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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Procedure: patients with GERD after LSG

• Registration Number: NCT05416645
• Lead Sponsor: Mansoura University

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2017-01
• Status Verified: 2022-01
• Primary Completion: 2022-01
• Study Completion: 2022-01
• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-08
• Last Update Submitted: 2022-06-11
• Study First Posted: 2022-06-13
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1537

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'

Read More

Exclusion Criteria

• Patients under the age of 16 or over 65,
• those with severe GERD,
• pregnancy, or
• inflammatory bowel disease,

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients in group I (G2) had no GERD	patients with GERD after LSG	Patients not developed GERD after LSG
Patients in group I (G1) had GERD	patients with GERD after LSG	Patients developed GERD after LSG

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
smoking	one month	YES (WITH SMOKING) OR NO (WITHOUT SMOKING)......RISK FACTORS AND PROTECTIVE FACTORS for GERD
Gastropexy	one month	YES (WITH GASTROPEXY) OR NO (WITHOUT GASTROPEXY) .....RISK FACTORS AND PROTECTIVE FACTORS for GERD

Trial Locations

Locations (1)

Ayman El Nakeeb; 🇪🇬 Mansoura, Egypt