Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): Study protocol for a randomized controlled trial
نویسندگان
چکیده
BACKGROUND Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality. Percutaneous cholecystostomy may be an alternative treatment option but the current literature does not provide the surgical community with evidence based advice. METHODS/DESIGN The CHOCOLATE trial is a randomised controlled, parallel-group, superiority multicenter trial. High risk patients, defined as APACHE-II score 7-14, with acute calculous cholecystitis will be randomised to laparoscopic cholecystectomy or percutaneous cholecystostomy. During a two year period 284 patients will be enrolled from 30 high volume teaching hospitals. The primary endpoint is a composite endpoint of major complications within three months following randomization and need for re-intervention and mortality during the follow-up period of one year. Secondary endpoints include all other complications, duration of hospital admission, difficulty of procedures and total costs. DISCUSSION The CHOCOLATE trial is designed to provide the surgical community with an evidence based guideline in the treatment of acute calculous cholecystitis in high risk patients. TRIAL REGISTRATION Netherlands Trial Register (NTR): NTR2666.
منابع مشابه
The ACTIVE (Acute Cholecystitis Trial Invasive Versus Endoscopic) study: Multicenter randomized, double-blind, controlled trial of laparoscopic (LC) versus open (LTC) surgery for acute cholecystitis (AC) in adults
BACKGROUND In some randomized trials successful laparoscopic cholecystectomy for cholecystitis is associated with an earlier recovery and shorter hospital stay when compared with open cholecystectomy. Other studies did not confirm these results and showed that the potential advantages of laparoscopic cholecystectomy for cholecystitis can be offset by a high conversion rate to open surgery. More...
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BACKGROUND Acute cholecystitis is a common diagnosis. However, the heterogeneity of presentation makes it difficult to standardize management. Although surgery is the mainstay of treatment, critically ill patients have been managed via percutaneous cholecystostomy. However, the role of percutaneous cholecystostomy in the management of such patients has not been clearly established. This systema...
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PURPOSE Laparoscopic cholecystectomy is the best treatment choice for acute cholecystitis. However, it still carries high conversion and mortality rates. The purpose of this study was to find out better treatment strategies for high surgical risk patients with acute cholecystitis. MATERIALS AND METHODS Between January 2002 and June 2008, we performed percutaneous cholecystostomy instead of em...
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عنوان ژورنال:
دوره 13 شماره
صفحات -
تاریخ انتشار 2012