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

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ClinicalTrials.gov Identifier: NCT00830479
Recruitment Status : Withdrawn (unable to enroll patients for randomization)
First Posted : January 28, 2009
Last Update Posted : August 12, 2011
Sponsor:
Information provided by:
Boston Children’s Hospital

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.

Condition or disease Intervention/treatment
Vesicoureteral Reflux Procedure: Anti-reflux surgery Procedure: Endoscopic injection

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2009
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy GERD
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Resolution of VUR at 4 months [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 11 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830479


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

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
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: August 2011

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