Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery
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|ClinicalTrials.gov Identifier: NCT02319629|
Recruitment Status : Recruiting
First Posted : December 18, 2014
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity||Drug: URSODIOL Drug: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: URSODIOL - URSODEOXYCHOLIC ACID
300 mg twice a day
preventive treatment with Ursolit to reduce the incidence of gallstones formation after bariatric surgery
Other Name: URSODEOXYCHOLIC ACID
Placebo Comparator: placebo
placebo twice a day
- Incidence of gallstones formation after bariatric surgery [ Time Frame: six month ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319629
|Contact: Nasser Sakran, MDemail@example.com|
|surgery department A||Recruiting|
|Contact: Nasser Sakran, MD|
|Principal Investigator:||Nasser Sakran, MD||Technion - Israel Institute of Technology, Faculty of Medicine|