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

Primary Purpose

Morbid Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
URSODIOL
Placebo
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Morbid Obesity focused on measuring Morbid obesity,, Cholelithiasis, Bariatric surgery, Ursodiol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • surgery department ARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

URSODIOL - URSODEOXYCHOLIC ACID

placebo

Arm Description

300 mg twice a day

placebo twice a day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 3, 2014
Last Updated
May 13, 2018
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT02319629
Brief Title
Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery
Official Title
Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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): 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Morbid obesity,, Cholelithiasis, Bariatric surgery, Ursodiol

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
266 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
URSODIOL - URSODEOXYCHOLIC ACID
Arm Type
Experimental
Arm Description
300 mg twice a day
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo twice a day
Intervention Type
Drug
Intervention Name(s)
URSODIOL
Other Intervention Name(s)
URSODEOXYCHOLIC ACID
Intervention Description
preventive treatment with Ursolit to reduce the incidence of gallstones formation after bariatric surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Incidence of gallstones formation after bariatric surgery
Description
- 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
Time Frame
six month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nasser Sakran, MD
Phone
+97246494491
Email
sakran_as@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasser Sakran, MD
Organizational Affiliation
Technion - Israel Institute of Technology, Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
surgery department A
City
Afula
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nasser Sakran, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
32666477
Citation
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.
Results Reference
derived

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

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