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

Trials, Jan 2008

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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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

Trials 0 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 1 Italian Society of Young Surgeons (S. P.I.G.C.), Via M Schipa 2, Napoli , Italy 2 General, Emergency and Transplant Surgery DPT, St Orsola-Malpighi University Hospital , Via Massarenti 9. 40138. Bologna , Italy 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. 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. - Introduction In the developmental stage of laparoscopic cholecystectomy it was considered 'unsafe' or 'technically difficult' to perform laparoscopic cholecystectomy for acute cholecystitis [1,2]. With increasing experience in laparoscopic surgery, a number of centers have reported on the use of laparoscopic cholecystectomy for acute cholecystitis, suggesting that it is technically feasible but at the expense of a high conversion rate, which can be up to 35 per cent [3,4] and common bile duct lesions [5]. Several randomized studies in the early 1980s had shown that performing early open cholecystectomy for acute cholecystitis was better than delayed cholecystectomy in terms of shorter hospital stay but both had similar operative morbidity and mortality rates [3]. Early surgery had since gained in popularity in the late 1980s [2]. Routine use of the open procedure might enable more patients to have the operations during the acute phase because most surgeons are practiced in this approach. The impact of hospital stay and morbidity must also be taken into account. There is the expectation that open operation is associated with more pain and longer hospital stay [6-8]. In some trials successful laparoscopic cholecystectomy during the period of acute inflammation is associated with an earlier recovery and shorter hospital stay when compared with open cholecystectomy [8]. Other studies did not confirm these results and the potential advantages of early laparoscopic cholecystectomy can be offset by a high conversion rate to open surgery [5]. Moreover in these studies a similar postoperative programme to optimize recovery comparing laparoscopic and open approaches was not standardized. Many studies also do not report all eligible patients and are not double blinded. Methods Design The study project is a prospective, randomized investigation. The study will be performed in the Department of Emergency 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 early LC (Laparoscopic Cholecystectomy) within 72 hours after the diagnosis of cholecystitis while in the second group will be submitted to early LTC (LaparoTomic Cholecystectomy) within 72 hours after the diagnosis. Randomization The randomization will be obtained through computergenerated schedule. The result of this randomization will be sealed in numbered envelopes. After cholecystitis diagnosis if the patient fulfils the inclusion criteria the responsible surgeon will ask the patient to partecipate to the study. If the patient agree, he/she will sign the informed consent. After patient's consent the randomization will be carried out. The responsible surgeon will record the patient name (and number). All eligible patients will be recorded. A sample size of 144 patients is calculated supposing that the hospital stay for LC is shorter than 2 days. The sample size will be 72 patients for each group (144 patients for the whole study). For comparison of the two groups, chi-square analysis and Fis (...truncated)


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Fausto Catena, Luca Ansaloni, Salomone Di Saverio, Filippo Gazzotti, Stefano Gagliardi, Federico Coccolini, Luigi D'Alessandro, Giorgio Ercolani, Carlo Talarico, Uberto A Bassi, Leonardo Leone, Filippo Calzolari, Antonio D Pinna. 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, Trials, 2008, pp. 1, 9, DOI: 10.1186/1745-6215-9-1