rsodeoxycholic acid for the prevention of symptomatic gallstone disease after Roux-en-Y Gastric Bypass and Sleeve Gastrectomy.
Phase 4
Completed
- Conditions
- Gallstone disease10017628
- Registration Number
- NL-OMON49056
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 985
Inclusion Criteria
* Scheduled to undergo Roux-en-Y gastric bypass or sleeve gastrectomy for morbid obesity
* An intact gallbladder
Exclusion Criteria
* Symptomatic gallstone disease already present before RYGB
* Prior bariatric surgery
* Prior gallbladder surgery
* Ascertained or presumptive hypersensitivity to active or excipient ingredients of ursodeoxycholic acid.
* Inflammatory bowel disease and other conditions of the small intestine and liver which may interfere with enterohepatic circulation of bile salts (ileal resection and stoma, extra and intra-hepatic cholestasis, severe liver disease)
* Intake of investigational drug within the last 30 days before the screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the difference between the two groups in symptomatic<br /><br>gallstone disease after 24 months, defined as admission or hospital visit for<br /><br>symptomatic gallstone disease. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints consist of the development of gallstones on ultrasound at<br /><br>24 months, side-effects of UDCA and cost-effectiveness, cost-utility and budget<br /><br>impact analyses </p><br>