Dutch Cholecystitis Snapshot Study (Dutch CHESS)

Variation in Cholecystitis Treatment and Outcome in the Netherlands; a Nation-wide Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Cholecystitis; Cholecystitis; Gallstone; Cholecystitis; Choledocholithiasis

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Teus Weijs; Phone Number: 0031612093752; Email: t.j.weijs@gmail.com
• Study Contact Backup: Name: Max van Maasakkers; Email: Dutch-CHESS@antoniusziekenhuis.nl

Study Locations

• Netherlands
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435CM
      • Recruiting
      • Heelkunde
      • Contact: D Boerma, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is descibed under in/exclusion criteria

Description

All patients >18 years with a calculous cholecystitis as primary reason for their hospital admittance. Location of diagnosis may the emergency department, the ward during admittance for diagnostics, or during diagnostic laparoscopy. Cholecystitis is defined according to the TG18 diagnostic criteria for a definitive diagnosis of cholecystitis: A. Local signs of inflammation (Murphy's sign and or RUQ mass/pain/tenderness) + B. Systemic signs of inflammation (Fever, elevated CRP and/or elevated WBC count) + C. Imaging findings characteristic of acute cholecystitis. Patients with a suspected diagnosis (one item in A + one item in B + C), of which the diagnosis is confirmed by peroperative findings, are also included. Patients will be identified by a local study investigator, e.g. a surgeon or surgeon in training.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First six months following diagnosis

Collaborators and Investigators

• Sponsor: St. Antonius Hospital
• Collaborators: St. Antonius Onderzoeksfonds; Nederlandse Leverpatientenvereniging; Dutch Snapshot Research Group

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: March 31, 2024
• First Submitted That Met QC Criteria: March 31, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Calculi; Cholelithiasis; Cholecystolithiasis; Cholecystitis; Acalculous Cholecystitis; Gallstones; Choledocholithiasis
• Other Study ID Numbers: W23.225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No