Clinical Trials Directory

Trials / Completed

CompletedNCT00951093

Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass

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

Status
Completed
Phase
Study type
Observational
Enrollment
53 (actual)
Sponsor
Clinica Gastrobese · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREGastric bypassOpen 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.

Timeline

Start date
2007-03-01
Primary completion
2012-12-01
Completion
2012-12-01
First posted
2009-08-04
Last updated
2025-04-01
Results posted
2014-04-04

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT00951093. Inclusion in this directory is not an endorsement.