Status:
TERMINATED
Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP
Lead Sponsor:
Clinica Gastrobese
Conditions:
Morbid Obesity
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-58 years
Phase:
NA
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 ...
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.
Eligibility Criteria
Inclusion
- 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
- Inferior and superior total teeth prosthesis
- Poor surgical conditions
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2014
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT01212835
Start Date
October 1 2010
End Date
January 1 2014
Last Update
December 23 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Clínica Gastrobese
Passo Fundo, Rio Grande do Sul, Brazil, 99010112
2
Gastrobese Clinic
Passo Fundo, Rio Grande do Sul, Brazil, 99020000
3
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil, 99020000