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LSG-GERD: Prevalence, Predictors and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT05416645
Collaborator
(none)
1,537
Enrollment
1
Location
2
Arms
60
Actual Duration (Months)
25.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

From January 2017 to January 2022, we looked at patients who had primary LSG and developed GERD. Before and after surgery, patients for LSG performed barium meal in Trendelenburg position and upper GIT endoscopy. Esophageal manometry and 24 h PH metery for patients who developed GERD.

Condition or Disease Intervention/Treatment Phase
  • Procedure: patients with GERD after LSG
 N/A

Detailed Description

Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study. Patients with morbid obesity, defined as a BMI of more than 40 or less than 35 with at least one comorbidity and ages ranging from 16 to 65, were patients' eligibility criteria for LSG. Patients under the age of 16 or over 65, as well as those with severe GERD, pregnancy, or inflammatory bowel disease, were excluded from the trial.

The data were recorded in a prospective manner in a computerized file, all patients signed the informed consent form after the description of the technique and possible postoperative morbidities.

Before and after surgery, patients for LSG performed barium meal in Trendelenburg position and upper GIT endoscopy. Esophageal manometry and 24 h PH metery for patients who developed GERD.

The study's purpose was to determine the prevalence of GERD symptoms, as well as potential predictors of GERD symptoms following LSG and how GERD symptoms were managed after LSG.

Study Design

Study Type:
Interventional
Actual Enrollment :
1537 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study.Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study.
Masking:
Double (Participant, Investigator)
Masking Description:
Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study.
Primary Purpose:
Treatment
Official Title:
Prevalence, Predictors, and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy Multicentric Cohort Study
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Patients in group I (G1) had GERD

Patients developed GERD after LSG

Procedure: patients with GERD after LSG
patients with GERD after LSG
Other Names:
  • GERD after LSG

    		•
    Active Comparator: Patients in group I (G2) had no GERD

    Patients not developed GERD after LSG

    Procedure: patients with GERD after LSG
    patients with GERD after LSG
    Other Names:
  • GERD after LSG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire [one month]

      GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire including GERD symptoms easch one scaled from 1 to 5 the less score the better out come (1 the best and 5 is the worset)

    Secondary Outcome Measures

    1. Gastropexy [one month]

      YES (WITH GASTROPEXY) OR NO (WITHOUT GASTROPEXY) .....RISK FACTORS AND PROTECTIVE FACTORS for GERD

    2. smoking [one month]

      YES (WITH SMOKING) OR NO (WITHOUT SMOKING)......RISK FACTORS AND PROTECTIVE FACTORS for GERD

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with morbid obesity defined as a BMI of more than 40 or

    • BMI less than 35 with at least one comorbidity and

    • ages ranging from 16 to 65, were patients'

    Exclusion Criteria:

    • Patients under the age of 16 or over 65,

    • those with severe GERD,

    • pregnancy, or

    • inflammatory bowel disease,

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ayman El Nakeeb Mansoura Egypt 356111

    Sponsors and Collaborators

    • Mansoura University

    Investigators

    • Principal Investigator: Ayman El E Nakeeb, Mansoura University, Gastrointestinal Surgery Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Ayman El Nakeeb, clinical professor, Mansoura University
    ClinicalTrials.gov Identifier:
    NCT05416645
    Other Study ID Numbers:
    • LSG
    First Posted:
    Jun 13, 2022
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ayman El Nakeeb, clinical professor, Mansoura University
    laparoscopic sleeve gastrectomy
    morbid obesity
    GERD
    Additional relevant MeSH terms:
    Gastroesophageal Reflux
    Esophagitis, Peptic

    Study Results

    No Results Posted as of Jun 15, 2022