rsodeoxycholic acid for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass and sleeve gastrectomy

Completed

• Conditions: Gastric bypass; bariatric surgery; gallstone disease

• Registration Number: NL-OMON20653
• Lead Sponsor: Amsterdam UMC, location AMC, Amsterdam, Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 980

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study is symptomatic gallstone disease after 24 months, defined as hospital admission or hospital visit for symptomatic gallstone disease. Hospital visit is a condition, because all patients with noteworthy symptoms will eventually visit the hospital. Mild and self-limiting complaints are not a large burden to the health care system or to the patient, and usually gallstone involvement is not objectified in these patients. <br /><br /><br><br>Symptomatic gallstone disease is defined as biliary disease (biliary pancreatitis, acute cholecystitis, choledocholithiasis, cholangitis, or biliairy colics). <br>

Secondary Outcome Measures

Name	Time	Method
1.The development of gallstones/sludge on ultrasound at 24 months in the gallstone negative group at baseline.<br /><br>2. Presence of gallstones/sludge on ultrasound at 24 months<br>3.Number of cholecystectomies in the intervention and the placebo group.<br /><br>4.Side-effects of UDCA.<br /><br>5.Therapy compliance.<br /><br>6.Quality of life, cost-effectiveness, cost-utility and budget impact analyses. <br>