Study of Endoscopic Versus Open Surgery for Urinary Reflux

Vesicoureteral Reflux Clinical Trial

— STRETCH  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00830479
• Other study ID #: 08-08-0354
• Status: Withdrawn
• Phase: N/A
• First received: January 27, 2009
• Last updated: August 11, 2011
• Start date: January 2009
• Est. completion date: January 2011

Study information

• Verified date: August 2011
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 11 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Vesico-Ureteral Reflux
• Vesicoureteral Reflux

Intervention

Procedure:
• Anti-reflux surgery
Open ureteroneocystostomy for correction of vesicoureteral reflux
• Endoscopic injection
Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of VUR at 4 months		4 months	No