Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy

• Status: Unknown status
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized double-blind placebo-controlled trial with a total of 100 patients who are free of gallstones at baseline. The study involves taking an oral drug (Ursodeoxycholic Acid 250mg) or a placebo twice daily for a period of six months and undergoing a total of three abdominal ultrasounds (at 6 months, at 12 months, and at 18 months) to check for gallstones.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American University of Beirut Medical Center
• Collaborator: Makassed General Hospital
• Treatments: Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• Obese patients (body mass index > 35 kg/m2) undergoing laparoscopic sleeve gastrectomy as a primary treatment for their obesity.

• No gallstone disease on initial ultrasounds

• No previous cholecystectomy

Exclusion Criteria:

• Bariatric patients with gallbladder stones on baseline ultrasound examination.

• Patients with a previous cholecystectomy