Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Morbid Obesity, Gastroesophageal Reflux Disease, Vomiting

Intervention / Treatment
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* Procedure: Sham Comparator: no ring
* Procedure: RYGBP-RING


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 58 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of gastroesophageal reflux disease | 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 | 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 | To identify food intolerance among the groups: 1) with the ring, and 2) without the ring. | March 2010 to March 2014 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, gastroesophageal reflux disease, Morbid obesity, esophagitis, GERD, silastic ring, Gastric bypass