Actively Recruiting

Age: 18Years - 120Years
All Genders
NCT06349863

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

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Heelkunde

Nieuwegein, Utrecht, Netherlands, 3435CM

Actively Recruiting

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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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