- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01212835
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
Status
Terminated
Intervention / Treatment
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Stomach Diseases
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Gastroenteritis
- Intestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Esophagitis
- Peptic Ulcer
- Duodenal Diseases
- Obesity
- Vomiting
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Obesity, Morbid
Other Study ID Numbers
- GASTROBESE 005
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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