NCT00830479

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vesicoureteral Reflux

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-01-28
• Last updated: 2011-08-12

Locations

1 site across 1 country: United States