MedTrace Logo

Dutch Cholecystitis Snapshot Study

NCT06349863 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2024-08-12

No results posted yet for this study

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.

Conditions

  • Cholecystitis
  • Cholecystitis; Gallstone
  • Cholecystitis; Choledocholithiasis

Sponsors & Collaborators

  • St. Antonius Onderzoeksfonds

    collaborator UNKNOWN

  • Dutch Snapshot Research Group

    collaborator UNKNOWN

  • Nederlandse Leverpatientenvereniging

    collaborator UNKNOWN

  • St. Antonius Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-06-30
Completion
2025-10-30

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06349863 on ClinicalTrials.gov