Study of Endoscopic Versus Open Surgery for Urinary Reflux

NCT ID: NCT00830479

Last Updated: 2011-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-01-31

Brief Summary

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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

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Conditions

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Vesicoureteral Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Surgery

Group Type ACTIVE_COMPARATOR

Anti-reflux surgery

Intervention Type PROCEDURE

Open ureteroneocystostomy for correction of vesicoureteral reflux

Endoscopic Surgery

Group Type ACTIVE_COMPARATOR

Endoscopic injection

Intervention Type PROCEDURE

Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux

Interventions

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Anti-reflux surgery

Open ureteroneocystostomy for correction of vesicoureteral reflux

Intervention Type PROCEDURE

Endoscopic injection

Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Children's Hospital Boston

Locations

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Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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08-08-0354

Identifier Type: -

Identifier Source: org_study_id

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