Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP

Not Applicable

Terminated

• Conditions: Vomiting; Morbid Obesity; Gastroesophageal Reflux Disease
• Interventions: Procedure: RYGBP-RING

• Registration Number: NCT01212835
• Lead Sponsor: Clinica Gastrobese

Brief 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.

Study Timeline

• Study First Submitted: 2010-09-29
• Study First Submitted QC: 2010-09-30
• Study Start: 2010-10
• Study First Posted: 2010-10-01
• Primary Completion: 2012-03
• Study Completion: 2014-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Indications for bariatric surgery (BMI over 40Kg/m2 or over 35Kg/m2 associated to a life-treating morbid conditions.
• Acceptance to be submitted to a 24h pH-monitoring and esophageal manometry
• No contra-indication for gastric bypass
• Absence of previous gastric surgery
• Option for open gastric bypass

Exclusion Criteria

• Inferior and superior total teeth prosthesis
• Poor surgical conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RYGBP-Ring	RYGBP-RING	Open Roux-en-Y gastric bypass with a silastic ring which is performed with linear cut stapler 100 mm and a biliopancreatic limb of 60 cm long and a alimentary limb of 100 cm long. All patients will have a 6.5 cm silastic ring located at the middle of the pouch above of the gastroenteroanastomosis.

Primary Outcome Measures

Name	Time	Method
Occurence of gastroesophageal reflux disease	march 2010 to march 2014	Patients are intra-operatively selected to receive or not a silastic ring following a open gastric bypass. These patients will be evaluated for GERD with upper endoscopy, 24h ph-monitoring, validated questionnaires which will be performed at 6 month, 1 and 2 years.

Secondary Outcome Measures

Name	Time	Method
The role of the ring in open GBP in terms of weight loss	march 2010 to march 2014	It will be possible to evaluate the weight loss among the groups: 1) with ring and, 2) without a ring
The impact of the ring on food tolerance	March 2010 to March 2014	To identify food intolerance among the groups: 1) with the ring, and 2) without the ring.

Trial Locations

Locations (3)

Gastrobese Clinic; 🇧🇷 Passo Fundo, RS, Brazil

Hospital Sao Vicente de Paulo; 🇧🇷 Passo Fundo, RS, Brazil

Clínica Gastrobese; 🇧🇷 Passo Fundo, RS, Brazil