NCT02319629

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (estimated)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study format: Prospective, randomized, blinded study. 266 candidates for sleeve gastrectomy or gastric bypass surgery due to morbid obesity with BMI range of 40-50 and aged 18-65 will be studied. The patients will be randomly divided into two groups (according to the last digit of the identity card number): 1. Treatment group will receive preventive therapy with Ursodiol 600 mg per day as of day 10 after the surgery (at the first routine visit after the surgery) and for six months or until the formation of gallstones. 2. Placebo group will receive placebo as of day 10 after the surgery (at the first routine visit after the surgery) and for six months or until the formation of gallstones.

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
DRUG	URSODIOL	preventive treatment with Ursolit to reduce the incidence of gallstones formation after bariatric surgery
DRUG	Placebo

Timeline

• Start date: 2014-12-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2014-12-18
• Last updated: 2018-05-17

Locations

1 site across 1 country: Israel