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

June 11, 2022 updated by: Ayman El Nakeeb, Mansoura University

Prevalence, Predictors, and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy Multicentric Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1537

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 356111
        • Ayman El Nakeeb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire
Time Frame: 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)
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastropexy
Time Frame: one month
YES (WITH GASTROPEXY) OR NO (WITHOUT GASTROPEXY) .....RISK FACTORS AND PROTECTIVE FACTORS for GERD
one month
smoking
Time Frame: one month
YES (WITH SMOKING) OR NO (WITHOUT SMOKING)......RISK FACTORS AND PROTECTIVE FACTORS for GERD
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

June 6, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (Actual)

June 13, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 11, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

the study protocol will be available for another researcher

IPD Sharing Time Frame

available for any researcher at any time

IPD Sharing Access Criteria

e-mail elnakeebayman@yahoo.com

IPD Sharing Supporting Information Type

  • Study Protocol

Study Data/Documents

  1. Study Protocol
    Information identifier: post LSG GERD
    Information comments: Postlaparoscopic sleeve gastrectomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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