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

This study has been withdrawn prior to enrollment.
(unable to enroll patients for randomization)
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00830479
First received: January 27, 2009
Last updated: August 11, 2011
Last verified: August 2011

January 27, 2009
August 11, 2011
January 2009
January 2011   (final data collection date for primary outcome measure)
Resolution of VUR at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00830479 on ClinicalTrials.gov 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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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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
Both
up to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00830479
08-08-0354
Yes
Caleb Nelson, MD, MPH / PI, Children's Hospital Boston
Children's Hospital Boston
Not Provided
Not Provided
Children's Hospital Boston
August 2011

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