NCT05123833Unknown不适用
The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Fistula
研究概览
简要总结
To explore the optimal urethral coverage in hypospadias repair by comparing the success rate of both covering techniques: Dartos fascia versus Tunica Vaginalis flap.
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
- 6 Months 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 6 months.
- •Distal, mid-shaft penile hypospadias.
排除标准
- •Glanular hypospadias.
- •Penoscrotal, Scrotal & Perineal hypospadias.
- •Recurrent cases.
研究组 & 干预措施
Dartos Fascia
Active Comparator
Dartos flap is used as a covering layer for urethra during repair of hypospadias
干预措施: Hypospadias repair (Procedure)
Tunica Vaginalis
Active Comparator
Tunica Vaginalis Flap is used as a covering layer for urethra during repair of hypospadias
干预措施: Hypospadias repair (Procedure)
结局指标
主要结局
Fistula
时间窗: Within the first three months after surgery.
Fistula prevalence will be recorded as a complication after surgery
次要结局
- Cosmetic outcome(Within the first three months after surgery.)
研究者
研究点 (1)
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