Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux

University of Turin

Status: Completed

Conditions: Gastroesophageal Reflux; Obesity

Study type: Observational

Funder types: Other

Identifiers

NCT02012894

RGEOB/76

Details and patient eligibility

About

Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated the relationship between LSG and GER the majority reported only changes in symptoms and manometric data, while assessment of GER using 24-hour pH monitoring is lacking.

The aim of this study is to evaluate the effect of LSG on GER in morbidly obese patients.

Full description

Consecutive morbidly obese patients selected for LSG are included in a prospective clinical study. Gastroesophageal function is evaluated using a clinical validated questionnaire, upper endoscopy, esophageal manometry and 24-h pH monitoring before and 24 months after LSG.

Enrollment: 65 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• history of obesity exceeding 5 years
• documented previous weight loss attempts,
• body mass index (BMI)) of 40-50 kg/m2
• age of 18-60 years.

Exclusion criteria

• contraindications to pneumoperitoneum
• large esophageal hiatal hernia
• pregnancy,
• drug or alcohol abuse,
• psychological disorders (e.g., bulimia, depression)
• hormonal or genetic obesity-related disease,
• previous gastric surgery

Trial design

65 participants in 2 patient groups

Obese patients with preoperative GER

Description:

Obese patients selected for laparoscopic sleeve gastrectomy with preoperative GER at 24 H pH-monitoring (Group A)

Obese patients without preoperative GER

Description:

Obese patients selected for laparoscopic sleeve gastrectomy without preoperative GER at 24 H pH-monitoring (Group B)