Gastroesophageal Reflux Disease, Morbid Obesity, Vomiting
Conditions
Keywords
Obesity, gastroesophageal reflux disease, Morbid obesity, esophagitis, GERD, silastic ring, Gastric bypass
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.
Interventions
PROCEDURESham Comparator: no ring
Open roux-en-Y gastric bypass not banded
PROCEDURERYGBP-RING
Vertical Roux-en-Y banded gastric bypass
Sponsors
Clinica Gastrobese
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 58 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of gastroesophageal reflux disease | 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
| Measure | Time frame | Description |
|---|---|---|
| The role of the ring in open GBP in terms of weight loss | 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 |
| The impact of the ring on food tolerance | March 2010 to March 2014 | To identify food intolerance among the groups: 1) with the ring, and 2) without the ring. |
Countries
Brazil
Outcome results
None listed