drugset / Trial / NCT02319629

Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery

NCT02319629 ↗

Unknown 266 enrolled HaEmek Medical Center, Israel
RandomizedParallel-groupDouble-blindPrevention

Summary

Risk factor of cholelithiasis is rapid weight loss after bariatric surgery and change in the gallbladder function which is secondary to surgery. Many observational studies support this fact, and a high incidence of 28% -71% after gastric bypass surgery (RYGB) was reported in them. According to another publication, the incidence of gallbladder diseases is 5-36% after jejunoileal bypass surgery and 2.8-36% after gastric bypass surgery.

Timeline

Start
2014-12
Primary completion
2018-12
Completion
2018-12

Outcome

Met primary endpoint

paper Gallstone formation was recorded in 45.7% (n = 21) vs. 23.9% (n = 11) of subjects among placebo vs. UDCA groups, respectively, p = 0.029. PMID 32666477 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ursodeoxycholic Acid Small molecule 300 mg —

Indications