Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP

Morbid Obesity Clinical Trial

— RING  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01212835
• Other study ID #: GASTROBESE 005
• Status: Terminated
• Phase: N/A
• First received: September 29, 2010
• Last updated: December 21, 2015
• Start date: October 2010
• Est. completion date: January 2014

Study information

• Verified date: December 2015
• Source: Clinica Gastrobese
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 114
• Est. completion date: January 2014
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 58 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Morbid Obesity
• Obesity
• Obesity, Morbid
• Vomiting

Intervention

Procedure:
• Sham Comparator: no ring
Open roux-en-Y gastric bypass not banded
• RYGBP-RING
Vertical Roux-en-Y banded gastric bypass

Locations

Country	Name	City	State
Brazil	Clínica Gastrobese	Passo Fundo	RS
Brazil	Gastrobese Clinic	Passo Fundo	RS
Brazil	Hospital Sao Vicente de Paulo	Passo Fundo	RS

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Gastrobese

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No