NCT00444431Unknown不适用
Ureteropelvic Junction Obstruction in Early Childhood: Comparison of Surgical Therapy and Surveillance in Children With Scintigraphically Prooved Obstruction. A Prospective, Randomized, Controlled Multi-Center Study
University Hospital, Essen4 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2007年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- partial renal function
研究概览
简要总结
In this randomized trial surgical therapy and surveillance of ureteropelvic junction obstruction will be compared, regarding partial renal function.
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
- 4 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unilateral ureteropelvic junction obstruction
- •diameter of renal pelvis greater 12 mm
- •partial renal function of 35%-55% proofed by scintigraphy
- •urodynamically relevant decrease in renal drainage proofed by diuresis scintigraphy at the age of 4 weeks up to 6 months
- •Abscence of clinical symptoms
- •Healthy contralateral kidney
排除标准
- •Global decrease in renal function
- •renal dystopia
- •megaureter
- •vesico-ureteral reflux
- •progressive hydronephrosis
- •oligohydrammnion
- •voiding dysfunction
- •bilateral hydronephrosis
- •severe chronical illness
- •decrease of partial renal function of more then 5% during allocation
结局指标
主要结局
partial renal function
次要结局
未报告次要终点
研究者
研究点 (4)
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