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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Procedure: patients with GERD after LSG


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients in group I (G1) had GERD<br>Patients developed GERD after LSG | Procedure: patients with GERD after LSG<br>* patients with GERD after LSG<br>* Other names: GERD after LSG;|
| Active Comparator: Patients in group I (G2) had no GERD<br>Patients not developed GERD after LSG | Procedure: patients with GERD after LSG<br>* patients with GERD after LSG<br>* Other names: GERD after LSG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire | 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 | YES (WITH GASTROPEXY) OR NO (WITHOUT GASTROPEXY) .....RISK FACTORS AND PROTECTIVE FACTORS for GERD | one month | 
| smoking | YES (WITH SMOKING) OR NO (WITHOUT SMOKING)......RISK FACTORS AND PROTECTIVE FACTORS for GERD | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic sleeve gastrectomy, morbid obesity, GERD