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

Kirsten Kortram; Bert van Ramshorst; Thomas L. Bollen; Marc G. H. Besselink; Dirk J. Gouma; Tom Karsten; Philip M. Kruyt; Grard A. P. Nieuwenhuijzen; Johannes C. Kelder; Ellen Tromp; Djamila Boerma

doi:https://doi.org/10.1186/1745-6215-13-7

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

Kirsten Kortram, Bert van Ramshorst, Thomas L. Bollen, Marc G. H. Besselink, Dirk J. Gouma, Tom Karsten, Philip M. Kruyt, Grard A. P. Nieuwenhuijzen, Johannes C. Kelder, Ellen Tromp, Djamila Boerma

Surgery (AMC)

Research output: Contribution to journal › Article › Academic › peer-review

87 Citations (Scopus)

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

Original language	English
Pages (from-to)	7
Journal	Trials
Volume	13
Issue number	1
DOIs	https://doi.org/10.1186/1745-6215-13-7
Publication status	Published - 2012

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https://doi.org/10.1186/1745-6215-13-7

Cite this

Kortram, K., van Ramshorst, B., Bollen, T. L., Besselink, M. G. H., Gouma, D. J., Karsten, T., Kruyt, P. M., Nieuwenhuijzen, G. A. P., Kelder, J. C., Tromp, E., & Boerma, D. (2012). Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): Study protocol for a randomized controlled trial. Trials, 13(1), 7. https://doi.org/10.1186/1745-6215-13-7

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

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",

author = "Kirsten Kortram and {van Ramshorst}, Bert and Bollen, {Thomas L.} and Besselink, {Marc G. H.} and Gouma, {Dirk J.} and Tom Karsten and Kruyt, {Philip M.} and Nieuwenhuijzen, {Grard A. P.} and Kelder, {Johannes C.} and Ellen Tromp and Djamila Boerma",

year = "2012",

doi = "https://doi.org/10.1186/1745-6215-13-7",

language = "English",

volume = "13",

pages = "7",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

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Kortram, K, van Ramshorst, B, Bollen, TL, Besselink, MGH, Gouma, DJ, Karsten, T, Kruyt, PM, Nieuwenhuijzen, GAP, Kelder, JC, Tromp, E & Boerma, D 2012, 'Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): Study protocol for a randomized controlled trial', Trials, vol. 13, no. 1, pp. 7. https://doi.org/10.1186/1745-6215-13-7

Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): Study protocol for a randomized controlled trial. / Kortram, Kirsten; van Ramshorst, Bert; Bollen, Thomas L. et al.
In: Trials, Vol. 13, No. 1, 2012, p. 7.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): Study protocol for a randomized controlled trial

AU - Kortram, Kirsten

AU - van Ramshorst, Bert

AU - Bollen, Thomas L.

AU - Besselink, Marc G. H.

AU - Gouma, Dirk J.

AU - Karsten, Tom

AU - Kruyt, Philip M.

AU - Nieuwenhuijzen, Grard A. P.

AU - Kelder, Johannes C.

AU - Tromp, Ellen

AU - Boerma, Djamila

PY - 2012

Y1 - 2012

N2 - 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

AB - 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

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DO - https://doi.org/10.1186/1745-6215-13-7

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SN - 1745-6215

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JO - Trials

JF - Trials

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