This study is designed to provide evidence regarding the prophylactic use of UDCA in preventing symptomatic gallstone disease after RYGB and Sleeve Gastrectomy.
ID
Source
Brief title
Condition
- Gallbladder disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
The number of bariatric interventions for morbid obesity is rapidly increasing
in the Netherlands. Rapid weight loss is a major risk factor for gallstone
development. Approximately eleven percent of patients who underwent Roux-en-Y
gastric bypass develop symptomatic gallstone disease. Similar rates of
gallstone disease are reported in patients who underwent Sleeve Gastrectomy.
Gallstone disease can lead to severe complications and often requires
hospitalization and surgery. Ursodeoxycholic acid (UDCA) prevents the formation
of gallstones after bariatric surgery. However, randomized controlled trials
with symptomatic gallstone disease as primary endpoint have not been conducted.
Currently, major guidelines make no definite statement about postoperative UDCA
prophylaxis and most bariatric centres do not prescribe UDCA.
Study objective
This study is designed to provide evidence regarding the prophylactic use of
UDCA in preventing symptomatic gallstone disease after RYGB and Sleeve
Gastrectomy.
Study design
Randomized, placebo-controlled, double-blind multicentre trial.
Intervention
The intervention group will receive UDCA 900mg once daily for six months. The
placebo group will receive similar-looking placebo tablets.
Study burden and risks
Most of the procedures required for this study are similar to the current
standard care. Additional measures include a gallbladder ultrasound
preoperatively and after 24 months, the prescription of investigational product
(UDCA or placebo) for 6 months, and several questionnaires that have to be
filled in at 5 different time points. The risks of this study are minimal. UDCA
has been used for several decades in the treatment of gallstone disease and
other biliary diseases, and is known to have only few side effects and no
serious side effects.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-003245-29-NL |
| CCMO | NL59657.048.16 |
| OMON | NL-OMON20653 |