Annals of surgery
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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double-blind crossover study.
This is the first double-blind multicenter study examining the effectiveness of sacral nerve stimulation in a significant number of fecally incontinent patients. ⋯ The significant improvement in FI during the ON versus OFF period indicated that the clinical benefit of sacral nerve stimulation was not due to placebo.
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Randomized Controlled Trial Clinical Trial
Metabolic and hormonal changes of severely burned children receiving long-term oxandrolone treatment.
When given to children for 1 year after a severe burn, oxandrolone significantly improves lean body mass, bone mineral content, and muscle strength. The beneficial effects of oxandrolone on height and weight were observed 1 year after treatment was discontinued. To study the efficacy of oxandrolone in severely burned children for 12 months after burn and 12 months after the drug was discontinued. ⋯ Oxandrolone improved body composition and strength in severely burned children during the 12 months of treatment. Its effect on height and weight continued after treatment was discontinued.
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Randomized Controlled Trial Comparative Study Clinical Trial
Laparoscopic versus open appendectomy: a prospective randomized double-blind study.
The value of laparoscopy in appendicitis is not established. Studies suffer from multiple limitations. Our aim is to compare the safety and benefits of laparoscopic versus open appendectomy in a prospective randomized double blind study. ⋯ Unlike other minimally invasive procedures, laparoscopic appendectomy did not offer a significant advantage over open appendectomy in all studied parameters except quality of life scores at 2 weeks. It also took longer to perform. The choice of the procedure should be based on surgeon or patient preference.
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Randomized Controlled Trial Comparative Study Clinical Trial
Postoperative ERCP versus laparoscopic choledochotomy for clearance of selected bile duct calculi: a randomized trial.
Prospectively evaluate whether for patients having laparoscopic cholecystectomy with failed trans-cystic duct clearance of bile duct (BD) stones they should have laparoscopic choledochotomy or postoperative endoscopic retrograde cholangiography (ERCP). ⋯ These data suggest that the majority of secondary BD stones can be diagnosed at the time of cholecystectomy and cleared trans-cystically, with those failing having either choledochotomy or postoperative ERCP. However, because of the small trial size, a significant chance exists that small differences in outcome may exist. We would avoid choledochotomy in ducts less than 7 mm measured at the time of operative cholangiogram and severely inflamed friable tissues leading to a difficult dissection. We would advocate choledochotomy as a good choice for patients after Billroth 11 gastrectomy, failed ERCP access, or where long delays would occur for patient transfer to other locations for the ERCP.
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Randomized Controlled Trial Comparative Study Clinical Trial
Increase of survival benefit in advanced resectable colon cancer by extent of adjuvant treatment: results of a randomized trial comparing modulation of 5-FU + levamisole with folinic acid or with interferon-alpha.
The benefit of adjuvant therapy in curatively resected lymph node-positive colon cancer was established using 5-fluorouracil (5-FU) and levamisole (LEV) for 12 months. 5-FU cytotoxicity can be modulated by folinic acid (FA) or interferon-alpha (INF-alpha). The aim of this study was to investigate the efficacy of modulating 5-FU+ LEV by either FA or IFN-alpha in the adjuvant treatment of high-risk colon cancer. ⋯ Addition of IFN-alpha was associated with increased toxicity without markedly influencing the outcome and should therefore not be recommended for adjuvant treatment. Addition of FA increased the 5-year recurrence-free and overall survival rate by 9.3 and 11.5 percentage points, respectively. 5-FU + LEV + FA for 12 months may be an effective adjuvant treatment option for locally advanced high-risk colon cancer.