NCT07421271已完成不适用
Evaluation of the Method and Duration of Urinary Diversion in the Management of Distal Penile Hypospadias Following Surgical Repair.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Decreased rate of fistula occurrence
研究概览
简要总结
This study aims to conduct a head-to-head comparison to determine the optimal method and duration of urinary diversion following distal penile hypospadias repair. Specifically, it will evaluate whether urethral diversion alone or a combination of urethral and suprapubic diversions provides better outcomes, and whether a postoperative duration of one week or two weeks is more effective.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with Distal Hypospadias (Glanular, Coronal, Subcoronal)
- •Patients have Adequate ventral penile skin mobility
排除标准
- •Patients with Crippled hypospadias.
- •Patients with Proximal hypospadias.
- •Patients with Hypoplastic urethra.
- •Patients with Neurogenic bladder
研究组 & 干预措施
Patient who will be left with urethral catheter for 2 weeks.
Active Comparator
干预措施: Application of urethral catheter alone for 2 weeks. (Procedure)
Patients who will be left with urethral stent and suprapubic catheter for 1 week
Active Comparator
干预措施: Application of urethral stent and suprapubic catheter for 1 week (Procedure)
Patients who will be left with urethral catheter alone for 1 week.
Active Comparator
干预措施: Application of urethral catheter alone for 1 week. (Procedure)
Patients who will be left with urethral stent and suprapubic catheter for 2 weeks
Active Comparator
干预措施: Application of urethral stent and suprapubic catheter for 2 weeks (Procedure)
结局指标
主要结局
Decreased rate of fistula occurrence
时间窗: 1 month
次要结局
未报告次要终点
研究者
研究点 (1)
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