Laparoscopic Roux-en-Y Gastric Bypass and Gastro-esophageal Reflux

Study Overview
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Brief Summary
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Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is considered the weight loss procedure of choice for patients suffering of gastro-esophageal reflux (GER). However, long term instrumental evaluations of GER after LRYGB are not available. The aim of this study is to evaluate the long-term effects of laparoscopic Roux-en-Y Gastric Bypass (LRYGB) on gastro-esophageal function.

Detailed Description
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Consecutive morbidly obese patients selected for LRYGB were included in a prospective study. The investigators performed clinical evaluation with GERD-HRQoL and GIS questionnaire, upper endoscopy, esophageal manometry and 24h-impedance pH monitoring (24h-MII-pH) preoperatively and at 12 and 60 months after surgery. Patients were divided into 2 groups according to the presence of GER at preoperative 24h-MII-pH.

Official Title
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Long Term Effects of Laparoscopic Roux-en-Y Gastric Bypass on Gastro-esophageal Reflux: Clinical Impact of Weakly Acidic Reflux

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 without preoperative GER<br>Obese patients selected for laparoscopic Roux-en-Y Gastric Bypass without preoperative GER at 24h-impedance pH monitoring (Group G-) | |
| Obese patients with preoperative GER<br>Obese patients selected for laparoscopic Roux-en-Y Gastric Bypass with preoperative GER at 24h-impedance pH monitoring (Group G+) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of weakly acidic reflux | number of weakly acidic reflux at 24 hour pH impedance monitoring | preoperatively, 12 and 60 months after LRYGB | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD-HRQoL clinical score | Standard and previous validated questionnaire was employed in the study to assess gastroesophageal function and quality of life | preoperatively, 12 and 60 months after LRYGB | 
| Lower esophageal sphincter pressure | Esophageal manometry measures lower esophageal sphincter pressure | preoperatively, 12 and 60 months after LRYGB | 
| Amplitude of esophageal peristaltic waves | Esophageal manometry evaluates amplitude of esophageal peristalsis | preoperatively, 12 and 60 months after LRYGB | 
| Grade of esophagitis | Upper endoscopy is performed to assess the presence of esophagitis | preoperatively, 12 and 60 months after LRYGB | 
| Number of acidic reflux | number of acidic reflux at 24 hour pH impedance monitoring | preoperatively, 12 and 60 months after LRYGB | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Gastroesophageal reflux, Esophageal manometry, 24 H impedance pH-monitoring, Laparoscopic Roux-en-Y Gastric Bypass