Study of Endoscopic Versus Open Surgery for Urinary Reflux (STRETCH)
Primary Purpose
Vesicoureteral Reflux
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anti-reflux surgery
Endoscopic injection
Sponsored by
About this trial
This is an interventional treatment trial for Vesicoureteral Reflux
Eligibility Criteria
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
Sites / Locations
- Children's Hospital Boston
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Open Surgery
Endoscopic Surgery
Arm Description
Outcomes
Primary Outcome Measures
Resolution of VUR at 4 months
Secondary Outcome Measures
Full Information
NCT ID
NCT00830479
First Posted
January 27, 2009
Last Updated
August 11, 2011
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00830479
Brief Title
Study of Endoscopic Versus Open Surgery for Urinary Reflux
Acronym
STRETCH
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Withdrawn
Why Stopped
unable to enroll patients for randomization
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vesicoureteral Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Surgery
Arm Type
Active Comparator
Arm Title
Endoscopic Surgery
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Anti-reflux surgery
Intervention Description
Open ureteroneocystostomy for correction of vesicoureteral reflux
Intervention Type
Procedure
Intervention Name(s)
Endoscopic injection
Intervention Description
Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux
Primary Outcome Measure Information:
Title
Resolution of VUR at 4 months
Time Frame
4 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Endoscopic Versus Open Surgery for Urinary Reflux
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