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Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass

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ClinicalTrials.gov Identifier: NCT00951093
Recruitment Status : Completed
First Posted : August 4, 2009
Results First Posted : April 4, 2014
Last Update Posted : April 4, 2014
Sponsor:
Information provided by (Responsible Party):
Carlos AS Madalosso, Clinica Gastrobese

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

Condition or disease Intervention/treatment
Gastroesophageal Reflux Disease Morbid Obesity Procedure: Gastric bypass

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 Design
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Study Type : Observational
Actual Enrollment : 53 participants
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
Study Start Date : March 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00951093


Locations
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Brazil
Clínica Gastrobese
Passo Fundo, RS, Brazil, 99010112
Sponsors and Collaborators
Clinica Gastrobese
Investigators
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Principal Investigator: Carlos AS Madalosso, PhD Clinica Gastrobese
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Carlos AS Madalosso, Director of Department of Metabolic and Bariatric Surgery, Clinica Gastrobese
ClinicalTrials.gov Identifier: NCT00951093    
Other Study ID Numbers: GASTROBESE-004
First Posted: August 4, 2009    Key Record Dates
Results First Posted: April 4, 2014
Last Update Posted: April 4, 2014
Last Verified: February 2014
Keywords provided by Carlos AS Madalosso, Clinica Gastrobese:
GERD
Gastric bypass
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases