Study of Endoscopic Versus Open Surgery for Urinary Reflux | NCT00830479

Studies
Study of Endoscopic Versus Open Surgery for Urinary Reflux

NCT00830479

Sponsor

Boston Children's Hospital

Status

Withdrawn

Last Update Posted

Aug 12, 2011Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Vesicoureteral Reflux

Interventions

Anti-reflux surgery
Endoscopic injection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

unable to enroll patients for randomization

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jan 27, 2009

First Submission Date that Met QC Criteria

Jan 27, 2009

First Posted Date

Jan 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2011

Last Update Posted Date

Aug 12, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Open Surgery	Active Comparator		Procedure: Anti-reflux surgery
Endoscopic Surgery	Active Comparator		Procedure: Endoscopic injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anti-reflux surgery	Procedure	Open ureteroneocystostomy for correction of vesicoureteral reflux	Open Surgery

Measure	Description	Time Frame
Resolution of VUR at 4 months		4 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Boston		Boston	Massachusetts	02115	United States

Condition Browse Module

MeSH Terms

ID	Term
D014718	Vesico-Ureteral Reflux

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004724	Endoscopy

Ancestor Terms

ID	Term
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D019060	Minimally Invasive Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided