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

Study Overview
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Brief Summary
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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
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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): 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. 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.

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

Conditions
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Morbid Obesity

Intervention / Treatment
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* Drug: URSODIOL
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidates for sleeve gastrectomy or gastric bypass surgery due to morbid obesity with BMI range of 40 to50. Aged 18 to 65. No presence of gallstones. Patients who have signed the consent form. Exclusion Criteria: Minors, Pregnant women, Age over 65, Sensitive to Ursodiol, Gallstones, Biliary tract pathologies, Gallbladder wall thickening, Patients after cholecystectomy, Patients participating in another clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: URSODIOL - URSODEOXYCHOLIC ACID<br>300 mg twice a day | Drug: URSODIOL<br>* preventive treatment with Ursolit to reduce the incidence of gallstones formation after bariatric surgery<br>* Other names: URSODEOXYCHOLIC ACID;|
| Placebo Comparator: placebo<br>placebo twice a day | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of gallstones formation after bariatric surgery | - Six months after the surgery the subjects will be invited to re-evaluation of the presence of gallstones using: Clinical interview: Did he experience epigastric pain? Was he hospitalized with diagnosis of biliary colic or cholecystitis? US of the upper abdomen to assess the presence of gallstones, gallbladder wall thickening or other disorder. Blood tests for liver functions and lipids profile | six month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid obesity,, Cholelithiasis, Bariatric surgery, Ursodiol