Clinical Trial

Dutch Cholecystitis Snapshot Study

Study acronym: Dutch CHESS
Recruiting
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Record status
This record was last updated August 12, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
Background: Cholecystitis is treated by in various types of hospitals by different specialists, and treatment strategy is influenced by logistical and medical reasons and personal preference. This may significantly impact hospital stay and other outcomes. Purpose: To determine the variation in treatment of cholecystitis in the Netherlands and its impact on outcome. Methods: Nation-wide cohort study of all patients diagnosed and treated for cholecystitis during a 6 month period. The primary outcome will be the proportion of patients with an acute cholecystitis in which the guideline is followed. This group will be compared to those in which the guideline is not followed, focussing on total hospital stay and complications. Secondary aims are to determine: factors related to guideline compliance; the best method of cystic duct closure; the best treatment strategy for a \>7-day existing cholecystitis; factors predictive for concomitant common bile duct stones; strategies following gallbladder drainage. Multivariable analysis and propensity score matching will be used when appropriate for the etiological study aims. The TRIPOD guideline for prediction modelling will be used for the predictive study aims. Hospitals will receive their own results, set out against the national average and best practices, thereafter subsequent changes in hospital practice will be recorded. Conclusion: This study will determine the variation in treatment of cholecystitis in the Netherlands and its impact on clinical outcome. Its results will serve as an important incentive to create optimal, uniform cholecystitis treatment in the Netherlands.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-03-31; most recent amendment 2024-08-08.
Status change: Not Yet Recruiting → Recruiting 2024-08-08
Trial Details
NCT Number NCT06349863
Lead Sponsor St. Antonius Hospital
Collaborators: St. Antonius Onderzoeksfonds, Dutch Snapshot Research Group, Nederlandse Leverpatientenvereniging
Conditions Cholecystitis, Cholecystitis; Gallstone, Cholecystitis; Choledocholithiasis
Enrollment 3,000 participants
Start Date 2024-04-01
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-10-30 (estimated)
Updated on ClinicalTrials.gov 2024-08-12