Study of Endoscopic Versus Open Surgery for Urinary Reflux

Not Applicable

Withdrawn

• Conditions: Vesicoureteral Reflux
• Interventions: Procedure: Endoscopic injection; Procedure: Anti-reflux surgery

• Registration Number: NCT00830479
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-28
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-11
• Last Update Posted: 2011-08-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic Surgery	Endoscopic injection	-
Open Surgery	Anti-reflux surgery	-

Primary Outcome Measures

Name	Time	Method
Resolution of VUR at 4 months	4 months

Trial Locations

Locations (1)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States