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Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): Study protocol for a randomized controlled trial

Authors :
Kortram Kirsten
van Ramshorst Bert
Bollen Thomas L
Besselink Marc GH
Gouma Dirk J
Karsten Tom
Kruyt Philip M
Nieuwenhuijzen Grard AP
Kelder Johannes C
Tromp Ellen
Boerma Djamila
Source :
Trials, Vol 13, Iss 1, p 7 (2012)
Publication Year :
2012
Publisher :
BMC, 2012.

Abstract

Abstract 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

Details

Language :
English
ISSN :
17456215
Volume :
13
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Trials
Publication Type :
Academic Journal
Accession number :
edsdoj.302b13435fd4719923a59f839dd047b
Document Type :
article
Full Text :
https://doi.org/10.1186/1745-6215-13-7