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

Primary Purpose

Morbid Obesity, Gastroesophageal Reflux Disease, Vomiting

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Sham Comparator: no ring
RYGBP-RING
Sponsored by
Clinica Gastrobese
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Obesity, gastroesophageal reflux disease, Morbid obesity, esophagitis, GERD, silastic ring, Gastric bypass

Eligibility Criteria

18 Years - 58 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clínica Gastrobese
  • Gastrobese Clinic
  • Hospital Sao Vicente de Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

no ring

RYGBP-Ring

Arm Description

Patients at this group will have RING REMOVED AT THE END OF SURGERY.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
The impact of the ring on food tolerance
To identify food intolerance among the groups: 1) with the ring, and 2) without the ring.

Full Information

First Posted
September 29, 2010
Last Updated
December 21, 2015
Sponsor
Clinica Gastrobese
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1. Study Identification

Unique Protocol Identification Number
NCT01212835
Brief Title
Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP
Acronym
RING
Official Title
The Use of a Silastic Ring in Open Gastric Bypass for Morbid Obesity and Its Association With Gastroesophageal Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
lack of follow up
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinica Gastrobese

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Gastroesophageal Reflux Disease, Vomiting
Keywords
Obesity, gastroesophageal reflux disease, Morbid obesity, esophagitis, GERD, silastic ring, Gastric bypass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
no ring
Arm Type
Sham Comparator
Arm Description
Patients at this group will have RING REMOVED AT THE END OF SURGERY.
Arm Title
RYGBP-Ring
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham Comparator: no ring
Intervention Description
Open roux-en-Y gastric bypass not banded
Intervention Type
Procedure
Intervention Name(s)
RYGBP-RING
Intervention Description
Vertical Roux-en-Y banded gastric bypass
Primary Outcome Measure Information:
Title
Occurence of gastroesophageal reflux disease
Description
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.
Time Frame
march 2010 to march 2014
Secondary Outcome Measure Information:
Title
The role of the ring in open GBP in terms of weight loss
Description
It will be possible to evaluate the weight loss among the groups: 1) with ring and, 2) without a ring
Time Frame
march 2010 to march 2014
Title
The impact of the ring on food tolerance
Description
To identify food intolerance among the groups: 1) with the ring, and 2) without the ring.
Time Frame
March 2010 to March 2014

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Navarini, M.D.
Organizational Affiliation
Clinica Gastrobese
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlos AS Madalosso, M.D.
Organizational Affiliation
Clinica Gastrobese
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Iran Moraes Jr, M.D.
Organizational Affiliation
Clinica Gastrobese
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fabio R Barao, Admn
Organizational Affiliation
Protocol control
Official's Role
Study Director
Facility Information:
Facility Name
Clínica Gastrobese
City
Passo Fundo
State/Province
RS
ZIP/Postal Code
99010112
Country
Brazil
Facility Name
Gastrobese Clinic
City
Passo Fundo
State/Province
RS
ZIP/Postal Code
99020000
Country
Brazil
Facility Name
Hospital Sao Vicente de Paulo
City
Passo Fundo
State/Province
RS
ZIP/Postal Code
99020000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
20010088
Citation
Madalosso CA, Gurski RR, Callegari-Jacques SM, Navarini D, Thiesen V, Fornari F. The impact of gastric bypass on gastroesophageal reflux disease in patients with morbid obesity: a prospective study based on the Montreal Consensus. Ann Surg. 2010 Feb;251(2):244-8. doi: 10.1097/SLA.0b013e3181bdff20.
Results Reference
result

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Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP

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