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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-12-31

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.

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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):

1. 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.
2. 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.

Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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URSODIOL - URSODEOXYCHOLIC ACID

300 mg twice a day

Group Type EXPERIMENTAL

URSODIOL

Intervention Type DRUG

preventive treatment with Ursolit to reduce the incidence of gallstones formation after bariatric surgery

placebo

placebo twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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URSODIOL

preventive treatment with Ursolit to reduce the incidence of gallstones formation after bariatric surgery

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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URSODEOXYCHOLIC ACID

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No