Clinico-functional Evaluation of GERD: Comparative Study of Vertical Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass

Study Overview
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Brief Summary
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The hypothesis of this study is that surgical techniques primarily designed for weight loss, ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients. Therefore the present study intends to evaluate such impact on patients submitted to two of the most common techniques available, the Roux-en-Y Gastric Bypass and Vertical Sleeve Gastrectomy.

Detailed Description
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In order to determine if weight loss surgeries do indeed ameliorate GERD in morbidly obese patients, esophageal syndromes will be evaluated following the Montreal Consensus, where troublesome symptoms were defined as score ≥ 2 on a validated questionnaire of symptoms for Portuguese language along with esophageal syndromes with injury assessed through upper endoscopy. Esophageal acid exposure will be determined through 24h pH monitoring. Increased acid exposure will be characterized when total esophageal pH < 4 for at least 4% of its total monitoring time.

Official Title
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Clinico-functional Evaluation of Gastroesophageal Reflux Disease (GERD): A Comparative Study Between the Vertical Sleeve Gastrectomy and Roux-en-Y Gastric Bypass Techniques

Conditions
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Morbid Obesity, Gastroesophageal Reflux Disease

Intervention / Treatment
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* Procedure: Roux-en-Y Gastric Bypass
* Procedure: Vertical Sleeve Gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 40 Kg/m2, or BMI > 35 Kg/m2 along with clinical comorbidities (such as Diabetes Mellitus, Systemic Arterial Hypertension or Articular Lesions) Been unable to loose or sustain weight loss after 2 years medical and nutritional treatments. Exclusion Criteria: Been previously submitted to any gastroesophageal surgical procedure Presence of chronical diseases that affects esophageal motility Do not tolerate any of the required exams

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BPG Group<br>Patients will be submitted to Roux-en-Y Bypass Gastric Surgery. | Procedure: Roux-en-Y Gastric Bypass<br>* The Roux-en-Y gastric bypass procedure involves creating a stomach pouch out of a small portion of the stomach and attaching it directly to the small intestine, bypassing a large part of the stomach and duodenum. Not only is the stomach pouch too small to hold large amounts of food, but by skipping the duodenum, fat absorption is substantially reduced.<br>* Other names: GBP;|
| Experimental: Sleeve Group<br>Patients will be submitted to Vertical Sleeve Gastrectomy Surgery. | Procedure: Vertical Sleeve Gastrectomy<br>* VSG surgery restricts food intake and decreases the amount of food used. Most of the stomach is removed during this surgery, which may decrease ghrelin, a hormone that prompts appetite. Lower amounts of ghrelin may reduce hunger more than other purely restrictive surgeries, such as AGB.<br>* Other names: Sleeve;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of Participants With Gastroesophageal Reflux Disease (GERD) | Prevalence of GERD in patients will be characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus. | Before Intervention, 1 year after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of Participants Presenting Reflux Symptoms | Prevalence of typical reflux syndrome as classified according to the Montreal Consensus. This Consensus institutes that GERD can be outlined when troublesome symptoms and/or complications induced by reflux of the gastric content back to the esophagus are present. In order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language will be used. | Before Intervention, 1 year after Intervention | 
| Change in number of Participants With Esophageal Injury | Syndromes with esophageal injury should be determined exclusively by the presence of reflux esophagitis | Before Intervention, 1 year after intervention | 
| Change in Total Esophageal Acid Exposure at 24h pH Monitoring | Esophageal acid exposure will be measured through 24h pH monitoring. During such period, esophageal pH will be measured and recorded as the percent of time pH stays below 4. | Before Intervention, 1 year after intervention | 
| Change in Esophageal Acid Exposure at 24h pH Monitoring in Upright Position | Esophageal acid exposure will be measured through 24h pH monitoring. Esophageal pH will be measured and recorded as the percent of time pH stays below 4 while participant in upright position | Before Intervention, 1 year after intervention | 
| Change in Esophageal Acid Exposure at 24h pH Monitoring in Supine Position | Esophageal acid exposure will be measured through 24h pH monitoring. Esophageal pH will be measured and recorded as the percent of time pH stays below 4 while participant in supine position | Before Intervention, 1 year after intervention | 
| Change in number of Participants With Increased Acid Exposure | Increased Acid Exposure occurs when esophageal pH is <4 for a period longer than 4% of the total test time on a 24h pH monitoring. | Before Intervention, 1 year after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Roux-en-Y Gastric Bypass, Vertical Sleeve Gastrectomy