Study of Endoscopic Versus Open Surgery for Urinary Reflux

Withdrawn before enrolling · Not applicable

Conditions studied: Vesicoureteral Reflux

In brief

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.

Key facts

Study ID

NCT00830479

Run by

Boston Children's Hospital

People needed

0

Starts

2009-01-01

Expected to finish

2011-01-01

Last updated by the study team

2011-08-12

Who can join

Age: any, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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