- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05803668
Incidence of Cholelithiasis After Bariatric Surgery in Sohag University Hospital
Study Overview
Status
Conditions
Detailed Description
To study the incidence and predictors of developing symptomatic gallstone disease following bariatric surgery.
A retrospective study with prospective collective data will be conducted including all patients underwent bariatric surgery in general surgical department, Sohag University between January 2015 and December 2022 who did not have gallstones in the preoperative abdominal ultrasound examinations.
Medical records will be reviewed. Demographic data such as age, gender, BMI, comorbidities as ( DM, hypertension and hyperlipidemia ) and time elapsed between the surgery to post-surgery US examination. The findings of the US examinations will be collected and analyzed. Data will be analyzed to obtain descriptive and inferential statistics.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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-
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Sohag, Egypt
- Sohag University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All adult patients underwent bariatric surgery with minimum postoperative follow up period of one year duration will be included in the study.
Exclusion Criteria:
- Patients who had cholecystectomy during the bariatric surgery.
- Pediatric age.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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patients who developed gall stones
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patients who did not develope gall stones
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients who develop gall bladder stones after bariatric surgery
Time Frame: one year
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Evalution of gall bladder stone formation postoperaive and its relation with comorbidities
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one year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- soh-Med-23-03-06MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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