Study of Endoscopic Versus Open Surgery for Urinary Reflux
Not Applicable
Withdrawn
- Conditions
- Vesicoureteral Reflux
- Registration Number
- NCT00830479
- Lead Sponsor
- Boston Children's Hospital
- 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-reflux technique versus endoscopic anti-reflux technique with injection of dextranomer/hyaluronic acid copolymer (Deflux). Primary endpoint will be resolution of VUR at initial cystogram after ARS. Secondary outcomes will include incidence of postoperative UTI, resolution of VUR at 1-year cystogram after ARS, surgical complications, and quality of life measures after ARS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Resolution of VUR at 4 months 4 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Children's Hospital Boston🇺🇸Boston, Massachusetts, United States