Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass

NCT ID: NCT00951093

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2012-12-31

Brief Summary

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

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.

Conditions

Gastroesophageal Reflux Disease; Morbid Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Gastric bypass

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Morbid obesity
• Acceptance to undergo open gastric bypass

Exclusion Criteria

• Prior gastroesophageal surgery
• Achalasia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinica Gastrobese

OTHER

Sponsor Role: lead

Responsible Party

Carlos AS Madalosso

Director of Department of Metabolic and Bariatric Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos AS Madalosso, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinica Gastrobese

Locations

Clínica Gastrobese

Passo Fundo, Rio Grande do Sul, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 20010088 (View on PubMed)

Other Identifiers

GASTROBESE-004

Identifier Type: -

Identifier Source: org_study_id