Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass

Study Overview
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Brief Summary
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The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.

Detailed Description
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The investigators studied the impact of this surgical procedure on GERD in patients with morbid obesity. Esophageal syndromes were evaluated according to 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 was determined through 24h pH monitoring. Increased acid exposure was characterized when total esophageal pH < 4 for at least 4% of the total monitoring time.

Official Title
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The Impact of Gastric Bypass on Gastroesophageal Reflux Disease in Patients With Morbid Obesity: a Prospective Study Based on Montreal Consensus

Conditions
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Gastroesophageal Reflux Disease, Morbid Obesity

Intervention / Treatment
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* Procedure: Gastric bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Morbid obesity Acceptance to undergo open gastric bypass Exclusion Criteria: Prior gastroesophageal surgery Achalasia

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients assessed for GERD<br>Patients who had an open gastric bypass were assessed for GERD before and after surgery following the Montreal Consensus through a validated questionnaire in Portuguese language | Procedure: Gastric bypass<br>* Open Silastic® ring Roux-en Y gastric bypass was performed through an upper midline incision. A gastric pouch was created by dividing the stomach with a 10-cm stapler from the lesser curvature (7 cm vertically from the cardia) to 1 cm to the left of the Hiss angle. The estimated volume of the gastric pouch was 20 to 30 ml that was banded with a 6.5 cm long Silastic® ring. A gastrojejunal anastomosis was performed with two-layers hand sewn absorbable suture over a 1.2 cm bougie distal to the ring, keeping an alimentary limb with 100 cm in length, and a biliopancreatic limb ranging 60 and 80 cm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Presenting Reflux Symptoms | Prevalence of typical reflux syndrome 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 was used. | Before GBP, 6 months after GBP and 39 months after GBP | 
| Number of Participants With Esophageal Injury | Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis | Before GBP, 6 months after GBP and 39 months after GBP | 
| Number of Participants With Gastroesophageal Reflux Disease (GERD) | Prevalence of GERD in patients characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus. | Before GBP, 6 months after GBP and 39 months after GBP | 
| Total Esophageal Acid Exposure at 24h pH Monitoring | Esophageal acid exposure was measured through 24h pH monitoring. During the entire period, esophageal pH was measured and recorded as the percent of time pH was below 4. | Before GBP, 6 months after GBP and 39 months after GBP | 
| Esophageal Acid Exposure at 24h pH Monitoring in Upright Position | Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in upright position | Before GBP, 6 months after GBP and 39 months after GBP | 
| Esophageal Acid Exposure at 24h pH Monitoring in Supine Position | Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in supine position | Before GBP, 6 months after GBP and 39 months after GBP | 
| 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 GBP, 6 months after GBP and 39 months after GBP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Gastric bypass