Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux

Completed

• Conditions: Gastroesophageal Reflux; Obesity

• Registration Number: NCT02012894
• Lead Sponsor: University of Turin, Italy

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2011-09
• Study Completion: 2013-09
• Status Verified: 2013-12
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-10
• Last Update Submitted: 2013-12-10
• Study First Posted: 2013-12-16
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in DeMeester's score	baseline, 24 months after LSG	Use of the composite score that evaluates GER at 24-h pH monitoring before and 24 months after LSG. It includes numbers of reflux episodes, upright time in reflux, recumbent time in reflux, total time in reflux, reflux episodes over 5 minutes, longest reflux episodes

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Gastroesophageal reflux disease Symptom Assessment Scale score	Baseline, 24 months after LSG	Standard and validated questionnaire is used to assess gastroesophageal symptoms and quality of life
Change from baseline in lower esophageal sphincter pressure	baseline, 24 months after LSG	Esophageal manometry measures several parameters including lower esophageal sphincter pressure
Change from baseline in amplitude of esophageal peristaltic waves	baseline, 24 months after LSG	Esophageal manometry evaluates quality and amplitude of esophageal peristalsis
Change from baseline in grade of esophagitis	baseline, 24 months after LSG	Upper endoscopy is performed to assess preoperative and postoperative presence and severity of esophagitis

Trial Locations

Locations (1)

University of Turin; 🇮🇹 Turin, Italy