Status:
WITHDRAWN
Study of Endoscopic Versus Open Surgery for Urinary Reflux
Lead Sponsor:
Boston Children's Hospital
Conditions:
Vesicoureteral Reflux
Eligibility:
All Genders
Up to 11 years
Phase:
NA
Brief Summary
This study seeks to compare outcomes after anti-reflux surgery (ARS) for correction of low-grade vesicoureteral reflux (VUR). It is a randomized controlled open-label trial of conventional open anti-r...
Eligibility Criteria
Inclusion
- Age \<12 years
- 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
- Grade 4 or 5 (VCUG) or Grade 3 (RNC) VUR
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00830479
Start Date
January 1 2009
End Date
January 1 2011
Last Update
August 12 2011
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115