Gallstone disease
Conditions
Interventions
The intervention group will receive UDCA 900mg once daily for six months. The
placebo group will receive similar-looking placebo tablets.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Scheduled to undergo Roux-en-Y gastric bypass or sleeve gastrectomy for morbid obesity * An intact gallbladder
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the difference between the two groups in symptomatic gallstone disease after 24 months, defined as admission or hospital visit for symptomatic gallstone disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints consist of the development of gallstones on ultrasound at 24 months, side-effects of UDCA and cost-effectiveness, cost-utility and budget impact analyses | — |
Countries
Netherlands
Outcome results
None listed