Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass

NCT00951093 | Completed Results

• 1 other identifier: GASTROBESE-004
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastroesophageal Reflux Disease; Morbid Obesity

Keywords

GERD; Gastric bypass

Outcome Measures

Primary Outcomes (7)

• Number of Participants Presenting Reflux Symptoms

  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

  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)

  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

  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

  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

  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

  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

Study Arms (1)

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

Interventions

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.

Patients assessed for GERD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic patients

You may qualify if:

• Morbid obesity
• Acceptance to undergo open gastric bypass

You may not qualify if:

• Prior gastroesophageal surgery
• Achalasia

Sponsors & Collaborators

• Clinica Gastrobese: lead

Study Sites (1)

Clínica Gastrobese

Passo Fundo, Rio Grande do Sul, 99010112, Brazil

Location

Related Publications (1)

• Madalosso CA, Gurski RR, Callegari-Jacques SM, Navarini D, Thiesen V, Fornari F. The impact of gastric bypass on gastroesophageal reflux disease in patients with morbid obesity: a prospective study based on the Montreal Consensus. Ann Surg. 2010 Feb;251(2):244-8. doi: 10.1097/SLA.0b013e3181bdff20.

  PMID: 20010088 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Obesity, Morbid

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Results Point of Contact

• Title: Carlos AS Madalosso, Director of Department of Metabolic and Bariatric Surgery
• Organization: Clinica Gastrobese

madalosso@gastrobese.com.br

+55(54)3045-4070

Study Officials

• Carlos AS Madalosso, PhD

  Clinica Gastrobese

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Metabolic and Bariatric Surgery

Study Record Dates

• First Submitted: August 2, 2009
• First Posted: August 4, 2009
• Study Start: March 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 1, 2025
• Results First Posted: April 4, 2014

Record last verified: 2025-03

Locations

BR (1)