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

Mansoura University

Status: Completed

Conditions: Gastroesophageal Reflux

Treatments: Procedure: patients with GERD after LSG

Study type: Interventional

Funder types: Other

Identifiers

NCT05416645

LSG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,537 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,537 participants in 2 patient groups

Patients in group I (G1) had GERD

Active Comparator group

Description:

Patients developed GERD after LSG

Treatment:

Procedure: patients with GERD after LSG

Patients in group I (G2) had no GERD

Active Comparator group

Description:

Patients not developed GERD after LSG

Treatment:

Procedure: patients with GERD after LSG