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

<p>Abstract</p> <p>Background</p> <p>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...

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Main Authors: Bassi Uberto A, Talarico Carlo, Ercolani Giorgio, D'Alessandro Luigi, Coccolini Federico, Gagliardi Stefano, Gazzotti Filippo, Di Saverio Salomone, Ansaloni Luca, Catena Fausto, Leone Leonardo, Calzolari Filippo, Pinna Antonio D
Format: Article
Language:English
Published: BMC 2008-01-01
Series:Trials
Online Access:http://www.trialsjournal.com/content/9/1/1
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author Bassi Uberto A
Talarico Carlo
Ercolani Giorgio
D'Alessandro Luigi
Coccolini Federico
Gagliardi Stefano
Gazzotti Filippo
Di Saverio Salomone
Ansaloni Luca
Catena Fausto
Leone Leonardo
Calzolari Filippo
Pinna Antonio D
author_facet Bassi Uberto A
Talarico Carlo
Ercolani Giorgio
D'Alessandro Luigi
Coccolini Federico
Gagliardi Stefano
Gazzotti Filippo
Di Saverio Salomone
Ansaloni Luca
Catena Fausto
Leone Leonardo
Calzolari Filippo
Pinna Antonio D
author_sort Bassi Uberto A
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Design</p> <p>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.</p> <p>Trial Registration</p> <p>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.</p>
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spelling doaj.art-dfc7f913b5b242faaca06fcc84a28f3f2022-12-21T21:03:21ZengBMCTrials1745-62152008-01-0191110.1186/1745-6215-9-1The 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 adultsBassi Uberto ATalarico CarloErcolani GiorgioD'Alessandro LuigiCoccolini FedericoGagliardi StefanoGazzotti FilippoDi Saverio SalomoneAnsaloni LucaCatena FaustoLeone LeonardoCalzolari FilippoPinna Antonio D<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Design</p> <p>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.</p> <p>Trial Registration</p> <p>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.</p>http://www.trialsjournal.com/content/9/1/1
spellingShingle Bassi Uberto A
Talarico Carlo
Ercolani Giorgio
D'Alessandro Luigi
Coccolini Federico
Gagliardi Stefano
Gazzotti Filippo
Di Saverio Salomone
Ansaloni Luca
Catena Fausto
Leone Leonardo
Calzolari Filippo
Pinna Antonio D
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url http://www.trialsjournal.com/content/9/1/1
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