NCT01212835

Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP

The Use of a Silastic Ring in Open Gastric Bypass for Morbid Obesity and Its Association With Gastroesophageal Reflux Disease

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Clinica Gastrobese · Academic / Other
• Sex: All
• Age: 18 Years – 58 Years
• Healthy volunteers: Not accepted

Summary

Silastic rings have been used around the gastric pouch in order to promote better weight loss after Roux-and-Y gastric bypass surgery ( RYGBP). However the investigators have shown that some patients developed gastroesophageal reflux disease after RYGBP in a previous study. The investigators hypothesized that the use of a silastic ring may play a role in promoting GERD after this operation.

Detailed description

This is a randomized controlled double blind trial designed to identify if the use of the ring induces food intolerance and vomiting which may lead a esophageal mucosal erosions and/or GERD symptoms.

Conditions

• Morbid Obesity
• Gastroesophageal Reflux Disease
• Vomiting

Interventions

Type	Name	Description
PROCEDURE	Sham Comparator: no ring	Open roux-en-Y gastric bypass not banded
PROCEDURE	RYGBP-RING	Vertical Roux-en-Y banded gastric bypass

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-03-01
• Completion: 2014-01-01
• First posted: 2010-10-01
• Last updated: 2015-12-23

Locations

3 sites across 1 country: Brazil