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Randomized Trial Comparing (randomized + trial_comparing)
Kinds of Randomized Trial Comparing Selected AbstractsSparing the larynx during gynecological laparoscopy: a randomized trial comparing the LMA SupremeÔ and the ETTACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 2 2010W. ABDI Background: We designed a prospective randomized single-blind study to compare efficiency and post-operative upper airway morbidity when the laryngeal mask airway (LMA) SupremeÔ is used as an alternative to the endotracheal tube (ETT). Methods: One hundred and thirty-eight elective pelvic laparoscopic ASA I,II female patients were assigned to receive either the LMA Supreme® or the ETT for airway management. Balanced anesthesia and ventilation techniques were standardized to control end-tidal CO2 and BIS value in the range 4.5,5 kPa and 40,50, respectively, and to maintain adequate hemodynamic stability. A single surgeon blinded to the airway management technique performed all surgical procedures. The ventilation efficiency of each airway was evaluated. Anesthesia- and surgery-related times were calculated and anesthesia details were recorded. Post-operative pain and pharyngolaryngeal morbidity were measured in a blind fashion using a numerical rating scale (NRS) (0,100). Results: Surgery duration was similar in both groups. Airway management duration was shorter with the LMA Supreme®. Post-operative pharyngolaryngeal morbidity incidence and all symptoms' intensity were significantly increased after ETT as compared with LMA Supreme® anesthesia. At the end of the PACU stage, the incidence and mean NRS of post-operative hoarseness were reduced when LMA Supreme® was used as an alternative to the ETT (16% vs. 47%; P<0.01 and 9 vs. 19, P<0.01, respectively). Conclusion: We demonstrated that choosing an LMA Supreme® was an efficient pharyngolaryngeal morbidity-sparing strategy. Moreover, we showed that the LMA Supreme® and the ETT were equally effective airways for a routine gynecological laparoscopy procedure. [source] Orthotopic Cardiac Transplantation: Comparison of Outcome Using Biatrial, Bicaval, and Total TechniquesJOURNAL OF CARDIAC SURGERY, Issue 1 2005Jeffrey A. Morgan M.D. More recently, however, bicaval and total techniques have been devised in an attempt to improve cardiac anatomy, physiology, and postoperative outcome. A bicaval approach preserves the donor atria and combines the standard left atrial anastomosis with a separate bicaval anastomosis. Total orthotopic heart transplantation involves complete excision of the recipient atria with separate bicaval end-to-end anastomoses, as well as pulmonary venous anastomoses. The aim of this study was to conduct a literature review of studies that compared the three surgical techniques (biatrial, bicaval, and total) for performing orthotopic cardiac transplantation. Numerous outcome variables were evaluated, and included post-transplant survival, atrial dimensions, atrioventricular valvular insufficiency, arrhythmias, pacing requirements, vasopressor requirements, and hospital stay. Methods: We conducted a Medline (Pubmed) search using the terms "biatrial and cardiac transplantation,""bicaval and cardiac transplantation," and "total technique and cardiac transplantation," which yielded 192 entries: 39 of these were studies that compared surgical techniques and were included in the review. Results: There was overwhelming evidence that the bicaval technique provided anatomic and functional advantages, with improvements in post-transplant survival, atrial geometry, and hemodynamics, as well as decreased valvular insufficiency, arrhythmias, pacing requirements, vasopressor requirements, and hospital stay. Conclusions: The bicaval technique was superior to both biatrial and total techniques for numerous outcome variables. To further elucidate this issue, a prospective randomized trial comparing the three techniques, with long-term follow-up, is warranted. [source] Direct Coronary Stenting in Noncomplex and Noncalcified Lesions: Immediate and Mid-term Results of a Prospective RegistryJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 4 2000MARC BEDOSSA M.D. Stenting of coronary arteries is currently used in clinical practice. The aim of this prospective registry was to assess the feasibility and the safety of stent implantation without balloon predilatation in noncomplex and noncalcifed lesions. One hundred six stents were implanted in 85 patients who underwent percutaneous coronary angioplasty (PTCA) of native vessels (n = 95) or bypass grafts (n = 11). The lesions were type A (21%) or B1 (79%). The stent was a tubular or a coil stent in 71 ± and 29% of the cases, respectively. The angiographic success rate was 94%. The maximal pressure was 12.1 ± 2.1 atm. In only 7 cases, it was not possible to cross the stenosis with the stent, necessitating retrieval of it and predilation with a balloon before stent implantation. Three dissections after stent implantation were treated by a second stent implantation. The primary success rate was 98% (no acute closure or myocardial infarction). A clinical follow-up was obtained in 98% of patients with a mean delay of 6 ± 0.5 months. Eighty-one percent of patients were asymptomatic. The target lesion revascularization rate was 9.4%. Four patients underwent a new PTCA and four patients a coronary artery bypass graft surgery. This technique of stent implantation appears to be safe with good immediate and midterm results. A prospective randomized trial comparing this technique to the standard technique of stent delivery in noncomplex lesions is currently ongoing with an intravascular ultrasound substudy. [source] Mixed incontinence: Comparing definitions in women having stress incontinence surgery,,§¶NEUROUROLOGY AND URODYNAMICS, Issue 4 2009Linda Brubaker Abstract Objective To develop an empirically derived definition of mixed urinary incontinence (MUI) for use in incontinence outcomes research. Methods Participants in a randomized trial comparing the fascial sling and. Burch colposuspension were assessed using standardized measures including the Medical, Epidemiologic and Social Aspects of Aging (MESA), UI questionnaire, the Urogenital Distress Inventory (UDI), 3-day urinary diary and urodynamic studies (UDS). Participants were required to have stress incontinence with a MESA stress subscale score,>,MESA urge subscale score. Several definitions of MUI were considered. Logistic and linear regression analysis methods were used to predict clinical outcomes based on the different MUI definitions. Analyses were carried out using SAS (SAS Institute, Inc., Cary, NC, Version 9.1). Statistical significance was defined at P -value <0.05. Results In 655 participants, the proportion of women with MUI varied from 8.3% to 93.3% depending on the MUI definition All definitions were associated with severity as measured by the frequency of incontinence episodes at baseline; however little of the variability was explained by any single definition. No strict cut-off value for these baseline measures was identified to predict clinical outcomes. Conclusions These MUI definitions do not adequately categorize clinically relevant UI subgroups. For research reporting, MUI subcomponents of stress and urge UI should be described separately rather than as a single dimension. Neurourol. Urodynam. 28:268,273, 2009. © 2009 Wiley-Liss, Inc. [source] High-dose cyclophosphamide versus monthly intravenous cyclophosphamide for systemic lupus erythematosus: A prospective randomized trial,ARTHRITIS & RHEUMATISM, Issue 5 2010Michelle Petri Objective Monthly intravenous (IV) cyclophosphamide for 6 months has been the standard induction regimen for lupus nephritis, followed by a maintenance regimen of quarterly infusions for 2 years. We undertook this study to compare the efficacy and safety of the standard regimen versus a high-dose IV cyclophosphamide regimen. Methods We performed a prospective randomized trial comparing monthly IV cyclophosphamide at 750 mg/m2 body surface area for 6 months followed by quarterly IV cyclophosphamide for 2 years (traditional treatment) against high-dose IV cyclophosphamide (50 mg/kg daily for 4 days) (high-dose treatment). Entry criteria included renal lupus, neurologic lupus, or other organ system involvement with moderate-to-severe activity. Results Fifty-one patients were randomized; 3 withdrew before treatment and 1 committed suicide after 2 months of high-dose treatment. Twenty-two had renal lupus, 14 had neurologic lupus, and 11 had other organ involvement. The outcome measure was the Responder Index for Lupus Erythematosus (complete response, partial response, no change, or worsening). At 6 months (the end of induction), 11 of 21 patients (52%) in the high-dose treatment group had a complete response compared with 9 of 26 patients (35%) in the traditional treatment group (P = 0.13). At the final visit (30 months), 10 of 21 patients (48%) in the high-dose treatment group had a complete response compared with 13 of 20 patients (65%) who continued with traditional treatment (P = 0.13). Six patients crossed over from traditional treatment to high-dose treatment because of lack of response, and 3 of those patients became complete responders. Conclusion There was not strong evidence that monthly IV cyclophosphamide and high-dose IV cyclophosphamide differed in complete or in any (complete or partial) response to induction or maintenance therapy. However, nonresponders to monthly IV cyclophosphamide can sometimes be rescued with high-dose IV cyclophosphamide. [source] A Geometric Approach to Comparing Treatments for Rapidly Fatal DiseasesBIOMETRICS, Issue 1 2006Peter F. Thall Summary In therapy of rapidly fatal diseases, early treatment efficacy often is characterized by an event, "response," which is observed relatively quickly. Since the risk of death decreases at the time of response, it is desirable not only to achieve a response, but to do so as rapidly as possible. We propose a Bayesian method for comparing treatments in this setting based on a competing risks model for response and death without response. Treatment effect is characterized by a two-dimensional parameter consisting of the probability of response within a specified time and the mean time to response. Several target parameter pairs are elicited from the physician so that, for a reference covariate vector, all elicited pairs embody the same improvement in treatment efficacy compared to a fixed standard. A curve is fit to the elicited pairs and used to determine a two-dimensional parameter set in which a new treatment is considered superior to the standard. Posterior probabilities of this set are used to construct rules for the treatment comparison and safety monitoring. The method is illustrated by a randomized trial comparing two cord blood transplantation methods. [source] Identification of risk factors for the development of complications following extended and superextended lymphadenectomies for gastric cancerBRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue 9 2005Y. Kodera Background: Extended lymphadenectomy for gastric carcinoma has been associated with high mortality and morbidity rates in several multicentre randomized trials. Methods: Using data from 523 patients registered for a prospective randomized trial comparing extended (D2) and superextended (D3) lymphadenectomies, risk factors for overall complications and major surgical complications (anastomotic leakage, intra-abdominal abscess and pancreatic fistula) were identified by multivariate logistic regression analysis. Results: Mortality and morbidity rates were 0·8 per cent (four of 523) and 24·5 per cent (128 of 523) respectively. Pancreatectomy (relative risk 5·62 (95 per cent confidence interval (c.i.) 1·94 to 16·27)) and prolonged operating time (relative risk 2·65 (95 per cent confidence interval 1·34 to 5·23)) were the most important risk factors for overall complications. A body mass index of 25 kg/m2 or above, pancreatectomy and age greater than 65 years were significant predictors of major surgical complications. Conclusion: Pancreatectomy should be reserved for patients with stage T4 disease. Age and obesity should be considered when planning surgery. Copyright © 2005 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [source] Randomized trial of paclitaxel versus pegylated liposomal doxorubicin for advanced human immunodeficiency virus-associated Kaposi sarcomaCANCER, Issue 16 2010Evidence of symptom palliation from chemotherapy Abstract BACKGROUND: Paclitaxel and pegylated liposomal doxorubicin (PLD) are active cytotoxic agents for the treatment of human immunodeficiency virus (HIV)-associated Kaposi sarcoma (KS). A randomized trial comparing the efficacy and toxicity of paclitaxel and PLD was performed, and the effects of therapy on symptom palliation and quality of life were determined. METHODS: Patients with advanced HIV-associated KS were randomly assigned to receive paclitaxel at a dose of 100 mg/m2 intravenously (iv) every 2 weeks or PLD at a dose of 20 mg/m2 iv every 3 weeks. The KS Functional Assessment of HIV (FAHI) quality of life instrument was used before and after every other treatment cycle. RESULTS: The study included 73 analyzable patients enrolled between 1998 and 2002, including 36 in the paclitaxel arm and 37 in the PLD arm; 73% of patients received highly active antiretroviral therapy (HAART) and 32% had an undetectable viral load (<400 copies/mL). Treatment was associated with significant improvements in pain (P = .024) and swelling (P < .001). Of the 36 patients who reported that pain interfered with their normal work or activities at baseline, 25 (69%) improved. Of the 41 patients who reported swelling at baseline, 38 (93%) improved. Comparing the paclitaxel and PLD arms revealed comparable response rates (56% vs 46%; P = .49), median progression-free survival (17.5 months vs 12.2 months; P = .66), and 2-year survival rates (79% vs 78%; P = .75), but somewhat more grade 3 to 5 toxicity for paclitaxel (84% vs 66%; P = .077). CONCLUSIONS: Treatment with either paclitaxel or PLD appears to produce significant improvements in pain and swelling in patients with advanced, symptomatic, HIV-associated KS treated in the HAART era. Cancer 2010. © 2010 American Cancer Society. [source] | ||||||||||