跳至主要内容
临床试验/NCT06808139
NCT06808139尚未招募不适用

Pearls and Pitfalls in Usage of Plasma-Rich Platelet Graft Versus Dartos Flap in Distal Penile Hypospadias Repair

Assiut University0 个研究点目标入组 70 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
incidence of occurrence of uretherocutanous fistula

研究概览

简要总结

Hypospadias is the most common congenital anomaly of penis. It is the second most common genital birth defect in boys after cryptorchidism The reinforcement of hypospadias repair with an intermediate layer is believed to reduce the incidence of postoperative complications such as uretherocautanous fistula.

Hypospadias is classified by the location of the abnormal urethral meatus into distal penile (glandular ,subcoronal and distal penile), mid penile and proximal penile hypospadias Indeed, uretherocautanous fistula is most common complication after urethroplasty, with introduction of a protective layer between the neourethra and the covering skin strongly reduces fistulas occurrence and the overall complication the aim of the study To evaluate and to compare the use of PRP covering layer and dartos fascia flap layer in regard to complication rates in hypospadias repair

详细描述

Hypospadias is the most common congenital anomaly of penis. It is the second most common genital birth defect in boys after cryptorchidism The reinforcement of hypospadias repair with an intermediate layer is believed to reduce the incidence of postoperative complications such as uretherocautanous fistula.

Hypospadias is classified by the location of the abnormal urethral meatus into distal penile (glandular ,subcoronal and distal penile), mid penile and proximal penile hypospadias Indeed, uretherocautanous fistula is most common complication after urethroplasty, with introduction of a protective layer between the neourethra and the covering skin strongly reduces fistulas occurrence and the overall complication the aim of the study To evaluate and to compare the use of PRP covering layer and dartos fascia flap layer in regard to complication rates in hypospadias repair

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Months 至 —(Child, Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Age >6 months
  • •Distal penile hypospadias
  • •Denovo hypospadias

排除标准

  • •Recurrent hypospadias -Mid and proximal penile hypospadias

研究组 & 干预措施

Group B

Active Comparator

Dartos Flap

干预措施: Dartos Flap (Procedure)

Group A

Active Comparator

Plasma-Rich Platelet Graft

干预措施: Plasma-Rich Platelet Graft (Procedure)

结局指标

主要结局

incidence of occurrence of uretherocutanous fistula

时间窗: 6 month

occurrence of conection between urthera and skin

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed ali amen diab

residant doctor

Assiut University

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