Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux

N/ACompletedNCT02012894

University of Turin, Italy65 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Gastroesophageal Reflux Obesity

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Turin

Turin, Turin, Italy

Outcomes

Primary Outcomes

Change from baseline in DeMeester's score

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

Time frame: baseline, 24 months after LSG

Secondary Outcomes

Change from baseline in lower esophageal sphincter pressure

Esophageal manometry measures several parameters including lower esophageal sphincter pressure

Time frame: baseline, 24 months after LSG

Change from baseline in amplitude of esophageal peristaltic waves

Esophageal manometry evaluates quality and amplitude of esophageal peristalsis

Time frame: baseline, 24 months after LSG

Change from baseline in grade of esophagitis

Upper endoscopy is performed to assess preoperative and postoperative presence and severity of esophagitis

Time frame: baseline, 24 months after LSG

Change from baseline in Gastroesophageal reflux disease Symptom Assessment Scale score

Standard and validated questionnaire is used to assess gastroesophageal symptoms and quality of life

Time frame: Baseline, 24 months after LSG

Data from ClinicalTrials.gov

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