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

Not Applicable

• Conditions: Morbid Obesity
• Interventions: Drug: URSODIOL; Drug: Placebo

• Registration Number: NCT02319629
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-14
• Study First Posted: 2014-12-18
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-13
• Last Update Posted: 2018-05-17
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 266

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
URSODIOL - URSODEOXYCHOLIC ACID	URSODIOL	300 mg twice a day
placebo	Placebo	placebo twice a day

Primary Outcome Measures

Name	Time	Method
Incidence of gallstones formation after bariatric surgery	six month	- Six months after the surgery the subjects will be invited to re-evaluation of the presence of gallstones using: 1. Clinical interview: Did he experience epigastric pain? Was he hospitalized with diagnosis of biliary colic or cholecystitis?; 2. US of the upper abdomen to assess the presence of gallstones, gallbladder wall thickening or other disorder.; 3. Blood tests for liver functions and lipids profile

Trial Locations

Locations (1)

surgery department A; 🇮🇱 Afula, Israel