Study of Endoscopic Versus Open Surgery for Urinary Reflux (STRETCH)
This study has been withdrawn prior to enrollment.
(unable to enroll patients for randomization)
Sponsor:
Children's Hospital Boston
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00830479
First received: January 27, 2009
Last updated: August 11, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Vesicoureteral Reflux |
Procedure: Anti-reflux surgery Procedure: Endoscopic injection |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Children's Hospital Boston:
Primary Outcome Measures:
- Resolution of VUR at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | January 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Open Surgery |
Procedure: Anti-reflux surgery
Open ureteroneocystostomy for correction of vesicoureteral reflux
|
| Active Comparator: Endoscopic Surgery |
Procedure: Endoscopic injection
Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux
|
Eligibility| Ages Eligible for Study: | up to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Caleb Nelson, MD, MPH / PI, Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT00830479 History of Changes |
| Other Study ID Numbers: | 08-08-0354 |
| Study First Received: | January 27, 2009 |
| Last Updated: | August 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Vesico-Ureteral Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases |
Gastrointestinal Diseases Digestive System Diseases Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on October 18, 2012
