Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physiopathologic Evaluation of Esophageal Function After Laparoscopic Sleeve Gastrectomy

Conditions
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Gastroesophageal Reflux, Obesity

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese patients with preoperative GER<br>Obese patients selected for laparoscopic sleeve gastrectomy with preoperative GER at 24 H pH-monitoring (Group A) | |
| Obese patients without preoperative GER<br>Obese patients selected for laparoscopic sleeve gastrectomy without preoperative GER at 24 H pH-monitoring (Group B) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline, 24 months after LSG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in lower esophageal sphincter pressure | Esophageal manometry measures several parameters including lower esophageal sphincter pressure | baseline, 24 months after LSG | 
| Change from baseline in amplitude of esophageal peristaltic waves | Esophageal manometry evaluates quality and amplitude of esophageal peristalsis | 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 | 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 | Baseline, 24 months after LSG | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Gastroesophageal reflux, sleeve gastrectomy, pH-monitoring, manometry