Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery
1 other identifier
interventional
266
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 3, 2014
CompletedFirst Posted
Study publicly available on registry
December 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 17, 2018
May 1, 2018
4 years
December 3, 2014
May 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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: 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
six month
Study Arms (2)
URSODIOL - URSODEOXYCHOLIC ACID
EXPERIMENTAL300 mg twice a day
placebo
PLACEBO COMPARATORplacebo twice a day
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
surgery department A
Afula, Israel
Related Publications (1)
Sakran N, Dar R, Assalia A, Neeman Z, Farraj M, Sherf-Dagan S, Gralnek IM, Hazzan R, Mokary SE, Nevo-Aboody H, Dola T, Kaplan U, Hershko D. The use of Ursolit for gallstone prophylaxis following bariatric surgery: a randomized-controlled trial. Updates Surg. 2020 Dec;72(4):1125-1133. doi: 10.1007/s13304-020-00850-2. Epub 2020 Jul 14.
PMID: 32666477DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nasser Sakran, MD
Technion - Israel Institute of Technology, Faculty of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
December 3, 2014
First Posted
December 18, 2014
Study Start
December 1, 2014
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
May 17, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will share