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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02721862 |
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Date of registration:
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18/03/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy
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Scientific title:
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Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy: A Prospective Randomized Multicenter Placebo-Controlled Trial |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02721862 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Ramzi S. Alami, MD, FACS |
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Address:
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Telephone:
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+961-1-350000 |
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Email:
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ra204@aub.edu.lb |
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Affiliation:
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Name:
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Ramzi S. Alami, Md, FACS |
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Address:
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Telephone:
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Email:
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Affiliation:
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American University of Beirut Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Obese patients (body mass index > 35 kg/m2) undergoing laparoscopic sleeve gastrectomy
as a primary treatment for their obesity.
- No gallstone disease on initial ultrasounds
- No previous cholecystectomy
Exclusion Criteria:
- Bariatric patients with gallbladder stones on baseline ultrasound examination.
- Patients with a previous cholecystectomy
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cholelithiasis
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Intervention(s)
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Radiation: Gallbladder Ultrasound
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Drug: Placebo
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Drug: Ursodeoxycholic Acid
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Primary Outcome(s)
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Incidence of gallstone formation after laparoscopic sleeve gastrectomy
[Time Frame: At 6 months to 18 months after laparoscopic sleeve gastrectomy]
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Secondary ID(s)
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SUR.RA.01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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