Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06349863
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-31
Brief Title:
Dutch Cholecystitis Snapshot Study
Sponsor:
St Antonius Hospital
Organization:
St Antonius Hospital
Study Overview
Official Title:
Variation in Cholecystitis Treatment and Outcome in the Netherlands a Nation-wide Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Dutch CHESS
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None