Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Urethrocutaneous fistula
研究概览
简要总结
The study aimed to evaluation of Tubularized incised palate urethroplasty with spongioplasty-dartosoraphy reinforcement (group A) through comparing of functional and cosmetic results of this technique with the conventional TIP urethroplasty (group B).
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 14 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •lees than 14 years Distal hypospadias urethral plate size more than 6mm glans size more than 14 mm
排除标准
- •recurrent cases Proximal; hypospadias
研究组 & 干预措施
Group with Spongioplasty
patients underwent TIPU with spongioplasty-Dartosoraphy reinforcement
干预措施: Tubularized Incised Plate (TIP) urethroplasty (Procedure)
Group without Spongioplasty
patients underwent TIPU with dorsal dartos flap interposition without spongioplasty
干预措施: Tubularized Incised Plate (TIP) urethroplasty (Procedure)
结局指标
主要结局
Urethrocutaneous fistula
时间窗: 12 months
Rate of fistula
glans dehiscence
时间窗: 12 months
Rate of glans dehiscence
meatal stenosis
时间窗: 12 months
Rate of metal stenosis
次要结局
未报告次要终点
研究者
Mohammad Daboos
Professor of pediatric surgery
Al-Azhar University