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GERD After Sleeve Gastrectomy

Sponsor
University of Foggia (Other)
Overall Status
Completed
CT.gov ID
NCT05178446
Collaborator
(none)
14,362
Enrollment
1
Location
11
Actual Duration (Months)
1308.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main adverse effect is gastroesophageal reflux disease (GERD), with concern on the development of Barrett's esophagus and esophageal adenocarcinoma in the long term. However, the relationship between SG and GERD is complex. The aim of this study is to systematically evaluate all published data existing in the literature to evaluate the effect of sleeve gastrectomy on GERD, esophagitis, BE in order to clarify the long-term clinical sequelae of this procedure.

This systematic review was conducted in accordance with the guidelines for Preferred Reporting Items for Systematic Review and Meta-analyzes (PRISMA).

Published studies that contained outcome data for primary sleeve gastrectomy associated with the primary and secondary outcomes listed below were included.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    14362 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    The New Onset of GERD After Sleeve Gastrectomy: a Systematic Review
    Actual Study Start Date :
    Jan 1, 2021
    Actual Primary Completion Date :
    Mar 1, 2021
    Actual Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Gastroesophageal reflux disease after bariatric surgery [from 2014 to 2018]

      Number of patients underwent sleeve gastrectomy with GERD

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients underwent to sleeve gastrectomy with reflux symptoms
    Exclusion Criteria:
    • Patients underwent to other bariatric procedures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Foggia Foggia Italy 71122

    Sponsors and Collaborators

    • University of Foggia

    Investigators

    • Study Director: Nicola Tartaglia, University of Foggia

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Giovanna Pavone, Medical Doctor, University of Foggia
    ClinicalTrials.gov Identifier:
    NCT05178446
    Other Study ID Numbers:
    • 3
    First Posted:
    Jan 5, 2022
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Dec 1, 2021
    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:
    Obesity, Morbid

    Study Results

    No Results Posted as of Jan 5, 2022