Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass

February 25, 2014 updated by: Carlos AS Madalosso, Clinica Gastrobese

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Passo Fundo, RS, Brazil, 99010112
        • Clínica Gastrobese

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic patients

Description

Inclusion Criteria:

  • Morbid obesity
  • Acceptance to undergo open gastric bypass

Exclusion Criteria:

  • Prior gastroesophageal surgery
  • Achalasia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients assessed for GERD
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Presenting Reflux Symptoms
Time Frame: 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.
Before GBP, 6 months after GBP and 39 months after GBP
Number of Participants With Esophageal Injury
Time Frame: Before GBP, 6 months after GBP and 39 months after GBP
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)
Time Frame: 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.
Before GBP, 6 months after GBP and 39 months after GBP
Total Esophageal Acid Exposure at 24h pH Monitoring
Time Frame: 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.
Before GBP, 6 months after GBP and 39 months after GBP
Esophageal Acid Exposure at 24h pH Monitoring in Upright Position
Time Frame: 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
Before GBP, 6 months after GBP and 39 months after GBP
Esophageal Acid Exposure at 24h pH Monitoring in Supine Position
Time Frame: 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
Before GBP, 6 months after GBP and 39 months after GBP
Number of Participants With Increased Acid Exposure
Time Frame: 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.
Before GBP, 6 months after GBP and 39 months after GBP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Gastrobese

Investigators

  • Principal Investigator: Carlos AS Madalosso, PhD, Clínica Gastrobese

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 2, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (Estimate)

August 4, 2009

Study Record Updates

Last Update Posted (Estimate)

April 4, 2014

Last Update Submitted That Met QC Criteria

February 25, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTROBESE-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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