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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.
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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)