evaluate the need for medical and surgical treatment in this subset of patients. Hospital clinical records of 490 consecutive Crohn's disease patients were reviewed. Patients were classified according to the Vienna criteria. Sex, extraintestinal manifestations, family history of inflammatory bowel diseases, appendectomy, smoking habit and medical/surgical treatments performed during the follow-up period were assessed. Kaplan-Meier survival method and Cox proportional hazards regression model. Of the 490 Crohn's disease patients, 115 had diagnosis of Crohn's disease at surgery for acute abdomen (Group A) and 375 by conventional clinical, radiological, endoscopic and histologic criteria (Group B). Patients in Group A showed a low risk of further surgery (Log Rank test pacute abdomen showed a low risk for reintervention and less use of steroids and immunosuppressants during follow-up than those not operated upon at diagnosis. Early surgery may represent a valid approach in the initial management of patients with Crohn's disease, at least in the subset of patients with ileal and complicated disease.

  14. Exergaming and older adult cognition: a cluster randomized clinical trial.

    Science.gov (United States)

    Anderson-Hanley, Cay; Arciero, Paul J; Brickman, Adam M; Nimon, Joseph P; Okuma, Naoko; Westen, Sarah C; Merz, Molly E; Pence, Brandt D; Woods, Jeffrey A; Kramer, Arthur F; Zimmerman, Earl A

    2012-02-01

    Dementia cases may reach 100 million by 2050. Interventions are sought to curb or prevent cognitive decline. Exercise yields cognitive benefits, but few older adults exercise. Virtual reality-enhanced exercise or "exergames" may elicit greater participation. To test the following hypotheses: (1) stationary cycling with virtual reality tours ("cybercycle") will enhance executive function and clinical status more than traditional exercise; (2) exercise effort will explain improvement; and (3) brain-derived neurotrophic growth factor (BDNF) will increase. Multi-site cluster randomized clinical trial (RCT) of the impact of 3 months of cybercycling versus traditional exercise, on cognitive function in older adults. Data were collected in 2008-2010; analyses were conducted in 2010-2011. 102 older adults from eight retirement communities enrolled; 79 were randomized and 63 completed. A recumbent stationary ergometer was utilized; virtual reality tours and competitors were enabled on the cybercycle. Executive function (Color Trails Difference, Stroop C, Digits Backward); clinical status (mild cognitive impairment; MCI); exercise effort/fitness; and plasma BDNF. Intent-to-treat analyses, controlling for age, education, and cluster randomization, revealed a significant group X time interaction for composite executive function (p=0.002). Cybercycling yielded a medium effect over traditional exercise (d=0.50). Cybercyclists had a 23% relative risk reduction in clinical progression to MCI. Exercise effort and fitness were comparable, suggesting another underlying mechanism. A significant group X time interaction for BDNF (p=0.05) indicated enhanced neuroplasticity among cybercyclists. Cybercycling older adults achieved better cognitive function than traditional exercisers, for the same effort, suggesting that simultaneous cognitive and physical exercise has greater potential for preventing cognitive decline. This study is registered at Clinicaltrials.gov NCT01167400. Copyright

  15. The clinical utility of new combination phenylephrine/ketorolac injection in cataract surgery

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    Lawuyi LE

    2015-07-01

    Full Text Available Lola Elizabeth Lawuyi, Avinash Gurbaxani Moorfields Eye Hospital Dubai, Dubai, UAE Abstract: The maintenance of mydriasis throughout cataract extraction surgery and the control of ocular inflammation are crucial for successful surgical outcomes. The development of miosis during cataract surgery compromises the visualization of the surgical field and working space for surgeons. This may lead to complications that include posterior capsular tear and associated vitreous loss, longer surgical time, and postoperative inflammation. Postoperative inflammation is often uncomfortable and frustrating for patients. It causes pain, redness, and photophobia. This compromises the best-uncorrected vision following surgery and often leads to multiple clinic visits. This article examines the literature published on the current treatments used to manage mydriasis, pain, and inflammation in cataract extraction surgery. Combination phenylephrine/ketorolac injection offers an exciting new class of medication for use in cataract surgery. With the recent approval of Omidria™ (combination of phenylephrine 1% and ketorolac 0.3% by the US Food and Drug Administration (FDA for intraocular use, we review the clinical utility of this new combination injection in cataract surgery. PubMed, MEDLINE, and conference proceedings were searched for the relevant literature using a combination of the following search terms: cataract extraction surgery, pupil dilation (mydriasis, miosis, phenylephrine, ketorolac, Omidria™, intracameral mydriatic. Relevant articles were reviewed and their references checked for further relevant literature. All abstracts were reviewed and full texts retrieved where available. Keywords: cataract extraction surgery, ketorolac, mydriasis, miosis, Omidria™, phenylephrine

  16. Postoperative pain management with transdermal fentanyl after forefoot surgery: a randomized, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Merivirta R

    2015-01-01

    Full Text Available Riika Merivirta,1 Mikko Pitkänen,2 Jouko Alanen,3 Elina Haapoja,1 Mari Koivisto,4 Kristiina Kuusniemi11Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine of Turku University Hospital and University of Turku, Turku, 2Department of Anaesthesia, Hospital Orton, Invalid Foundation, Helsinki, 3Terveystalo Clinic Hospital, Helsinki, 4Department of Biostatistics, University of Turku, Turku, FinlandBackground: Quality of life is decreased in patients with hallux valgus deformity, mainly because of pain. Significant improvement is usually achieved by surgery. However, postoperative pain can be moderate to severe for 2–3 days. The aim of the present study was to evaluate the use of transdermal fentanyl for postoperative pain management after forefoot surgery.Methods: Sixty patients undergoing hallux valgus or hallux rigidus surgery were allocated to receive a patch delivering either fentanyl 12 µg/hour or placebo for postoperative pain. The consumption of rescue opioid oxycodone, the primary outcome measure, was evaluated daily until the fourth postoperative day. Total consumption of oxycodone during the study period was also assessed. Pain scores and possible adverse effects were evaluated every 6 hours during the first 24 hours and on the fourth postoperative day.Results: The use of rescue opioid was low in both groups, the median (range consumption of oxycodone being 10 (0–50 mg on the day of surgery (no difference between the groups, P=0.31 and 0 (0–35 mg thereafter. The total combined consumption was 10 (0–105 mg in the fentanyl group and 20 (0–70 mg in the placebo group (P=0.23. There were no statistically significant differences in pain scores or adverse effects between the groups.Conclusion: As a part of multimodal analgesia with ibuprofen and acetaminophen, a patch delivering fentanyl 12 µg/hour did not significantly decrease the consumption of rescue opioid or pain scores after forefoot surgery

  17. Investigational Clinical Trial of a Prototype Optoelectronic Computer-Aided Navigation Device for Dental Implant Surgery.

    Science.gov (United States)

    Jokstad, Asbjørn; Winnett, Brenton; Fava, Joseph; Powell, David; Somogyi-Ganss, Eszter

    New digital technologies enable real-time computer-aided (CA) three-dimensional (3D) guidance during dental implant surgery. The aim of this investigational clinical trial was to demonstrate the safety and effectiveness of a prototype optoelectronic CA-navigation device in comparison with the conventional approach for planning and effecting dental implant surgery. Study participants with up to four missing teeth were recruited from the pool of patients referred to the University of Toronto Graduate Prosthodontics clinic. The first 10 participants were allocated to either a conventional or a prototype device study arm in a randomized trial. The next 10 participants received implants using the prototype device. All study participants were restored with fixed dental prostheses after 3 (mandible) or 6 (maxilla) months healing, and monitored over 12 months. The primary outcome was the incidence of any surgical, biologic, or prosthetic adverse events or device-related complications. Secondary outcomes were the incidence of positioning of implants not considered suitable for straightforward prosthetic restoration (yes/no); the perception of the ease of use of the prototype device by the two oral surgeons, recorded by use of a Likert-type questionnaire; and the clinical performance of the implant and superstructure after 1 year in function. Positioning of the implants was appraised on periapical radiographs and clinical photographs by four independent blinded examiners. Peri-implant bone loss was measured on periapical radiographs by a blinded examiner. No adverse events occurred related to placing any implants. Four device-related complications led to a switch from using the prototype device to the conventional method. All implants placed by use of the prototype device were in a position considered suitable for straightforward prosthetic restoration (n = 21). The qualitative evaluation by the surgeons was generally positive, although ergonomic challenges were identified

  18. Dedicated Operating Room Teams and Clinical Outcomes in an Enhanced Recovery after Surgery Pathway for Colorectal Surgery.

    Science.gov (United States)

    Grant, Michael C; Hanna, Andrew; Benson, Andrew; Hobson, Deborah; Wu, Christopher L; Yuan, Christina T; Rosen, Michael; Wick, Elizabeth C

    2018-03-01

    Our aim was to determine whether the establishment of a dedicated operating room team leads to improved process measure compliance and clinical outcomes in an Enhanced Recovery after Surgery (ERAS) program. Enhanced Recovery after Surgery programs involve the application of bundled best practices to improve the value of perioperative care. Successful implementation and sustainment of ERAS programs has been linked to compliance with protocol elements. Development of dedicated teams of anesthesia providers was a component of ERAS implementation. Intraoperative provider team networks (surgeons, anesthesiologists, and certified registered nurse anesthetists) were developed for all cases before and after implementation of colorectal ERAS. Four measures of centrality were analyzed in each network based on case assignments, and these measures were correlated with both rates of process measure compliance and clinical outcomes. Enhanced Recovery after Surgery provider teams led to a decrease in the closeness of anesthesiologists (p = 0.04) and significant increase in the clustering coefficient of certified registered nurse anesthetists (p = 0.005) compared with the pre-ERAS network. There was no significant change in centrality among surgeons (p = NS for all measures). Enhanced Recovery after Surgery designation among anesthesiologists and nurse anesthetists-whereby individual providers received an in-service on protocol elements and received compliance data was strongly associated with high compliance (>0.6 of measures; p < 0.001 for each group). In addition, high compliance was associated with a significant reduction in length of stay (p < 0.01), surgical site infection (p < 0.002), and morbidity (p < 0.009). Dedicated operating room teams led to increased centrality among anesthesia providers, which in turn not only increased compliance, but also improved several clinical outcomes. Copyright © 2017 American College of Surgeons. Published by Elsevier Inc. All rights

  19. Adjunctive Mitomycin C or Amniotic Membrane Transplantation for Ahmed Glaucoma Valve Implantation: A Randomized Clinical Trial.

    Science.gov (United States)

    Yazdani, Shahin; Mahboobipour, Hassan; Pakravan, Mohammad; Doozandeh, Azadeh; Ghahari, Elham

    2016-05-01

    To determine whether adjunctive mitomycin C (MMC) or amniotic membrane transplantation (AMT) improve the outcomes of Ahmed glaucoma valve (AGV) implantation. This double-blind, stratified, 3-armed randomized clinical trial includes 75 eyes of 75 patients aged 7 to 75 years with refractory glaucoma. Eligible subjects underwent stratified block randomization; eyes were first stratified to surgery in the superior or inferior quadrants based on feasibility; in each subgroup, eyes were randomly assigned to the study arms using random blocks: conventional AGV implantation (group A, 25 eyes), AGV with MMC (group B, 25 eyes), and AGV with AMT (group C, 25 eyes). The 3 study groups were comparable regarding baseline characteristics and mean follow-up (P=0.288). A total of 68 patients including 23 eyes in group A, 25 eyes in group B, and 20 eyes group C completed the follow-up period and were analyzed. Intraocular pressure was lower in the MMC group only 3 weeks postoperatively (P=0.04) but comparable at other time intervals. Overall success rate was comparable in the 3 groups at 12 months (P=0.217). The number of eyes requiring medications (P=0.30), time to initiation of medications (P=0.13), and number of medications (P=0.22) were comparable. Hypertensive phase was slightly but insignificantly more common with standard surgery (82%) as compared with MMC-augmented (60%) and AMT-augmented (70%) procedures (P=0.23). Complications were comparable over 1 year (P=0.28). Although adjunctive MMC and AMT were safe during AGV implantation, they did not influence success rates or intraocular pressure outcomes. Complications, including hypertensive phase, were also comparable.

  20. Music listening for anxiety relief in children in the preoperative period: a randomized clinical trial

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    Mariana André Honorato Franzoi

    Full Text Available ABSTRACT Objective: to investigate the effects of music listening, for 15 minutes, on the preoperative anxiety levels in children undergoing elective surgery in comparison with conventional pediatric surgical care. Method: randomized controlled clinical trial pilot study with 52 children in the preoperative period, aged 3 to 12 years, undergoing elective surgery and randomly allocated in the experimental group (n = 26 and control group (n = 26. Anxiety was assessed in both groups by the application of the modified Yale Preoperative Anxiety Scale and measurement of the physiological variables, upon arrival and 15 minutes after the first measurement. Results: there was a statistically significant difference in preoperative anxiety between the two groups only in relation to the physiological variable, since the respiratory rate of preschool children in the experimental group reduced in the second measurement compared to the control group (p = 0.0453. The experimental group showed a statistically significant reduction in anxiety levels after 15 minutes of music listening (p = 0.0441, specifically with regard to the behavioral domains of activity, vocalization, emotional expression and apparent awakening state. Conclusion: music listening emerges as a potential nursing intervention for relief of preoperative anxiety in children undergoing surgical procedures. RBR-7mcr59.

  1. Financial Management of a Large Multi-site Randomized Clinical Trial

    Science.gov (United States)

    Sheffet, Alice J.; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E.; Longbottom, Mary E.; Howard, Virginia J.; Marler, John R.; Brott, Thomas G.

    2014-01-01

    Background The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years’ funding ($21,112,866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2,500 randomized participants at 40 sites. Aims Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Methods Projections of the original grant’s fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant’s fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Results Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2,500 targeted sample size, 138 (5.5%) were randomized during the first five years and 1,387 (55.5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13,845) of the projected per-patient costs ($152,992) of the fixed model. Conclusions Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. PMID:24661748

  2. NIKE: a new clinical tool for establishing levels of indications for cataract surgery.

    Science.gov (United States)

    Lundström, Mats; Albrecht, Susanne; Håkansson, Ingemar; Lorefors, Ragnhild; Ohlsson, Sven; Polland, Werner; Schmid, Andrea; Svensson, Göran; Wendel, Eva

    2006-08-01

    The purpose of this study was to construct a new clinical tool for establishing levels of indications for cataract surgery, and to validate this tool. Teams from nine eye clinics reached an agreement about the need to develop a clinical tool for setting levels of indications for cataract surgery and about the items that should be included in the tool. The tool was to be called 'NIKE' (Nationell Indikationsmodell för Kataraktextraktion). The Canadian Cataract Priority Criteria Tool served as a model for the NIKE tool, which was modified for Swedish conditions. Items included in the tool were visual acuity of both eyes, patients' perceived difficulties in day-to-day life, cataract symptoms, the ability to live independently, and medical/ophthalmic reasons for surgery. The tool was validated and tested in 343 cataract surgery patients. Validity, stability and reliability were tested and the outcome of surgery was studied in relation to the indication setting. Four indication groups (IGs) were suggested. The group with the greatest indications for surgery was named group 1 and that with the lowest, group 4. Validity was proved to be good. Surgery had the greatest impact on the group with the highest indications for surgery. Test-retest reliability test and interexaminer tests of indication settings showed statistically significant intraclass correlations (intraclass correlation coefficients [ICCs] 0.526 and 0.923, respectively). A new clinical tool for indication setting in cataract surgery is presented. This tool, the NIKE, takes into account both visual acuity and the patient's perceived problems in day-to-day life because of cataract. The tool seems to be stable and reliable and neutral towards different examiners.

  3. Assessment of a Standardized Pre-Operative Telephone Checklist Designed to Avoid Late Cancellation of Ambulatory Surgery: The AMBUPROG Multicenter Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Sonia Gaucher

    Full Text Available To assess the impact of a standardized pre-operative telephone checklist on the rate of late cancellations of ambulatory surgery (AMBUPROG trial.Multicenter, two-arm, parallel-group, open-label randomized controlled trial.11 university hospital ambulatory surgery units in Paris, France.Patients scheduled for ambulatory surgery and able to be reached by telephone.A 7-item checklist designed to prevent late cancellation, available in five languages and two versions (for children and adults, was administered between 7 and 3 days before the planned date of surgery, by an automated phone system or a research assistant. The control group received standard management alone.Rate of cancellation on the day of surgery or the day before.The study population comprised 3900 patients enrolled between November 2012 and September 2013: 1950 patients were randomized to the checklist arm and 1950 patients to the control arm. The checklist was administered to 68.8% of patients in the intervention arm, 1002 by the automated phone system and 340 by a research assistant. The rate of late cancellation did not differ significantly between the checklist and control arms (109 (5.6% vs. 113 (5.8%, adjusted odds ratio [95% confidence interval] = 0.91 [0.65-1.29], (p = 0.57. Checklist administration revealed that 355 patients (28.0% had not undergone tests ordered by the surgeon or anesthetist, and that 254 patients (20.0% still had questions concerning the fasting state.A standardized pre-operative telephone checklist did not avoid late cancellations of ambulatory surgery but enabled us to identify several frequent causes.ClinicalTrials.gov NCT01732159.

  4. A randomized controlled trial of skin care protocols for facial resurfacing: lessons learned from the Plastic Surgery Educational Foundation's Skin Products Assessment Research study.

    Science.gov (United States)

    Pannucci, Christopher J; Reavey, Patrick L; Kaweski, Susan; Hamill, Jennifer B; Hume, Keith M; Wilkins, Edwin G; Pusic, Andrea L

    2011-03-01

    The Skin Products Assessment Research Committee was created by the Plastic Surgery Educational Foundation in 2006. The Skin Products Assessment Research study aims were to (1) develop an infrastructure for Plastic Surgery Educational Foundation-conducted, industry-sponsored research in facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi Nu-Derm System versus conventional therapy as treatment adjuncts for facial resurfacing procedures. The Skin Products Assessment Research study was designed as a multicenter, double-blind, randomized, controlled trial. The study was conducted in women with Fitzpatrick type I to IV skin, moderate to severe facial photodamage, and periocular and/or perioral fine wrinkles. Patients underwent chemical peel or laser facial resurfacing and were randomized to the Obagi Nu-Derm System or a standard care regimen. The study endpoints were time to reepithelialization, erythema, and pigmentation changes. Fifty-six women were enrolled and 82 percent were followed beyond reepithelialization. There were no significant differences in mean time to reepithelialization between Obagi Nu-Derm System and control groups. The Obagi Nu-Derm System group had a significantly higher median erythema score on the day of surgery (after 4 weeks of product use) that did not persist after surgery. Test-retest photographic evaluations demonstrated that both interrater and intrarater reliability were adequate for primary study outcomes. The authors demonstrated no significant difference in time to reepithelialization between patients who used the Obagi Nu-Derm System or a standard care regimen as an adjunct to facial resurfacing procedures. The Skin Products Assessment Research team has also provided a discussion of future challenges for Plastic Surgery Educational Foundation-sponsored clinical research for readers of this article.

  5. Alterações lipídicas em pacientes com câncer colorretal em fase pós-operatória: ensaio clínico randomizado e duplo-cego com fungos Agaricus sylvaticus Lipidic alterations in patients with colorectal cancer in post-surgery phase: a randomized and double-blind clinical trial with Agaricus sylvaticus fungus

    Directory of Open Access Journals (Sweden)

    Renata Costa Fortes

    2008-09-01

    Full Text Available INTRODUÇÃO: Alterações no metabolismo lipídico são comuns em pacientes com câncer. Fungos medicinais podem exibir atividade hipolipidêmica. OBJETIVO: Avaliar os efeitos da suplementação dietética com fungos Agaricus sylvaticus no perfil lipídico de pacientes com câncer colorretal em fase pós-operatória. MÉTODOS: Ensaio clínico randomizado, duplo-cego, placebo-controlado, realizado no Hospital de Base do Distrito Federal por seis meses. Amostra constituída por 56 pacientes, estádios I, II e III, separados em dois grupos: placebo e suplementado com Agaricus sylvaticus (30mg/kg/dia. Resultados analisados pelos programas Microsoft Excel 2003 e SPSS 14.0 com p = 0.05. RESULTADOS: O grupo Agaricus sylvaticus apresentou níveis séricos iniciais de colesterol total de 207.36±52.67mg/dL, lipoproteína de baixa densidade de 120.79±44.02mg/dL e triglicérides de 181.64±187.52mg/dL. Após seis meses de suplementação, observou-se redução para 191.11±39.72mg/dL (p = 0.01, 103.08±39.20mg/dL (p = 0.0001 e 168.04±146.91mg/dL (p = 0.18, respectivamente. No grupo placebo, observou-se aumento não-significativo de colesterol total (p = 0.08 e aumento significativo de lipoproteína de baixa densidade (p = 0.01 e triglicérides (p = 0.0001. Não foram observadas, em ambos os grupos, alterações significantes nos níveis de lipoproteína de alta densidade e lipoproteína de muito baixa densidade. CONCLUSÃO: Os resultados sugerem que a suplementação dietética com Agaricus sylvaticus pode melhorar significativamente o perfil lipídico de pacientes com câncer colorretal em fase pós-operatória.INTRODUCTION: Alterations in the lipidic metabolism are common in patients with cancer. Medicinal fungus may show hypolipidemic activity. OBJECTIVE: To evaluate the effects of dietary supplementation with Agaricus sylvaticus fungus in lipidic profile of patients with colorectal cancer in post-surgery phase. MEHTODS: Randomized, double

  6. Efficiency of Calatonia on clinical parameters in the immediate post-surgery period: a clinical study

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    Elaine Ferreira Lasaponari

    2013-09-01

    Full Text Available OBJECTIVE: to assess the efficiency of the Calatonia technique about clinical parameters and pain in the immediate post-surgical phase. METHOD: a randomised study was carried out with 116 patients subjected to a cholecystectomy, by laparoscopy, divided into an experimental group (58 patients and a placebo group (58 patients. The experimental group received the Calatonia technique, while the placebo was only subjected to non-intentional touches. RESULTS: The placebo group and the experimental group were considered homogeneous in terms of the variables: sex, age, physical status classification, duration of surgical procedures and also the time spent recovering in the Post-Anaesthetic Recovery Room. The only variable to show a statistically significant difference was the axillary temperature of the body. In relation to pain, the experimental group showed significant results, and hence it is possible to deduce that the relaxation caused by the Calatonia technique brought some relief of the general situation of pain. CONCLUSION: The application of Calatonia can take up the function of a resource complementary to assistance in the period immediately after surgery. Brazilian Register of Clinical Trials, UTN U1111-1129-9629.

  7. Clinical effects of conjunctival sac flushing using different concentration of povidoneiodine on corneal epithelium before cataract surgeries

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    Xue-Lian Gu

    2015-10-01

    Full Text Available AIM:To determine the most optimal concentration of the safe usage of povidone-iodine(PVP-Iin the flushing to disinfect the conjunctive sac before cataract surgeries, in order to provide a scientific basis for clinical eye surgery work.METHODS:Sixty-two patients with phacoemulsification and intraocular lens implantation in our hospital from October 2012 to October 2014 were randomly divided into 0.25g/L PVP-I group(Ⅰand 5g/L PVP-I group(Ⅱ. Sterilizing effect and the complications postoperative were analyzed.RESULTS:The sterilizing effects of the two groups after flushing conjunctiva sac using different concentrations of PVP-I were both remarkable, but the difference between the two groups was not statistically significant(P>0.05. No endophthalmitis occurred in the two groups. Observing the corneal condition after rinsing, no severe conjunctival hyperemia, corneal edema and other serious complications occurred. There was slightly punctate corneal epithelial shedding in groupⅡ, and the difference was statistically significant(PPCONCLUSION:Using 0.25g/L PVP-I in the conjunctiva sac rinsing before surgeries can inhibit the growth of bacteria in the conjunctival sac, reduce the impact on the corneal epithelium thereby reducing the incidence of postoperative complications and the positive rate of bacterial culture, increasing the comfort degree of patients, bringing a better area for the surgeries.

  8. Impact of empiric nesiritide or milrinone infusion on early postoperative recovery after Fontan surgery: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Costello, John M; Dunbar-Masterson, Carolyn; Allan, Catherine K; Gauvreau, Kimberlee; Newburger, Jane W; McGowan, Francis X; Wessel, David L; Mayer, John E; Salvin, Joshua W; Dionne, Roger E; Laussen, Peter C

    2014-07-01

    We sought to determine whether empirical nesiritide or milrinone would improve the early postoperative course after Fontan surgery. We hypothesized that compared with milrinone or placebo, patients assigned to receive nesiritide would have improved early postoperative outcomes. In a single-center, randomized, double-blinded, placebo-controlled, multi-arm parallel-group clinical trial, patients undergoing primary Fontan surgery were assigned to receive nesiritide, milrinone, or placebo. A loading dose of study drug was administered on cardiopulmonary bypass followed by a continuous infusion for ≥12 hours and ≤5 days after cardiac intensive care unit admission. The primary outcome was days alive and out of the hospital within 30 days of surgery. Secondary outcomes included measures of cardiovascular function, renal function, resource use, and adverse events. Among 106 enrolled subjects, 35, 36, and 35 were randomized to the nesiritide, milrinone, and placebo groups, respectively, and all were analyzed based on intention to treat. Demographics, patient characteristics, and operative factors were similar among treatment groups. No significant treatment group differences were found for median days alive and out of the hospital within 30 days of surgery (nesiritide, 20 [minimum to maximum, 0-24]; milrinone, 18 [0-23]; placebo, 20 [0-23]; P=0.38). Treatment groups did not significantly differ in cardiac index, arrhythmias, peak lactate, inotropic scores, urine output, duration of mechanical ventilation, intensive care or chest tube drainage, or adverse events. Compared with placebo, empirical perioperative nesiritide or milrinone infusions are not associated with improved early clinical outcomes after Fontan surgery. http://www.clinicaltrials.gov. Unique identifier: NCT00543309. © 2014 American Heart Association, Inc.

  9. Perioperative dexketoprofen or lornoxicam administration for pain management after major orthopedic surgery: a randomized, controlled study.

    Science.gov (United States)

    Sivrikoz, Nükhet; Koltka, Kemalettin; Güresti, Ece; Büget, Mehmet; Sentürk, Mert; Özyalçın, Süleyman

    2014-01-01

    Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended for multimodal postoperative pain management. The purpose of this study was to evaluate the postoperative pain relief and opioid-sparing effects of dexketoprofen and lornoxicam after major orthopedic surgery. After obtaining ethical committee approval and informed consent, 120 patients undergoing elective hip or knee replacement under general anesthesia were randomized to receive two intravenous injections of 50 mg dexketoprofen (GD), 8 mg lornoxicam (GL) or saline as placebo (GP) intravenously. Postoperatively, patient-controlled analgesia (PCA) morphine was started as a 0.01 mg.kg-1 bolus dose, with lockout time of 10 minutes without continuous infusion. Pain assessment was made using the Visual Analogue Scale (VAS) at rest or during movement at postoperative 1, 2, 4, 6, 8, 12, and 24 hours. The three groups were similar in terms of age, gender, American Society of Anesthesiologists (ASA) class, number of patients who underwent hip or knee surgery, weight, height, and operation duration. Patients in GD and GL demonstrated significantly reduced pain scores at rest and active motion compared to GP, with lower scores in the dexketoprofen group. Patients in GD and GL used significantly less morphine in the postoperative period compared to GP. The total morphine consumption of patients in GD was lower than in GL. Intravenous application of 50 mg dexketoprofen twice a day and 8 mg lornoxicam twice a day improved analgesia and decreased morphine consumption following major orthopedic surgery. When the two active drugs were compared, it was found that dexketoprofen was superior to lornoxicam in terms of analgesic efficacy and opioid consumption.

  10. The Resident-Run Minor Surgery Clinic: A Pilot Study to Safely Increase Operative Autonomy.

    Science.gov (United States)

    Wojcik, Brandon M; Fong, Zhi Ven; Patel, Madhukar S; Chang, David C; Petrusa, Emil; Mullen, John T; Phitayakorn, Roy

    General surgery training has evolved to align with changes in work hour restrictions, supervision regulations, and reimbursement practices. This has culminated in a lack of operative autonomy, leaving residents feeling inadequately prepared to perform surgery independently when beginning fellowship or practice. A resident-run minor surgery clinic increases junior resident autonomy, but its effects on patient outcomes have not been formally established. This pilot study evaluated the safety of implementing a resident-run minor surgery clinic within a university-based general surgery training program. Single institution case-control pilot study of a resident-run minor surgery clinic from 9/2014 to 6/2015. Rotating third-year residents staffed the clinic once weekly. Residents performed operations independently in their own procedure room. A supervising attending surgeon staffed each case prior to residents performing the procedure and viewed the surgical site before wound closure. Postprocedure patient complications and admissions to the hospital because of a complication were analyzed and compared with an attending control cohort. Massachusetts General Hospital General in Boston, MA; an academic tertiary care general surgery residency program. Ten third-year general surgery residents. Overall, 341 patients underwent a total of 399 procedures (110 in the resident clinic vs. 289 in the attending clinic). Minor surgeries included soft tissue mass excision (n = 275), abscess incision and drainage (n = 66), skin lesion excision (n = 37), skin tag removal (n = 15), and lymph node excision (n = 6). There was no significant difference in the overall rate of patients developing a postprocedure complication within 30 days (3.6% resident vs. 2.8% attending; p = 0.65); which persisted on multivariate analysis. Similar findings were observed for the rate of hospital admission resulting from a complication. Resident evaluations overwhelmingly supported the rotation, citing

  11. Early versus conventional stoma closure following bowel surgery: A randomized controlled trial

    Science.gov (United States)

    Nelson, Thirugnanasambandam; Pranavi, Amuda R.; Sureshkumar, Sathasivam; Sreenath, Gubbi S.; Kate, Vikram

    2018-01-01

    Background/Aim: To compare early stoma closure with conventional stoma closure following defunctioning diversion stoma surgery with respect to the frequency of complications, health-related quality of life (QoL), and length of hospitalization (LoH). Patients and Methods: This study was designed as a prospective parallel-arm randomized controlled trial. Patients who underwent temporary stoma following bowel surgery between February 2014 and November 2015 were included. The rate of complications (medical and surgical) following early and conventional stoma closure was assessed. Health-related QoL and LoH were also measured. Results: One hundred patients were included, with 50 cases in each group. Postoperative complications including laparostoma (6% vs. 2%;P = 0.307), wound infection (32% vs. 18%; P = 0.106), intra-abdominal collection (14% vs. 18%; P = 0.585), anastomotic leak (4%vs. 8%;P = 0.400), and medical complications were comparable (22% vs. 32%;P = 0.257). The length of hospital stay, overall mortality and morbidity (64% vs. 44%; P = 0.05) were similar across the two groups. There was a significant reduction in the cost towards stoma care (96% vs. 2%; P = 0.001) in the early stoma closure group. Patients in the early stoma closure group also had a significantly better QoL. Conclusion: Early stoma closure does not carry an increased risk of postoperative complications, reduces cost towards stoma care, and leads to better a QoL. PMID:29451185

  12. Morphine versus Nalbuphine for Open Gynaecological Surgery: A Randomized Controlled Double Blinded Trial

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    Shiv Akshat

    2014-01-01

    Full Text Available Introduction. Pain is the commonest morbidity after open surgical procedures. The most effective treatment of postoperative pain is opioid therapy. Morphine, the commonly used opioid, is associated with many side effects including respiratory depression, sedation, postoperative nausea vomiting, and pruritus. Nalbuphine, on the other hand, is known to cause less respiratory depression. Thus this study was undertaken to compare the intraoperative and postoperative analgesic efficacy and side effect profile of the two drugs. Methodology. 60 patients undergoing open gynaecological surgery were randomized to receive either morphine (Group M or nalbuphine (Group N in the intraoperative and postoperative period. Intraoperative analgesic efficacy (measured by need for rescue analgesics, postoperative pain by visual analogue scale, and side effects like postoperative nausea, vomiting, sedation, respiratory depression, and pruritus were compared in both groups. Intraoperative and postoperative heart rate and blood pressure were also compared between the groups. Results. Need for intraoperative analgesia was significantly more in Group N (P=0.023. Postoperative VAS scores were significantly different between the groups at various time points; however, none of the patients required any rescue analgesia. The incidence of various side effects was not significantly different between the groups. The haemodynamic profile of patients was comparable between the groups in both intraoperative and postoperative period. Conclusion. Nalbuphine provides less effective intraoperative analgesia than morphine in patients undergoing open gynaecological surgery under general anaesthesia. Both drugs, however, provided similar postoperative analgesia and had similar haemodynamic and side effect profile.

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

    Science.gov (United States)

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

    2011-04-01

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

  14. Randomized Clinical Trial of Interceptive and Comprehensive Orthodontics

    Science.gov (United States)

    King, G.J.; Spiekerman, C.F.; Greenlee, G.M.; Huang, G.J.

    2012-01-01

    Focusing public insurance programs on interceptive orthodontics (IO) may increase access for low-income children. This report presents outcomes from a randomized clinical trial (RCT) comparing IO with comprehensive orthodontics (CO) in Medicaid patients. One hundred seventy pre-adolescents with Medicaid-eligible malocclusions were randomized to IO (n = 86) followed by observation (OBS) or OBS followed by CO (n = 84). One hundred thirty-four completed the trial. Models at pre-treatment (baseline) and following ≤ 2 years of intervention and 2 years of OBS (48 mos) were scored by calibrated examiners using the Peer Assessment Rating (PAR) and Index of Complexity, Outcome and Need (ICON). Overall outcomes and clinically meaningful categorical ICON data on need/acceptability, complexity, and improvement were compared. At baseline, groups were balanced by age, gender, ethnicity, and PAR/ICON scores. Most were minorities. Most (77%) were rated as difficult-to-very difficult. Scores improved significantly for both groups, but CO more than IO (PAR, 18.6 [95%CI 15.1, 22.1] vs.10.1 [95%CI 6.7, 13.4]; ICON, 44.8 [95% CI 39.7, 49.9] vs. 35.2 [95%CI 29.7, 40.6], respectively). On average, IO is effective at reducing malocclusions in Medicaid patients, but less than CO. (ClinicalTrials.gov number CT00067379) PMID:22699670

  15. To Pack or Not to Pack? A Randomized Trial of Vaginal Packing After Vaginal Reconstructive Surgery.

    Science.gov (United States)

    Westermann, Lauren B; Crisp, Catrina C; Oakley, Susan H; Mazloomdoost, Donna; Kleeman, Steven D; Benbouajili, Janine M; Ghodsi, Vivian; Pauls, Rachel N

    2016-01-01

    Placement of vaginal packing after pelvic reconstructive surgery is common; however, little evidence exists to support the practice. Furthermore, patients have reported discomfort from the packs. We describe pain and satisfaction in women treated with and without vaginal packing. This institutional review board-approved randomized-controlled trial enrolled patients undergoing vaginal hysterectomy with prolapse repairs. The primary outcome was visual analog scales (VASs) for pain on postoperative day 1. Allocation to "packing" ("P") or "no-packing" ("NP") arms occurred intraoperatively at the end of surgery. Visual analog scales regarding pain and satisfaction were completed early on postoperative day 1 before packing removal. Visual analog scale scores for pain, satisfaction, and bother attributable to packing were recorded before discharge. All packing and perineal pads were weighed to calculate a "postoperative vaginal blood loss." Perioperative data were collected from the hospital record. Our sample size estimation required 74 subjects. Ninety-three women were enrolled. After exclusions, 77 were randomized (P, 37; NP, 40). No differences were found in surgical information, hemoglobin levels, or narcotic use between groups. However, "postoperative vaginal blood loss" was greater in packed subjects (P discharge (P, 35.0 vs NP, 40.0; P = 0.43] were not significantly different between treatment arms. Likewise, VAS scores for satisfaction before removal of packing (P, 81.0 vs NP, 90.0; P = 0.08] and before discharge (P, 90.0 vs NP, 90.5; P = 0.60] were not significantly different. Packed patients noted lower nursing verbal pain scores (P = 0.04) and used less ketorolac (P = 0.01). Bother from packing was low overall. Although there was no difference based on VAS, women receiving vaginal packing had lower nursing documented pain and used less ketorolac than packed women. Vaginal packing may provide benefit and can remain part of the surgical practice.

  16. Short-term influence of cataract surgery on circadian biological rhythm and related health outcomes (CLOCK-IOL trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Saeki, Keigo; Obayashi, Kenji; Nishi, Tomo; Miyata, Kimie; Maruoka, Shinji; Ueda, Tetsuo; Okamoto, Masahiro; Hasegawa, Taiji; Matsuura, Toyoaki; Tone, Nobuhiro; Ogata, Nahoko; Kurumatani, Norio

    2014-12-29

    Light information is the most important cue of circadian rhythm which synchronizes biological rhythm with external environment. Circadian misalignment of biological rhythm and external environment is associated with increased risk of depression, insomnia, obesity, diabetes, cardiovascular disease, and cancer. Increased light transmission by cataract surgery may improve circadian misalignment and related health outcomes. Although some observational studies have shown improvement of depression and insomnia after cataract surgery, randomized controlled trials are lacking. We will conduct a parallel-group, assessor-blinded, simple randomized controlled study comparing a cataract surgery group at three months after surgery with a control group to determine whether cataract surgery improves depressive symptoms, sleep quality, body mass regulation, and glucose and lipid metabolism. We will recruit patients who are aged 60 years and over, scheduled to receive their first cataract surgery, and have grade 2 or higher nuclear opacification as defined by the lens opacities classification system III. Exclusion criteria will be patients with major depression, severe corneal opacity, severe glaucoma, vitreous haemorrhage, proliferative diabetic retinopathy, macular oedema, age-related macular degeneration, and patients needing immediate or combined cataract surgery. After baseline participants will be randomized to two groups. Outcomes will be measured at three months after surgery among the intervention group, and three months after baseline among the control group. We will assess depressive symptoms as a primary outcome, using the short version geriatric depression scale (GDS-15). Secondary outcomes will be subjective and actigraph-measured sleep quality, sleepiness, glycated haemoglobin, fasting plasma glucose and triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, body mass index, abdominal circumference, circadian rhythms of physical

  17. Telemedicine in vascular surgery: clinical experience in a single centre.

    Science.gov (United States)

    Robaldo, Alessandro; Rousas, Nikolaos; Pane, Bianca; Spinella, Giovanni; Palombo, Domenico

    2010-01-01

    Over a three-year period we performed 630 carotid endarterectomy procedures in 588 patients. From these we selected 90 patients (group A) who fulfilled the criteria for discharge one day after surgery. These patients were given an electronic blood pressure meter, a video phone for use at home and an antihypertensive drug (amlodipine). Using web-based video conferencing, we monitored the patients every 4 hours for the first two days. The other 498 patients (group B) were discharged on the second postoperative day. There were no significant differences between the groups in demographic characteristics, risk factors, carotid lesions, operative time, postoperative complications or blood loss. No cervical hematomas developed in group A. No patients needed to be readmitted because of major complications relating to the carotid endarterectomy. During the video-communication, 28 patients (31%) with a hypertensive crisis were treated by administration of amlodipine. At discharge, a questionnaire showed that there was a feeling of insecurity in both groups: 87% in group A vs. 79% in group B (P > 0.05). In group A, insecurity decreased after the first video connection and disappeared after the 8th day postoperatively. Telemedicine appears feasible and useful in carotid endarterectomy and may have other applications in vascular surgery care.

  18. Nudging guideline-concordant antibiotic prescribing: a randomized clinical trial.

    Science.gov (United States)

    Meeker, Daniella; Knight, Tara K; Friedberg, Mark W; Linder, Jeffrey A; Goldstein, Noah J; Fox, Craig R; Rothfeld, Alan; Diaz, Guillermo; Doctor, Jason N

    2014-03-01

    "Nudges" that influence decision making through subtle cognitive mechanisms have been shown to be highly effective in a wide range of applications, but there have been few experiments to improve clinical practice. To investigate the use of a behavioral "nudge" based on the principle of public commitment in encouraging the judicious use of antibiotics for acute respiratory infections (ARIs). Randomized clinical trial in 5 outpatient primary care clinics. A total of 954 adults had ARI visits during the study timeframe: 449 patients were treated by clinicians randomized to the posted commitment letter (335 in the baseline period, 114 in the intervention period); 505 patients were treated by clinicians randomized to standard practice control (384 baseline, 121 intervention). The intervention consisted of displaying poster-sized commitment letters in examination rooms for 12 weeks. These letters, featuring clinician photographs and signatures, stated their commitment to avoid inappropriate antibiotic prescribing for ARIs. Antibiotic prescribing rates for antibiotic-inappropriate ARI diagnoses in baseline and intervention periods, adjusted for patient age, sex, and insurance status. Baseline rates were 43.5% and 42.8% for control and poster, respectively. During the intervention period, inappropriate prescribing rates increased to 52.7% for controls but decreased to 33.7% in the posted commitment letter condition. Controlling for baseline prescribing rates, we found that the posted commitment letter resulted in a 19.7 absolute percentage reduction in inappropriate antibiotic prescribing rate relative to control (P = .02). There was no evidence of diagnostic coding shift, and rates of appropriate antibiotic prescriptions did not diminish over time. Displaying poster-sized commitment letters in examination rooms decreased inappropriate antibiotic prescribing for ARIs. The effect of this simple, low-cost intervention is comparable in magnitude to costlier, more

  19. Percutaneous nephrolithotomy with and without retrograde pyelography: a randomized clinical trial

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    Ali Tabibi

    2007-02-01

    Full Text Available OBJECTIVE: Since the introduction of percutaneous nephrolithotomy (PCNL, many changes have been added regarding the entrance to pyelocalyceal system such as insertion of the needle pointed to an opaque stone as a guided landmark. We aim at comparing the outcomes of managing renal calculi with and without retrograde pyelography. MATERIALS AND METHODS: In a randomized clinical trial, 55 cases with opaque renal calculi candidates for PCNL with stone in one calyce, in the pelvis or both in one calyce and the pelvis simultaneously were included in a nine-month study. They were randomized into 2 groups, noncatheterized (n = 28 and catheterized (n = 27, called intervention and control groups, respectively. RESULTS: The 2 groups had similar distributions regarding gender, age, duration of operation, length of hospital stay, past history of any surgical procedures on kidney, and stone size. Outcome (residual stone based on aforementioned management was evaluated with plain X-ray on the morning following the operation. Postoperative hemoglobin decrease was significantly higher in controls than in the intervention group (p < 0.001 (with no clinical significance. No difference in outcome, postoperative fever, duration of surgery, duration of hospital stay and radiation exposure was observed between the 2 groups. CONCLUSION: Our findings showed no differences in major clinical outcomes between the 2 groups (with and without catheter insertion for retrograde pyelography.

  20. Analysis of clinical efficacy and complications of titanium mini plate internal fixation and reconstructive surgery for patients with orbital fracture

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    Yang Liu

    2016-07-01

    Full Text Available AIM: To analyze the clinical efficacy and complications of titanium mini plate internal fixation and reconstructive surgery for patients with orbital fracture. METHODS: Fifty-seven cases(60 eyeswith orbital fracture from March 2013 to April 2014 in our hospital were researched. According to the random number table method, the patients were divided into observation group(29 cases with 30 eyesand control group(28 cases with 30 eyes. The control group was treated with hydroxyapatite artificial bone plate for internal fixation, and the observation group with titanium mini plate internal fixation and reconstructive surgery. The diplopia grading, grading of ocular movement disorder before and at 1, 3mo after treatment and postoperative complications(prolapse, dislocation, infectionwere compared between the two groups. RESULTS: In both group, all the 60 eyes were healed without scar formation. The rate of diplopia grading as grade 0 1mo postoperatively of observation group and the control groups were 63% and 40%(PPPCONCLUSION: The clinical curative effect of titanium mini plate internal fixation and reconstructive surgery has a good effect for orbital fractures, which can improve the therapeutic effect and reduce the incidence of adverse reactions.

  1. Phrenic Nerve Palsy and Regional Anesthesia for Shoulder Surgery: Anatomical, Physiologic, and Clinical Considerations.

    Science.gov (United States)

    El-Boghdadly, Kariem; Chin, Ki Jinn; Chan, Vincent W S

    2017-07-01

    Regional anesthesia has an established role in providing perioperative analgesia for shoulder surgery. However, phrenic nerve palsy is a significant complication that potentially limits the use of regional anesthesia, particularly in high-risk patients. The authors describe the anatomical, physiologic, and clinical principles relevant to phrenic nerve palsy in this context. They also present a comprehensive review of the strategies for reducing phrenic nerve palsy and its clinical impact while ensuring adequate analgesia for shoulder surgery. The most important of these include limiting local anesthetic dose and injection volume and performing the injection further away from the C5-C6 nerve roots. Targeting peripheral nerves supplying the shoulder, such as the suprascapular and axillary nerves, may be an effective alternative to brachial plexus blockade in selected patients. The optimal regional anesthetic approach in shoulder surgery should be tailored to individual patients based on comorbidities, type of surgery, and the principles described in this article.

  2. A clinical study of navigation accuracy during surgery

    International Nuclear Information System (INIS)

    Hirabayashi, Hidehiro; Uchiyama, Yoshitomo; Hoshida, Toru; Nakase, Hiroyuki; Morimoto, Tetsuya; Sakaki, Toshisuke

    2000-01-01

    It is essential to implement image-guided surgery or neuronavigation technologies that can be applied during functional surgery to localize targets accurately in the surgical field. Various navigation systems have been developed, such as the optical system and mechanical-arm-based system, to localize targets in the operative field. However, either the reference system, in optical systems, or the arm joint, in mechanical-arm-based systems, can sometimes interfere with surgical maneuvers. Therefore, we used the magnetic-force-based Computed Assisted Neurosurgery system (CANS system, Shimadzu, Co. Ltd., Kyoto, Japan) for neuronavigation. The purpose of this study was to evaluate the accuracy of the CANS navigation system. Ten patients with medically refractory epilepsy underwent implantation of subdural electrode grids to detect the epilepsy focus, and then lobectomy or multiple subpial transection was performed after informed consent was obtained. The male/female ratio was 6:4 and the mean age was 30.7 years. The CANS navigator system consists mainly of a magnetic source, a localizer probe with magnetic sensor, a three-dimensional locating measuring instrument (digitizer), an image scanner, and a personal computer. To determine the localization accuracy, the probe was moved on the subdural electrode grid which typically consists of 64 or 16 platinum-iridium electrode contacts (3 mm in the diameter) embedded in a Silastic sheet. The array of electrodes was 8 x 8 cm or 2 x 8 cm and the center-to-center inter-electrode distance was 10 mm. We evaluated the inter-electrode distances and spatial relationships among the electrodes to quantitate the precision of the probe tip localization and assumed the nasion origin reference system to assess the distribution of target coordinates. The measurement errors of each component derived from different planes for the same targets were evaluated in ten patients. The error in X-dimension ranged from 0.38 mm to 7.8 mm, the error in Y

  3. The Hip Fracture Surgery in Elderly Patients (HIPELD study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery

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    Coburn Mark

    2012-09-01

    Full Text Available Abstract Background Strategies to protect the brain from postoperative delirium (POD after hip fracture are urgently needed. The development of delirium often is associated with the loss of independence, poor functional recovery, and increased morbidity, as well as increases in length of hospital stay, discharges to nursing facilities, and healthcare costs. We hypothesize that xenon may reduce the burden of POD, (i by avoiding the need to provide anesthesia with a drug that targets the γ-amino-butyric acid (GABAA receptor and (ii through beneficial anesthetic and organ-protective effects. Methods and design An international, multicenter, phase 2, prospective, randomized, blinded, parallel group and controlled trial to evaluate the incidence of POD, diagnosed with the Confusion Assessment Method (CAM, in older patients undergoing hip fracture surgery under general anesthesia with xenon or sevoflurane, for a period of 4 days post surgery (primary outcome is planned. Secondary objectives are to compare the incidence of POD between xenon and sevoflurane, to evaluate the incidence of POD from day 5 post surgery until discharge from hospital, to determine the time to first POD diagnosis, to evaluate the duration of POD, to evaluate the evolution of the physiological status of the patients in the postoperative period, to evaluate the recovery parameters, to collect preliminary data to evaluate the economical impact of POD in the postoperative period and to collect safety data. Patients are eligible if they are older aged (≥ 75 years and assigned to a planned hip fracture surgery within 48 h after the hip fracture. Furthermore, patients need to be willing and able to complete the requirements of this study including the signature of the written informed consent. A total of 256 randomized patients in the 10 participating centers will be recruited, that is, 128 randomized patients in each of the 2 study groups (receiving either xenon or sevoflurane

  4. Twenty-year perspective of randomized controlled trials for surgery of chronic nonspecific low back pain: citation bias and tangential knowledge.

    Science.gov (United States)

    Andrade, Nicholas S; Flynn, John P; Bartanusz, Viktor

    2013-11-01

    After decades of clinical research, the role of surgery for chronic nonspecific low back pain (CNLBP) remains equivocal. Despite significant intellectual, human, and economic investments into randomized controlled trials (RCTs) in the past two decades, the role of surgery in the treatment for CNLBP has not been clarified. To delineate the historical research agenda of surgical RCTs for CNLBP performed between 1993 and 2012 investigating whether conclusions from earlier published trials influenced the choice of research questions of subsequent RCTs on elucidating the role of surgery in the management of CNLBP. Literature review. We searched the literature for all RCTs involving surgery for CNLBP. We reviewed relevant studies to identify the study question, comparator arms, and sample size. Randomized controlled trials were classified as "indication" trials if they evaluated the effectiveness of surgical therapy versus nonoperative care or as "technical" if they compared different surgical techniques, adjuncts, or procedures. We used citation analysis to determine the impact of trials on subsequent research in the field. Altogether 33 technical RCTs (3,790 patients) and 6 indication RCTs (981 patients) have been performed. Since 2007, despite the unclear benefits of surgery reported by the first four indication trials published in 2001 to 2006, technical trials have continued to predominate (16 vs. 2). Of the technical trials, types of instrumentation (13 trials, 1,332 patients), bone graft materials and substitutes (11 trials, 833 patients), and disc arthroplasty versus fusion (5 trials, 1,337 patients) were the most common comparisons made. Surgeon authors have predominantly cited one of the indication trials that reported more favorable results for surgery, despite a lack of superior methodology or sample size. Trials evaluating bone morphogenic protein, instrumentation, and disc arthroplasty were all cited more frequently than the largest trial of surgical versus

  5. Combination of gabapentin and ramosetron for the prevention of postoperative nausea and vomiting after gynecologic laparoscopic surgery: a prospective randomized comparative study.

    Science.gov (United States)

    Kim, Kyung Mi; Huh, Jin; Lee, Soo Kyung; Park, Eun Young; Lee, Jung Min; Kim, Hyo Ju

    2017-05-19

    As a drug originally introduced for its anticonvulsant effects, gabapentin has been recently shown to be effective in the treatment of nausea and vomiting in various clinical settings. This study compared the antiemetic efficacy of oral gabapentin, intravenous ramosetron and gabapentin plus ramosetron in patients receiving fentanyl-based patient-controlled analgesia after laparoscopic gynecologic surgery. One hundred and thirty two patients undergoing laparoscopic gynecologic surgery under general anesthesia were allocated randomly into three groups: group G received 300 mg oral gabapentin 1 h before anesthesia, group R received 0.3 mg intravenous ramosetron at the end of surgery, and group GR received a combination of 300 mg oral gabapentin 1 h before anesthesia and 0.3 mg intravenous ramosetron at the end of surgery. Postoperative nausea, retching, vomiting, rescue antiemetic drug use, pain, rescue analgesic requirements and adverse effects were assessed at 0-2, 2-24 and 24-48 h after surgery. Postoperative nausea and vomiting (PONV) was defined as the presence of nausea, retching or vomiting. The incidence of complete response (no PONV and no rescue antiemetics up to 48 h postoperatively) was significantly higher in group GR (26/40, 65%) than group G (16/40, 40%; P = 0.025) and group R (18/44, 41%; P = 0.027), whereas there was no significant difference between group G and group R (P = 0.932). There were no significant between-group differences in the incidence of emetic episodes, use of rescue antiemetics, severe emesis, use of rescue analgesics or any adverse effects. Postoperative pain scores were also similar among groups. The combination with gabapentin and ramosetron is superior to either drug alone for prevention of PONV after laparoscopic gynecologic surgery. ClinicalTrials.gov NCT02617121 , registered November 25, 2015.

  6. Sustained effects of a psychoeducational group intervention following bariatric surgery: follow-up of the randomized controlled BaSE study.

    Science.gov (United States)

    Wild, Beate; Hünnemeyer, Katharina; Sauer, Helene; Schellberg, Dieter; Müller-Stich, Beat Peter; Königsrainer, Alfred; Weiner, Rudolf; Zipfel, Stephan; Herzog, Wolfgang; Teufel, Martin

    2017-09-01

    Evidence regarding the efficacy of psychosocial interventions after bariatric surgery is rare and shows conflicting results. The Bariatric Surgery and Education (BaSE) study aimed to assess the efficacy of a psychoeducational group intervention in patients after bariatric surgery. The BaSE study was a randomized, controlled, multicenter clinical trial involving 117 patients who underwent bariatric surgery. Patients received either conventional postsurgical visits or, in addition, a 1-year psychoeducational group program. The present study evaluated the sustained effects of the intervention program. Mean follow-up duration was 37.9 months (standard deviation [SD] 8.2 months) after surgery. Outcome measures were as follows: body mass index (BMI), weight loss, self-efficacy, depression severity, and health-related quality of life (HRQOL). Groups were compared using an intention-to-treat approach with a mixed model for repeated measurements. A total of 74 patients (63.2%) completed the follow-up (T5) assessment. Mean weight loss for all patients was 43 kg (SD 15.5 kg) at T5 (mean BMI 35.1 kg/m 2 ). Mean excess weight loss was 60.4%. The effects of the surgery during the first postsurgical year were reflected, on average, by both decreasing weight and psychosocial burden. At the T5 time point, patients had slowly started to regain weight and to deteriorate regarding psychosocial aspects. However, at T5, patients who had participated in the intervention program (n = 39) showed significantly lower depression severity scores (p = .03) and significantly higher self-efficacy (p = .03) compared to the control group (n = 35). The 2 groups did not differ regarding weight loss and quality of life. Psychoeducational intervention shows sustained effects on both depression severity scores and self-efficacy. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  7. Effectiveness of a multidisciplinary care program on recovery and return to work of patients after gynaecological surgery; design of a randomized controlled trial

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    Vonk Noordegraaf Antonie

    2012-02-01

    Full Text Available Abstract Background Return to work after gynaecological surgery takes much longer than expected, irrespective of the level of invasiveness. In order to empower patients in recovery and return to work, a multidisciplinary care program consisting of an e-health intervention and integrated care management including participatory workplace intervention was developed. Methods/Design We designed a randomized controlled trial to assess the effect of the multidisciplinary care program on full sustainable return to work in patients after gynaecological surgery, compared to usual clinical care. Two hundred twelve women (18-65 years old undergoing hysterectomy and/or laparoscopic adnexal surgery on benign indication in one of the 7 participating (university hospitals in the Netherlands are expected to take part in this study at baseline. The primary outcome measure is sick leave duration until full sustainable return to work and is measured by a monthly calendar of sickness absence during 26 weeks after surgery. Secondary outcome measures are the effect of the care program on general recovery, quality of life, pain intensity and complications, and are assessed using questionnaires at baseline, 2, 6, 12 and 26 weeks after surgery. Discussion The discrepancy between expected physical recovery and actual return to work after gynaecological surgery contributes to the relevance of this study. There is strong evidence that long periods of sick leave can result in work disability, poorer general health and increased risk of mental health problems. We expect that this multidisciplinary care program will improve peri-operative care, contribute to a faster return to work of patients after gynaecological surgery and, as a consequence, will reduce societal costs considerably. Trial registration Netherlands Trial Register (NTR: NTR2087

  8. Effectiveness of a multidisciplinary care program on recovery and return to work of patients after gynaecological surgery; design of a randomized controlled trial.

    Science.gov (United States)

    Vonk Noordegraaf, Antonie; Huirne, Judith A F; Brölmann, Hans A M; Emanuel, Mark H; van Kesteren, Paul J M; Kleiverda, Gunilla; Lips, Jos P; Mozes, Alexander; Thurkow, Andreas L; van Mechelen, Willem; Anema, Johannes R

    2012-02-01

    Return to work after gynaecological surgery takes much longer than expected, irrespective of the level of invasiveness. In order to empower patients in recovery and return to work, a multidisciplinary care program consisting of an e-health intervention and integrated care management including participatory workplace intervention was developed. We designed a randomized controlled trial to assess the effect of the multidisciplinary care program on full sustainable return to work in patients after gynaecological surgery, compared to usual clinical care. Two hundred twelve women (18-65 years old) undergoing hysterectomy and/or laparoscopic adnexal surgery on benign indication in one of the 7 participating (university) hospitals in the Netherlands are expected to take part in this study at baseline. The primary outcome measure is sick leave duration until full sustainable return to work and is measured by a monthly calendar of sickness absence during 26 weeks after surgery. Secondary outcome measures are the effect of the care program on general recovery, quality of life, pain intensity and complications, and are assessed using questionnaires at baseline, 2, 6, 12 and 26 weeks after surgery. The discrepancy between expected physical recovery and actual return to work after gynaecological surgery contributes to the relevance of this study. There is strong evidence that long periods of sick leave can result in work disability, poorer general health and increased risk of mental health problems. We expect that this multidisciplinary care program will improve peri-operative care, contribute to a faster return to work of patients after gynaecological surgery and, as a consequence, will reduce societal costs considerably. Netherlands Trial Register (NTR): NTR2087.

  9. Nutritional Recommendations for Adult Bariatric Surgery Patients: Clinical Practice12

    Science.gov (United States)

    Sherf Dagan, Shiri; Goldenshluger, Ariela; Globus, Inbal; Schweiger, Chaya; Kessler, Yafit; Kowen Sandbank, Galit; Ben-Porat, Tair; Sinai, Tali

    2017-01-01

    Bariatric surgery is currently the most effective treatment for morbid obesity and its associated metabolic complications. To ensure long-term postoperative success, patients must be prepared to adopt comprehensive lifestyle changes. This review summarizes the current evidence and expert opinions with regard to nutritional care in the perioperative and long-term postoperative periods. A literature search was performed with the use of different lines of searches for narrative reviews. Nutritional recommendations are divided into 3 main sections: 1) presurgery nutritional evaluation and presurgery diet and supplementation; 2) postsurgery diet progression, eating-related behaviors, and nutritional therapy for common gastrointestinal symptoms; and 3) recommendations for lifelong supplementation and advice for nutritional follow-up. We recognize the need for uniform, evidence-based nutritional guidelines for bariatric patients and summarize recommendations with the aim of optimizing long-term success and preventing complications. PMID:28298280

  10. Recurrent Laryngeal Nerve Palsy After Cervical Spine Surgery: A Multicenter AOSpine Clinical Research Network Study

    OpenAIRE

    Gokaslan, Ziya L.; Bydon, Mohamad; De la Garza-Ramos, Rafael; Smith, Zachary A.; Hsu, Wellington K.; Qureshi, Sheeraz A.; Cho, Samuel K.; Baird, Evan O.; Mroz, Thomas E.; Fehlings, Michael; Arnold, Paul M.; Riew, K. Daniel

    2017-01-01

    Study Design: Multicenter retrospective study. Objectives: To investigate the risk of symptomatic recurrent laryngeal nerve palsy (RLNP) following cervical spine surgery, to examine risk factors for its development, and to report its treatment and outcomes. Methods: A multicenter study from 21 high-volume surgical centers from the AOSpine North America Clinical Research Network was performed. Each center screened for rare complications following cervical spine surgery, including RLNP. Patient...

  11. Patient Education for Endoscopic Sinus Surgery: Preliminary Experience Using 3D-Printed Clinical Imaging Data.

    Science.gov (United States)

    Sander, Ian M; Liepert, Taimi T; Doney, Evan L; Leevy, W Matthew; Liepert, Douglas R

    2017-04-07

    Within the Ear, Nose, and Throat (ENT) medical space, a relatively small fraction of patients follow through with elective surgeries to fix ailments such as a deviated septum or occluded sinus passage. Patient understanding of their diagnosis and treatment plan is integral to compliance, which ultimately yields improved medical outcomes and better quality of life. Here we report the usage of advanced, polyjet 3D printing methods to develop a multimaterial replica of human nasal sinus anatomy, derived from clinical X-ray computed tomography (CT) data, to be used as an educational aid during physician consultation. The final patient education model was developed over several iterations to optimize material properties, anatomical accuracy and overall display. A two-arm, single-center, randomized, prospective study was then performed in which 50 ENT surgical candidates (and an associated control group, n = 50) were given an explanation of their anatomy, disease state, and treatment options using the education model as an aid. Statistically significant improvements in patient ratings of their physician's explanation of their treatment options ( p = 0.020), self-rated anatomical understanding ( p = 0.043), self-rated understanding of disease state ( p = 0.016), and effectiveness of the visualization ( p = 0.007) were noted from the population that viewed the 3D education model, indicating it is an effective tool which ENT surgeons may use to educate and interact with patients.

  12. Marginal artery stump pressure in left colic artery-preserving rectal cancer surgery: a clinical trial.

    Science.gov (United States)

    Guo, Yuchen; Wang, Daguang; He, Liang; Zhang, Yang; Zhao, Shishun; Zhang, Luyao; Sun, Xuan; Suo, Jian

    2017-07-01

    The aim of this clinical trial is to evaluate the influence of high and low ligation of the inferior mesenteric artery with apical lymph node dissection on the anastomotic blood supply, lymph node retrieval rate, operative time and anastomotic leakage rate in rectal cancer surgery. A total of 57 Chinese patients were randomly distributed into group A and group B and underwent radical resection of rectal cancer. Patients in group A underwent high ligation of the inferior mesenteric artery, and patients in group B underwent apical lymph node resection around the root of the inferior mesenteric artery with preservation of the left colic artery. The marginal artery stump pressure was measured after colon and artery reconstruction. Systemic pressure, distal colon length, operative time and lymph node retrieval rate were measured and recorded. The results were analysed and related to patient characteristics and post-operative complications. The anastomotic blood supply negatively and linearly correlated with age and distal colon length and showed a positive linear correlation with systemic pressure. Patients who received low ligation with apical lymph node dissection had a better anastomotic blood supply than those who received high ligation. No differences were found in lymph node retrieval rate, operative time and anastomotic leakage rate. Anastomotic leakage was associated with a worse anastomotic blood supply. Low ligation with apical lymph node dissection in rectal cancer treatment provides better anastomotic blood supply but is not associated with differences in node retrieval rate or operation time. © 2015 Royal Australasian College of Surgeons.

  13. A random walk rule for phase I clinical trials.

    Science.gov (United States)

    Durham, S D; Flournoy, N; Rosenberger, W F

    1997-06-01

    We describe a family of random walk rules for the sequential allocation of dose levels to patients in a dose-response study, or phase I clinical trial. Patients are sequentially assigned the next higher, same, or next lower dose level according to some probability distribution, which may be determined by ethical considerations as well as the patient's response. It is shown that one can choose these probabilities in order to center dose level assignments unimodally around any target quantile of interest. Estimation of the quantile is discussed; the maximum likelihood estimator and its variance are derived under a two-parameter logistic distribution, and the maximum likelihood estimator is compared with other nonparametric estimators. Random walk rules have clear advantages: they are simple to implement, and finite and asymptotic distribution theory is completely worked out. For a specific random walk rule, we compute finite and asymptotic properties and give examples of its use in planning studies. Having the finite distribution theory available and tractable obviates the need for elaborate simulation studies to analyze the properties of the design. The small sample properties of our rule, as determined by exact theory, compare favorably to those of the continual reassessment method, determined by simulation.

  14. Prospective randomized clinical studies involving reirradiation. Lessons learned

    International Nuclear Information System (INIS)

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

    2016-01-01

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

  15. Do Implant Overdentures Improve Dietary Intake? A Randomized Clinical Trial

    Science.gov (United States)

    Hamdan, N.M.; Gray-Donald, K.; Awad, M.A.; Johnson-Down, L.; Wollin, S.; Feine, J.S.

    2013-01-01

    People wearing mandibular two-implant overdentures (IOD) chew food with less difficulty than those wearing conventional complete dentures (CD). However, there is still controversy over whether or not this results in better dietary intake. In this randomized clinical trials (RCT), the amounts of total dietary fiber (TDF), macronutrients, 9 micronutrients, and energy in diets consumed by persons with IOD and CD were compared. Male and female edentate patients ≥ 65 yrs (n = 255) were randomly divided into 2 groups and assigned to receive a maxillary CD and either a mandibular IOD or a CD. One year following prosthesis delivery, 217 participants (CD = 114, IOD = 103) reported the food and quantities they consumed to a registered dietician through a standard 24-hour dietary recall method. The mean and median values of TDF, macro- and micronutrients, and energy consumed by both groups were calculated and compared analytically. No significant between-group differences were found (ps > .05). Despite quality-of-life benefits from IODs, this adequately powered study reveals no evidence of nutritional advantages for independently living medically healthy edentate elders wearing two-implant mandibular overdentures over those wearing conventional complete dentures in their dietary intake at one year following prosthesis delivery (International Clinical Trials ISRCTN24273915). PMID:24158335

  16. Renal effects of dexmedetomidine during coronary artery bypass surgery: a randomized placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Scheinin Harry

    2011-05-01

    Full Text Available Abstract Background Dexmedetomidine, an alpha2-adrenoceptor agonist, has been evaluated as an adjunct to anesthesia and for the delivery of sedation and perioperative hemodynamic stability. It provokes dose-dependent and centrally-mediated sympatholysis. Coronary artery bypass grafting (CABG with extracorporeal circulation is a stressful procedure increasing sympathetic nervous system activity which could attenuate renal function due the interrelation of sympathetic nervous system, hemodynamics and renal function. We tested the hypothesis that dexmetomidine would improve kidney function in patients undergoing elective CABG during the first two postoperative days. Methods This was a double-blind, randomized, parallel-group study. Patients with normal renal function and scheduled for elective CABG were randomized to placebo or to infusion of dexmedetomidine to achieve a pseudo steady-state plasma concentration of 0.60 ng/ml. The infusion was started after anesthesia induction and continued until 4 h after surgery. The primary endpoint was creatinine clearance. Other variables included urinary creatinine and output, fractional sodium and potassium excretion, urinary potassium, sodium and glucose, serum and urinary osmolality and plasma catecholamine concentrations. The data were analyzed with repeated-measures ANOVA or Cochran-Mantel-Haenszel test. Results Sixty-six of 87 randomized patients were evaluable for analysis. No significant between-group differences were recorded for any indices of renal function except for a mean 74% increase in urinary output with dexmedetomidine in the first 4 h after insertion of a urinary catheter (p Conclusions Use of intravenous dexmedetomidine did not alter renal function in this cohort of relatively low-risk elective CABG patients but was associated with an increase in urinary output. This study was carried out in 1994-1997 and was thus not registered.

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

    Science.gov (United States)

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

    2014-04-01

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

  18. Clinical study on lorazepam for treating postoperative pain of wound after spinal meningioma surgery

    Directory of Open Access Journals (Sweden)

    Yi-peng WANG

    2018-01-01

    Full Text Available Objective To estimate the effect of lorazepam in relieving postoperative wound pain and anxiety after spinal meningioma surgery. Methods A total of 106 patients underwent spinal meningioma resection with endotracheal general anesthesia. They were randomly divided into lorazepam group (N = 53 and control group (N = 53. Patients in lorazepam group were given lorazepam 0.50 mg one night before surgery and 6 h after surgery, while control group were given compound vitamin B at the same time. Operation time, intraoperative bleeding and wound healing after surgery were recorded. McCormick grade and Self-Rating Anxiety Scale (SAS were used to evaluate the spinal function and anxiety. At 48 h after surgery, Visual Analogue Scale (VAS was used to evaluate the degree of postoperative pain. Results All patients underwent tumor total resection, and spent the perioperative period safely. No complications such as infection happened. Neurological function were relieved to varying degrees and there was no worsening case. Compared with control group, SAS score in lorazepam group was significantly decreased at 48 h after surgery (P = 0.000. Compared with before surgery, SAS score in lorazepam group was significantly decreased at 48 h after surgery (P = 0.000. The VAS score at 48 h after surgery in lorazepam group was significantly lower than control group [(5.40 ± 1.24 score vs. (7.15 ± 1.12 score; t = 7.593, P = 0.000]. Conclusions Lorazepam as an antianxiety agent can effectively relieve postoperative pain after spinal meningioma resection. DOI: 10.3969/j.issn.1672-6731.2017.12.011

  19. Systemic Review and Meta-analysis of Randomized Clinical Trials Comparing Primary vs Delayed Primary Skin Closure in Contaminated and Dirty Abdominal Incisions

    Science.gov (United States)

    2013-06-26

    Trials. 1986;7(3):177-188. 14. ChatwiriyacharoenW. Surgical wound infection post surgery in perforated appendicitis in children. J Med Assoc Thai ...randomized clinical trial. Anesth Analg. 2012;115(4):849-854. 36. Dharan S, Pittet D. Environmental controls in operating theatres . J Hosp Infect

  20. Safety and effects of two red blood cell transfusion strategies in pediatric cardiac surgery patients: a randomized controlled trial

    NARCIS (Netherlands)

    de Gast-Bakker, D. H.; de Wilde, R. B. P.; Hazekamp, M. G.; Sojak, V.; Zwaginga, J. J.; Wolterbeek, R.; de Jonge, E.; Gesink-van der Veer, B. J.

    2013-01-01

    To investigate the safety and effects of a restrictive red blood cell (RBC) transfusion strategy in pediatric cardiac surgery patients. Randomized controlled trial. Pediatric ICU in an academic tertiary care center, Leiden University Medical Center, Leiden, The Netherlands. One hundred seven

  1. Do authors report surgical expertise in open spine surgery related randomized controlled trials? A systematic review on quality of reporting

    NARCIS (Netherlands)

    van Oldenrijk, Jakob; van Berkel, Youri; Kerkhoffs, Gino M. M. J.; Bhandari, Mohit; Poolman, Rudolf W.

    2013-01-01

    A systematic review of published trials in orthopedic spine literature. To determine the quality of reporting in open spine surgery randomized controlled trials (RCTs) between 2005 and 2010 with special focus on the reporting of surgical skill or expertise. In technically demanding procedures such

  2. Patient-reported genitourinary dysfunction after laparoscopic and open rectal cancer surgery in a randomized trial (COLOR II)

    DEFF Research Database (Denmark)

    Andersson, J; Abis, G; Gellerstedt, M

    2014-01-01

    BACKGROUND: This article reports on patient-reported sexual dysfunction and micturition symptoms following a randomized trial of laparoscopic and open surgery for rectal cancer. METHODS: Patients in the COLOR II randomized trial, comparing laparoscopic and open surgery for rectal cancer, completed...... laparoscopic and open approaches. An improvement in sexual dysfunction was seen in the first year, but some male sexual problems persisted. Before operation 64·5 per cent of men in the laparoscopic group and 55·6 per cent in the open group reported some degree of erectile dysfunction. This increased to 81...... radiotherapy, did not change these results. CONCLUSION: Sexual dysfunction is common in patients with rectal cancer, and treatment (including surgery) increases the proportion of patients affected. A laparoscopic approach does not change this. REGISTRATION NUMBER: NCT0029779 (http://www.clinicaltrials.gov)....

  3. Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized Clinical Trial.

    Science.gov (United States)

    Salminen, Paulina; Paajanen, Hannu; Rautio, Tero; Nordström, Pia; Aarnio, Markku; Rantanen, Tuomo; Tuominen, Risto; Hurme, Saija; Virtanen, Johanna; Mecklin, Jukka-Pekka; Sand, Juhani; Jartti, Airi; Rinta-Kiikka, Irina; Grönroos, Juha M

    2015-06-16

    An increasing amount of evidence supports the use of antibiotics instead of surgery for treating patients with uncomplicated acute appendicitis. To compare antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis confirmed by computed tomography (CT). The Appendicitis Acuta (APPAC) multicenter, open-label, noninferiority randomized clinical trial was conducted from November 2009 until June 2012 in Finland. The trial enrolled 530 patients aged 18 to 60 years with uncomplicated acute appendicitis confirmed by a CT scan. Patients were randomly assigned to early appendectomy or antibiotic treatment with a 1-year follow-up period. Patients randomized to antibiotic therapy received intravenous ertapenem (1 g/d) for 3 days followed by 7 days of oral levofloxacin (500 mg once daily) and metronidazole (500 mg 3 times per day). Patients randomized to the surgical treatment group were assigned to undergo standard open appendectomy. The primary end point for the surgical intervention was the successful completion of an appendectomy. The primary end point for antibiotic-treated patients was discharge from the hospital without the need for surgery and no recurrent appendicitis during a 1-year follow-up period. There were 273 patients in the surgical group and 257 in the antibiotic group. Of 273 patients in the surgical group, all but 1 underwent successful appendectomy, resulting in a success rate of 99.6% (95% CI, 98.0% to 100.0%). In the antibiotic group, 70 patients (27.3%; 95% CI, 22.0% to 33.2%) underwent appendectomy within 1 year of initial presentation for appendicitis. Of the 256 patients available for follow-up in the antibiotic group, 186 (72.7%; 95% CI, 66.8% to 78.0%) did not require surgery. The intention-to-treat analysis yielded a difference in treatment efficacy between groups of -27.0% (95% CI, -31.6% to ∞) (P = .89). Given the prespecified noninferiority margin of 24%, we were unable to demonstrate noninferiority of

  4. Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study

    Directory of Open Access Journals (Sweden)

    Scholten Pieter

    2007-07-01

    Full Text Available Abstract Background Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion. Methods/design Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS. Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures

  5. Surgery planning and navigation by laser lithography plastic replica. Features, clinical applications, and advantages

    International Nuclear Information System (INIS)

    Kihara, Tomohiko; Tanaka, Yuuko; Furuhata, Kentaro

    1995-01-01

    The use of three-dimensional replicas created using laserlithography has recently become popular for surgical planning and intraoperative navigation in plastic surgery and oral maxillofacial surgery. In this study, we investigated many clinical applications that we have been involved in regarding the production of three-dimensional replicas. We have also analyzed the features, application classes, and advantages of this method. As a result, clinical applications are categorized into three classes, which are 'three-dimensional shape recognition', 'simulated surgery', and 'template'. The distinct features of three-dimensional replicas are 'direct recognition', 'fast manipulation', and 'free availability'. Meeting the requirements of surgical planning and intraoperative navigation, they have produced satisfactory results in clinical applications. (author)

  6. Clinical results of salvage surgery in hypopharynx carcinoma after chemoradiotherapy

    International Nuclear Information System (INIS)

    Mitani, Hiroki; Gakibuchi, Masao; Asano, Takayuki; Sakurai, Hiroyuki; Kurita, Tomoyuki; Inoue, Youjiro

    2008-01-01

    The incidence of post-operative complications and treatment results of 60 cases of hypopharynx carcinoma receiving laryngo-pharyngo-esophagectomy followed by reconstruction with jejunum after chemoradiotherapy (CRT) from 1997 to 2006 in 6 hospitals was analyzed. The overall complication rate was 57%. There were 3 cases with carotid artery rupture (5%), 4 with jejunum necrosis (6%), 6 with major salivary fistula (10%), 8 with minor salivary fistula (13%), 8 with abscess alone (13%), 3 with trachea stoma necrosis (5%), and 3 with skin flap necrosis (5%). The death rate due to surgical complications was 3% (2/60). When the cases were divided into two groups, namely the cases with fistula and the cases without fistula, the number of days that permitted drinking was 18.1 in the latter and 81.8 in the former. The 5-year overall survival rate among all cases was 37%. We found that salvage surgery after CRT was effective for recurrent cases. These findings suggest that reconstruction with jejunum is a suitable type of operation with better surgical results. Care is required to reduce the incidence of post-operative complications. (author)

  7. Recent clinical innovations in thoracic surgery in Hong Kong.

    Science.gov (United States)

    Zhao, Ze-Rui; Li, Zheng; Situ, Dong-Rong; Ng, Calvin S H

    2016-08-01

    The concept of personalized medicine, which aims to provide patients with targeted therapies while greatly reducing surgical trauma, is gaining popularity among Asian clinicians. Single port video-assisted thoracic surgery (VATS) has rapidly gained popularity in Hong Kong for major lung resections, despite bringing new challenges such as interference between surgical instruments and insertion of the optical source through a single incision. Novel types of endocutters and thoracoscopes can help reduce the difficulties commonly encountered during single-port VATS. Our region has been the testing ground and has led the development of many of these innovations. Performing VATS, in particular single-port VATS in hybrid operating theatre helps to localise small pulmonary lesions with real-time images, thus increasing surgical accuracy and pushes the boundaries in treating subcentimeter diseases. Such approach may be assisted by use of electromagnetic navigational bronchoscopy in the same setting. In addition, sublobar resection can also be more individualised according to pathologic tumour subtype that require rapid intraoperative diagnostic test to guide appropriate surgical therapy. A focus on technology and innovation for large tumours that require chest wall resection and reconstructions have also been on going, with new materials and prostheses that may be tailored to each individual needs. The current paper reviews the literature pertaining to the above topics and discusses recent related innovations in Hong Kong, highlighting the study results and future perspectives.

  8. Timing and approaches in congenital cataract surgery: a four-year, two-layer randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jin-Chao Liu

    2017-12-01

    Full Text Available "AIM: To compare visual prognoses and postoperative adverse events of congenital cataract surgery performed at different times and using different surgical approaches. METHODS: In this prospective, randomized controlled trial, we recruited congenital cataract patients aged 3mo or younger before cataract surgery. Sixty-one eligible patients were randomly assigned to two groups according to surgical timing: a 3-month-old group and a 6-month-old group. Each eye underwent one of three randomly assigned surgical procedures, as follows: surgery A, lens aspiration (I/A; surgery B, lens aspiration with posterior continuous curvilinear capsulorhexis (I/A+PCCC; and surgery C, lens aspiration with posterior continuous curvilinear capsulorhexis and anterior vitrectomy (I/A+PCCC+A-Vit. The long-term best-corrected visual acuity (BCVA and the incidence of complications in the different groups were compared and analyzed. RESULTS: A total of 57 participants (114 eyes with a mean follow-up period of 48.7mo were included in the final analysis. The overall logMAR BCVA in the 6-month-old group was better than that in the 3-month-old group (0.81±0.28 vs 0.96±0.30; P=0.02. The overall logMAR BCVA scores in the surgery B group were lower than the scores in the A and C groups (A: 0.80±0.29, B: 1.02±0.28, and C: 0.84±0.28; P=0.007. A multivariate linear regression revealed no significant relationships between the incidence of complications and long-term BCVA. CONCLUSION: It might be safer and more beneficial for bilateral total congenital cataract patients to undergo surgery at 6mo of age than 3mo. Moreover, with rigorous follow-up and timely intervention, the postoperative complications in these patients are treatable and do not compromise visual outcomes."

  9. Randomized multicentre feasibility trial of intermediate care versus standard ward care after emergency abdominal surgery (InCare trial)

    DEFF Research Database (Denmark)

    Vester-Andersen, M; Waldau, T; Wetterslev, J

    2015-01-01

    BACKGROUND: Emergency abdominal surgery carries a considerable risk of death and postoperative complications. Early detection and timely management of complications may reduce mortality. The aim was to evaluate the effect and feasibility of intermediate care compared with standard ward care...... ward within 24 h of emergency abdominal surgery. Participants were randomized to either intermediate care or standard surgical ward care after surgery. The primary outcome was 30-day mortality. RESULTS: In total, 286 patients were included in the modified intention-to-treat analysis. The trial...... was terminated after the interim analysis owing to slow recruitment and a lower than expected mortality rate. Eleven (7·6 per cent) of 144 patients assigned to intermediate care and 12 (8·5 per cent) of 142 patients assigned to ward care died within 30 days of surgery (odds ratio 0·91, 95 per cent c.i. 0·38 to 2...

  10. Infections in orthopaedic surgery : clinical and experimental studies

    NARCIS (Netherlands)

    Vogely, Henri Charles

    2000-01-01

    The diagnostic difficulties, variability in outcome and the heterogeinity of the problem of orthopaedic infections stimulated the author to a study of the literature, and several clinical and experimental studies. The diagnosis prosthesis-related infection can only be reached with an acceptable

  11. The Effect of Dexamethasone on Symptoms of Posttraumatic Stress Disorder and Depression After Cardiac Surgery and Intensive Care Admission: Longitudinal Follow-Up of a Randomized Controlled Trial.

    Science.gov (United States)

    Kok, Lotte; Hillegers, Manon H; Veldhuijzen, Dieuwke S; Cornelisse, Sandra; Nierich, Arno P; van der Maaten, Joost M; Rosseel, Peter M; Hofland, Jan; Sep, Milou S; Dieleman, Jan M; Vinkers, Christiaan H; Peelen, Linda M; Joëls, Marian; van Dijk, Diederik

    2016-03-01

    Cardiac surgery and postoperative admission to the ICU may lead to posttraumatic stress disorder and depression. Perioperatively administered corticosteroids potentially alter the risk of development of these psychiatric conditions, by affecting the hypothalamic-pituitary-adrenal axis. However, findings of previous studies are inconsistent. We aimed to assess the effect of a single dose of dexamethasone compared with placebo on symptoms of posttraumatic stress disorder and depression and health-related quality of life after cardiac surgery and ICU admission. Follow-up study of a randomized clinical trial. Five Dutch heart centers. Cardiac surgery patients (n = 1,244) who participated in the Dexamethasone for Cardiac Surgery trial. A single intraoperative IV dose of dexamethasone or placebo was administered in a randomized, double-blind way. Symptoms of posttraumatic stress disorder, depression, and health-related quality of life were assessed with validated questionnaires 1.5 years after randomization. Data were available for 1,125 patients (90.4%); of which 561 patients received dexamethasone and 564 patients received placebo. Overall, the prevalence of psychopathology was not influenced by dexamethasone. Posttraumatic stress disorder and depression were present in, respectively, 52 patients (9.3%) and 69 patients (12.3%) who received dexamethasone and in 66 patients (11.7%) and 78 patients (13.8%) who received placebo (posttraumatic stress disorder: odds ratio, 0.82; 95% CI, 0.55-1.20; p = 0.30; depression: odds ratio, 0.92; 95% CI, 0.64-1.31; p = 0.63). Subgroup analysis revealed a lower prevalence of posttraumatic stress disorder (odds ratio, 0.23; 95% CI, 0.07-0.72; p stress disorder and depression. However, in female patients, beneficial effects on the occurrence of posttraumatic stress disorder and depression may be present.

  12. Clinical Factors Associated with Dose of Loop Diuretics After Pediatric Cardiac Surgery: Post Hoc Analysis.

    Science.gov (United States)

    Haiberger, Roberta; Favia, Isabella; Romagnoli, Stefano; Cogo, Paola; Ricci, Zaccaria

    2016-06-01

    A post hoc analysis of a randomized controlled trial comparing the clinical effects of furosemide and ethacrynic acid was conducted. Infants undergoing cardiac surgery with cardiopulmonary bypass were included in order to explore which clinical factors are associated with diuretic dose in infants with congenital heart disease. Overall, 67 patients with median (interquartile range) age of 48 (13-139) days were enrolled. Median diuretic dose was 0.34 (0.25-0.4) mg/kg/h at the end of postoperative day (POD) 0 and it significantly decreased (p = 0.04) over the following PODs; during this period, the ratio between urine output and diuretic dose increased significantly (p = 0.04). Age (r -0.26, p = 0.02), weight (r -0.28, p = 0.01), cross-clamp time (r 0.27, p = 0.03), administration of ethacrynic acid (OR 0.01, p = 0.03), and, at the end of POD0, creatinine levels (r 0.3, p = 0.009), renal near-infrared spectroscopy saturation (-0.44, p = 0.008), whole-blood neutrophil gelatinase-associated lipocalin levels (r 0.30, p = 0.01), pH (r -0.26, p = 0.02), urinary volume (r -0.2755, p = 0.03), and fluid balance (r 0.2577, p = 0.0266) showed a significant association with diuretic dose. At multivariable logistic regression cross-clamp time (OR 1.007, p = 0.04), use of ethacrynic acid (OR 0.2, p = 0.01) and blood pH at the end of POD0 (OR 0.0001, p = 0.03) was independently associated with diuretic dose. Early resistance to loop diuretics continuous infusion is evident in post-cardiac surgery infants: Higher doses are administered to patients with lower urinary output. Independently associated variables with diuretic dose in our population appeared to be cross-clamping time, the administration of ethacrynic acid, and blood pH.

  13. Couple-Based Psychosexual Support Following Prostate Cancer Surgery: Results of a Feasibility Pilot Randomized Control Trial.

    Science.gov (United States)

    Robertson, Jane; McNamee, Phillip; Molloy, Gerry; Hubbard, Gill; McNeill, Alan; Bollina, Prasad; Kelly, Daniel; Forbat, Liz

    2016-08-01

    Surgery for prostate cancer can result in distressing side effects such as sexual difficulties, which are associated with lower levels of dyadic functioning. The study developed and tested an intervention to address sexual, relational, and emotional aspects of the relationship after prostate cancer by incorporating elements of family systems theory and sex therapy. To develop and test the feasibility and acceptability of relational psychosexual treatment for couples with prostate cancer, determine whether a relational-psychosexual intervention is feasible and acceptable for couples affected by prostate cancer, and determine the parameters for a full-scale trial. Forty-three couples were recruited for this pilot randomized controlled trial and received a six-session manual-based psychosexual intervention or usual care. Outcomes were measured before, after, and 6 months after the intervention. Acceptability and feasibility were established from recruitment and retention rates and adherence to the manual. The primary outcome measurement was the sexual bother subdomain of the Expanded Prostate Cancer Index Composite. The Hospital Anxiety and Depression Scale and the 15-item Systemic Clinical Outcome and Routine Evaluation (SCORE-15) were used to measure emotional and relational functioning, respectively. The intervention was feasible and acceptable. The trial achieved adequate recruitment (38%) and retention (74%) rates. The intervention had a clinically and statistically significant effect on sexual bother immediately after the intervention. Small decreases in anxiety and depression were observed for the intervention couples, although these were not statistically significant. Practitioners reported high levels of adherence to the manual. The clinically significant impact on sexual bother and positive feedback on the study's feasibility and acceptability indicate that the intervention should be tested in a multicenter trial. The SCORE-15 lacked specificity for this

  14. Using an International Medical Advisory Board to guide clinical governance in a corporate refractive surgery model.

    Science.gov (United States)

    Vukich, John A

    2009-07-01

    To describe the role played by the International Medical Advisory Board (IMAB) in clinical and corporate governance at Optical Express, a corporate provider of refractive surgery. A review of goals, objectives, and actions of the IMAB. The IMAB has contributed to study design, data analysis, and selection of instruments and procedures. Through interactions with Optical Express corporate and clinical staff, the IMAB has supported management's effort to craft a corporate culture focused on continuous improvement in the safety and visual outcomes of refractive surgery. The IMAB has fashioned significant changes in corporate policies and procedures and has had an impact on corporate culture at Optical Express.

  15. Clinical impact of anatomo-functional evaluation of brain function during brain tumor surgery

    International Nuclear Information System (INIS)

    Mikuni, Nobuhiro; Kikuchi, Takayuki; Matsumoto, Atsushi; Yokoyama, Yohei; Takahashi, Jun; Hashimoto, Nobuo

    2009-01-01

    To attempt to improve surgical outcome of brain surgery, clinical significance of anatomo-functional evaluation of brain function during resection of brain tumors was assessed. Seventy four patients with glioma located near eloquent areas underwent surgery while awake. Intraoperative tractography-integrated functional neuronavigation and cortical/subcortical electrical stimulation were correlated with clinical symptoms during and after resection of tumors. Cortical functional areas were safely removed with negative electric stimulation and eloquent cortices could be removed in some circumstances. Subcortical functional mapping was difficult except for motor function. Studying cortical functional compensation allows more extensive removal of brain tumors located in the eloquent areas. (author)

  16. Single-Incision Transumbilical Surgery (SITUS) versus Single-Port Laparoscopic Surgery and conventional laparoscopic surgery: a prospective randomized comparative study of performance with novices in a dry laboratory.

    Science.gov (United States)

    Schoenthaler, Martin; Avcil, Tuba; Sevcenco, Sabina; Nagele, Udo; Hermann, Thomas E W; Kuehhas, Franklin E; Shariat, Shahrokh F; Frankenschmidt, Alexander; Wetterauer, Ulrich; Miernik, Arkadiusz

    2015-01-01

    To evaluate the Single-Incision Transumbilical Surgery (SITUS) technique as compared to an established laparoendoscopic single-site surgery (LESS) technique (Single-Port Laparoscopic Surgery, SPLS) and conventional laparoscopy (CLS) in a surgical simulator model. Sixty-three medical students without previous laparoscopic experience were randomly assigned to one of the three groups (SITUS, SPLS and CLS). Subjects were asked to perform five standardized tasks of increasing difficulty adopted from the Fundamentals of Laparoscopic Surgery curriculum. Statistical evaluation included task completion times and accuracy. Overall performances of all tasks (except precision cutting) were significantly faster and of higher accuracy in the CLS and SITUS groups than in the SPLS group (p = 0.004 to p port-assisted LESS technique such as SPLS. The demonstrated advantages of SITUS may be attributed to a preservation of the basic principles of conventional laparoscopy, such as the use of straight instruments and an adequate degree of triangulation.

  17. Autologous fibrin sealant reduces the incidence of prolonged air leak and duration of chest tube drainage after lung volume reduction surgery: a prospective randomized blinded study.

    Science.gov (United States)

    Moser, C; Opitz, I; Zhai, W; Rousson, V; Russi, E W; Weder, W; Lardinois, D

    2008-10-01

    Prolonged air leak is reported in up to 50% of patients after lung volume reduction surgery. The effect of an autologous fibrin sealant on the intensity and duration of air leak and on the time to chest drain removal after lung volume reduction surgery was investigated in a randomized prospective clinical trial. Twenty-five patients underwent bilateral thoracoscopic lung volume reduction surgery. In each patient, an autologous fibrin sealant was applied along the staple lines on one side, whereas no additional measure was taken on the other side. Randomization of treatment was performed at the end of the resection on the first side. Air leak was assessed semiquantitatively by use of a severity score (0 = no leak; 4 = continuous severe leak) by two investigators blinded to the treatment. Mean value of the total severity scores for the first 48 hours postoperative was significantly lower in the treated group (4.7 +/- 7.7) than in the control group (16.0 +/- 10.1) (P drainage were also significantly reduced after application of the sealant (4.5% and 2.8 +/- 1.9 days versus 31.8% and 5.9 +/- 2.9 days) (P = .03 and P drainage.

  18. A randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery.

    Science.gov (United States)

    Leurcharusmee, Prangmalee; Elgueta, Maria Francisca; Tiyaprasertkul, Worakamol; Sotthisopha, Thitipan; Samerchua, Artid; Gordon, Aida; Aliste, Julian; Finlayson, Roderick J; Tran, De Q H

    2017-06-01

    This two-centre randomized trial compared costoclavicular and paracoracoid ultrasound-guided infraclavicular brachial plexus block in patients undergoing upper limb surgery. We hypothesized that both techniques would result in similar onset times and designed the study as an equivalence trial. Ninety patients undergoing upper limb surgery at or distal to the elbow were randomly allocated to receive a costoclavicular (n = 45) or paracoracoid (n = 45) ultrasound-guided infraclavicular brachial plexus block. Both groups received a 35-mL mixture of 1% lidocaine-0.25% bupivacaine with epinephrine 5 µg·mL -1 . In the costoclavicular group, local anesthetic was injected into the costoclavicular space in the middle of the three cords of the brachial plexus. In the paracoracoid group, local anesthetic was deposited dorsal to the axillary artery in the lateral infraclavicular fossa. A blinded observer recorded the block onset time (primary endpoint), success rate (i.e., surgical anesthesia), block-related pain scores, as well as the incidence of hemidiaphragmatic paralysis. Performance time and the number of needle passes were also recorded during the performance of the block. The total anesthesia-related time was defined as the sum of the performance and onset times. The mean (SD) onset times were comparable between the costoclavicular and paracoracoid groups [16.0 (7.5) min vs 16.8 (6.2) min, respectively; mean difference, 0.8; 95% confidence interval, -2.3 to 3.8; P = 0.61]. Furthermore, no intergroup differences were found in terms of performance time (P = 0.09), total anesthesia-related time (P = 0.90), surgical anesthesia (P > 0.99), and hemidiaphragmatic paralysis (P > 0.99). The paracoracoid technique required marginally fewer median [interquartile range] needle passes than the costoclavicular technique (2 [1-4] vs 2 [1-6], respectively; P = 0.048); however, procedural pain was comparable between the two study groups. Costoclavicular and paracoracoid ultrasound

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

    International Nuclear Information System (INIS)

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

    2016-01-01

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

  20. Comparison of palonosetron, granisetron, and ramosetron for the prevention of postoperative nausea and vomiting after laparoscopic gynecologic surgery: a prospective randomized trial.

    Science.gov (United States)

    Lee, Won-Suk; Lee, Kwang-Beom; Lim, Soyi; Chang, Young Gin

    2015-09-03

    Selective 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists are reported to have potent antiemetic effects for postoperative nausea and vomiting (PONV). The purpose of this study was to prospectively evaluate the efficacy of palonosetron, granisetron, and ramosetron for the prevention of PONV in patients undergoing laparoscopic gynecologic surgery. In this prospective, randomized observational study, 105 healthy female patients who were undergoing laparocopic hystectomy under general anaesthesia were enrolled (clinical trial number: NCT01752374, www.clinicaltrials.gov ). Patients were divided into three groups: the palonostron (0.075 mg i.v.; n = 35), the granisetron group (3 mg i.v.; n = 35), and the ramosetron group (0.3 mg i.v.; n = 35). The treatments were given before the end of surgery. The incidence of PONV, severity of nausea/vomiting, and the use of rescue antiemetic requirements during the first 48 h after surgery were evaluated. The overall incidence of PONV was 33.3 % for this series. The number of complete responders at 48 h after the surgery was 21 (60.0 %) for palonosetron, 24 (68.6 %) for granisetron, and 26 (71.4 %) for ramosetron, representing no statistical difference (P = 0.086). There were no significant differences in the overall incidence of postoperative nausea and vomiting and complete responders for palonosetron, granisetron and ramosetron group. NCT01752374 , www.clinicaltrials.gov .

  1. Pregabalin as a perioperative strategy for pain management in patients undergoing cosmetic surgery. A randomized, double-blind, and placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Lorena Duque

    2008-11-01

    Full Text Available BACKGROUND: Preoperative Gabapentin has demonstrated to be as analgesic strategy in the control of perioperative pain. Pregabalin -an analogue of Gabapentin- has only a few trials demonstrating its effectiveness on this clinical setting. We wanted to assess the effectiveness of pregabalin given not only as a single dose in the preoperative period, but also continuing its administration 75 mg bid up to the fourth day after surgery. METHODS: Previous consent by the Ethical Committee of the University, we enrolled 110 patients undergoing ambulatory liposuction. They were randomized and blindedallocated to receive Pregabalin (75 mg bid versus placebo, starting 12 hours before surgery up to the fourth day after surgery. We use the postoperative pain intensity by numerical rating scale, pain intensity by categorical pain scale and tramadol-ibuprofen request as primary outcomes. RESULTS: We had 9 dropouts during the recruitment and follow up. 24 hours after surgery we had 18/51 (35.3% versus 16/50 (32% (p=0.7. We also found no difference in opioid request at the same time point, being 6.3 mg morphine equivalents in the pregabalin versus 6.7 mg in the Placebo Group. Subsequent evaluations at 48, 72 and 96 hours demonstrated no difference between groups for analgesic request and pain intensity. CONCLUSION: Perioperative use of Pregabalin (75 mg bid does not offer benefit as analgesic strategy in terms of pain intensity and opioid requirement in patients undergoing cosmetic liposuction.

  2. The conflict between randomized clinical trials and the therapeutic obligation.

    Science.gov (United States)

    Gifford, F

    1986-11-01

    The central dilemma concerning randomized clinical trials (RCTs) arises out of some simple facts about causal methodology (RCTs are the best way to generate the reliable causal knowledge necessary for optimally-informed action) and a prima facie plausible principle concerning how physicians should treat their patients (always do what it is most reasonable to believe will be best for the patient). A number of arguments related to this in the literature are considered. Attempts to avoid the dilemma fail. Appeals to informed consent and mechanisms for minimizing the resulting harm are important for policy, but informed consent is problematic and mechanisms for minimization of harm do not address the dilemma. Appeals to some sort of contract model of justification are promising and illuminating.

  3. Philosophers assess randomized clinical trials: the need for dialogue.

    Science.gov (United States)

    Miké, V

    1989-09-01

    In recent years a growing number of professional philosophers have joined in the controversy over ethical aspects of randomized clinical trials (RCTs). Morally questionable in their utilitarian approach, RCTs are claimed by some to be in direct violation of the second form of Kant's Categorical Imperative. But the arguments used in these critiques at times derive from a lack of insight into basic statistical procedures and the realities of the biomedical research process. Presented to physicians and other nonspecialists, including the lay public, such distortions can be harmful. Given the great complexity of statistical methodology and the anomalous nature of concepts of evidence, more sustained input into the interdisciplinary dialogue is needed from the statistical profession.

  4. Generalizing Evidence From Randomized Clinical Trials to Target Populations

    Science.gov (United States)

    Cole, Stephen R.; Stuart, Elizabeth A.

    2010-01-01

    Properly planned and conducted randomized clinical trials remain susceptible to a lack of external validity. The authors illustrate a model-based method to standardize observed trial results to a specified target population using a seminal human immunodeficiency virus (HIV) treatment trial, and they provide Monte Carlo simulation evidence supporting the method. The example trial enrolled 1,156 HIV-infected adult men and women in the United States in 1996, randomly assigned 577 to a highly active antiretroviral therapy and 579 to a largely ineffective combination therapy, and followed participants for 52 weeks. The target population was US people infected with HIV in 2006, as estimated by the Centers for Disease Control and Prevention. Results from the trial apply, albeit muted by 12%, to the target population, under the assumption that the authors have measured and correctly modeled the determinants of selection that reflect heterogeneity in the treatment effect. In simulations with a heterogeneous treatment effect, a conventional intent-to-treat estimate was biased with poor confidence limit coverage, but the proposed estimate was largely unbiased with appropriate confidence limit coverage. The proposed method standardizes observed trial results to a specified target population and thereby provides information regarding the generalizability of trial results. PMID:20547574

  5. Bariatric Surgery in the United Kingdom: A Cohort Study of Weight Loss and Clinical Outcomes in Routine Clinical Care

    Science.gov (United States)

    Douglas, Ian J.; Bhaskaran, Krishnan; Batterham, Rachel L.; Smeeth, Liam

    2015-01-01

    Background Bariatric surgery is becoming a more widespread treatment for obesity. Comprehensive evidence of the long-term effects of contemporary surgery on a broad range of clinical outcomes in large populations treated in routine clinical practice is lacking. The objective of this study was to measure the association between bariatric surgery, weight, body mass index, and obesity-related co-morbidities. Methods and Findings This was an observational retrospective cohort study using data from the United Kingdom Clinical Practice Research Datalink. All 3,882 patients registered in the database and with bariatric surgery on or before 31 December 2014 were included and matched by propensity score to 3,882 obese patients without surgery. The main outcome measures were change in weight and body mass index over 4 y; incident diagnoses of type 2 diabetes mellitus (T2DM), hypertension, angina, myocardial infarction (MI), stroke, fractures, obstructive sleep apnoea, and cancer; mortality; and resolution of hypertension and T2DM. Weight measures were available for 3,847 patients between 1 and 4 mo, 2,884 patients between 5 and 12 mo, and 2,258 patients between 13 and 48 mo post-procedure. Bariatric surgery patients exhibited rapid weight loss for the first four postoperative months, at a rate of 4.98 kg/mo (95% CI 4.88–5.08). Slower weight loss was sustained to the end of 4 y. Gastric bypass (6.56 kg/mo) and sleeve gastrectomy (6.29 kg/mo) were associated with greater initial weight reduction than gastric banding (2.77 kg/mo). Protective hazard ratios (HRs) were detected for bariatric surgery for incident T2DM, 0.68 (95% CI 0.55–0.83); hypertension, 0.35 (95% CI 0.27–0.45); angina, 0.59 (95% CI 0.40–0.87);MI, 0.28 (95% CI 0.10–0.74); and obstructive sleep apnoea, 0.55 (95% CI 0.40–0.87). Strong associations were found between bariatric surgery and the resolution of T2DM, with a HR of 9.29 (95% CI 6.84–12.62), and between bariatric surgery and the resolution of

  6. Effects of preoperative ultrasound-guided transversus abdominis plane block on pain after laparoscopic surgery for colorectal cancer: a double-blind randomized controlled trial.

    Science.gov (United States)

    Oh, Tak Kyu; Yim, Jiyeon; Kim, Jaehyun; Eom, Woosik; Lee, Soon Ae; Park, Sung Chan; Oh, Jae Hwan; Park, Ji Won; Park, Boram; Kim, Dae Hyun

    2017-01-01

    Although laparoscopic colorectal surgery decreases postoperative pain and facilitates a speedier recovery compared with laparotomy, postoperative pain at trocar insertion sites remains a clinical concern. The objective of this study was to assess the effects of a preoperative ultrasound-guided transversus abdominis plane (TAP) block on pain after laparoscopic surgery for colorectal cancer. In total, 58 patients scheduled to undergo laparoscopic surgery following a diagnosis of colorectal cancer were included in this study. The patients were randomized into TAP and control groups; the TAP group patients received a preoperative ultrasound-guided bilateral TAP block with 0.5 mL/kg of 0.25 % bupivacaine, while the control patients received the block with an equal amount of saline. Pain on coughing and at rest was assessed during postanesthetic recovery (PAR; 1 h after surgery) and on postoperative days (PODs) 1 (24 h), 2 (48 h), and 3 (72 h) by an investigator blinded to group allocations using the numeric rating scale (NRS). The primary outcome was pain on coughing on postoperative day (POD) 1. Fifty-five patients were included in the final analysis, including 28 in the TAP and 27 in the control groups. The pain intensity on coughing and at rest during PAR and on PODs 1, 2, and 3 showed no significant differences between groups. Furthermore, there was no significant difference in postoperative opioid consumption, sedation scores, nausea scores at the four time points, complication rates, and length of hospital stay between groups. In colorectal cancer patients undergoing laparoscopic colorectal surgery, a TAP block did not offer enough benefit for clinical efficacy in terms of postoperative pain or analgesic consumption.

  7. Development and implementation of a clinical pathway approach to simulation-based training for foregut surgery.

    Science.gov (United States)

    Miyasaka, Kiyoyuki W; Buchholz, Joseph; LaMarra, Denise; Karakousis, Giorgos C; Aggarwal, Rajesh

    2015-01-01

    Contemporary demands on resident education call for integration of simulation. We designed and implemented a simulation-based curriculum for Post Graduate Year 1 surgery residents to teach technical and nontechnical skills within a clinical pathway approach for a foregut surgery patient, from outpatient visit through surgery and postoperative follow-up. The 3-day curriculum for groups of 6 residents comprises a combination of standardized patient encounters, didactic sessions, and hands-on training. The curriculum is underpinned by a summative simulation "pathway" repeated on days 1 and 3. The "pathway" is a series of simulated preoperative, intraoperative, and postoperative encounters in following up a single patient through a disease process. The resident sees a standardized patient in the clinic presenting with distal gastric cancer and then enters an operating room to perform a gastrojejunostomy on a porcine tissue model. Finally, the resident engages in a simulated postoperative visit. All encounters are rated by faculty members and the residents themselves, using standardized assessment forms endorsed by the American Board of Surgery. A total of 18 first-year residents underwent this curriculum. Faculty ratings of overall operative performance significantly improved following the 3-day module. Ratings of preoperative and postoperative performance were not significantly changed in 3 days. Resident self-ratings significantly improved for all encounters assessed, as did reported confidence in meeting the defined learning objectives. Conventional surgical simulation training focuses on technical skills in isolation. Our novel "pathway" curriculum targets an important gap in training methodologies by placing both technical and nontechnical skills in their clinical context as part of managing a surgical patient. Results indicate consistent improvements in assessments of performance as well as confidence and support its continued usage to educate surgery residents

  8. Complications of nonbiliary laparoscopic gastrointestinal surgery : Radiologic findings and clinical courses

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    Jung, Seon Ah; Lee, Sang Hoon; Won, Yong Sung; Park, Young Ha; Kim, Jun Gi [St. Vincent' s Hospital, College of Medicine, The Catholic University, Suwon (Korea, Republic of); Kim, Hyun [St. Mary' s Hospital, College of Medicine, The Catholic University, Taejon (Korea, Republic of)

    2000-05-01

    To evaluate the radiological findings and clinical course of the complications arising after nonbiliay laparoscopic gastrointestinal surgery (NLGS). We retrospectively reviewed the clinical records of 131 patients who underwent NLGS (83 cases involving colorectal surgery, 18 splenectomies, 14 appendectomies, ten adrenalectomies, three lumbar sympathectomies, two Duhamel's operation, and one peptic ulcer perforation repair) over a four-year period. Among these 131 patients, the findings of fifteen in whom postoperative complications were confirmed were analysed. The radiologic examinations these patients underwent included CT (n=3D8), barium enema and fistulography (n=3D4), ultrasonography (n=3D3), ascending venography of the lower legs (n=3D2), and penile Doppler sonography (n=3D1). We evaluated the radiologic findings and clinical courses of early (within 2 weeks) and late (after 2 weeks) postoperative complications. Sixteen cases of postoperative complications developed in fifteen patients ; in 14 (17%) after colorectal surgery and in one (6%) after splenectomy. Eleven of the sixteen cases (69%) involved early complications, consisting of an abscess in three, ischemic colitis in two, hemoperitoneum in one, perforation of the colon in one, pancreatitis in one, recto-vaginal fistula in one, deep vein thrombosis after colorectal surgery in one, and abscess after splenectomy in one. The remaining five cases (31%) involved late complications which developed after colorectal surgery, comprising anastomosic site stricture in two, abdominal wall (trocar site) metastasis in one, colo-cutaneous fistula in one, and impotence in one. Among the 16 cases involving postoperative complications, recto-vaginal fistula, colon perforation, and abdominal wall metastasis were treated by surgery, while the other thirteen cases were treated conservatively. Various postoperative complications develop after NLGS, with a higher rate of these being noted in cases involving colorectal

  9. Complications of nonbiliary laparoscopic gastrointestinal surgery : Radiologic findings and clinical courses

    International Nuclear Information System (INIS)

    Jung, Seon Ah; Lee, Sang Hoon; Won, Yong Sung; Park, Young Ha; Kim, Jun Gi; Kim, Hyun

    2000-01-01

    To evaluate the radiological findings and clinical course of the complications arising after nonbiliay laparoscopic gastrointestinal surgery (NLGS). We retrospectively reviewed the clinical records of 131 patients who underwent NLGS (83 cases involving colorectal surgery, 18 splenectomies, 14 appendectomies, ten adrenalectomies, three lumbar sympathectomies, two Duhamel's operation, and one peptic ulcer perforation repair) over a four-year period. Among these 131 patients, the findings of fifteen in whom postoperative complications were confirmed were analysed. The radiologic examinations these patients underwent included CT (n=3D8), barium enema and fistulography (n=3D4), ultrasonography (n=3D3), ascending venography of the lower legs (n=3D2), and penile Doppler sonography (n=3D1). We evaluated the radiologic findings and clinical courses of early (within 2 weeks) and late (after 2 weeks) postoperative complications. Sixteen cases of postoperative complications developed in fifteen patients ; in 14 (17%) after colorectal surgery and in one (6%) after splenectomy. Eleven of the sixteen cases (69%) involved early complications, consisting of an abscess in three, ischemic colitis in two, hemoperitoneum in one, perforation of the colon in one, pancreatitis in one, recto-vaginal fistula in one, deep vein thrombosis after colorectal surgery in one, and abscess after splenectomy in one. The remaining five cases (31%) involved late complications which developed after colorectal surgery, comprising anastomosic site stricture in two, abdominal wall (trocar site) metastasis in one, colo-cutaneous fistula in one, and impotence in one. Among the 16 cases involving postoperative complications, recto-vaginal fistula, colon perforation, and abdominal wall metastasis were treated by surgery, while the other thirteen cases were treated conservatively. Various postoperative complications develop after NLGS, with a higher rate of these being noted in cases involving colorectal

  10. Intrathecal sufentanil versus fentanyl for lower limb surgeries - A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Poonam Motiani

    2011-01-01

    Full Text Available Background:To compare the efficacy and safety of intrathecal sufentanil or fentanyl as adjuvants to hyperbaric bupivacaine in patients undergoing major orthopaedic lower limb surgeries in terms of onset and duration of sensory block, motor block and post-operative pain relief. Patients & Methods: Ninety patients were recruited in this Prospective, randomized double blind study to receive either intrathecal sufentanil 5 μg (Group S, fentanyl 25 μg (Group F or normal saline 0.5 ml (Group C as adjuvants to 15 mg of 0.5% hyperbaric bupivacaine. The onset and duration of sensory and motor block were assessed intraoperatively. The pain scores were assessed postoperatively. Duration of complete and effective analgesia was recorded. The incidence of side effects such as nausea, vomiting, pruritus, shivering and PDPH was recorded. Results: The Demographic data, hemodynamic and respiratory parameters were comparable in the three groups. There was a significantly earlier onset and prolonged duration of sensory block in the sufentanil and fentanyl groups. The duration of complete and effective analgesia were also significantly prolonged in the fentanyl and sufentanil groups. Pruritus was noticed in the study groups (Groups S&F. Conclusions: Intrathecal sufentanil (5 μg and fentanyl (25 μg, as adjuvants lead to an earlier onset and prolonged duration of sensory block. The duration of effective analgesia with intrathecal sufentanil and fentanyl as adjuvants to hyperbaric bupivacaine is longer than that of bupivacaine alone.

  11. A randomized trial of prewarming on patient satisfaction and thermal comfort in outpatient surgery.

    Science.gov (United States)

    Akhtar, Zohaib; Hesler, Brian D; Fiffick, Alexa N; Mascha, Edward J; Sessler, Daniel I; Kurz, Andrea; Ayad, Sabry; Saager, Leif

    2016-09-01

    To test the primary hypothesis that forced-air prewarming improves patient satisfaction after outpatient surgery and to evaluate the effect on core temperature and thermal comfort. Prospective randomized controlled trial. Preoperative area, operating room, and postanesthesia care unit. A total of 115 patients aged 18 to 75 years with American Society of Anesthesiologists status thermal comfort via visual analog scales. Data from 102 patients were included in the final analysis. Prewarming did not significantly reduce redistribution hypothermia, with prewarmed minus not prewarmed core temperature differing by only 0.18°C (95% confidence interval [CI], -0.001 to 0.37) during the initial hour of anesthesia (P=.052). Prewarming increased the mean EVAN-G satisfaction score, although not significantly, with an overall difference (prewarmed minus not prewarmed) of 5.6 (95% CI, -0.9 to 12.2; P=.09). Prewarming increased thermal comfort, with an overall difference of 6.6 mm (95% CI, 1.0-12.9; P=.02). Active prewarming increased thermal comfort but did not significantly reduce redistribution hypothermia or improve postoperative patient satisfaction. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Supplemental Peri-Operative Oxygen and Incision Site Infection after Surgery for Perforated Peptic Ulcer: A Randomized, Double-Blind Monocentric Trial.

    Science.gov (United States)

    Schietroma, Mario; Cecilia, Emanuela Marina; De Santis, Giuseppe; Carlei, Francesco; Pessia, Beatrice; Amicucci, Gianfranco

    2016-02-01

    The clinical role of hyperoxia for preventing surgical site infection (SSI) remains uncertain because randomized controlled trials on this topic have reported disparate results. One of the principal reasons for this outcome may be that prior trials have entered heterogeneous populations of patients and a variety of procedures. The aim of our study was to assess the influence of hyperoxygenation on SSI using a homogeneous study population. From January 2004 to April 2013, we studied, in a randomized trial, 239 patients, who underwent open surgery for perforated peptic ulcer (PPU). The surgical procedure was performed through an upper abdominal midline incision, and closure of PPU was achieved by suture alone or in combination with an omental patch. Patients were assigned randomly to an oxygen/air mixture with a fraction of inspired oxygen (FiO2) of 30% (n = 120) or 80% (n = 119). Administration was commenced after induction of anesthesia and maintained for 6 hours after surgery. The overall incision infection rate was 38.4% (92 of 239): 61 patients (50.8%) had an infection in the 30% FiO2 group and 31 (26%) in the 80% FiO2 group (p operative SSI, should be considered part of ongoing quality improvement activities related to surgical care, with few risks to the patient and little associated cost.

  13. Significance of Objective Structured Clinical Examinations to Plastic Surgery Residency Training.

    Science.gov (United States)

    Simmons, Brian J; Zoghbi, Yasmina; Askari, Morad; Birnbach, David J; Shekhter, Ilya; Thaller, Seth R

    2017-09-01

    Objective structured clinical examinations (OSCEs) have proven to be a powerful tool. They possess more than a 30-year track record in assessing the competency of medical students, residents, and fellows. Objective structured clinical examinations have been used successfully in a variety of medical specialties, including surgery. They have recently found their way into the subspecialty of plastic surgery. This article uses a systematic review of the available literature on OSCEs and their recent use in plastic surgery. It incorporates survey results assessing program directors' views on the use of OSCEs. Approximately 40% of programs surveyed use OSCEs to assess the Accreditation Council for Graduate Medical Education core competencies. We found that 40% use OSCEs to evaluate specific plastic surgery milestones. Objective structured clinical examinations are usually performed annually. They cost anywhere between $100 and more than $1000 per resident. Four milestones giving residents the most difficulties on OSCEs were congenital anomalies, noncancer breast surgery, breast reconstruction, and practice-based learning and improvement. It was determined that challenges with milestones were due to lack of adequate general knowledge and surgical ward patient care, as well as deficits in professionalism and system-based problems. Programs were able to remediate weakness found by OSCEs using a variety of methods. Objective structured clinical examinations offer a unique tool to objectively assess the proficiency of residents in key areas of the Accreditation Council for Graduate Medical Education core competencies. In addition, they can be used to assess the specific milestones that plastic surgery residents must meet. This allows programs to identify and improve identified areas of weakness.

  14. Comparison of clinical parameters and environmental noise levels between regular surgery and piezosurgery for extraction of impacted third molars.

    Science.gov (United States)

    Chang, Hao-Hueng; Lee, Ming-Shu; Hsu, You-Chyun; Tsai, Shang-Jye; Lin, Chun-Pin

    2015-10-01

    Impacted third molars can be extracted by regular surgery or piezosurgery. The aim of this study was to compare clinical parameters and device-produced noise levels between regular surgery and piezosurgery for the extraction of impacted third molars. Twenty patients (18 women and 2 men, 17-29 years of age) with bilateral symmetrical impacted mandibular or maxillary third molars of the same level were included in this randomized crossover clinical trial. The 40 impacted third molars were divided into a control group (n = 20), in which the third molar was extracted by regular surgery using a high-speed handpiece and an elevator, and an experimental group (n = 20), in which the third molar was extracted by piezosurgery using a high-speed handpiece and a piezotome. The clinical parameters were evaluated by a self-reported questionnaire. The noise levels produced by the high-speed handpiece and piezotome were measured and compared between the experimental and control groups. Patients in the experimental group had a better feeling about tooth extraction and force delivery during extraction and less facial swelling than patients in the control group. However, there were no significant differences in noise-related disturbance, extraction period, degree of facial swelling, pain score, pain duration, any noise levels produced by the devices under different circumstances during tooth extraction between the control and experimental groups. The piezosurgery device produced noise levels similar to or lower than those of the high-speed drilling device. However, piezosurgery provides advantages of increased patient comfort during extraction of impacted third molars. Copyright © 2014. Published by Elsevier B.V.

  15. Clinical and radiographic outcome of revision surgery of radial head prostheses: midterm results in 16 patients

    NARCIS (Netherlands)

    Viveen, Jetske; Kodde, Izaäk F.; Koenraadt, Koen L. M.; Beumer, Annechien; The, Bertram; Eygendaal, Denise

    2017-01-01

    Little is known about revision surgery of radial head arthroplasty. The aim of this study was to report on the clinical and radiographic outcome of revision arthroplasty of the elbow with a bipolar metallic radial head prosthesis. Between 2006 and 2013, we used either a press-fit or cemented RHS

  16. Clinical evaluation of an automatic blood pressure controller during cardiac surgery

    NARCIS (Netherlands)

    Meijers, R.H.A.M.; Schmartz, D.; Cantraine, F.R.L.; Barvais, L.; d Hollander, A.A.; Blom, J.A.

    1997-01-01

    During surgery, computers can be of great use to support the anesthesiologist in providing task automation. In this paper we describe a closed loop blood pressure controller and show the results of its clinical evalua- tion.Methods. The controller is based on a simple and robust

  17. Identification of Best Practices for Resident Aesthetic Clinics in Plastic Surgery Training: The ACAPS National Survey

    Directory of Open Access Journals (Sweden)

    C. Scott Hultman, MD, MBA, FACS

    2015-03-01

    Conclusions: RACs are an important component of plastic surgery education. Most clinics are financially viable but carry high malpractice risk and consume significant resources. Best practices, to maximize patient safety and optimize resident education, include use of accredited procedural rooms and direct faculty supervision of all components of care.

  18. Towards patient-centered colorectal cancer surgery : focus on risks, decisions and clinical auditing

    NARCIS (Netherlands)

    Snijders, Heleen Simone

    2014-01-01

    The aim of this thesis was to explore several aspects of both clinical decision making and quality assessment in colorectal cancer surgery. Part one focusses on benefits and risks of treatment options, preoperative information provision and Shared Decision Making (SDM); part two investigates changes

  19. Combining Clinical Information and Patient Reported Outcome Measures in Orthopaedic Surgery and Sports Medicine

    NARCIS (Netherlands)

    Kampen, D.A. van

    2013-01-01

    In this thesis we investigated the use of clinical information and Patient Reported Outcome Measures (PROMs) for patient evaluation in orthopaedic surgery and sports medicine. In the first part, we showed that the Dutch version of the Simple Shoulder Test (SST) is a valid and reliable

  20. Surgery in sickle cell anemia | Fokam | Clinics in Mother and Child ...

    African Journals Online (AJOL)

    Sickle cell anemia is a hemoglobin disorder with a wide range of clinical manifestations and complications. Medical treatment is the mainstay of management but surgery is indicated in some cases. The authors review the main surgical indications in sickle cell anemia as frequently encountered and review treatment ...

  1. Clinical pathway for video-assisted thoracic surgery: the Hong Kong story.

    Science.gov (United States)

    Sihoe, Alan D L

    2016-02-01

    A clinical pathway provides a scheduled, objective protocol for the multi-disciplinary, evidence-based management of patients with a specific condition or undergoing a specific procedure. In implementing a clinical pathway for the care of patients receiving video-assisted thoracic surgery (VATS) in Hong Kong, many insights were gained into what makes a clinical pathway work: meticulous preparation and team-building are keys to success; the pathway must be constantly reviewed and revisions made in response to evolving clinical need; and data collection is a key element to allow auditing and clinical research. If these can be achieved, a clinical pathway delivers not only measurable improvements in patient outcomes, but also fundamentally complements clinical advances such as VATS. This article narrates the story of how the clinical pathway for VATS in Hong Kong was created and evolved, highlighting how the above lessons were learned.

  2. Gabapentin May Relieve Post-Coronary Artery Bypass Graft Pain: A Double Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    MSoltanzadeh

    2011-09-01

    Full Text Available Background: One of the most common complaints after coronary artery bypass graft (CABG is post-operative pain. Gabapentin is an anticonvulsant and antineuralgic agent. Objective: To evaluate the analgesic effect of preemptive gabapentin on post-operative pain and morphine consumption after cardiac surgery. Methods: A double-blind randomized clinical trial was conducted on 60 male candidates for CABG. The patients were divided into two groups—the gabapentin (n=30 and the control group (n=30. The test group received 800 mg gabapentin orally two hours before the surgery followed by 400 mg of the drug two hours post-extubation. The control group received placebo instead. Then severity of pain was recorded according to an 11-point visual analog pain scale. The amount of morphine consumed, its side effects and hemodynamic changes were also recorded during and at 2, 6, 12, 18 and 24 hours after extubation. Results: The mean±SD cumulative morphine consumption at the first 24 hours after extubation in gabapentin group was 0.9±1.5 mg while it was 1.5±4 mg for the control group. Therefore, gabapentin group consumed 38% less than the control group (P=0.01. The pain scores during rest and coughing at 2, 6, and 12 hours after extubation were also significantly lower in the gabapentin group compared with the control group (P=0.02. The mean±SD mechanical ventilation time was 5.4±1.7 hours for gabapentin group and 1.6±4.4 hours for the control group (P=0.035. The other variables including hemodynamic changes (HR, SBP and DBP, and incidence of nausea, vomiting and respiratory depression showed no significant difference between the studied groups within 24 hours after extubation. Conclusion: Oral pre-medication with gabapentin before CABG significantly reduces post-operative pain and morphine consumption in adult cardiac surgery.

  3. Low tidal volume mechanical ventilation against no ventilation during cardiopulmonary bypass heart surgery (MECANO): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Nguyen, Lee S; Merzoug, Messaouda; Estagnasie, Philippe; Brusset, Alain; Law Koune, Jean-Dominique; Aubert, Stephane; Waldmann, Thierry; Grinda, Jean-Michel; Gibert, Hadrien; Squara, Pierre

    2017-12-02

    Postoperative pulmonary complications are a leading cause of morbidity and mortality after cardiac surgery. There are no recommendations on mechanical ventilation associated with cardiopulmonary bypass (CPB) during surgery and anesthesiologists perform either no ventilation (noV) at all during CPB or maintain low tidal volume (LTV) ventilation. Indirect evidence points towards better pulmonary outcomes when LTV is performed but no large-scale prospective trial has yet been published in cardiac surgery. The MECANO trial is a single-center, double-blind, randomized, controlled trial comparing two mechanical ventilation strategies, noV and LTV, during cardiac surgery with CPB. In total, 1500 patients are expected to be included, without any restrictions. They will be randomized between noV and LTV on a 1:1 ratio. The noV group will receive no ventilation during CPB. The LTV group will receive 5 breaths/minute with a tidal volume of 3 mL/kg and positive end-expiratory pressure of 5 cmH2O. The primary endpoint will be a composite of all-cause mortality, early respiratory failure defined as a ratio of partial pressure of oxygen/fraction of inspired oxygen ventilation, mechanical ventilation or high-flow oxygen) at 2 days after arrival in the ICU or ventilator-acquired pneumonia defined by the Center of Disease Control. Lung recruitment maneuvers will be performed in the noV and LTV groups at the end of surgery and at arrival in ICU with an insufflation at +30 cmH20 for 5 seconds. Secondary endpoints are those composing the primary endpoint with the addition of pneumothorax, CPB duration, quantity of postoperative bleeding, red blood cell transfusions, revision surgery requirements, length of stay in the ICU and in the hospital and total hospitalization costs. Patients will be followed until hospital discharge. The MECANO trial is the first of its kind to compare in a double-blind design, a no-ventilation to a low-tidal volume strategy for mechanical ventilation during

  4. The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

    Directory of Open Access Journals (Sweden)

    Scardino Peter T

    2009-03-01

    Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.

  5. Clinical experience of magnetic resonance angiography in hand surgery

    International Nuclear Information System (INIS)

    Kawabata, Hidehiko; Yasui, Natsuo; Kitano, Motohiro; Sai, Eikoh

    1996-01-01

    Magnetic resonance angiography was performed in fourteen patients with congenital hand abnormalities. A two-dimentional time-of-flight imaging clearly demonstrated presence or absence of the radial, ulnar, and anterior interosseous arteires at forearm. However, smaller arteries such as digital arteries were depressed sometimes. This fact makes clinical application of the method somewhat limited. At present. appropriate applications in orthopaedic fields are evaluation of run-off of the major vessels after trauma or atherosclerotic diseases, venous vascular problems such as thrombophlebitis and aneurysm, and preoperative and post operative evaluation in microsurgery. If more detailed information is required, for example, in differential diagnosis of tumors conventional angiography or digital subtraction angiography is recommended. Because magnetic resonance angiography is non-invasive and does not need anesthesia, it is suitable especially for children. No requirement of contrast medium makes it easy to apply angiography to high risk patients and allergic patients to iodine. Technical advancement in near future will rise up magnetic resonance angiography to a standard evaluation method for vascular problems in orthopaedic fields very soon. (author)

  6. Video- or text-based e-learning when teaching clinical procedures? A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Buch SV

    2014-08-01

    Full Text Available Steen Vigh Buch,1 Frederik Philip Treschow,2 Jesper Brink Svendsen,3 Bjarne Skjødt Worm4 1Department of Vascular Surgery, Rigshospitalet, Copenhagen, Denmark; 2Department of Anesthesia and Intensive Care, Herlev Hospital, Copenhagen, Denmark; 3Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; 4Department of Anesthesia and Intensive Care, Bispebjerg Hospital, Copenhagen, Denmark Background and aims: This study investigated the effectiveness of two different levels of e-learning when teaching clinical skills to medical students. Materials and methods: Sixty medical students were included and randomized into two comparable groups. The groups were given either a video- or text/picture-based e-learning module and subsequently underwent both theoretical and practical examination. A follow-up test was performed 1 month later. Results: The students in the video group performed better than the illustrated text-based group in the practical examination, both in the primary test (P<0.001 and in the follow-up test (P<0.01. Regarding theoretical knowledge, no differences were found between the groups on the primary test, though the video group performed better on the follow-up test (P=0.04. Conclusion: Video-based e-learning is superior to illustrated text-based e-learning when teaching certain practical clinical skills. Keywords: e-learning, video versus text, medicine, clinical skills

  7. Identifying randomized clinical trials in Spanish-language dermatology journals.

    Science.gov (United States)

    Sanclemente, G; Pardo, H; Sánchez, S; Bonfill, X

    2015-06-01

    The necessary foundation for good clinical practice lies in knowledge derived from clinical research. Evidence from randomized clinical trials (RCTs) is the pillar on which decisions about therapy are based. To search exhaustively and rigorously to identify RCTs in dermatology journals published in Spanish. We located dermatology journals through the following search engines and indexes: PubMed, LILACS, SciELO, Periódica, Latindex, Índice Médico Español, C-17, IBECS, EMBASE, and IMBIOMED. We also sought information through dermatology associations and dermatologists in countries where Spanish was the usual language of publication, and we searched the Internet (Google). Afterwards we searched the journals electronically and manually to identify RCTs in all available volumes and issues, checking from the year publication started through 2012. Of 28 journals identified, we included 21 in the search. We found a total of 144 RCTs published since 1969; 78 (54%) were in Latin American journals and 66 (46%) were in Spanish journals. The most frequent disease contexts for RCTs in Spanish journals were psoriasis, mycoses, and acne vulgaris. In Latin American journals, the most frequent disease contexts were common warts, mycoses, acne vulgaris, and skin ulcers on the lower limbs. Manual searches identified more RCTs than electronic searches. Manual searches found a larger number of RCTs. Relatively fewer RCTs are published in Spanish and Latin American journals than in English-language journals. Internet facilitated access to full texts published by many journals; however, free open access to these texts is still unavailable and a large number of journal issues are still not posted online. Copyright © 2014 Elsevier España, S.L.U. and AEDV. All rights reserved.

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

    Science.gov (United States)

    Raunest, J; Löhnert, J

    1990-01-01

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

  9. Value of Prophylactic Postoperative Antibiotic Therapy after Bimaxillary Orthognathic Surgery: A Clinical Trial

    Directory of Open Access Journals (Sweden)

    Majid Eshghpour

    2014-10-01

    Full Text Available Introduction: Antibiotic therapy before or after orthognathic surgery is commonly recommended by surgeons to minimize the risk of wound infection. This article evaluates the value of Prophylactic antibiotic therapy in order to diminish the incidence of postoperative wound infection after orthognathic surgery.   Materials and Methods: Fifty candidates for bimaxillary orthognathic surgery were divided into cases and controls. Cefazolin (1g was administered intravenously to all participants 30 mins prior to surgery followed by a similar dose 4 hours later. Case-group patients ingested amoxicillin (500 mg orally for 7 days after surgery. Postoperative wound infection was assessed using clinical features, and the P-value significance was set at P  Results: Both groups were similar according to gender, age, and operating time. During the follow-up period no infection was observed in either the case or control group.   Conclusion:  The results of this study suggest that long-term postoperative antibiotic therapy is not essential for the prevention of postoperative infection, and that application of aseptic surgical technique and hygiene instruction after surgery are sufficient.

  10. Single incision laparoscopic surgery (SILS) inguinal hernia repair - recent clinical experiences of this novel technique.

    Science.gov (United States)

    Yussra, Y; Sutton, P A; Kosai, N R; Razman, J; Mishra, R K; Harunarashid, H; Das, S

    2013-01-01

    Inguinal hernia remains the most commonly encountered surgical problem. Various methods of repair have been described, and the most suitable one debated. Single port access (SPA) surgery is a rapidly evolving field, and has the advantage of affording 'scarless' surgery. Single incision laparoscopic surgery (SILS) for inguinal hernia repair is seen to be feasible in both total extraperitoneal (TEP) and transabdominal pre-peritoneal (TAPP) approaches. Data and peri-operative information on both of these however are limited. We aimed to review the clinical experience, feasibility and short term complications related to laparoscopic inguinal hernia repair via single port access. A literature search was performed using Google Scholar, Springerlink Library, Highwire Press, Surgical Endoscopy Journal, World Journal of Surgery and Medscape. The following search terms were used: laparoscopic hernia repair, TAPP, TEP, single incision laparoscopic surgery (SILS). Fourteen articles in English language related to SILS inguinal hernia repair were identified. Nine articles were related to TEP repair and the remaining 5 to TAPP. A total of 340 patients were reported within these studies: 294 patients having a TEP repair and 46 a TAPP. Only two cases of recurrence were reported. Various ports have been utilized, including the SILS port, Tri-Port and a custom- made port using conventional laparoscopic instruments. The duration of surgery was 40-100 minutes and the average length of hospital stay was one day. Early outcomes of this novel technique show it to be feasible, safe and with potentially better cosmetic outcome.

  11. Arterial Stump Thrombosis after Lung Resection Surgery: Clinical Presentation, Treatment and Progress.

    Science.gov (United States)

    López-Padilla, Daniel; Peghini Gavilanes, Esteban; Revilla Ostolaza, Teresa Yolanda; Trujillo, María Dolores; Martínez Serna, Iván; Arenas Valls, Nuria; Girón Matute, Walther Iván; Larrosa-Barrero, Roberto; Manrique Mutiozabal, Adriana; Pérez Gallán, Marta; Zevallos, Annette; Sayas Catalán, Javier

    2016-10-01

    To determine the prevalence of arterial stump thrombosis (AST) after pulmonary resection surgery for lung cancer and to describe subsequent radiological follow-up and treatment. Observational, descriptive study of AST detected by computerized tomography angiography (CT) using intravenous contrast. Clinical and radiological variables were compared and a survival analysis using Kaplan-Meier curves was performed after dividing patients into 3 groups: patients with AST, patients with pulmonary embolism (PE), and patients without AST or PE. Nine cases of AST were detected after a total of 473 surgeries (1.9%), 6 of them in right-sided surgeries (67% of AST cases). Median time to detection after surgery was 11.3 months (interquartile range 2.7-42.2 months), and range 67.5 months (1.4-69.0 months). Statistically significant differences were found only in the number of CTs performed in AST patients compared to those without AST or PE, and in tumor recurrence in PE patients compared to the other 2 groups. No differences were found in baseline or oncological characteristics, nor in the survival analysis. In this series, AST prevalence was low and tended to occur in right-sided surgeries. Detection over time was variable, and unrelated to risk factors previous to surgery, histopathology, and tumor stage or recurrence. AST had no impact on patient survival. Copyright © 2016 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.

  12. Efficacy of leukocyte- and platelet-rich fibrin in wound healing: a randomized controlled clinical trial.

    Science.gov (United States)

    Chignon-Sicard, Bérengère; Georgiou, Charalambos A; Fontas, Eric; David, Sylvain; Dumas, Pierre; Ihrai, Tarik; Lebreton, Elisabeth

    2012-12-01

    Application of platelet concentrates to wounds could speed healing. Leukocyte- and platelet-rich fibrin, a relatively recent development, stands out from the other preparations. This prospective, randomized, controlled clinical trial studied the rate of healing of postoperative hand wounds after a single application of leukocyte- and platelet-rich fibrin. Eligible patients were healthy individuals older than 18 years who had been scheduled for elective McCash (open palm) surgery for Dupuytren disease at the Plastic and Hand Surgery Department of Nice's University Hospital between August of 2007 and February of 2010. The control group received the reference care of petroleum jelly mesh (Vaselitulle), and test patients had leukocyte- and platelet-rich fibrin applied. The primary endpoint was healing delay measured in postoperative days. Secondary endpoints included pain, bleeding, and wound exudate. The trial was carried out as a single-blind trial. Among the 68 randomized patients, 33 patients in the leukocyte- and platelet-rich fibrin group and 31 in the Vaselitulle group were analyzed. Primary endpoint analysis showed a median healing delay of 24 days (interquartile range, 18 to 28 days) for the fibrin group and 29 days (interquartile range, 26 to 35 days) for the Vaselitulle group (p = 0.014, log-rank test). Postoperative pain assessment, bleeding, and exudate were always lower for the fibrin group, but not significantly so. The authors trial demonstrates that a single leukocyte- and platelet-rich fibrin application on fresh postoperative hand wounds shows a median improvement of 5 days in comparison with the standard treatment. Therapeutic, II.

  13. Quality of Life After Cardiac Surgery Based on the Minimal Clinically Important Difference Concept.

    Science.gov (United States)

    Grand, Nathalie; Bouchet, Jean Baptiste; Zufferey, Paul; Beraud, Anne Marie; Awad, Sahar; Sandri, Fabricio; Campisi, Salvator; Fuzellier, Jean François; Molliex, Serge; Vola, Marco; Morel, Jerome

    2018-03-23

    Health-related quality of life (HRQOL) is an increasingly important issue in assessing the consequences of any surgical or medical intervention. Our study aimed to evaluate change in HRQOL 6 months after elective cardiac surgery and to identify specific predictors of poor HRQOL. In this prospective, single-center study, HRQOL was evaluated before and 6 months after surgery using the SF-36 questionnaire and its two components: the physical component summary (PCS) and the mental component summary (MCS). We distinguished patients with worsening of HRQOL according to the minimal clinically important difference. All consecutive adult patients undergoing cardiac surgery were included. 326 patients completed the preoperative and postoperative SF-36 questionnaires and 24 patients died before completing follow-up questionnaires. Based on the definition used, clinically significant deterioration of HRQOL was observed in 93 patients (26.6%) for PCS and 99 patients (28.2%) for MCS. Renal replacement for acute renal failure and mechanical ventilation for longer than 48 hours were independent risk factors for PCS and MCS worsening or death. Although our study showed overall improvement of QOL after cardiac surgery, over a quarter of the patients manifested deterioration of HRQOL at 6 months post-surgery. The findings from this study should help clinicians to inform patients about their likely postoperative functional status and quality of life. Copyright © 2018. Published by Elsevier Inc.

  14. Comparative Clinical Study of Conventional Dental Implants and Mini Dental Implants for Mandibular Overdentures: A Randomized Clinical Trial.

    Science.gov (United States)

    Aunmeungtong, Weerapan; Kumchai, Thongnard; Strietzel, Frank P; Reichart, Peter A; Khongkhunthian, Pathawee

    2017-04-01

    Dental implant-retained overdentures have been chosen as the treatment of choice for complete mandibular removable dentures. Dental implants, such as mini dental implants, and components for retaining overdentures, are commercially available. However, comparative clinical studies comparing mini dental implants and conventional dental implants using different attachment for implant-retained overdentures have not been well documented. To compare the clinical outcomes of using two mini dental implants with Equator ® attachments, four mini dental implants with Equator attachments, or two conventional dental implants with ball attachments, by means of a randomized clinical trial. Sixty patients received implant-retained mandibular overdentures in the interforaminal region. The patients were divided into three groups. In Groups 1 and 2, two and four mini dental implants, respectively, were placed and immediately loaded by overdentures, using Equator ® attachments. In Group 3, conventional implants were placed. After osseointegration, the implants were loaded by overdentures, using ball attachments. The study distribution was randomized and double-blinded. Outcome measures included changes in radiological peri-implant bone level from surgery to 12 months postinsertion, prosthodontic complications and patient satisfaction. The cumulative survival rate in the three clinical groups after one year was 100%. There was no significant difference (p < 0.05) in clinical results regarding the number (two or four) of mini dental implants with Equator attachments. However, there was a significant difference in marginal bone loss and patient satisfaction between those receiving mini dental implants with Equator attachments and conventional dental implants with ball attachments. The marginal bone resorption in Group 3 was significantly higher than in Groups 1 and 2 (p < 0.05); there were no significant differences between Groups 1 and 2. There was no significant difference in

  15. Clinical Benefit of Valvular Surgery in Patients with Chronic Kidney Disease.

    Science.gov (United States)

    Chen, Yan; Au, Wing-Kuk; Chan, Daniel; Sit, Ko-Yung; Zhen, Zhe; Ho, Kar-Lai; Wong, Debbie; Ho, Lai-Ming; Yap, Desmond; Lam, Yui-Ming; Lau, Chu-Pak; Tse, Hung-Fat; Chan, Tak-Mao; Yiu, Kai-Hang

    2018-06-20

    Concomitant chronic kidney disease (CKD) is common in patients with significant valvular heart disease (VHD). This study sought to evaluate the clinical benefit of valvular surgery in patients with concomitant CKD.We evaluated 349 patients with significant VHD who were referred for surgery. Patients were divided into those with CKD stage ≥ 3 (CKD patients; n = 88) and those with CKD stage 1 or 2 (no CKD patients; n = 261). 63 patients did not receive surgery, of which 20 patients had CKD and 43 had no CKD. Mortality and change in eGFR were assessed after a median follow-up of 21 months.In the whole study population, 25% of the patients had CKD and these patients had higher mortality than those with no CKD. The annual mortality rates of patients with CKD who did and did not undergo surgery were 7.9% and 28.0%, respectively. In patients with no CKD, the annual mortality rates of those who did and did not undergo surgery were 1.8% and 2.3%, respectively. Importantly, surgery was associated with significant survival benefit in patients with CKD (log-rank test, P < 0.01), but was neutral in patients with no CKD. Multivariable analysis confirmed the survival benefit of valvular surgery in all patients, which was most significant in patients with CKD. Furthermore, eGFR was preserved in patients who underwent valvular surgery but declined significantly in those who did not.CKD is common in patients with significant VHD and, if left untreated surgically, these patients exhibit a high mortality.

  16. A randomized clinical trial of alpha(1)-antitrypsin augmentation therapy.

    Science.gov (United States)

    Dirksen, A; Dijkman, J H; Madsen, F; Stoel, B; Hutchison, D C; Ulrik, C S; Skovgaard, L T; Kok-Jensen, A; Rudolphus, A; Seersholm, N; Vrooman, H A; Reiber, J H; Hansen, N C; Heckscher, T; Viskum, K; Stolk, J

    1999-11-01

    We have investigated whether restoration of the balance between neutrophil elastase and its inhibitor, alpha(1)-antitrypsin, can prevent the progression of pulmonary emphysema in patients with alpha(1)-antitrypsin deficiency. Twenty-six Danish and 30 Dutch ex-smokers with alpha(1)-antitrypsin deficiency of PI*ZZ phenotype and moderate emphysema (FEV(1) between 30% and 80% of predicted) participated in a double-blind trial of alpha(1)-antitrypsin augmentation therapy. The patients were randomized to either alpha(1)-antitrypsin (250 mg/kg) or albumin (625 mg/kg) infusions at 4-wk intervals for at least 3 yr. Self-administered spirometry performed every morning and evening at home showed no significant difference in decline of FEV(1) between treatment and placebo. Each year, the degree of emphysema was quantified by the 15th percentile point of the lung density histogram derived from computed tomography (CT). The loss of lung tissue measured by CT (mean +/- SEM) was 2.6 +/- 0.41 g/L/yr for placebo as compared with 1.5 +/- 0.41 g/L/yr for alpha(1)-antitrypsin infusion (p = 0.07). Power analysis showed that this protective effect would be significant in a similar trial with 130 patients. This is in contrast to calculations based on annual decline of FEV(1) showing that 550 patients would be needed to show a 50% reduction of annual decline. We conclude that lung density measurements by CT may facilitate future randomized clinical trials of investigational drugs for a disease in which little progress in therapy has been made in the past 30 yr.

  17. Use of computer-based clinical examination to assess medical students in surgery.

    Science.gov (United States)

    El Shallaly, Gamal E H A; Mekki, Abdelrahman M

    2012-01-01

    To improve the viewing of the video-projected structured clinical examination (ViPSCE), we developed a computerized version; the computer-based clinical examination (CCE). This was used to assess medical students' higher knowledge and problem solving skills in surgery. We present how we did this, test score descriptive statistics, and the students' evaluation of the CCE. A CCE in surgery was administered to assess a class of 43 final year medical students at the end of their surgical clerkship. Like the ViPSCE, the exam was delivered as a slide show, using a PowerPoint computer program. However, instead of projecting it onto a screen, each student used a computer. There were 20 slides containing either still photos or short video clips of clinical situations in surgery. The students answered by hand writing on the exam papers. At the end, they completed evaluation forms. The exam papers were corrected manually. Test score descriptive statistics were calculated and correlated with the students' scores in other exams in surgery. Administration of the CCE was straightforward. The test scores were normally distributed (mean = median = 4.9). They correlated significantly with the total scores obtained by the students in surgery (r = 0.68), and with each of the other exam modalities in surgery, such as the multiple choice and structured essay questions. Acceptability of the CCE to the students was high and they recommended the use of the CCE in other departments. CCE is feasible and popular with students. It inherits the validity and reliability of the ViPSCE with the added advantage of improving the viewing of the slides.

  18. Laser vs bur for bone cutting in impacted mandibular third molar surgery: A randomized controlled trial.

    Science.gov (United States)

    Passi, Deepak; Pal, Uma Shankar; Mohammad, Shadab; Singh, Rakesh Kumar; Mehrotra, Divya; Singh, Geeta; Kumar, Manoj; Chellappa, Arul A L; Gupta, Chandan

    2013-01-01

    The aim of this study was to assess the feasibility of Er: YAG laser in bone cutting for removal of impacted lower third molar teeth and compare its outcomes with that of surgical bur. The study comprised 40 subjects requiring removal of impacted mandibular third molar, randomly categorized into two equal groups of 20 each, who had their impacted third molar removed either using Er: YAG laser or surgical bur as per their group, using standard methodology of extraction of impacted teeth. Clinical parameters like pain, bleeding, time taken for bone cutting, postoperative swelling, trismus, wound healing and complications were compared for both groups. Clinical parameters like pain, bleeding and swelling were lower in laser group than bur group, although the difference was statistically not significant. However, postoperative swelling showed significant difference in the two groups. Laser group required almost double the time taken for bone cutting with bur. Trismus persisted for a longer period in laser group. Wound healing and complications were assessed clinically and there was no significant difference in both the groups. Based on the results of our study, the possibility of bone cutting using lasers is pursued, the osteotomy is easily performed and the technique is better suited to minimally invasive surgical procedures. The use of Er: YAG laser may be considered as an alternative tool to surgical bur, specially in anxious patients.

  19. Analgesic Effect of Intraperitoneal Bupivacaine Hydrochloride After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial.

    Science.gov (United States)

    Alamdari, Nasser Malekpour; Bakhtiyari, Mahmood; Gholizadeh, Barmak; Shariati, Catrine

    2018-03-01

    The indications for sleeve gastrectomy as a primary procedure for the surgical treatment of morbid obesity have increased worldwide. Pain is the most common complaint for patients on the first day after laparoscopic sleeve gastrectomy. There are various methods for decreasing pain after laparoscopic sleeve gastrectomy such as the use of intraperitoneal bupivacaine hydrochloride. This clinical trial was an attempt to discover the effects of intraperitoneal bupivacaine hydrochloride on alleviating postoperative pain after laparoscopic sleeve gastrectomy. In general, 120 patients meeting the inclusion criteria were enrolled. Patients were randomly allocated into two interventions and control groups using a balanced block randomization technique. One group received intraperitoneal bupivacaine hydrochloride (30 cm 3 ), and the other group served as the control one and did not receive bupivacaine hydrochloride. Diclofenac suppository and paracetamol injection were administered to both groups for postoperative pain management. The mean subjective postoperative pain score was significantly decreased in patients who received intraperitoneal bupivacaine hydrochloride within the first 24 h after the surgery; thus, the instillation of bupivacaine hydrochloride was beneficial in managing postoperative pain. The intraoperative peritoneal irrigation of bupivacaine hydrochloride (30 cm 3 , 0.25%) in sleeve gastrectomy patients was safe and effective in reducing postoperative pain, nausea, and vomiting (IRCT2016120329181N4).

  20. A Study of Clinical Coding Accuracy in Surgery: Implications for the Use of Administrative Big Data for Outcomes Management.

    Science.gov (United States)

    Nouraei, S A R; Hudovsky, A; Frampton, A E; Mufti, U; White, N B; Wathen, C G; Sandhu, G S; Darzi, A

    2015-06-01

    Clinical coding is the translation of clinical activity into a coded language. Coded data drive hospital reimbursement and are used for audit and research, and benchmarking and outcomes management purposes. We undertook a 2-center audit of coding accuracy across surgery. Clinician-auditor multidisciplinary teams reviewed the coding of 30,127 patients and assessed accuracy at primary and secondary diagnosis and procedure levels, morbidity level, complications assignment, and financial variance. Postaudit data of a randomly selected sample of 400 cases were reaudited by an independent team. At least 1 coding change occurred in 15,402 patients (51%). There were 3911 (13%) and 3620 (12%) changes to primary diagnoses and procedures, respectively. In 5183 (17%) patients, the Health Resource Grouping changed, resulting in income variance of £3,974,544 (+6.2%). The morbidity level changed in 2116 (7%) patients (P data are a key engine for knowledge-driven health care provision. They are used, increasingly at individual surgeon level, to benchmark performance. Surgical clinical coding is prone to subjectivity, variability, and error (SVE). Having a specialty-by-specialty understanding of the nature and clinical significance of informatics variability and adopting strategies to reduce it, are necessary to allow accurate assumptions and informed decisions to be made concerning the scope and clinical applicability of administrative data in surgical outcomes improvement.

  1. 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

  2. Perioperative intravenous acetaminophen attenuates lipid peroxidation in adults undergoing cardiopulmonary bypass: a randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Frederic T Billings

    Full Text Available Cardiopulmonary bypass (CPB lyses erythrocytes and induces lipid peroxidation, indicated by increasing plasma concentrations of free hemoglobin, F2-isoprostanes, and isofurans. Acetaminophen attenuates hemeprotein-mediated lipid peroxidation, reduces plasma and urine concentrations of F2-isoprostanes, and preserves kidney function in an animal model of rhabdomyolysis. Acetaminophen also attenuates plasma concentrations of isofurans in children undergoing CPB. The effect of acetaminophen on lipid peroxidation in adults has not been studied. This was a pilot study designed to test the hypothesis that acetaminophen attenuates lipid peroxidation in adults undergoing CPB and to generate data for a clinical trial aimed to reduce acute kidney injury following cardiac surgery.In a prospective double-blind placebo-controlled clinical trial, sixty adult patients were randomized to receive intravenous acetaminophen or placebo starting prior to initiation of CPB and for every 6 hours for 4 doses. Acetaminophen concentrations measured 30 min into CPB and post-CPB were 11.9 ± 0.6 μg/mL (78.9 ± 3.9 μM and 8.7 ± 0.3 μg/mL (57.6 ± 2.0 μM, respectively. Plasma free hemoglobin increased more than 15-fold during CPB, and haptoglobin decreased 73%, indicating hemolysis. Plasma and urinary markers of lipid peroxidation also increased during CPB but returned to baseline by the first postoperative day. Acetaminophen reduced plasma isofuran concentrations over the duration of the study (P = 0.05, and the intraoperative plasma isofuran concentrations that corresponded to peak hemolysis were attenuated in those subjects randomized to acetaminophen (P = 0.03. Perioperative acetaminophen did not affect plasma concentrations of F2-isoprostanes or urinary markers of lipid peroxidation.Intravenous acetaminophen attenuates the increase in intraoperative plasma isofuran concentrations that occurs during CPB, while urinary markers were unaffected.ClinicalTrials.gov NCT

  3. The Efficacy of Programmed Intermittent Epidural Bolus for Postoperative Analgesia after Open Gynecological Surgery: A Randomized Double-Blinded Study

    Directory of Open Access Journals (Sweden)

    Shiho Satomi

    2018-01-01

    Full Text Available Background. It is well known that the programmed intermittent epidural bolus (PIEB technique effectively provides epidural anesthesia in labor. This randomized double-blind trial compared the postoperative analgesic efficacy of PIEB with that of continuous epidural infusion (CEI in patients undergoing gynecological surgery under combined general-epidural anesthesia. Methods. Patients undergoing open gynecological surgery under combined general-epidural anesthesia were randomized at a 1 : 1 ratio to receive PIEB or CEI. In the PIEB group, the pump delivered 4 mL ropivacaine 0.2% plus fentanyl 2 μg/mL every hour. In the CEI group, the pump delivered the same solution at a rate of 4 mL/h. In both groups, additional 4 mL boluses of ropivacaine 0.2% plus fentanyl 2 μg/mL were provided, when necessary, by patient-controlled epidural analgesia after surgery. The primary outcome was the total ropivacaine dose 40 hours after surgery. The secondary outcomes were the number of PCEA boluses and postoperative pain (evaluated on an 11-point numerical rating scale 3, 24, and 48 hours after surgery. Results. In total, 57 patients were randomized (n=28 and 29 in the PIEB and CEI groups, resp.. The two groups differ significantly in terms of the total ropivacaine dose 40 hours after surgery (mean (standard deviation: 155.38 (4.55 versus 159.73 (7.87 mL, P=0.016. Compared to the CEI group, the PIEB group had significantly lower numerical rating scale scores 3 hours (median [lower–upper quartiles]: 0 [0–0.5] versus 3 [0–5.5], P=0.002, 24 hours (1 [0–2] versus 3 [1–4], P=0.003, and 48 hours (1 [0–2] versus 2 [2–3.5], P=0.002 after surgery. Conclusion. PIEB was better than CEI in terms of providing postoperative analgesia after open gynecological surgery under combined general-epidural anesthesia.

  4. Use of piezosurgery device in management of oral surgery complications: clincal case and clinical experience report.

    Science.gov (United States)

    Sammartino, G; Riccitiello, F; Trosino, O; Marenzi, G; Cioffi, A; Mortellaro, C

    2012-05-01

    The root displacement into the maxillary sinus could be a complication of oral surgery in the upper jaw. In these cases, the root removal is needed in order to avoid the occurrence of sinus pathologies. Piezosurgery techniques could assure a safer management of such complications, because of the clear surgical visibility and the selective ability of cut. The aim of this article is to present a case of oral surgery complication (root displacement in the right maxillary sinus), in which piezosurgery technique helped for a correct and safe clinical management, allowing to reduce the soft tissue damage.

  5. From Diagnosis to Treatment: Clinical Applications of Nanotechnology in Thoracic Surgery.

    Science.gov (United States)

    Digesu, Christopher S; Hofferberth, Sophie C; Grinstaff, Mark W; Colson, Yolonda L

    2016-05-01

    Nanotechnology is an emerging field with potential as an adjunct to cancer therapy, particularly thoracic surgery. Therapy can be delivered to tumors in a more targeted fashion, with less systemic toxicity. Nanoparticles may aid in diagnosis, preoperative characterization, and intraoperative localization of thoracic tumors and their lymphatics. Focused research into nanotechnology's ability to deliver both diagnostics and therapeutics has led to the development of nanotheranostics, which promises to improve the treatment of thoracic malignancies through enhanced tumor targeting, controlled drug delivery, and therapeutic monitoring. This article reviews nanoplatforms, their unique properties, and the potential for clinical application in thoracic surgery. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Using Texting for Clinical Communication in Surgery: A Survey of Academic Staff Surgeons.

    Science.gov (United States)

    Firdouse, Mohammed; Devon, Karen; Kayssi, Ahmed; Goldfarb, Jeremy; Rossos, Peter; Cil, Tulin D

    2018-03-01

    Text messaging has become ubiquitous and is being increasingly used within the health care system. The purpose of this study was to understand texting practices for clinical communication among staff surgeons at a large academic institution. Staff surgeons in 4 subspecialties (vascular, plastics, urology, and general surgery) were surveyed electronically. A total of 62 surgeons from general surgery (n = 33), vascular surgery (n = 6), plastic surgery (n = 13), and urology (n = 10) completed the study (response rate 30%). When conveying urgent patient-related information, staff surgeons preferred directly calling other staff surgeons (61.5%) and trainees (58.8%). When discussing routine patient information, staff surgeons used email to reach other staff surgeons (54.9%) but preferred texting (62.7%) for trainees. The majority of participants used texting because it is fast (65.4%), convenient (69.2%) and allows transmitting information to multiple recipients simultaneously (63.5%). Most felt that texting enhances patient care (71.5%); however, only half believed that it enhanced trainees' educational experiences. The majority believed that texting identifiable patient information breaches patient confidentiality. Our data showed high adoption of text messaging for clinical communication among surgeons, particularly with trainees. The majority of surgeons acknowledge security concerns inherent in texting for patient care. Existing mobile communication platforms fail to meet the needs of academic surgeons. Further research should include guidelines related to texting in clinical practice, educational implications of texting, and technologies to better meet the needs of clinicians working in an academic surgical settings.

  7. Success and spontaneous pregnancy rates following systemic methotrexate versus laparoscopic surgery for tubal pregnancies: A randomized trial

    DEFF Research Database (Denmark)

    Krag Moeller, Lars Bo; Moeller, Charlotte; Thomsen, Sten Grove

    2009-01-01

    . A total of 106 women diagnosed with ectopic pregnancy (EP). Methods. Between March 1997 and September 2000, 1,265 women were diagnosed with EP, 395 (31%) were eligible, 109 (9%) were randomized of whom 106 had an EP. The study was originally powered to a sample size of 422 patients. The women were......Objective. To determine which treatment should be offered to women with a non-ruptured tubal pregnancy: a single dose of methotrexate (MTX) or laparoscopic surgery. Design. Prospective, randomized, open multicenter study. Setting. Seven Danish departments of obstetrics and gynecology. Sample...... (n.s.). Conclusions. In women with an EP, who are hemodynamically stable and wishing to preserve their fertility, medical treatment with single dose MTX tends to be equal to treatment with laparoscopic surgery regarding success rate, complications, and subsequent fertility. Although the two treatment...

  8. The effects of foot reflexology massage on anxiety in patients following coronary artery bypass graft surgery: a randomized controlled trial.

    Science.gov (United States)

    Bagheri-Nesami, Masoumeh; Shorofi, Seyed Afshin; Zargar, Nahid; Sohrabi, Maryam; Gholipour-Baradari, Afshin; Khalilian, Alireza

    2014-02-01

    To examine the effects of foot reflexology massage on anxiety in patients following CABG surgery. In this randomized controlled trial, 80 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups after they were matched on age and gender. On the days following surgery, the experimental group received foot reflexology massage on their left foot 20 min a day for 4 days, while the control group was given a gentle foot rub with oil for one minute. Anxiety was measured using the short-form of the Spielberger State-Trait Anxiety Inventory and the Visual Analogue Scale-Anxiety. Both measurement instruments confirmed a significant decrease in anxiety following the foot reflexology massage. The significant decrease in anxiety in the experimental group following the foot reflexology massage supports the use of this complementary therapy technique for the relief of anxiety. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

  9. A Prospective Randomized Clinical Study of the Influence of Primary ...

    African Journals Online (AJOL)

    of closure of the socket after surgical extraction of impacted mandibular third molar. ... mandibular third molar surgery concluded that there was a reduction in .... round bur (carbide no: 8) in a high speed straight hand piece under constant ...

  10. Clinical Application of Three-Dimensional Printing Technology in Craniofacial Plastic Surgery

    Directory of Open Access Journals (Sweden)

    Jong Woo Choi

    2015-05-01

    Full Text Available Three-dimensional (3D printing has been particularly widely adopted in medical fields. Application of the 3D printing technique has even been extended to bio-cell printing for 3D tissue/organ development, the creation of scaffolds for tissue engineering, and actual clinical application for various medical parts. Of various medical fields, craniofacial plastic surgery is one of areas that pioneered the use of the 3D printing concept. Rapid prototype technology was introduced in the 1990s to medicine via computer-aided design, computer-aided manufacturing. To investigate the current status of 3D printing technology and its clinical application, a systematic review of the literature was conducted. In addition, the benefits and possibilities of the clinical application of 3D printing in craniofacial surgery are reviewed, based on personal experiences with more than 500 craniofacial cases conducted using 3D printing tactile prototype models.

  11. Clinical Application of Three-Dimensional Printing Technology in Craniofacial Plastic Surgery

    Science.gov (United States)

    Kim, Namkug

    2015-01-01

    Three-dimensional (3D) printing has been particularly widely adopted in medical fields. Application of the 3D printing technique has even been extended to bio-cell printing for 3D tissue/organ development, the creation of scaffolds for tissue engineering, and actual clinical application for various medical parts. Of various medical fields, craniofacial plastic surgery is one of areas that pioneered the use of the 3D printing concept. Rapid prototype technology was introduced in the 1990s to medicine via computer-aided design, computer-aided manufacturing. To investigate the current status of 3D printing technology and its clinical application, a systematic review of the literature was conducted. In addition, the benefits and possibilities of the clinical application of 3D printing in craniofacial surgery are reviewed, based on personal experiences with more than 500 craniofacial cases conducted using 3D printing tactile prototype models. PMID:26015880

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

    Directory of Open Access Journals (Sweden)

    Debasis Banerjee

    2014-01-01

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

  13. Lysine clonixinate in minor dental surgery: double-blind randomized parallel study versus paracetamol.

    Science.gov (United States)

    Martí, M L; De los Santos, A R; Di Girolamo, G; Gil, M; Manero, E O; Fraga, C

    1993-01-01

    Lysine clonixinate (LC), an effective and well tolerated non-morphinic analgesic whose mechanism of action is basically due to the inhibition of cyclo-oxygenase, was assessed with a double-blind randomized dummy design versus paracetamol (P) on 200 patients suffering from pain after minor dental surgery. Patients received according to their needs 1 or 2 tablets of 125 mg lysine clonixinate or 500 mg paracetamol every 8 h during 48 h or until pain relief. Both groups, each composed of 100 patients, were comparable in terms of demographic conditions (t test), initial symptoms (chi-square test), characteristics of the extracted dental pieces, surgical complications and wound treatment (chi-square test). Pain intensity scores and daily average intake of tablets (3.4/day) documented in the patients' diary revealed no statistically significant differences between the two treatments (chi-square test). It was found that spontaneous pain measured using a visual analogue scale (VAS) decreased significantly in both treatment groups at the 24-h control examination. The following values were observed in the LC group: baseline 4.38 +/- 1.7; 24-h * 1.20 +/- 1.4; 48-h * 0.36 +/- 1.2. In the P group the values were: baseline 4.28 +/- 1.6; 24-h * 1.11 +/- 1.4; 48-h * 0.30 +/- 0.7 (*p < 0.05). Other variables like facial swelling and night pain, evaluated on a score from 0 to 4 and symptom presence or absence respectively, showed a similar response.(ABSTRACT TRUNCATED AT 250 WORDS)

  14. CORE STABILIZATION EXERCISES AFTER ACL RECONSTRUCTION SURGERY PROVIDES BETTER OUTCOMES: A RANDOMIZED CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    Dilpreet Kaur

    2015-12-01

    Full Text Available Background: Decreased core stability displaces center of gravity away from base of support reducing activity participation of athlete. Present study was conducted to study the effect of core stabilization exercises after reconstruction surgery of ACL on functional outcomes. Methods: 30 subjects following 5 months of ACL reconstruction were randomly assigned to either group that performed (study group or did not performed (control group additional core stabilization exercises in conjugation with standard rehabilitation protocol. Outcome measures were: activity level using Tegnar activity level scale and functional performance using triple hop test. Outcome measures were compared at day 1 and day 42 of the treatment. Result: Significant improvement was seen in the study group for Tegnar score with mean difference changing from 4.5 to 1.5 from day 1 to day 42 of treatment (p=0.039 while the control group showed improvement in mean difference changing from 3.8 to 1.4 (p=.045 from day 1 to day 42 of treatment. Highly significant improvement was seen in the study group for triple hop test with mean difference changing from 25 to 6.7 (p<.001 compared to the control group with mean difference changing from 15.2 to 9.7(p=.005 from day 1 to day 42 of treatment. Conclusions: Both the groups showed improvement for activity level and functional performance but highly significant improvement was seen in the study group for functional performance. Core stabilization exercises in conjugation with the standard ACL rehabilitation protocol results better improvement in the triple hop test.

  15. Ear Acupuncture for Post-Operative Pain Associated with Ambulatory Arthroscopic Knee Surgery: A Randomized Controlled Trial

    Science.gov (United States)

    2014-01-14

    E7(/(3+21(180%(5 ,QFOXGHDUHDFRGH 14 Jan 2014 Final Report Ear acupuncture for post-operative pain associated with ambulatory arthroscopic...DISTRIBUTION A. Approved for public release: distribution unlimited. The purpose of this study is to compare ear acupuncture plus standard therapy versus...3298 Ear Acupuncture for Post-operative Pa111 Assoc1ated With Ambulatory Arthroscopic Knee Surgery A Randomized Controlled Trial ’• V ’’ ’-’ I

  16. Clinical negligence claims in pediatric surgery in England: pattern and trends.

    Science.gov (United States)

    Thyoka, Mandela

    2015-02-01

    We hypothesized that there has been an increase in the number of successful litigation claims in pediatric surgery in England. Our aim was to report the incidence, causes, and costs of clinical negligence claims against the National Health Service (NHS) in relation to pediatric surgery. We queried the NHS Litigation Authority (NHSLA) on litigation claims among children undergoing pediatric surgery in England (2004-2012). We decided a priori to only examine closed cases (decision and payment made). Data included year of claim, year of payment of claim, payment per claim, paid-to-closed ratio, and severity of outcome of clinical incident. Out of 112 clinical negligence claims in pediatric surgery, 93 (83%) were finalized-73 (65%) were settled and damages paid to the claimant and 20 (18%) were closed with no payment, and 19 (17%) remain open. The median payment was £13,537 (600-500,000) and median total cost borne by NHSLA was £31,445 (600-730,202). Claims were lodged at a median interval of 2 (0-13) years from time of occurrence with 55 (75%) cases being settled within the 3 years of being received. The commonest reasons for claims were postoperative complications (n=20, 28%), delayed treatment (n=16, 22%), and/or diagnosis (n=14, 19%). Out of 73, 17 (23%) closed claims resulted in case fatality. Conclusion: Two-thirds of all claims in pediatric surgery resulted in payment to claimant, and the commonest reasons for claims were postoperative complications, delayed treatment, and/or diagnosis. Nearly a quarter of successful claims were in cases where negligence resulted in case fatality. Pediatric surgeons should be aware of common diagnostic and treatment shortfalls as high-risk areas of increased susceptibility to clinical negligence claims. Georg Thieme Verlag KG Stuttgart · New York.

  17. Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer. Results of the first prospective randomized phase II trial

    International Nuclear Information System (INIS)

    Golcher, Henriette; Merkel, Susanne; Hohenberger, Werner; Brunner, Thomas B.; Witzigmann, Helmut; Marti, Lukas; Bechstein, Wolf-Otto; Bruns, Christiane; Jungnickel, Henry; Schreiber, Stefan; Grabenbauer, Gerhard G.; Meyer, Thomas; Fietkau, Rainer

    2015-01-01

    In nonrandomized trials, neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer. As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial. Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging. Patients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery (Arm A) or neoadjuvant chemoradiotherapy followed by surgery (Arm B), which was followed by adjuvant chemotherapy in both arms. A total of 254 patients were required to detect a 4.33-month improvement in median overall survival (mOS). The trial was stopped after 73 patients; 66 patients were eligible for analysis. Twenty nine of 33 allocated patients received chemoradiotherapy. Radiotherapy was completed in all patients. Chemotherapy was changed in 3 patients due to toxicity. Tumor resection was performed in 23 vs. 19 patients (A vs. B). The R0 resection rate was 48 % (A) and 52 % (B, P = 0.81) and (y)pN0 was 30 % (A) vs. 39 % (B, P = 0.44), respectively. Postoperative complications were comparable in both groups. mOS was 14.4 vs. 17.4 months (A vs. B; intention-to-treat analysis; P = 0.96). After tumor resection, mOS was 18.9 vs. 25.0 months (A vs. B; P = 0.79). This worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity, perioperative morbidity, and mortality. Nevertheless, the trial was terminated early due to slow recruiting and the results were not significant. ISRCTN78805636; NCT00335543. (orig.) [de

  18. Generated effect modifiers (GEM's) in randomized clinical trials.

    Science.gov (United States)

    Petkova, Eva; Tarpey, Thaddeus; Su, Zhe; Ogden, R Todd

    2017-01-01

    In a randomized clinical trial (RCT), it is often of interest not only to estimate the effect of various treatments on the outcome, but also to determine whether any patient characteristic has a different relationship with the outcome, depending on treatment. In regression models for the outcome, if there is a non-zero interaction between treatment and a predictor, that predictor is called an "effect modifier". Identification of such effect modifiers is crucial as we move towards precision medicine, that is, optimizing individual treatment assignment based on patient measurements assessed when presenting for treatment. In most settings, there will be several baseline predictor variables that could potentially modify the treatment effects. This article proposes optimal methods of constructing a composite variable (defined as a linear combination of pre-treatment patient characteristics) in order to generate an effect modifier in an RCT setting. Several criteria are considered for generating effect modifiers and their performance is studied via simulations. An example from a RCT is provided for illustration. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  19. Generated effect modifiers (GEM’s) in randomized clinical trials

    Science.gov (United States)

    Petkova, Eva; Tarpey, Thaddeus; Su, Zhe; Ogden, R. Todd

    2017-01-01

    In a randomized clinical trial (RCT), it is often of interest not only to estimate the effect of various treatments on the outcome, but also to determine whether any patient characteristic has a different relationship with the outcome, depending on treatment. In regression models for the outcome, if there is a non-zero interaction between treatment and a predictor, that predictor is called an “effect modifier”. Identification of such effect modifiers is crucial as we move towards precision medicine, that is, optimizing individual treatment assignment based on patient measurements assessed when presenting for treatment. In most settings, there will be several baseline predictor variables that could potentially modify the treatment effects. This article proposes optimal methods of constructing a composite variable (defined as a linear combination of pre-treatment patient characteristics) in order to generate an effect modifier in an RCT setting. Several criteria are considered for generating effect modifiers and their performance is studied via simulations. An example from a RCT is provided for illustration. PMID:27465235

  20. Anethum graveolens and hyperlipidemia: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mahmoud Mirhosseini

    2014-01-01

    Full Text Available Background: It has been established that hyperlipidemia increases the incidence and mortality associated with coronary heart disease. In this study, the effects of Dill (Anethum graveolens were evaluated on lipid profile of hypercholesterolemic patients. Materials and Methods: In this clinical study, 91 hyperlipidemic patients were randomly designated into two groups. One group received gemfibrozil (900 mg daily and the other group received Dill tablet (six tablets daily for 2 months. The blood lipids including total cholesterol, triglyceride and high density lipoprotein (HDL-cholesterol from each group were assessed at the beginning and end of the trial. Results: Use of gemfibrozil brought about increased HDL-cholesterol by 3.91% (P < 0.05 and reduced triglyceride and total cholesterol by 32.7% (P < 0.05 and 9.41% (P < 0.05, respectively. Applying Dill tablet for 2 months resulted in reduction of total cholesterol up to 18% (P < 0.05 and triglyceride by 7.38% (P < 0.05. However, circulating HDL-cholesterol was not affected by this treatment. In this study, gemfibrozil decreased triglyceride and increased HDL-cholesterol more than anethum (P < 0.05. Anethum decreased total cholesterol more than gemfibrozil (P < 0.05. Patients treated with anethum did not report any side effects. Conclusion: The results of this trial indicate that Dill might be beneficial for hypercholesterolemic and hypertriglycemic patients.

  1. Referral to Cardiac Rehabilitation After Percutaneous Coronary Intervention, Coronary Artery Bypass Surgery, and Valve Surgery: Data From the Clinical Outcomes Assessment Program.

    Science.gov (United States)

    Beatty, Alexis L; Bradley, Steven M; Maynard, Charles; McCabe, James M

    2017-06-01

    Despite guideline recommendations that patients undergoing percutaneous coronary intervention (PCI), coronary artery bypass surgery, or valve surgery be referred to cardiac rehabilitation, cardiac rehabilitation is underused. The objective of this study was to examine hospital-level variation in cardiac rehabilitation referral after PCI, coronary artery bypass surgery, and valve surgery. We analyzed data from the Clinical Outcomes Assessment Program, a registry of all nonfederal hospitals performing PCI and cardiac surgery in Washington State. We included eligible PCI, coronary artery bypass surgery, and valve surgery patients from 2010 to 2015. We analyzed PCI and cardiac surgery separately by performing multivariable hierarchical logistic regression for the outcome of cardiac rehabilitation referral at discharge, clustered by hospital. Patient-level covariates included age, sex, race/ethnicity, comorbidities, and procedure indication/status. Cardiac rehabilitation referral was reported in 48% (34 047/71 556) of PCI patients and 91% (21 831/23 972) of cardiac surgery patients. The hospital performing the procedure was a stronger predictor of referral than any individual patient characteristic for PCI (hospital referral range 3%-97%; median odds ratio, 5.94; 95% confidence interval, 4.10-9.49) and cardiac surgery (range 54%-100%; median odds ratio, 7.09; 95% confidence interval, 3.79-17.80). Hospitals having an outpatient cardiac rehabilitation program explained only 10% of PCI variation and 0% of cardiac surgery variation. Cardiac rehabilitation referral at discharge was less prevalent after PCI than cardiac surgery. The strongest predictor of cardiac rehabilitation referral was the hospital performing the procedure. Efforts to improve cardiac rehabilitation referral should focus on increasing referral after PCI, especially in low referral hospitals. © 2017 American Heart Association, Inc.

  2. The Influence of Preoperative and Postoperative Psychological Symptoms on Clinical Outcome after Shoulder Surgery: A Prospective Longitudinal Cohort Study.

    Science.gov (United States)

    Koorevaar, Rinco C T; van 't Riet, Esther; Gerritsen, Marleen J J; Madden, Kim; Bulstra, Sjoerd K

    2016-01-01

    Psychological symptoms are highly prevalent in patients with shoulder complaints. Psychological symptoms in patients with shoulder complaints might play a role in the aetiology, perceived disability and pain and clinical outcome of treatment. The aim of this study was to assess whether preoperative symptoms of distress, depression, anxiety and somatisation were associated with a change in function after shoulder surgery and postoperative patient perceived improvement of pain and function. In addition, the change of psychological symptoms after shoulder surgery was analyzed and the influence of postoperative symptoms of psychological disorders after surgery on the change in function after shoulder surgery and perceived postoperative improvement of pain and function. A prospective longitudinal cohort study was performed in a general teaching hospital. 315 consecutive patients planned for elective shoulder surgery were included. Outcome measures included change of Disabilities of the Arm, Shoulder and Hand (DASH) score and anchor questions about improvement in pain and function after surgery. Psychological symptoms were identified before and 12 months after surgery with the validated Four-Dimensional Symptom Questionnaire (4DSQ). Psychological symptoms were encountered in all the various shoulder diagnoses. Preoperative symptoms of psychological disorders persisted after surgery in 56% of patients, 10% of patients with no symptoms of psychological disorders before surgery developed new psychological symptoms. Preoperative symptoms of psychological disorders were not associated with the change of DASH score and perceived improvement of pain and function after shoulder surgery. Patients with symptoms of psychological disorders after surgery were less likely to improve on the DASH score. Postoperative symptoms of distress and depression were associated with worse perceived improvement of pain. Postoperative symptoms of distress, depression and somatisation were

  3. Virtual reality in the treatment of body image disturbances after bariatric surgery: a clinical case.

    Science.gov (United States)

    Riva, Giuseppe; Cárdenas-López, Georgina; Duran, Ximena; Torres-Villalobos, Gonzalo M; Gaggioli, Andrea

    2012-01-01

    Bariatric surgery is an operation on the stomach and/or intestines that helps patients with extreme obesity to lose weight. Even if bariatric surgery, compared with traditional obesity treatment, is more effective in reducing BMI, this approach does not achieve equal results in every patient. More, following bariatric surgery common problems are body image dissatisfaction and body disparagement: there is a significant difference between the weight loss clinicians consider successful (50% of excess weight) and the weight loss potential patients expect to achieve (at least 67% of the excess weight). The paper discusses the possible role of virtual reality (VR) in addressing this problem within an integrated treatment approach. More, the clinical case of a female bariatric patient who experienced body dissatisfaction even after a 30% body weight loss and a 62% excess body weight loss, is presented and discussed.

  4. Effectiveness of Standardized Physical Therapy Exercises for Patients With Difficulty Returning to Usual Activities After Decompression Surgery for Subacromial Impingement Syndrome: Randomized Controlled Trial.

    Science.gov (United States)

    Christiansen, David Høyrup; Frost, Poul; Falla, Deborah; Haahr, Jens Peder; Frich, Lars Henrik; Andrea, Linda Christie; Svendsen, Susanne Wulff

    2016-06-01

    Little is known about the effectiveness of exercise programs after decompression surgery for subacromial impingement syndrome. For patients with difficulty returning to usual activities, special efforts may be needed to improve shoulder function. The purpose of this study was to evaluate the effectiveness at 3 and 12 months of a standardized physical therapy exercise intervention compared with usual care in patients with difficulty returning to usual activities after subacromial decompression surgery. A multicenter randomized controlled trial was conducted. The study was conducted in 6 public departments of orthopedic surgery, 2 departments of occupational medicine, and 2 physical therapy training centers in Central Denmark Region. One hundred twenty-six patients reporting difficulty returning to usual activities at the postoperative clinical follow-up 8 to 12 weeks after subacromial decompression surgery participated. A standardized exercise program consisting of physical therapist-supervised individual training sessions and home training was used. The primary outcome measure was the Oxford Shoulder Score. Secondary outcome measures were the Constant Score and the Fear-Avoidance Beliefs Questionnaire. At 3 and 12 months, follow-up data were obtained for 92% and 83% of the patients, respectively. Intention-to-treat analyses suggested a between-group difference on the Oxford Shoulder Score favoring the exercise group at 3 months, with an adjusted mean difference of 2.0 (95% confidence interval=-0.5, 4.6), and at 12 months, with an adjusted mean difference of 5.8 (95% confidence interval=2.8, 8.9). Significantly larger improvements for the exercise group were observed for most secondary and supplementary outcome measures. The nature of the exercise intervention did not allow blinding of patients and care providers. The standardized physical therapy exercise intervention resulted in statistically significant and clinically relevant improvement in shoulder pain and

  5. Liver Function in Patients With Nonalcoholic Fatty Liver Disease Randomized to Roux-en-Y Gastric Bypass Versus Sleeve Gastrectomy: A Secondary Analysis of a Randomized Clinical Trial.

    Science.gov (United States)

    Kalinowski, Piotr; Paluszkiewicz, Rafał; Ziarkiewicz-Wróblewska, Bogna; Wróblewski, Tadeusz; Remiszewski, Piotr; Grodzicki, Mariusz; Krawczyk, Marek

    2017-11-01

    The aim of the study was to compare the influence of sleeve gastrectomy (SG) versus Roux-en-Y gastric bypass (RYGB) on liver function in bariatric patients with non-alcoholic fatty liver disease (NAFLD) in a randomized clinical trial (NCT01806506). Rapid weight loss and malabsorption after bariatric surgery in patients with NAFLD or steatohepatitis (NASH) may impair liver function. Sixty-six morbidly obese patients randomized to SG or RYGB were included in a secondary outcome analysis. Intraoperative liver biopsies were categorized with NAFLD Activity Score (NAS) and liver function tests were done before surgery and after 1, 6 and 12 months. NASH was present in 54.5% RYGB and 51.5% SG patients (P > 0.05). At 12 months excess weight loss was 68.7 ± 19.7% after SG and 62.8 ± 18.5% after RYGB (P > 0.05). At 1 month international normalized ratio (INR) increased after RYGB (0.98 ± 0.05 vs 1.14 ± 0.11; P liver function than after SG.

  6. The effect of perhexiline on myocardial protection during coronary artery surgery: a two-centre, randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Drury, Nigel E; Howell, Neil J; Calvert, Melanie J; Weber, Ralf J M; Senanayake, Eshan L; Lewis, Michael E; Hyde, Jonathan A J; Green, David H; Mascaro, Jorge G; Wilson, Ian C; Graham, Timothy R; Rooney, Stephen J; Viant, Mark R; Freemantle, Nick; Frenneaux, Michael P; Pagano, Domenico

    2015-03-01

    Perhexiline is thought to modulate metabolism by inhibiting mitochondrial carnitine palmitoyltransferase-1, reducing fatty acid uptake and increasing carbohydrate utilization. This study assessed whether preoperative perhexiline improves markers of myocardial protection in patients undergoing coronary artery bypass graft surgery and analysed its effect on the myocardial metabolome. In a prospective, randomized, double-blind, placebo-controlled trial, patients at two centres were randomized to receive either oral perhexiline or placebo for at least 5 days prior to surgery. The primary outcome was a low cardiac output episode in the first 6 h. All pre-specified analyses were conducted according to the intention-to-treat principle with a statistical power of 90% to detect a relative risk of 0.5 and a conventional one-sided α-value of 0.025. A subset of pre-ischaemic left ventricular biopsies was analysed using mass spectrometry-based metabolomics. Over a 3-year period, 286 patients were randomized, received the intervention and were included in the analysis. The incidence rate of a low cardiac output episode in the perhexiline arm was 36.7% (51/139) vs 34.7% (51/147) in the control arm [odds ratio (OR) 0.92, 95% confidence interval (CI) 0.56-1.50, P = 0.74]. Perhexiline was associated with a reduction in the cardiac index at 6 h [difference in means 0.19, 95% CI 0.07-0.31, P = 0.001] and an increase in inotropic support in the first 12 h (OR 0.55, 95% CI 0.34-0.89, P = 0.015). There were no significant differences in myocardial injury with troponin-T or electrocardiogram, reoperation, renal dysfunction or length of stay. No difference in the preischaemic left ventricular metabolism was identified between groups on metabolomics analysis. Preoperative perhexiline does not improve myocardial protection in patients undergoing coronary surgery and in fact reduced perioperative cardiac output, increasing the need for inotropic support. Perhexiline has no significant effect

  7. Clinical evaluation of complete solo surgery with the "ViKY®" robotic laparoscope manipulator.

    Science.gov (United States)

    Takahashi, Masahiro; Takahashi, Masanori; Nishinari, Naoto; Matsuya, Hideki; Tosha, Tsutomu; Minagawa, Yukihiro; Shimooki, Osamu; Abe, Tadashi

    2017-02-01

    Advancement in both surgical technique and medical equipment has enabled solo surgery. ViKY ® Endoscope Positioning System (ViKY ® ) is a robotic system that remotely controls an endoscope and provides direct vision control to the surgeon. Here, we report our experience with ViKY ® -assisted solo surgery. We retrospectively examined 25 cases of solo surgery TAPP with ViKY ® . ViKY ® was setup by the surgeon alone, and the setup duration was determined as the time at which the side rail was positioned and that when the endoscope was installed. For assessing the control unit, the number of false movements was counted. We compared the operative results between ViKY ® -assisted solo surgery TAPP and the conventional method with an assistant. The average time to set up ViKY ® was 7.9 min. The average number of commands for ViKY ® during surgery was 98.3, and the average number of errors and no response of control unit was 7.9. The mean duration of surgery was 136 min for the ViKY ® group, including the setup time, and 117 min for the conventional method. No case required an assistant during the operation. There was also no difference between the two groups with regard to postoperative complications and the rate of recurrence. ViKY ® proved reliable in recognizing orders with very few failures, and the operations were performed safely and were comparable to the conventional operations with assistants. Solo surgery with ViKY ® was beneficial in this clinical evaluation.

  8. Characteristics and clinical aspects of patients with spinal cord injury undergoing surgery

    Directory of Open Access Journals (Sweden)

    João Simão de Melo-Neto

    Full Text Available ABSTRACT OBJECTIVE: To identify the characteristics of patients with spinal cord injury (SCI undergoing surgery. METHODS: Previously, 321 patients with SCI were selected. Clinical and socio-demographic variables were collected. RESULTS: A total of 211 patients were submitted to surgery. Fall and injuries in the upper cervical and lumbosacral regions were associated with conservative treatment. Patients with lesions in the lower cervical spine, worse neurological status, and unstable injuries were associated with surgery. Individuals undergoing surgery were associated with complications after treatment. The authors assessed whether age influenced the characteristics of patients submitted to surgery. Subjects with <60 years of age were associated with motorcycle accidents and the morphologies of injury were fracture-dislocation. Elderly individuals were associated to fall, SCI in the lower cervical spine and the morphology of injury was listhesis. Subsequently, the authors analyzed the gender characteristics in these patients. Women who suffered car accidents were associated to surgery. Women were associated with paraparesis and the morphologic diagnosis was fracture-explosion, especially in the thoracolumbar transition and lumbosacral regions. Men who presented traumatic brain injury and thoracic trauma were related to surgery. These individuals had a worse neurological status and were associated to complications. Men and the cervical region were most affected, thereby, these subjects were analyzed separately (n= 92. The presence of complications increased the length of hospital stay. The simultaneous presence of morphological diagnosis, worst neurological status, tetraplegia, sensory, and motor alterations were associated with complications. Pneumonia and chest trauma were associated with mortality. CONCLUSION: These factors enable investments in prevention, rehabilitation, and treatment.

  9. Robotic surgery for rectal cancer: current immediate clinical and oncological outcomes.

    Science.gov (United States)

    Araujo, Sergio Eduardo Alonso; Seid, Victor Edmond; Klajner, Sidney

    2014-10-21

    Laparoscopic rectal surgery continues to be a challenging operation associated to a steep learning curve. Robotic surgical systems have dramatically changed minimally invasive surgery. Three-dimensional, magnified and stable view, articulated instruments, and reduction of physiologic tremors leading to superior dexterity and ergonomics. Therefore, robotic platforms could potentially address limitations of laparoscopic rectal surgery. It was aimed at reviewing current literature on short-term clinical and oncological (pathological) outcomes after robotic rectal cancer surgery in comparison with laparoscopic surgery. A systematic review was performed for the period 2002 to 2014. A total of 1776 patients with rectal cancer underwent minimally invasive robotic treatment in 32 studies. After robotic and laparoscopic approach to oncologic rectal surgery, respectively, mean operating time varied from 192-385 min, and from 158-297 min; mean estimated blood loss was between 33 and 283 mL, and between 127 and 300 mL; mean length of stay varied from 4-10 d; and from 6-15 d. Conversion after robotic rectal surgery varied from 0% to 9.4%, and from 0 to 22% after laparoscopy. There was no difference between robotic (0%-41.3%) and laparoscopic (5.5%-29.3%) surgery regarding morbidity and anastomotic complications (respectively, 0%-13.5%, and 0%-11.1%). Regarding immediate oncologic outcomes, respectively among robotic and laparoscopic cases, positive circumferential margins varied from 0% to 7.5%, and from 0% to 8.8%; the mean number of retrieved lymph nodes was between 10 and 20, and between 11 and 21; and the mean distal resection margin was from 0.8 to 4.7 cm, and from 1.9 to 4.5 cm. Robotic rectal cancer surgery is being undertaken by experienced surgeons. However, the quality of the assembled evidence does not support definite conclusions about most studies variables. Robotic rectal cancer surgery is associated to increased costs and operating time. It also seems to be

  10. Clinical outcomes of laparoscopic surgery for transverse and descending colon cancers in a community setting.

    Science.gov (United States)

    Matsuda, Takeru; Fujita, Hirofumi; Kunimoto, Yukihiro; Kimura, Taisei; Hayashi, Tomomi; Maeda, Toshiyuki; Yamakawa, Junichi; Mizumoto, Takuya; Ogino, Kazunori

    2013-08-01

    The feasibility, safety and oncological outcomes of laparoscopic surgery for transverse and descending colon cancers in a community hospital setting were evaluated. Twenty-six patients with transverse or descending colon cancers who underwent laparoscopic surgery at our hospital were included in this retrospective analysis (group A). Their outcomes were compared with those of 71 patients who underwent laparoscopic surgery for colon cancer at other tumor sites (group B). There were no significant differences between the two groups in terms of operative time, estimated blood loss, postoperative hospital stay and morbidity rate. Extended lymphadenectomy was performed more frequently and the number of harvested lymph nodes was significantly higher in group B than in group A. However, no recurrence developed in group A, while recurrence occurred in four patients from group B. The 3-year disease-free survival rates were 100% for group A and 93.5% for group B. The 3-year overall survival rates were 100% for group A and 91.6% for group B. Laparoscopic surgery for transverse and descending colon cancers can be performed safely with oncological validity in a community hospital setting, provided there is careful selection of the patients and adequate lymphadenectomy considering the clinical stage of their disease. © 2013 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and Wiley Publishing Asia Pty Ltd.

  11. Perioperative synbiotics administration decreases postoperative infections in patients with colorectal cancer: a randomized, double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    ALINE TABORDA FLESCH

    Full Text Available ABSTRACT Objective: to evaluate the effect of perioperative administration of symbiotics on the incidence of surgical wound infection in patients undergoing surgery for colorectal cancer. Methods: We conducted a randomized clinical trial with colorectal cancer patients undergoing elective surgery, randomly assigned to receive symbiotics or placebo for five days prior to the surgical procedure and for 14 days after surgery. We studied 91 patients, 49 in the symbiotics group (Lactobacillus acidophilus 108 to 109 CFU, Lactobacillus rhamnosus 108 to 109 CFU, Lactobacillus casei 108 to 109 CFU, Bifi dobacterium 108 to 109 CFU and fructo-oligosaccharide (FOS 6g and 42 in the placebo group. Results: surgical site infection occurred in one (2% patient in the symbiotics group and in nine (21.4% patients in the control group (p=0.002. There were three cases of intraabdominal abscess and four cases of pneumonia in the control group, whereas we observed no infections in patients receiving symbiotics (p=0.001. Conclusion: the perioperative administration of symbiotics significantly reduced postoperative infection rates in patients with colorectal cancer. Additional studies are needed to confirm the role of symbiotics in the surgical treatment of colorectal cancer.

  12. Timing of surgery for sciatica: Subgroup analysis alongside a randomized trial

    NARCIS (Netherlands)

    W.C. Peul (Wilco); M.P. Arts (Mark); R. Brand (René); B.W. Koes (Bart)

    2009-01-01

    textabstractSurgery speeds up recovery for sciatica. Prolonged conservative care with surgery for those patients with persistent sciatica however, yields similar results at 1 year. To investigate whether baseline variables modify the difference in recovery rates between these treatment strategies,

  13. A randomized trial of laparoscopic versus open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Bonjer, H Jaap; Deijen, Charlotte L; Abis, Gabor A

    2015-01-01

    BACKGROUND: Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal ar...

  14. Brief smoking cessation intervention in relation to breast cancer surgery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Thomsen, Thordis; Tønnesen, Hanne; Okholm, Mette

    2010-01-01

    Smokers are more prone to develop postoperative complications. Smoking cessation intervention beginning 4-8 weeks prior to surgery improves the postoperative outcome. Cancer patients, however, often undergo surgery less than 4 weeks after diagnosis. The primary objective of this study was therefo...

  15. Effects of auriculotherapy on labour pain: a randomized clinical trial.

    Science.gov (United States)

    Mafetoni, Reginaldo Roque; Shimo, Antonieta Keiko Kakuda

    2016-01-01

    Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes); caesarean section rates were higher in the placebo group (50%) and the same in the other groups (10%). Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj. Avaliar os efeitos da auriculoterapia no controle da dor e seus desfechos na duração do trabalho de parto. Trata-se de um ensaio controlado, randomizado e duplo-cego, com dados preliminares. Foram selecionadas 30 parturientes com idade gestacional ≥ 37 semanas, dilatação cervical ≥ 4 cm e duas ou mais contrações em 10 minutos, divididas aleatoriamente em três grupos: auriculoterapia, placebo ou controle. A auriculoterapia foi aplicada com microesferas de cristais em quatro pontos estratégicos. Não houve significância estatística entre os grupos com relação à dor; no entanto, as mulheres do grupo de auriculoterapia, apresentaram menor intensidade e menor percepção da dor aos 30, 60 e 120 minutos do tratamento. A média de duração do trabalho de

  16. Use of adjunctive mitomycin C in external dacryocystorhinostomy surgery compared with surgery alone in patients with nasolacrimal duct obstruction: A prospective, double-masked, randomized, controlled trial.

    Science.gov (United States)

    Ari, Seyhmus; Gun, Ramazan; Surmeli, Serdar; Atay, Ahmet Engin; Caca, Ihsan

    2009-08-01

    The most common cause for the failure of external dacryocystorhinostomy (DCR) surgery is the formation of granulation tissue at the osteotomy site or common canaliculus. The aims of this study were to assess the efficacy of intraoperative adjunctive mitomycin C (MMC) treatment in external DCR surgery and to compare this procedure with the standard DCR procedure alone in the long term (1 year). In this prospective, double-masked, randomized, controlled trial, patients with primary acquired nasolacrimal duct obstruction were randomized (using a random number table) into 2 groups based on surgical procedure. In the MMC group, intraoperative adjunctive MMC 0.2 mg/mL was applied to the osteotomy site for 30 minutes. The control group underwent standard DCR procedure only. The results of the DCR surgeries were assessed using objective findings (eg, cessation of excessive tearing via nasolacrimal duct irrigation and the improvement in height of tear meniscus) and subjective symptoms (asking patients to describe the degree of tearing improvement). Both the patients and the researchers who were assessing the study outcomes were masked to treatment group. One hundred eyes of 100 Turkish patients were assessed and equally randomized to the MMC (27 women, 23 men; mean [SD] age, 47.0 [7.6] years) and control (26 women, 24 men; mean age, 46.6 [8.8] years) groups. The follow-up period was not significantly different between the MMC and the control groups (13.1 [1.1] vs 13.2 [1.4] months). Significantly more eyes in the MMC group than the control group remained symptom-free throughout the 1-year follow-up period (45/50 [90%] vs 33/50 [66%]; P=0.005). Significantly more patients in the control group than the MMC group had an improvement in symptoms at the 1-year follow-up (8/50 [16%] vs 2/50 [4%] eyes; P=0.005). Based on the patency of the drainage system, the success rate was significantly greater in the MMC group than the control group (48/50 [96%] vs 42/50 [84%]; P=0.005). Based

  17. Surgery for vertigo: 10-year audit from a contemporary vertigo clinic.

    Science.gov (United States)

    Patnaik, U; Srivastava, A; Sikka, K; Thakar, A

    2015-12-01

    To present the profile of patients undergoing surgical treatment for vertigo at a contemporary institutional vertigo clinic. A retrospective analysis of clinical charts. The charts of 1060 patients, referred to an institutional vertigo clinic from January 2003 to December 2012, were studied. The clinical profile and long-term outcomes of patients who underwent surgery were analysed. Of 1060 patients, 12 (1.13 per cent) were managed surgically. Of these, disease-modifying surgical procedures included perilymphatic fistula repair (n = 7) and microvascular decompression of the vestibular nerve (n = 1). Labyrinth destructive procedures included transmastoid labyrinthectomy (n = 2) and labyrinthectomy with vestibular nerve section (n = 1). One patient with vestibular schwannoma underwent both a disease-modifying and destructive procedure (translabyrinthine excision). All patients achieved excellent vertigo control, classified as per the American Academy of Otolaryngology - Head and Neck Surgery 1995 criteria. With the advent of intratympanic treatments, surgical treatments for vertigo have become further limited. However, surgery with directed intent, in select patients, can give excellent results.

  18. Octogenarians' post-acute care use after cardiac valve surgery and recovery: clinical implications.

    Science.gov (United States)

    Edmiston, Elizabeth; Dolansky, Mary A; Zullo, Melissa; Forman, Daniel E

    2017-12-21

    Octogenarians receiving cardiac valve surgery is increasing and recovery is challenging. Post-acute care (PAC) services assist with recovery, yet services provided in facilities do not provide adequate cardiac-focused care or long-term self-management support. The purpose of the paper was to report post-acute care discharge rates in octogenarians and propose clinical implications to improve PAC services. Using a 2003 Medicare Part A database, we studied post-acute care service use in octogenarians after cardiac valve surgery. We propose expansion of the Geriatric Cardiac Care model to include broader clinical therapy dynamics. The sample (n = 10,062) included patients over 80 years discharged from acute care following valve surgery. Post-acute care services were used by 68% of octagarians following cardiac valve surgery (1% intermediate rehabilitation, 35% skilled nursing facility, 32% home health). The large percentage of octagarians using PAC point to the importance of integrating geriatric cardiac care into post-acute services to optimize recovery outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. A Clinical Prediction Model for Postcardiac Surgery Atrial Fibrillation in an Asian Population.

    Science.gov (United States)

    Zhang, Wei; Liu, Weiling; Chew, Sophia T H; Shen, Liang; Ti, Lian Kah

    2016-08-01

    Postoperative atrial fibrillation (AF) is associated with increased morbidity, mortality, and resource utilization. Current prediction models for postoperative AF are based primarily on Western populations. In this study, we sought to develop a clinical prediction rule for postcardiac surgery AF for a multiethnic Asian population. Two thousand one hundred sixty-eight patients undergoing coronary artery bypass graft or valve surgery with cardiopulmonary bypass were prospectively enrolled in this observational study between August 2008 and July 2012 at Singapore's 2 national heart centers. Postoperative AF was defined as an irregularly irregular electrocardiogram rhythm without identifiable P wave after surgery and before hospital discharge that lasted more than an hour, or affected hemodynamics (ie, systolic blood pressure 120 minutes (OR, 1.92; 95% CI, 1.47-2.52, P Chinese ethnicity (Chinese versus Indian OR, 2.09; 95% CI, 1.28-3.41, P = 0.003) or Malay (Malay versus Indian OR, 2.43; 95% CI, 1.36-4.05, P = 0.002) to be independently associated with postoperative AF. The area under the receiver-operator characteristic curve of the model was 0.704 (95% CI, 0.674-0.734). Internal validation produced an area under the receiver-operator characteristic curve of 0.756 (95% CI, 0.690-0.821). Clinical risk factors for AF after cardiac surgery in an Asian population are similar to that reported from primarily Western populations, but specific ethnicity influences susceptibility.

  20. Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial.

    Science.gov (United States)

    Pastora-Bernal, Jose-Manuel; Martín-Valero, Rocío; Barón-López, Francisco Javier; García-Gómez, Oscar

    2017-02-23

    Shoulder pain is common in society, with high prevalence in the general population. Shoulder impingement syndrome (SIS) is the most frequent cause. Patients suffer pain, muscle weakness and loss of movement in the affected joint. Initial treatment is predominantly conservative. The surgical option has high success rates and is often used when conservative strategy fails. Traditional physiotherapy and post-operative exercises are needed for the recovery of joint range, muscle strength, stability and functionality. Telerehabilitation programmes have shown positive results in some orthopaedic conditions after surgery. Customized telerehabilitation intervention programmes should be developed to recover shoulder function after SIS surgery. The objective of this study is to evaluate the feasibility and effectiveness of a telerehabilitation intervention compared with usual care in patients after subacromial decompression surgery. We will compare an intervention group receiving videoconferences and a telerehabilitation programme to a control group receiving traditional physiotherapy intervention in a single-blind, randomized controlled non-inferiority trial study design. Through this study, we will further develop our preliminary data set and practical experience with the telerehabilitation programmes to evaluate their effectiveness and compare this with traditional intervention. We will also explore patient satisfaction and cost-effectiveness. Patient enrolment is ongoing. ClinicalTrials.gov, NCT02909920 . 14 September 2016.

  1. Clinical research on high oxygen permeable contact lens used after photorefractive keratectomy surgery

    Directory of Open Access Journals (Sweden)

    Hao-Jiang Yang

    2013-07-01

    Full Text Available AIM: To evaluate the outcome of high oxygen permeable contact lens used after photorefractive keratectomy(PRKsurgery.METHODS: Totally 95 patients(190 eyesafter PRK were included. Patients were randomly assigned to wear high oxygen permeable contact lens in one eye and normal lens in the fellow eye after surgery. The subjective symptoms and corneal epithelial status after PRK were evaluated. Uncorrected visual acuity(UCVAand haze were assessed at 6 months after PRK.RESULTS: Complaints of blurred vision, pain and photophobia were statistically more among the normal lens group than high oxygen permeable contact lens group(PPP=0.35. There was no difference in UCVA and haze 6 months after surgery(P=0.55. CONCLUSION: High oxygen permeable contact lens can significantly produce less the corneal irritated symptoms, reduce the discomfort feeling and promote healing of corneal epithelium after PRK.

  2. Telephone follow-up by nurse following total knee arthroplasty - protocol for a randomized clinical trial (NCT01771315)

    DEFF Research Database (Denmark)

    Szöts, Kirsten; Konradsen, Hanne; Solgaard, Søren

    2014-01-01

    to the orthopaedic outpatient clinic during the rehabilitation period. METHOD/DESIGN: The design is a randomized un-blinded parallel group clinical trial conducted at the Department of Orthopaedic Surgery, Gentofte Hospital, the Capital Region of Denmark. In total, 116 patients will be allocated by an external...... are structured by key subjects relevant to assess the health status according to the VIPS-model (the Swedish acronym for the concepts Well-being, Integrity, Prevention and Safety). The content of the consultations can vary according to the patients´ individual situations and needs. All consultations...... of life, general self-efficacy and the number of acute visits to the orthopaedic outpatient clinic. DISCUSSION: The result of this trial is expected to provide new knowledge to support the development of targeted and effective follow-up after total knee arthroplasty in order to improve the patients...

  3. Repurposing Diflunisal for Familial Amyloid Polyneuropathy: A Randomized Clinical Trial

    Science.gov (United States)

    Berk, John L.; Suhr, Ole B.; Obici, Laura; Sekijima, Yoshiki; Zeldenrust, Steven R.; Yamashita, Taro; Heneghan, Michael A.; Gorevic, Peter D.; Litchy, William J.; Wiesman, Janice F.; Nordh, Erik; Corato, Manuel; Lozza, Alessandro; Cortese, Andrea; Robinson-Papp, Jessica; Colton, Theodore; Rybin, Denis V.; Bisbee, Alice B.; Ando, Yukio; Ikeda, Shu-ichi; Seldin, David C.; Merlini, Giampaolo; Skinner, Martha; Kelly, Jeffery W.; Dyck, Peter J.

    2014-01-01

    Importance Familial amyloid polyneuropathy (ATTR-FAP), a lethal genetic disease caused by aggregation of variant transthyretin, induces progressive peripheral nerve deficits and disability. Diflunisal, a non-steroidal anti-inflammatory agent, stabilizes transthyretin tetramers and prevents amyloid fibril formation in vitro. Objective To determine the effect of diflunisal on polyneuropathy progression in patients with ATTR-FAP. Design, Setting, and Patients We conducted an investigator-initiated international, randomized, double-blind, placebo-controlled study at amyloid centers in Sweden (Umea), Italy (Pavia), Japan (Matsumoto and Kumamoto), England (London), and the United States (Boston, New York, Rochester, MN) from 2006 through 2012. 130 ATTRFAP patients with clinically detectable peripheral or autonomic neuropathy were randomly assigned to diflunisal 250 mg or placebo twice daily for 2 years. Main Outcome Measures The primary endpoint, the difference in polyneuropathy progression between treatments, was measured by the Neuropathy Impairment Score plus 7 nerve tests (NIS+7) which ranges from 0 (no neurologic deficits) to 270 points (no detectable peripheral nerve function). Secondary outcomes included a quality of life questionnaire (Short Form-36 (SF-36)) and modified body mass index (mBMI). Results One hundred thirty randomized patients (66 placebo, 64 diflunisal) underwent serial NIS+7 evaluations over 2 years. Due to attrition, we employed likelihood based modeling and multiple imputation (MI) analysis of baseline to 2 year data. By MI, NIS+7 increased 25.0 points (95% CI, 18.4 to 31.6) among placebo and 8.7 points (95% CI, 3.3 to 14.1) in the diflunisal group, a difference of 16.3 points (95% CI, 8.1 to 24.5, p=0.001). Mean SF-36 physical scores fell 4.9 points (95% CI, −7.6 to −2.2) among placebo and rose 1.5 points (95% CI, −0.8 to 3.7) in the diflunisal group (p=0.003). SF-36 mental scores declined 1.1 (95% CI, −4.3 to 2.0) among placebo while

  4. Antibiotic treatment to prevent postextraction complications: a monocentric, randomized clinical trial. Preliminary outcomes.

    Science.gov (United States)

    Barone, Antonio; Marchionni, Francesco S; Cinquini, Chiara; Cipolli Panattoni, Andrea; Toti, Paolo; Marconcini, Simone; Covani, Ugo; Gabriele, Mario

    2017-08-01

    Tooth extraction is a very common procedure in oral surgery. Despite this, very little information is available in the literature as to the antibiotic management of the patient. The aim of this study is to evaluate whether the antibiotic prophylaxis could be beneficial in preventing postextraction local complications and whether the use of a probiotic could help reduce the antibiotic gastro-intestinal side effects. One hundred eleven patients meeting the inclusion criteria were initially included in this randomized clinical trial and randomly allocated to one of the three experimental groups according to a computer-generated randomization list. Patients allocated to the group 1 were given amoxicillin+clavulanic acid (2 g/day for 6 days), patients allocated to the group 2 received antibiotic + probiotic (Bifidobacterium longum+lactoferrin) and patients allocated to the group 3 received no antibiotic therapy after the extraction. To evaluate post-extractive complications, controls were performed at days 7, 14 and 21 after the extraction. At T1 pain at the surgical site was present in the 48%, 30% and 71.4% of the patients belonging respectively to the antibiotic alone group, to the antibiotic+probiotic group and to the control group. The mean Numeric Rating Score (NRS) score was 1.56±1.91, 1.08±1.93, 2.02±2.27 respectively (P=0.0498). Two patients belonging to the control group experienced dry socket. In addition, 9 patients (33.3%) in the antibiotic-alone group and 1 patient (2.7%) in the antibiotic+probiotic group reported intestinal distension (P=0.0012), 7 days after surgery. Finally, diarrhea was recorded in 5 patients of the antibiotic alone group (18.5%), on the other hand, no patients of the antibiotic+probiotic group and the control group reported diarrhea. Postextractive complications observed in each group have been mild and fast to resolve. The antibiotic administration showed a decrease in pain suffered by patients but a higher incidence of

  5. Fast-track surgery protocol in elderly patients undergoing laparoscopic radical gastrectomy for gastric cancer: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Liu G

    2016-06-01

    Full Text Available Guozheng Liu,1 Fengguo Jian,2 Xiuqin Wang,2 Lin Chen1 1Department of General Surgery, Chinese PLA General Hospital, Beijing, People’s Republic of China; 2Second Department of General Surgery, Changyi People’s Hospital, Shandong, People’s Republic of China Aim: To study the efficacy of the fast-track surgery (FTS program combined with laparoscopic radical gastrectomy for elderly gastric cancer (GC patients.Methods: Eighty-four elderly patients diagnosed with GC between September 2014 and August 2015 were recruited to participate in this study and were divided into four groups randomly based on the random number table as follows: FTS + laparoscopic group (Group A, n=21, FTS + laparotomy group (Group B, n=21, conventional perioperative care (CC + laparoscopic group (Group C, n=21, and CC + laparotomy group (Group D, n=21. Observation indicators include intrasurgery indicators, postoperative recovery indicators, nutritional status indicators, and systemic stress response indicators.Results: Preoperative and intraoperative baseline characteristics showed no significant differences between patients in each group (P>0.05. There were no significant differences between each group in nausea and vomiting, intestinal obstruction, urinary retention, incision infection, pulmonary infection, and urinary tract infection after operation (P>0.05. Time of first flatus and postoperative hospital stay time of FTS Group A were the shortest, and total medical cost of this group was the lowest. For all groups, serum albumin, prealbumin, and transferrin significantly decreased, while CRP and interleukin 6 were significantly increased postoperative day 1. From postoperative day 4–7, all indicators of the four groups gradually recovered, but compared with other three groups, those of Group A recovered fastest.Conclusion: FTS combined with laparoscopic surgery can promote faster postoperative recovery, improve early postoperative nutritional status, and more

  6. Web-Based Education Prior to Outpatient Orthopaedic Surgery Enhances Early Patient Satisfaction Scores: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    van Eck, Carola F; Toor, Aneet; Banffy, Michael B; Gambardella, Ralph A

    2018-01-01

    A good patient-surgeon relationship relies on adequate preoperative education and counseling. Several multimedia resources, such as web-based education tools, have become available to enhance aspects of perioperative care. The purpose of this study was to evaluate the effect of an interactive web-based education tool on perioperative patient satisfaction scores after outpatient orthopaedic surgery. It was hypothesized that web-based education prior to outpatient orthopaedic surgery enhances patient satisfaction scores. Randomized controlled trial; Level of evidence, 1. All patients undergoing knee arthroscopy with meniscectomy, chondroplasty, or anterior cruciate ligament reconstruction or shoulder arthroscopy with rotator cuff repair were eligible for inclusion and were randomized to the study or control group. The control group received routine education by the surgeon, whereas the study group received additional web-based education. At the first postoperative visit, all patients completed the OAS CAHPS (Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems) survey. Differences in patient satisfaction scores between the study and control groups were determined with an independent t test. A total of 177 patients were included (104 [59%] males; mean age, 42 ± 14 years); 87 (49%) patients were randomized to receive additional web-based education. Total patient satisfaction score was significantly higher in the study group (97 ± 5) as compared with the control group (94 ± 8; P = .019), specifically for the OAS CAHPS core measure "recovery" (92 ± 13 vs 82 ± 23; P = .001). Age, sex, race, workers' compensation status, education level, overall health, emotional health, procedure type and complexity, and addition of a video did not influence patient satisfaction scores. Supplemental web-based patient education prior to outpatient orthopaedic surgery enhances patient satisfaction scores.

  7. Review of the randomized clinical stroke rehabilitation trials in 2009.

    Science.gov (United States)

    Rabadi, Meheroz H

    2011-02-01

    Recent review of the available evidence on interventions for motor recovery after stroke, showed that improvements in recovery of arm function were seen for constraint-induced movement therapy, electromyographic biofeedback, mental practice with motor imagery, and robotics. Similar improvement in transfer ability or balance were seen with repetitive task training, biofeedback, and training with a moving platform. Walking speed was improved by physical fitness training, high-intensity physiotherapy and repetitive task training. However, most of these trials were small and had design limitations. In this article, randomized control trials (RCT's) published in 2009 of rehabilitation therapies for acute (≤ 2 weeks), sub-acute (2 to 12 weeks) and chronic (≥ 12 weeks) stroke was reviewed. A Medline search was performed to identify all RCT's in stroke rehabilitation in the year 2009. The search strategy that was used for PubMed is presented in the Appendix 1. The objective was to examine the effectiveness of these treatment modalities in stroke rehabilitation. This generated 35 RCT's under 5 categories which were found and analyzed. The methodological quality was assessed by using the PEDro scale for external and internal validity. These trials were primarily efficacy studies. Most of these studies enrolled small numbers of patient which precluded their clinical applicability (limited external validity). However, the constraint induced movement therapy (CIT), regularly used in chronic stroke patients did not improve affected arm-hand function when used in acute stroke patients at ≤ 4 weeks. Intensive CIT did not lead to motor improvement in arm-hand function. Robotic arm treatment helped decrease motor impairment and improved function in chronic stroke patients only. Therapist provided exercise programs (when self-administered by patients during their off-therapy time in a rehabilitation setting) did improve arm-hand function. Tai Chi exercises helped improve

  8. A Review of Current Clinical Applications of Three-Dimensional Printing in Spine Surgery.

    Science.gov (United States)

    Cho, Woojin; Job, Alan Varkey; Chen, Jing; Baek, Jung Hwan

    2018-02-01

    Three-dimensional (3D) printing is a transformative technology with a potentially wide range of applications in the field of orthopaedic spine surgery. This article aims to review the current applications, limitations, and future developments of 3D printing technology in orthopaedic spine surgery. Current preoperative applications of 3D printing include construction of complex 3D anatomic models for improved visual understanding, preoperative surgical planning, and surgical simulations for resident education. Intraoperatively, 3D printers have been successfully used in surgical guidance systems and in the creation of patient specific implantable devices. Furthermore, 3D printing is revolutionizing the field of regenerative medicine and tissue engineering, allowing construction of biocompatible scaffolds suitable for cell growth and vasculature. Advances in printing technology and evidence of positive clinical outcomes are needed before there is an expansion of 3D printing applied to the clinical setting.

  9. [Clinical safety and professional liability claims in Orthopaedic Surgery and Traumatology].

    Science.gov (United States)

    Bori, G; Gómez-Durán, E L; Combalia, A; Trilla, A; Prat, A; Bruguera, M; Arimany-Manso, J

    2016-01-01

    The specialist in orthopaedic and traumatological surgery, like any other doctor, is subject to the current legal provisions while exercising their profession. Mandatory training in the medical-legal aspects of health care is essential. Claims against doctors are a reality, and orthopaedic and traumatological surgery holds first place in terms of frequency of claims according to the data from the General Council of Official Colleges of Doctors of Catalonia. Professionals must be aware of the fundamental aspects of medical professional liability, as well as specific aspects, such as defensive medicine and clinical safety. The understanding of these medical-legal aspects in the routine clinical practice can help to pave the way towards a satisfactory and safe professional career. The aim of this review is to contribute to this training, for the benefit of professionals and patients. Copyright © 2015 SECOT. Published by Elsevier Espana. All rights reserved.

  10. Vascular care in patients with Alzheimer's disease with cerebrovascular lesions-a randomized clinical trial

    NARCIS (Netherlands)

    Richard, Edo; Kuiper, Roy; Dijkgraaf, Marcel G. W.; van Gool, Willem A.

    2009-01-01

    OBJECTIVES: To investigate whether vascular care slows dementia progression in patients with Alzheimer's disease with cerebrovascular lesions on neuroimaging. DESIGN: Multicenter randomized controlled clinical trial with 2-year follow-up. SETTING: Neurological and geriatric outpatient clinics in 10

  11. STUDY OF CLINICAL OUTCOMES OF SUBFASCIAL PERFORATOR LIGATION SURGERY IN PERFORATOR INCOMPETENCE

    Directory of Open Access Journals (Sweden)

    Vasuki Rajam

    2017-02-01

    Full Text Available BACKGROUND Chronic venous insufficiency presents with a spectrum of clinical features ranging from pain or heaviness of affected limbs to non-healing ulcers over the lower limbs and usually require some form of surgical intervention, performing direct perforator vein division preferably by subfascial endoscopic perforator ligation surgery for perforator incompetence, as despite aggressive conservative therapy including compression, lifestyle modification and venotonic medications which are of high cost treatment with increased risk of increasing symptoms. MATERIALS AND METHODS A prospective longitudinal clinical study of 30 patients selected by systematic sampling method from November 2014 to September 2015 at our institution was conducted to determine the results of subfascial endoscopic perforator vein surgery (SEPS in perforator incompetence. RESULTS For venous clinical severity scoring pre operatively and after 3 weeks post-surgery, the mean for VCSS pre-operatively was 6.66 and a standard deviation of 2.399. The T value was calculated and was found to be 4.9321 and p value of 0.00001(p value less than 0.05 is significant. Similarly for the cases with active ulcer, the size assessment pre-operatively and post-SEPS was again analysed using student t test and the mean ulcer size prior to surgery was found to be 3.3 and standard deviation of 1.984. The T value was calculated and was found to be 1.789009 and a p value of 0.04 (p value less than 0.05 is significant. CONCLUSION Our study concluded that favourable and significant ulcer healing rate with improvement and reduction in clinical severity suggests that SEPS plays an important role in surgical management of advanced stages of venous insufficiency.

  12. Validity of randomized clinical trials in gastroenterology from 1964-2000

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian

    2002-01-01

    The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....

  13. Control of anxiety through music in a head and neckoutpatient clinic: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mariana Alves Firmeza

    Full Text Available Abstract OBJECTIVE Evaluating the effectiveness of a musical intervention in reducing anxiety and vital parameters in people suffering from head and neck cancer. METHOD A randomized controlled clinical trial, performed in a head and neck outpatient clinic with 40 participants, subdivided into two groups (intervention and control.The classicalmusic“Spring” from The Four Seasons by Vivaldi was used as an intervention.The State-Trait Anxiety Inventory (STAI was used as the data collectioninstrument,along with an inventory of socio-demographic and clinical data. Student'st-test was used to verify intragroup and intergroup statistical significance. RESULTS Participants presented a statistically significant reduction in levels of perceived anxiety (t= 12.68; p<0.001,as well as blood pressure levels (t = 4.56; p<0.001; pulse (t = 6.15; p<0.001 and respiratory rate (t = 5.10; p<0.001. CONCLUSION Music has proven to be an effective non-pharmacological therapeutic resource in managinganxiety in an outpatient setting for people with cancer, as well as in reducing blood pressure, pulse and respiratory rate. Brazilian Registry of Clinical Trials: RBR-7W4YJJ

  14. Incidence, predictive factors, and clinical outcomes of acute kidney injury after gastric surgery for gastric cancer.

    Directory of Open Access Journals (Sweden)

    Chang Seong Kim

    Full Text Available BACKGROUND: Postoperative acute kidney injury (AKI, a serious surgical complication, is common after cardiac surgery; however, reports on AKI after noncardiac surgery are limited. We sought to determine the incidence and predictive factors of AKI after gastric surgery for gastric cancer and its effects on the clinical outcomes. METHODS: We conducted a retrospective study of 4718 patients with normal renal function who underwent partial or total gastrectomy for gastric cancer between June 2002 and December 2011. Postoperative AKI was defined by serum creatinine change, as per the Kidney Disease Improving Global Outcomes guideline. RESULTS: Of the 4718 patients, 679 (14.4% developed AKI. Length of hospital stay, intensive care unit admission rates, and in-hospital mortality rate (3.5% versus 0.2% were significantly higher in patients with AKI than in those without. AKI was also associated with requirement of renal replacement therapy. Multivariate analysis revealed that male gender; hypertension; chronic obstructive pulmonary disease; hypoalbuminemia (<4 g/dl; use of diuretics, vasopressors, and contrast agents; and packed red blood cell transfusion were independent predictors for AKI after gastric surgery. Postoperative AKI and vasopressor use entailed a high risk of 3-month mortality after multiple adjustments. CONCLUSIONS: AKI was common after gastric surgery for gastric cancer and associated with adverse outcomes. We identified several factors associated with postoperative AKI; recognition of these predictive factors may help reduce the incidence of AKI after gastric surgery. Furthermore, postoperative AKI in patients with gastric cancer is an important risk factor for short-term mortality.

  15. Single dose systemic acetaminophen to improve patient reported quality of recovery after ambulatory segmental mastectomy: A prospective, randomized, double-blinded, placebo controlled, clinical trial.

    Science.gov (United States)

    De Oliveira, Gildasio S; Rodes, Meghan E; Bialek, Jane; Kendall, Mark C; McCarthy, Robert J

    2017-11-15

    Few systemic drug interventions are efficacious to improve patient reported quality of recovery after ambulatory surgery. We aimed to evaluate whether a single dose systemic acetaminophen improve quality of recovery in female patients undergoing ambulatory breast surgery. We hypothesized that patients receiving a single dose systemic acetaminophen at the end of the surgical procedure would have a better global quality of postsurgical recovery compared to the ones receiving saline. The study was a prospective randomized double blinded, placebo controlled, clinical trial. Healthy female subjects were randomized to receive 1 g single dose systemic acetaminophen at the end of the surgery or the same volume of saline. The primary outcome was the Quality of Recovery 40 (QOR-40) questionnaire at 24 hours after surgery. Other data collected included opioid consumption and pain scores. Data were analyzed using group t tests and the Wilcoxon exact test. The association between opioid consumption and quality of recovery was evaluated using Spearman rho. P quality of recovery, P = .007. A single dose of systemic acetaminophen improves patient reported quality of recovery after ambulatory breast surgery. The use of systemic acetaminophen is an efficacious strategy to improve patient perceived quality of postsurgical recovery and analgesic outcomes after hospital discharge for ambulatory breast surgery. © 2017 Wiley Periodicals, Inc.

  16. Clinical application of 3D computer simulation for upper limb surgery

    International Nuclear Information System (INIS)

    Murase, Tsuyoshi; Moritomo, Hisao; Oka, Kunihiro; Arimitsu, Sayuri; Shimada, Kozo

    2008-01-01

    To perform precise orthopaedic surgery, we have been developing a surgical method using a custom-made surgical device designed based on preoperative three-dimensional computer simulation. The purpose of this study was to investigate the preliminary results of its clinical application for corrective osteotomy of the upper extremity. Twenty patients with long bone deformities of the upper extremities (four cubitus varus deformities, nine malunited forearm fractures, six malunited distal radial fractures and one congenital deformity of the forearm) participated in this study. Three-dimensional computer models of the affected bone and the contralateral normal bone were constructed from computed tomography data. By comparing these models, the three-dimensional deformity axis and the accurate amount of deformity around it were quantified. Three-dimensional deformity correction was then simulated. A custom-made osteotomy template was designed and manufactured as a real plastic model aiming to reproduce the preoperative simulation in the actual operation. In the operation, we put the template on the bone surface, cut the bone through a slit on the template, and corrected the deformity as preoperatively simulated, followed by internal fixation. Radiographic and clinical evaluations were made in all cases before surgery and at the most recent follow-up. Corrective osteotomy was achieved as simulated in all cases. All patients had bone fusion within six months. Regarding the cubitus varus deformity, the average carrying angle and tilting angle were 5deg and 28deg after surgery. For malunited forearm fractures, angular deformities on radiographs were nearly nonexistent after surgery. All radiographic parameters in malunited distal radius fractures were normalized. The range of forearm rotation in cases of forearm malunion and that of wrist flexion-extension in cases of malunited distal radius improved after surgery. (author)

  17. Evaluation of Oral Robenacoxib for the Treatment of Postoperative Pain and Inflammation in Cats: Results of a Randomized Clinical Trial

    Science.gov (United States)

    King, Stephen; Roberts, Elizabeth S.; Roycroft, Linda M.; King, Jonathan N.

    2012-01-01

    The efficacy and safety of robenacoxib were assessed for the control of postoperative pain and inflammation in cats. The study was a multicenter, prospective, randomized, blinded, and parallel group clinical trial. A total of 249 client-owned cats scheduled for forelimb onychectomy plus either ovariohysterectomy or castration surgeries were included. All cats received butorphanol prior to anesthesia and forelimb four-point regional nerve blocks with bupivacaine after induction of general anesthesia. Cats were randomized to receive daily oral tablet robenacoxib, at a mean (range) dosage of 1.84 (1.03–2.40) mg/kg (n = 167), or placebo (n = 82), once prior to surgery and for two days postoperatively. Significantly (P < 0.05) fewer robenacoxib cats received additional analgesia rescue therapy (16.5%) than placebo cats (46.3%). Pain elicited on palpation of the soft tissue incision site, behavior following social interaction, and posture assessed during the first 8 hours after extubation were significantly (P < 0.05) improved in cats receiving robenacoxib. Frequency of reported adverse clinical signs, hematology, serum chemistry and urinalysis variables, and body weight changes weresimilar between groups. In conclusion, robenacoxib was effective and well tolerated in the control of postoperative pain and inflammation in cats undergoing onychectomy with ovariohysterectomy or castration. PMID:23738129

  18. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Spieth, Peter M; Güldner, Andreas; Uhlig, Christopher; Bluth, Thomas; Kiss, Thomas; Schultz, Marcus J; Pelosi, Paolo; Koch, Thea; Gama de Abreu, Marcelo

    2014-05-02

    General anesthesia usually requires mechanical ventilation, which is traditionally accomplished with constant tidal volumes in volume- or pressure-controlled modes. Experimental studies suggest that the use of variable tidal volumes (variable ventilation) recruits lung tissue, improves pulmonary function and reduces systemic inflammatory response. However, it is currently not known whether patients undergoing open abdominal surgery might benefit from intraoperative variable ventilation. The PROtective VARiable ventilation trial ('PROVAR') is a single center, randomized controlled trial enrolling 50 patients who are planning for open abdominal surgery expected to last longer than 3 hours. PROVAR compares conventional (non-variable) lung protective ventilation (CV) with variable lung protective ventilation (VV) regarding pulmonary function and inflammatory response. The primary endpoint of the study is the forced vital capacity on the first postoperative day. Secondary endpoints include further lung function tests, plasma cytokine levels, spatial distribution of ventilation assessed by means of electrical impedance tomography and postoperative pulmonary complications. We hypothesize that VV improves lung function and reduces systemic inflammatory response compared to CV in patients receiving mechanical ventilation during general anesthesia for open abdominal surgery longer than 3 hours. PROVAR is the first randomized controlled trial aiming at intra- and postoperative effects of VV on lung function. This study may help to define the role of VV during general anesthesia requiring mechanical ventilation. Clinicaltrials.gov NCT01683578 (registered on September 3 3012).

  19. Pain control in laparoscopic gynecologic surgery with/without preoperative (preemptive) parecoxib sodium injection: a randomized study.

    Science.gov (United States)

    Ratchanon, Sarwinee; Phaloprakarn, Chadakarn; Traipak, Khanitta

    2011-10-01

    To determine the effectiveness of preoperative parecoxib sodium injection for pain relief after laparoscopic gynecologic surgery. A prospective double-blind, randomized study was conducted in 268 patients who underwent laparoscopic gynecologic surgery at Vajira Hospital between November 1, 2010 and March 31, 2011. The patients were randomly allocated into two groups to receive either single intravenous 40 mg parecoxib (treatment group; n = 133) or normal saline (control group; n = 135) 30 min before surgery. The degree of postoperative pain was assessed every 2 h in the first 8 h postoperation, then every 4 h until completion of 24 h by using a verbal rating scale. Total consumption of meperidine over a 24-h period and the adverse events relevant to parecoxib sodium were also recorded. Mean pain scores at all measured times in the treatment group were insignificantly lower than those in the control group (p = 0.106). The mean 24-h postoperative meperidine consumption in the treatment group was significantly lower compared to that in the control group (26.3 +/- 28.1 mg and 39.1 +/- 34.6 mg, respectively, p = 0.001). The proportion of patients requiring meperidine in the treatment group was significantly lower than that in the control group (58.6% and 70.3%, respectively, p = 0. 045). No serious adverse events were observed in both groups. Preoperative parecoxib sodium significantly reduced postoperative meperidine requirement and consumption, while insignificantly declined the pain scores. Serious adverse events were not encountered

  20. Does analgesia affect the diagnostic process in acute abdomen? a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Khashayar P.

    2008-03-01

    Full Text Available Background: About one-forth of the patients admitted to the emergency department complain of acute abdominal pain. According to surgical records, most surgeons believe that pain relief for these patients may interfere with the clinical examinations and the final diagnoses. As a result, analgesics are withheld in patients with acute abdominal pain until the determination of a definite diagnosis and suitable management plan. The purpose of this study was to evaluate the effect of analgesics on the evaluation course and treatment in acute abdomen.Methods: Two hundred patients at a surgical emergency department with acute abdominal pain were enrolled in this prospective study and randomly divided into two groups at the time of admission. The case group consisted of 98 patients who received intravenous analgesia immediately after admission. The other 102 patients in the control group did not receive analgesia until a definite diagnosis was made. Diagnostic and therapeutic procedures were similar between the two groups. The primary and final diagnoses, and the time intervals between the admission and definite diagnosis, and that between admission and surgery were gathered and analyzed.Results: The mean time to definitive diagnosis was 1.7 and 2.04 hours in the case and control groups, respectively. There was no statistically significant relationship between analgesic use and gender, age, time to definite diagnosis, or accuracy of the diagnosis. In fact, the time required to achieve a definite diagnosis and the time between admission and surgery were less in the group that had received analgesics. Conclusions: In spite of the fact that analgesics remove the very symptoms that brings patients to the emergency room, appropriate use of analgesics does not reduce diagnostic efficiency for patients with acute abdominal pain.

  1. Clinical evaluation on the coaxial microincision cataract surgery in hard nuclear cataracts

    Directory of Open Access Journals (Sweden)

    Qing-Cheng Shi

    2013-05-01

    Full Text Available AIM: To assess and compare the results of 2.2mm microincision coaxial cataract surgery(MCCSphacoemulsification with the conventional 3.0mm MCCS in hard nuclear cataracts. METHODS: Totally 132 eyes with hard cataract(Ⅳ level and abovewere randomized to two groups: 2.2mm MCCS(group 1:60 eyesand 3.0mm MCCS(group 2:72 eyes. All patients underwent standard phacoemulsification and intraocular lens implantation surgery by one experienced surgeon. The average ultrasound power(AVEwas recorded during the operation. The incidences of capsule rupture and postoperative corneal edema were compared.Visual acuity, surgically induced astigmatism(SIAand the descent rate of endothelial cell density were compared at intervals of 1 day, 1 month and 3 months after surgery. Statistic analysis was taken by Student's t test and Chi square test. RESULTS: There was no significant difference on the incidences of capsule rupture, postoperative corneal edema and AVE(P> 0.05between the two groups(3.3%, 10.0%, 65.09±20.15and(4.2%, 11.1%, 69.13±15.44. One day after the surgery, the 2.2mm MCCS group showed better uncorrected visual acuity as compared to the 3.0mm MCCS group(P < 0.05. There were no significant differences on best-corrected visual acuity on 1 month and 3 months after the surgery. There was no significant difference on the descent rate of endothelial cell density(16.54%±10.20%, 17.69%±10.65%3 months after the surgery. One day, 1 month and 3 months after the surgery, SIA was 0.77±0.31,0.66±0.29, 0.52±0.25D in the 2.2mm MCCS group, and 1.41±0.73,0.98±0.61D,0.82±0.35D in the 3.0mm MCCS group, respectively. The differences were statistically significant. CONCLUSION: The operative safety of the 2.2mm MCCS group were the same as 3.0mm MCCS group with the hard nuclear cataracts. The 2.2mm MCCS phacoemulsification could significantly reduce SIA and get better earlier visual rehabilitation.

  2. Analysis of bedside entertainment services' effect on post cardiac surgery physical activity: a prospective, randomised clinical trial.

    Science.gov (United States)

    Papaspyros, Sotiris; Uppal, Shitansu; Khan, Shakeeb A; Paul, Sanjoy; O'Regan, David J

    2008-11-01

    A rising number of acute hospitals in the UK have been providing patients with bedside entertainment services (BES) since 1995. However, their effect on postoperative patient mobility has not been explored. The aim of this prospective randomised clinical trial was to compare the level of postoperative physical activity and length of in-hospital stay of patients undergoing cardiac surgery depending on whether they had access to BES or not. One hundred patients requiring elective cardiac surgery were randomised to receive access to BES (52 patients) or not (48 patients). Pedometers were used to quantify postoperative physical activity for 5 days. To assess the significance of the effect of intervention (TV off or on) on the pedometer counts over time a mixed effect Poisson regression model is used, with the time varying aspect as random component. The potential influence of gender difference and age on pedometer counts were assessed by incorporating these two factors as covariates in the Poisson model. On average, patients with no access to BES walked more than those with BES access. This difference ranged between 192 and 609 steps in favour of the first group for each individual postoperative day. Patients with no access to BES were 84% more likely (risk ratio: 1.84, 95% CI: 1.29-2.63) to walk higher number of steps than patients with access to BES. On average, participants with access to BES were likely to stay longer in hospital (median of 7 days with interquartile range 6-7 days), than participants with no access to BES (median of 6 days with interquartile range 5-7 days), however the difference did not reach statistical significance. We have demonstrated that the bedside entertainment systems may have an adverse effect on post cardiac surgery patient ambulation and may contribute to an increase in hospital stay.

  3. Prevalence of Body Dysmorphic Disorder and Surgeon Diagnostic Accuracy in Facial Plastic and Oculoplastic Surgery Clinics.

    Science.gov (United States)

    Joseph, Andrew W; Ishii, Lisa; Joseph, Shannon S; Smith, Jane I; Su, Peiyi; Bater, Kristin; Byrne, Patrick; Boahene, Kofi; Papel, Ira; Kontis, Theda; Douglas, Raymond; Nelson, Christine C; Ishii, Masaru

    2017-07-01

    Body dysmorphic disorder (BDD) is a relative contraindication for facial plastic surgery, but formal screening is not common in practice. The prevalence of BDD in patients seeking facial plastic surgery is not well documented. To establish the prevalence of BDD across facial plastic and oculoplastic surgery practice settings, and estimate the ability of surgeons to screen for BDD. This multicenter prospective study recruited a cohort of 597 patients who presented to academic and private facial plastic and oculoplastic surgery practices from March 2015 to February 2016. All patients were screened for BDD using the Body Dysmorphic Disorder Questionnaire (BDDQ). After each clinical encounter, surgeons independently evaluated the likelihood that a participating patient had BDD. Validated instruments were used to assess satisfaction with facial appearance including the FACE-Q, Blepharoplasty Outcomes Evaluation (BOE), Facelift Outcomes Evaluation (FOE), Rhinoplasty Outcomes Evaluation (ROE), and Skin Rejuvenation Outcomes Evaluation (SROE). Across participating practices (9 surgeons, 3 sites), a total of 597 patients were screened for BDD: 342 patients from site 1 (mean [SD] age, 44.2 [16.5] years); 158 patients, site 2 (mean [SD] age, 46.0 [16.2] years), site 3, 97 patients (mean [SD] age, 56.3 [15.5] years). Overall, 58 patients [9.7%] screened positive for BDD by the BDDQ instrument, while only 16 of 402 patients [4.0%] were clinically suspected of BDD by surgeons. A higher percentage of patients presenting for cosmetic surgery (37 of 283 patients [13.1%]) compared with those presenting for reconstructive surgery (21 of 314 patients [6.7%]) screened positive on the BDDQ (odds ratio, 2.10; 95% CI, 1.20-3.68; P = .01). Surgeons were only able to correctly identify 2 of 43 patients (4.7%) who screened positive for BDD on the BDDQ, and the positive likelihood ratio was only 1.19 (95% CI, 0.28-5.07). Patients screening positive for BDD by the BDDQ had lower

  4. Higher Dose of Dexamethasone Does Not Further Reduce Facial Swelling After Orthognathic Surgery: A Randomized Controlled Trial Using 3-Dimensional Photogrammetry.

    Science.gov (United States)

    Lin, Hsiu Hsia; Kim, Sun-Goo; Kim, Hye-Young; Niu, Lien-Shin; Lo, Lun-Jou

    2017-03-01

    The objective of this prospective, double-blind, randomized clinical trial was to compare the effect of 2 dexamethasone dosages on reducing facial swelling after orthognathic surgery through 3-dimensional (3D) photogrammetry. Patients were classified into group 1 (control group) and group 2 (study group), depending on the administered dexamethasone dosage (5 and 15 mg, respectively). Three-dimensional images were recorded at 5 time points: preoperative (T0) and postoperative at 48 ± 6 hours (T1), 1 week (T2), 1 month (T3), and 6 months (T4). A preliminary study was performed on 5 patients, in whom 3D images were captured