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Completed

NCT Number: NCT00951093

Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass

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

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Key information

Conditions

Gastroesophageal Reflux Disease Body Weight Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Morbid Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica Gastrobese

Passo Fundo, Rio Grande do Sul, 99010112, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Morbid obesity
  • Acceptance to undergo open gastric bypass

Exclusion criteria

  • Prior gastroesophageal surgery
  • Achalasia

Treatment and study plan

Gastric bypass

Procedure

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Clinica Gastrobese

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Aug 4, 2009
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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