Study of Endoscopic Versus Open Surgery for Urinary Reflux
NCT ID: NCT00830479
Last Updated: 2011-08-12
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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WITHDRAWN
NA
INTERVENTIONAL
2009-01-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Open Surgery
Anti-reflux surgery
Open ureteroneocystostomy for correction of vesicoureteral reflux
Endoscopic Surgery
Endoscopic injection
Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux
Interventions
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Anti-reflux surgery
Open ureteroneocystostomy for correction of vesicoureteral reflux
Endoscopic injection
Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux
Eligibility Criteria
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Inclusion Criteria
* Unilateral or Bilateral Primary VUR
* Grade 2 or 3 (VCUG) or Grade 2 (RNC) VUR in at least 1 ureter
* Recommended for surgical correction of VUR by Urologist
Exclusion Criteria
* Secondary VUR (neurogenic bladder, exstrophy, or other causes of secondary VUR)
* Ureterocele
* Periureteral diverticulum
* Complete duplication of duplex collecting system on side with VUR
* Prior ARS, either open or endoscopic, regardless of success or failure
* History of other prior urinary tract surgery other than circumcision
* Solitary functional kidney
* Congenital or acquired immunodeficiency
* Chronic renal insufficiency or renal failure
11 Years
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Children's Hospital Boston
Locations
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Children's Hospital Boston
Boston, Massachusetts, United States
Countries
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Other Identifiers
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08-08-0354
Identifier Type: -
Identifier Source: org_study_id
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