Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP (RING)

December 21, 2015 updated by: Carlos AS Madalosso, Clinica Gastrobese

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • RS
      • Passo Fundo, RS, Brazil, 99010112
        • Clínica Gastrobese
      • Passo Fundo, RS, Brazil, 99020000
        • Gastrobese Clinic
      • Passo Fundo, RS, Brazil, 99020000
        • Hospital São Vicente de Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: no ring
Patients at this group will have RING REMOVED AT THE END OF SURGERY.
Open roux-en-Y gastric bypass not banded
Active Comparator: 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.
Vertical Roux-en-Y banded gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of gastroesophageal reflux disease
Time Frame: 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.
march 2010 to march 2014

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The role of the ring in open GBP in terms of weight loss
Time Frame: 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
march 2010 to march 2014
The impact of the ring on food tolerance
Time Frame: March 2010 to March 2014
To identify food intolerance among the groups: 1) with the ring, and 2) without the ring.
March 2010 to March 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Daniel Navarini, M.D., Clínica Gastrobese
  • Principal Investigator: Carlos AS Madalosso, M.D., Clínica Gastrobese
  • Study Chair: Iran Moraes Jr, M.D., Clínica Gastrobese
  • Study Director: Fabio R Barao, Admn, Protocol control

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 29, 2010

First Submitted That Met QC Criteria

September 30, 2010

First Posted (Estimate)

October 1, 2010

Study Record Updates

Last Update Posted (Estimate)

December 23, 2015

Last Update Submitted That Met QC Criteria

December 21, 2015

Last Verified

December 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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