Dutch Cholecystitis Snapshot Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorSt. Antonius Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
This is descibed under in/exclusion criteria
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Total hospital stay
Median (IQR) or mean (+/-SD) hospital stay in days for patients diagnosed with calculous cholecystitis for the cholecystitis or new complications related to their gallstones following the initial cholecystitis episode, this also includes admission for complications of treatments received. This is the primary outcome for the primary comparison: patients with a 0-7 day cholecystitis receiving early cholecystectomy conform the guidelines versus patients with a 0-7 day cholecystitis who receive alternative treatments.
Time frame
First six months following diagnosisSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Antonius Hospital
Lead sponsor
St. Antonius Onderzoeksfonds
Collaborator
Dutch Snapshot Research Group
Collaborator
Nederlandse Leverpatientenvereniging
Collaborator
Source ClinicalTrials.gov