Study of Endoscopic Versus Open Surgery for Urinary Reflux (STRETCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00830479
Recruitment Status : Withdrawn (unable to enroll patients for randomization)
First Posted : January 28, 2009
Last Update Posted : August 12, 2011
Information provided by:
Boston Children’s Hospital

January 27, 2009
January 28, 2009
August 12, 2011
January 2009
January 2011   (Final data collection date for primary outcome measure)
Resolution of VUR at 4 months [ Time Frame: 4 months ]
Same as current
Complete list of historical versions of study NCT00830479 on Archive Site
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Study of Endoscopic Versus Open Surgery for Urinary Reflux
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
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.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Vesicoureteral Reflux
  • Procedure: Anti-reflux surgery
    Open ureteroneocystostomy for correction of vesicoureteral reflux
  • Procedure: Endoscopic injection
    Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux
  • Active Comparator: Open Surgery
    Intervention: Procedure: Anti-reflux surgery
  • Active Comparator: Endoscopic Surgery
    Intervention: Procedure: Endoscopic injection
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2011
January 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 11 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
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Caleb Nelson, MD, MPH / PI, Children's Hospital Boston
Boston Children’s Hospital
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Boston Children’s Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP