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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014