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Incidence of Cholelithiasis After Bariatric Surgery in Sohag University Hospital

Sponsor
Sohag University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05803668
Collaborator
(none)
30
Enrollment
1
Location
12
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To study the incidence and predictors of developing symptomatic gallstone disease following bariatric surgery.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Incidence of Cholelithiasis After Bariatric Surgery in Sohag University Hospital
    Actual Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Feb 28, 2024
    Anticipated Study Completion Date :
    Feb 28, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    patients who developed gall stones
    patients who did not develope gall stones

    Outcome Measures

    Primary Outcome Measures

    1. To demonstrate the incidence of cholelithiasis in patients underwent bariatric suregery [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag University Sohag Egypt

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Salah Mohamed, Ahmed Salah Mohammed Abd Elaal, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05803668
    Other Study ID Numbers:
    • soh-Med-23-03-06MS
    First Posted:
    Apr 7, 2023
    Last Update Posted:
    Apr 7, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cholelithiasis
    Cholecystolithiasis
    Gallstones

    Study Results

    No Results Posted as of Apr 7, 2023