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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Vesicoureteral Reflux
Procedure: Anti-reflux surgery
Procedure: Endoscopic injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Resolution of VUR at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Open Surgery Procedure: Anti-reflux surgery
Open ureteroneocystostomy for correction of vesicoureteral reflux
Active Comparator: Endoscopic Surgery Procedure: Endoscopic injection
Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux

  Eligibility

Ages Eligible for Study:   up to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830479

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Caleb Nelson, MD, MPH / PI, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00830479     History of Changes
Other Study ID Numbers: 08-08-0354
Study First Received: January 27, 2009
Last Updated: August 11, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gastroesophageal Reflux
Vesico-Ureteral Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 15, 2014