Evaluation of Ursodeoxycholic acid effect on gallstone in pateint undergoing bariatric surgery

Phase 1

Recruiting

• Conditions: Morbid Obesity.; E66.01; Morbid (severe) obesity due to excess calories

• Registration Number: IRCT20190128042520N5
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion criteria include morbidly obese patients who are candidates for bariatric surgery (Sleeve, Classic Bypass or OAGB) and have asymptomatic gallstones.

Exclusion Criteria

Patients with symptomatic gallstones
Impaired liver tests
History of previous bariatric surgery
History of taking Ursodeoxycholic acid during the last month of pregnancy
history of taking Oral contraceptive pills (OCP)
Drug and alcohol abuse
Sensitivity to Ursodeoxycholic acid

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Size of gallstones. Timepoint: Measuring the size of gallstones at the beginning of the study (before the start of the intervention) and after the completion of the ursodeoxycholic acid drug (6 months after surgery). Method of measurement: With sonography to mm.;Number of gallstones. Timepoint: Measuring the number of gallstones at the beginning of the study (before the start of the intervention) and after the completion of the ursodeoxycholic acid drug (6 months after surgery). Method of measurement: With sonography to number.

Secondary Outcome Measures

Name	Time	Method
ausea. Timepoint: One, three and six months after surgery. Method of measurement: Examination by a doctor.;Vomitting. Timepoint: One, three and six months after surgery. Method of measurement: Examination by a doctor.;Upper abdominal pain. Timepoint: One, three and six months after surgery. Method of measurement: Examination by a doctor.;Early satiety. Timepoint: One, three and six months after surgery. Method of measurement: Examination by a doctor.