Dutch Cholecystitis Snapshot Study

NCT06349863 | Recruiting

• 1 other identifier: W23.225
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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.

  First six months following diagnosis

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is descibed under in/exclusion criteria

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• St. Antonius Hospital: lead
• St. Antonius Onderzoeksfonds: collaborator
• Dutch Snapshot Research Group: collaborator
• Nederlandse Leverpatientenvereniging: collaborator

Study Sites (1)

Heelkunde

Nieuwegein, Utrecht, 3435CM, Netherlands

RECRUITING

Related Publications (1)

• van Maasakkers MHG, Weijs TJ, Goense L, van Lienden KP, van Duijvendijk P, Verdonk RC, Boerma D. Uncovering variation in cholecystitis treatment: protocol and statistical analysis plan for a nationwide observational study - the Dutch Cholecystitis Snapshot Study (Dutch CHESS). BMJ Open. 2025 May 13;15(5):e093821. doi: 10.1136/bmjopen-2024-093821.

  PMID: 40360397 DERIVED

MeSH Terms

Conditions

Cholecystitis; Gallstones; Choledocholithiasis

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Common Bile Duct Diseases; Bile Duct Diseases

Central Study Contacts

Teus Weijs

CONTACT

0031612093752; t.j.weijs@gmail.com

Max van Maasakkers

CONTACT

Dutch-CHESS@antoniusziekenhuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 5, 2024
• Study Start: April 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: October 30, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)