Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlos AS Madalosso, Clinica Gastrobese
ClinicalTrials.gov Identifier:
NCT00951093
First received: August 2, 2009
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Gastroesophageal Reflux Disease
Morbid Obesity
Procedure: Gastric bypass

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Gastric Bypass on Gastroesophageal Reflux Disease in Patients With Morbid Obesity: a Prospective Study Based on Montreal Consensus

Resource links provided by NLM:


Further study details as provided by Clinica Gastrobese:

Primary Outcome Measures:
  • Number of Participants Presenting Reflux Symptoms [ Time Frame: Before GBP, 6 months after GBP and 39 months after GBP ] [ Designated as safety issue: No ]

    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.


  • Number of Participants With Esophageal Injury [ Time Frame: Before GBP, 6 months after GBP and 39 months after GBP ] [ Designated as safety issue: No ]
    Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis

  • Number of Participants With Gastroesophageal Reflux Disease (GERD) [ Time Frame: Before GBP, 6 months after GBP and 39 months after GBP ] [ Designated as safety issue: No ]
    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 [ Time Frame: Before GBP, 6 months after GBP and 39 months after GBP ] [ Designated as safety issue: No ]
    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 [ Time Frame: Before GBP, 6 months after GBP and 39 months after GBP ] [ Designated as safety issue: No ]
    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

  • Esophageal Acid Exposure at 24h pH Monitoring in Supine Position [ Time Frame: Before GBP, 6 months after GBP and 39 months after GBP ] [ Designated as safety issue: No ]
    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 Increased Acid Exposure [ Time Frame: Before GBP, 6 months after GBP and 39 months after GBP ] [ Designated as safety issue: No ]
    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.


Enrollment: 53
Study Start Date: March 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic patients

Criteria

Inclusion Criteria:

  • Morbid obesity
  • Acceptance to undergo open gastric bypass

Exclusion Criteria:

  • Prior gastroesophageal surgery
  • Achalasia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951093

Locations
Brazil
Clínica Gastrobese
Passo Fundo, RS, Brazil, 99010112
Sponsors and Collaborators
Clinica Gastrobese
Investigators
Principal Investigator: Carlos AS Madalosso, PhD Clinica Gastrobese
  More Information

No publications provided by Clinica Gastrobese

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlos AS Madalosso, Director of Department of Metabolic and Bariatric Surgery, Clinica Gastrobese
ClinicalTrials.gov Identifier: NCT00951093     History of Changes
Other Study ID Numbers: GASTROBESE-004
Study First Received: August 2, 2009
Results First Received: December 4, 2013
Last Updated: February 25, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Clinica Gastrobese:
GERD
Gastric bypass

Additional relevant MeSH terms:
Gastroesophageal Reflux
Obesity
Obesity, Morbid
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014