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

HaEmek Medical Center, Israel

Status: Unknown

Conditions: Morbid Obesity

Treatments: Drug: URSODIOL; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02319629

EMC- 0129-12 -CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 266 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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266 participants in 2 patient groups, including a placebo group

URSODIOL - URSODEOXYCHOLIC ACID

Experimental group

Description:

300 mg twice a day

Treatment:

Drug: URSODIOL

placebo

Placebo Comparator group

Description:

placebo twice a day

Treatment:

Drug: Placebo