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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Netherlands Trial Register (NTR): NTR2666.
authors.affiliation: Dept of Surgery, St, Antonius Hospital Nieuwegein.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Kortram
authors.forename: Bert
authors.initials: B
authors.lastname: van Ramshorst
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Bollen
authors.forename: Marc G H
authors.initials: MG
authors.lastname: Besselink
authors.forename: Dirk J
authors.initials: DJ
authors.lastname: Gouma
authors.forename: Tom
authors.initials: T
authors.lastname: Karsten
authors.forename: Philip M
authors.initials: PM
authors.lastname: Kruyt
authors.forename: Grard A P
authors.initials: GA
authors.lastname: Nieuwenhuijzen
authors.forename: Johannes C
authors.initials: JC
authors.lastname: Kelder
authors.forename: Ellen
authors.initials: E
authors.lastname: Tromp
authors.forename: Djamila
authors.initials: D
authors.lastname: Boerma
mesh_terms: D017081:Cholecystectomy, Laparoscopic / Q000009:adverse effects / Q000191:economics / Q000401:mortality; D041881:Cholecystitis, Acute / Q000175:diagnosis / Q000191:economics / Q000401:mortality / Q000601:surgery*; D002767:Cholecystostomy / Q000009:adverse effects / Q000191:economics / Q000379:methods / Q000401:mortality; D017721:Hospital Costs; D006784:Hospitals, Teaching; D006801:Humans; D007902:Length of Stay; D009426:Netherlands; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome