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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01212835
Recruitment Status : Terminated (lack of follow up)
First Posted : October 1, 2010
Last Update Posted : December 23, 2015
Information provided by (Responsible Party):
Carlos AS Madalosso, 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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Gastroesophageal Reflux Disease Vomiting Procedure: Sham Comparator: no ring Procedure: RYGBP-RING Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of a Silastic Ring in Open Gastric Bypass for Morbid Obesity and Its Association With Gastroesophageal Reflux Disease
Study Start Date : October 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Sham Comparator: no ring
Patients at this group will have RING REMOVED AT THE END OF SURGERY.
Procedure: Sham Comparator: no ring
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.
Procedure: RYGBP-RING
Vertical Roux-en-Y banded gastric bypass

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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.

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Ages Eligible for Study:   18 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01212835

Clínica Gastrobese
Passo Fundo, RS, Brazil, 99010112
Gastrobese Clinic
Passo Fundo, RS, Brazil, 99020000
Hospital Sao Vicente de Paulo
Passo Fundo, RS, Brazil, 99020000
Sponsors and Collaborators
Clinica Gastrobese
Study Chair: Daniel Navarini, M.D. Clinica Gastrobese
Principal Investigator: Carlos AS Madalosso, M.D. Clinica Gastrobese
Study Chair: Iran Moraes Jr, M.D. Clinica Gastrobese
Study Director: Fabio R Barao, Admn Protocol control

Publications of Results:
Responsible Party: Carlos AS Madalosso, Clinica Gastrobese Identifier: NCT01212835     History of Changes
Other Study ID Numbers: GASTROBESE 005
First Posted: October 1, 2010    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015

Keywords provided by Carlos AS Madalosso, Clinica Gastrobese:
gastroesophageal reflux disease
Morbid obesity
silastic ring
Gastric bypass

Additional relevant MeSH terms:
Gastroesophageal Reflux
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive