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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.

Kortram K, van Ramshorst B, Bollen TL, Besselink MG, Gouma DJ, Karsten T, Kruyt PM, Nieuwenhuijzen GA, Kelder JC, Tromp E, Boerma D - Trials (2012)

Bottom Line: 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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Dept of Surgery, St, Antonius Hospital Nieuwegein.

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.

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Related in: MedlinePlus

Flowchart of study outline of included patients.
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Figure 1: Flowchart of study outline of included patients.

Mentions: Patients will be randomly assigned to group A (laparoscopic cholecystectomy) or group B (percutaneous drainage) as shown in the flowchart (Figure 1). Randomisation is done by the study coordinator or primary investigator using an online generator (ALEA 2.2, Academic Medical Centre Amsterdam, the Netherlands https://nl.tenalea.net/amc/ALEA/). Permuted-block randomisation with varying block sizes with a maximum block size of four patients is used to minimize the occurrence of chance imbalance and preserve unpredictability. The sequence of the different blocks is predetermined by an independent programmer and concealed to all investigators. The blocks are generated separately within the different study sites, so stratification according to hospital can be performed.


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

Kortram K, van Ramshorst B, Bollen TL, Besselink MG, Gouma DJ, Karsten T, Kruyt PM, Nieuwenhuijzen GA, Kelder JC, Tromp E, Boerma D - Trials (2012)

Flowchart of study outline of included patients.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3285056&req=5

Figure 1: Flowchart of study outline of included patients.
Mentions: Patients will be randomly assigned to group A (laparoscopic cholecystectomy) or group B (percutaneous drainage) as shown in the flowchart (Figure 1). Randomisation is done by the study coordinator or primary investigator using an online generator (ALEA 2.2, Academic Medical Centre Amsterdam, the Netherlands https://nl.tenalea.net/amc/ALEA/). Permuted-block randomisation with varying block sizes with a maximum block size of four patients is used to minimize the occurrence of chance imbalance and preserve unpredictability. The sequence of the different blocks is predetermined by an independent programmer and concealed to all investigators. The blocks are generated separately within the different study sites, so stratification according to hospital can be performed.

Bottom Line: 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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Dept of Surgery, St, Antonius Hospital Nieuwegein.

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.

Show MeSH
Related in: MedlinePlus