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Trials. 2008 Jan 10;9:1. doi: 10.1186/1745-6215-9-1.

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.

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1
General, Emergency and Transplant Surgery DPT, St Orsola-Malpighi University Hospital, Via Massarenti 9, 40138, Bologna, Italy. fcatena@aosp.bo.it

Abstract

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. Moreover in these studies a similar postoperative programme to optimize recovery comparing laparoscopic and open approaches was not standardized. These studies also do not report all eligible patients and are not double blinded.

DESIGN:

The present study project is a prospective, randomized investigation. The study will be performed in the Department of General, Emergency and Transplant Surgery St Orsola-Malpighi University Hospital (Bologna, Italy), a large teaching institutions, with the participation of all surgeons who accept to be involved in (and together with other selected centers). The patients will be divided in two groups: in the first group the patient will be submitted to laparoscopic cholecystectomy within 72 hours after the diagnosis while in the second group will be submitted to laparotomic cholecystectomy within 72 hours after the diagnosis.

TRIAL REGISTRATION:

TRIAL REGISTRATION NUMBER ISRCTN27929536 - The ACTIVE (Acute Cholecystitis Trial Invasive Versus Endoscopic) study. A multicentre randomised, double-blind, controlled trial of laparoscopic versus open surgery for acute cholecystitis in adults.

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