- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00830479
Study of Endoscopic Versus Open Surgery for Urinary Reflux (STRETCH)
August 11, 2011 updated by: Boston Children's Hospital
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Open Surgery
|
Open ureteroneocystostomy for correction of vesicoureteral reflux
|
Active Comparator: Endoscopic Surgery
|
Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Resolution of VUR at 4 months
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
January 27, 2009
First Submitted That Met QC Criteria
January 27, 2009
First Posted (Estimate)
January 28, 2009
Study Record Updates
Last Update Posted (Estimate)
August 12, 2011
Last Update Submitted That Met QC Criteria
August 11, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-08-0354
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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