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

Title
Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): Study protocol for a randomized controlled trial
Author
Kortram, Kirsten 1 ; van Ramshorst, Bert 1 ; Bollen, Thomas L 2 ; Besselink, Marc G H 1 ; Gouma, Dirk J 3 ; Karsten, Tom 4 ; Kruyt, Philip M 5 ; Nieuwenhuijzen, Grard A P 6 ; Kelder, Johannes C 7 ; Tromp, Ellen 7 ; Boerma, Djamila 1 

1  St. Antonius Hospital Nieuwegein, Dept. of Surgery, The Netherlands (GRID:grid.415960.f) (ISNI:0000000406221269) 
2  St. Antonius Hospital Nieuwegein, Dept. of Radiology, The Netherlands (GRID:grid.415960.f) (ISNI:0000000406221269) 
3  Academic Medical Centre Amsterdam, Dept. of Surgery, The Netherlands (GRID:grid.5650.6) (ISNI:0000000404654431) 
4  Onze Lieve Vrouwe Gasthuis Amsterdam, Dept. of Surgery, The Netherlands (GRID:grid.440209.b) 
5  Hospital Gelderse Vallei Ede, Dept. of Surgery, The Netherlands (GRID:grid.415351.7) (ISNI:0000 0004 0398 026X) 
6  Catharina Hospital Eindhoven, Dept. of Surgery, The Netherlands (GRID:grid.413532.2) (ISNI:0000000403988384) 
7  St. Antonius Hospital Nieuwegein, Dept. of Clinical Epidemiology, The Netherlands (GRID:grid.415960.f) (ISNI:0000000406221269) 
Pages
7
Publication year
2012
Publication date
Dec 2012
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/1745-6215-13-7
ProQuest document ID
2794929158
Copyright
© Kortram et al; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0 ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. This work is published under http://creativecommons.org/licenses/by/2/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.