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Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP

NCT01212835 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2015-12-23

No results posted yet for this study

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.

Conditions

  • Morbid Obesity
  • Gastroesophageal Reflux Disease
  • Vomiting

Interventions

PROCEDURE

Sham Comparator: no ring

Open roux-en-Y gastric bypass not banded

PROCEDURE

RYGBP-RING

Vertical Roux-en-Y banded gastric bypass

Sponsors & Collaborators

  • Clinica Gastrobese

    lead OTHER

Principal Investigators

  • Daniel Navarini, M.D. · Clinica Gastrobese

  • Carlos AS Madalosso, M.D. · Clinica Gastrobese

  • Iran Moraes Jr, M.D. · Clinica Gastrobese

  • Fabio R Barao, Admn · Protocol control

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
58 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-03-31
Completion
2014-01-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01212835 on ClinicalTrials.gov