Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass

Completed

Conditions: Gastroesophageal Reflux Disease
Morbid Obesity

Interventions: Procedure: Gastric bypass

Registration Number: NCT00951093

Lead Sponsor: Clinica Gastrobese

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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 53

Inclusion Criteria

Morbid obesity
Acceptance to undergo open gastric bypass

Exclusion Criteria

Prior gastroesophageal surgery
Achalasia

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients assessed for GERD	Gastric bypass	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

Primary Outcome Measures

Name	Time	Method
Number of Participants Presenting Reflux Symptoms	Before GBP, 6 months after GBP and 39 months after GBP	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.
Esophageal Acid Exposure at 24h pH Monitoring in Supine Position	Before GBP, 6 months after GBP and 39 months after GBP	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
Number of Participants With Esophageal Injury	Before GBP, 6 months after GBP and 39 months after GBP	Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis
Number of Participants With Gastroesophageal Reflux Disease (GERD)	Before GBP, 6 months after GBP and 39 months after GBP	Prevalence of GERD in patients characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.
Total Esophageal Acid Exposure at 24h pH Monitoring	Before GBP, 6 months after GBP and 39 months after GBP	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.
Esophageal Acid Exposure at 24h pH Monitoring in Upright Position	Before GBP, 6 months after GBP and 39 months after GBP	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
Number of Participants With Increased Acid Exposure	Before GBP, 6 months after GBP and 39 months after GBP	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.