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

Determination of effect of Ursodeoxycholic acid on gallstone in pateint undergoing bariatric surgery while having asymptomatic gallstone

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190128042520N5

Enrollment

Registered

2024-01-26

Start date

2024-02-20

Completion date

Unknown

Last updated

2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity. Morbid (severe) obesity due to excess calories

Interventions

Intervention 1: Intervention group: The group receiving the drug will receive UDCA capsules (Ursobil) made by the AANIDARMAN company with a dose of 300 mg every 12 hours for 6 months for free. Interve

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
Nausea. 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.	—

Measure

Time frame

Nausea. 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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Kerman Saravi

Iran University of Medical Sciences

mkermansaravi@yahoo.com+98 21 8871 7272

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026