Study Stopped
unable to enroll patients for randomization
Study of Endoscopic Versus Open Surgery for Urinary Reflux
STRETCH
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 27, 2009
CompletedFirst Posted
Study publicly available on registry
January 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedAugust 12, 2011
August 1, 2011
2 years
January 27, 2009
August 11, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Resolution of VUR at 4 months
4 months
Study Arms (2)
Open Surgery
ACTIVE COMPARATOREndoscopic Surgery
ACTIVE COMPARATORInterventions
Open ureteroneocystostomy for correction of vesicoureteral reflux
Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 27, 2009
First Posted
January 28, 2009
Study Start
January 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
August 12, 2011
Record last verified: 2011-08