NCT00830479WithdrawnNot Applicable
A Randomized Trial of Endoscopic vs. Open Anti-Reflux Surgery For Treatment of Low-Grade Vesicoureteral Reflux: Surgical Treatment of Reflux: Endoscopic vs. Traditional CHoices (STRETCH) Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Boston Children's Hospital
- Locations
- 2
- Primary Endpoint
- Resolution of VUR at 4 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Resolution of VUR at 4 months
Time Frame: 4 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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