## Protocol Section
### Identification Module
**NCT ID:** NCT00830479

**Acronym:** STRETCH

**Brief Title:** Study of Endoscopic Versus Open Surgery for Urinary Reflux

**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

#### Organization Study ID Info
**ID:** 08-08-0354
#### Organization
**Class:** OTHER
**Full Name:** Boston Children's Hospital
### Status Module
#### Completion Date
**Date:** 2011-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-08-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-08-11

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2011-01

**Type:** ACTUAL

#### Start Date
**Date:** 2009-01

**Status Verified Date:** 2011-08

#### Study First Post Date
**Date:** 2009-01-28
**Type:** ESTIMATED
**Study First Submit Date:** 2009-01-27
**Study First Submit QC Date:** 2009-01-27
**Why Stopped:** unable to enroll patients for randomization
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Boston Children's Hospital

#### Responsible Party

**Old Name Title:** Caleb Nelson, MD, MPH / PI

**Old Organization:** Children's Hospital Boston

### Oversight Module

**Oversight Has DMC:** True

### 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.

### Conditions Module

**Conditions:**

- Vesicoureteral Reflux

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: Anti-reflux surgery

**Label:** Open Surgery

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Procedure: Endoscopic injection

**Label:** Endoscopic Surgery

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Open Surgery

**Description:** Open ureteroneocystostomy for correction of vesicoureteral reflux

**Name:** Anti-reflux surgery

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Endoscopic Surgery

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

**Name:** Endoscopic injection

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Resolution of VUR at 4 months

**Time Frame:** 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

**Maximum Age:** 11 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Children's Hospital Boston

**State:** Massachusetts

**Zip:** 02115

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000015154

- Term: Esophageal Motility Disorders

- ID: D000003680

- Term: Deglutition Disorders

- ID: D000004935

- Term: Esophageal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000001745

- Term: Urinary Bladder Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

### Condition Browse Module - Browse Leaves

- ID: M8880

- Name: Gastroesophageal Reflux

- Relevance: HIGH

- As Found: Reflux

- ID: M17463

- Name: Vesico-Ureteral Reflux

- Relevance: HIGH

- As Found: Vesicoureteral Reflux

- ID: M17874

- Name: Esophageal Motility Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17875

- Name: Esophageal Spasm, Diffuse

- Relevance: LOW

- As Found: Unknown

- ID: M6882

- Name: Deglutition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M8085

- Name: Esophageal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5026

- Name: Urinary Bladder Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005764

- Term: Gastroesophageal Reflux

- ID: D000014718

- Term: Vesico-Ureteral Reflux

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9878

- Name: Hyaluronic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
