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

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02319629
• Other study ID #: EMC- 0129-12 -CTIL
• Status: Recruiting
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: HaEmek Medical Center, Israel
• Contact: Nasser Sakran, MD
• Phone: +97246494491
• Email: sakran_as[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gallstones
• Morbid Obesity
• Obesity, Morbid

Intervention

Drug:
• URSODIOL
preventive treatment with Ursolit to reduce the incidence of gallstones formation after bariatric surgery
• Placebo

Locations

Country	Name	City	State
Israel	surgery department A	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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