Actively Recruiting
Dutch Cholecystitis Snapshot Study
Led by St. Antonius Hospital · Updated on 2024-08-12
3000
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
S
St. Antonius Hospital
Lead Sponsor
S
St. Antonius Onderzoeksfonds
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Dutch Cholecystitis Snapshot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged over 18 years
- Patients admitted to hospital with calculous cholecystitis as the primary reason
- Diagnosis made in emergency department, hospital ward, or during diagnostic laparoscopy
- Diagnosis based on TG18 criteria including local inflammation signs, systemic inflammation signs, and imaging
- Patients with suspected diagnosis confirmed by surgical findings
- Identification by a local study investigator such as a surgeon or surgeon in training
You will not qualify if you...
- Patients younger than 18 years
- Patients without calculous cholecystitis as the primary reason for admission
- Patients whose diagnosis does not meet TG18 criteria or is not confirmed by surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Heelkunde
Nieuwegein, Utrecht, Netherlands, 3435CM
Actively Recruiting
Research Team
T
Teus Weijs
CONTACT
M
Max van Maasakkers
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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