NCT00830479撤回不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Resolution of VUR at 4 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 11 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Resolution of VUR at 4 months
时间窗: 4 months
次要结局
未报告次要终点
研究者
研究点 (2)
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