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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
114
Open roux-en-Y gastric bypass not banded
Vertical Roux-en-Y banded gastric bypass
Clínica Gastrobese
Passo Fundo, Rio Grande do Sul, Brazil
Gastrobese Clinic
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
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.
Time frame: march 2010 to march 2014
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
Time frame: march 2010 to march 2014
The impact of the ring on food tolerance
To identify food intolerance among the groups: 1) with the ring, and 2) without the ring.
Time frame: March 2010 to March 2014
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