Cholelithiasis Clinical Trial
Official title:
Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy: A Prospective Randomized Multicenter Placebo-Controlled Trial
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 2019 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Lebanon | American University of Beirut Medical Center | Beirut | |
Lebanon | Makassed General Hospital | Beirut |
Lead Sponsor | Collaborator |
---|---|
American University of Beirut Medical Center | Makassed General Hospital |
Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of gallstone formation after laparoscopic sleeve gastrectomy | Patients in both arms will undergo a total of three abdominal ultrasounds after their bariatric surgery (at 6 months, at 12 months, and at 18 months) to check for gallstones. Once gallstone formation is detected at any of these time points, no additional ultrasounds will be done and the incidence of gallstone formation (Percentage of patients with gallstone formation on ultrasound) will be calculated. | At 6 months to 18 months after laparoscopic sleeve gastrectomy |
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