Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP
NCT ID: NCT01212835
Last Updated: 2015-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
114 participants
INTERVENTIONAL
2010-10-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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no ring
Patients at this group will have RING REMOVED AT THE END OF SURGERY.
Sham Comparator: no ring
Open roux-en-Y gastric bypass not banded
RYGBP-Ring
Open Roux-en-Y gastric bypass with a silastic ring which is performed with linear cut stapler 100 mm and a biliopancreatic limb of 60 cm long and a alimentary limb of 100 cm long. All patients will have a 6.5 cm silastic ring located at the middle of the pouch above of the gastroenteroanastomosis.
RYGBP-RING
Vertical Roux-en-Y banded gastric bypass
Interventions
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Sham Comparator: no ring
Open roux-en-Y gastric bypass not banded
RYGBP-RING
Vertical Roux-en-Y banded gastric bypass
Eligibility Criteria
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Inclusion Criteria
* 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
* Poor surgical conditions
18 Years
58 Years
ALL
No
Sponsors
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Clinica Gastrobese
OTHER
Responsible Party
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Carlos AS Madalosso
Carlos AS Madalosso
Principal Investigators
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Daniel Navarini, M.D.
Role: STUDY_CHAIR
Clinica Gastrobese
Carlos AS Madalosso, M.D.
Role: PRINCIPAL_INVESTIGATOR
Clinica Gastrobese
Iran Moraes Jr, M.D.
Role: STUDY_CHAIR
Clinica Gastrobese
Fabio R Barao, Admn
Role: STUDY_DIRECTOR
Protocol control
Locations
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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
Countries
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References
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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):244-8. doi: 10.1097/SLA.0b013e3181bdff20.
Other Identifiers
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GASTROBESE 005
Identifier Type: -
Identifier Source: org_study_id