跳至主要内容
临床试验/NCT06598215
NCT06598215招募中不适用

Hybrid Duckett Urethroplasty Versus Modified Single Stage Duckett Uteothroplasty for Management of Proximal Hypospadias: a Randomized Clinical Trial

Tanta University2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
43
试验地点
2
主要终点
repair of proximal hypospadias without fistula

研究概览

简要总结

proximal hypospadias presents a serious anomaly for both infants and their care givers. a variety of techniques were described through decades. None of them is completely curable. hundred of modifications were adopted to the original techniques. during the current study, we will do hybrid Duckett urethroplasty which is a staged procedure and compare it to modified Duckett urethroplasty which is a single stage procedure.

详细描述

two groups of infants diagnosed with proximal hypospadias will be allocated in two groups. group A will include cases of who will be operated upon using hybrid Duckett urethroplasty. group B will include patients who will be operated upon using modified duckett urethroplasty.

recruitment in either group will be done using sealed envelop method. in group A patient will have a double face Duckett tube which will be transferred to the ventral of the penis. the tube will be secured in place however, no proximal anastomosis with the meatus. the anastomosis will be scheduled six months later. In group B patients a double face Duckett tube will be transferred to the ventral aspect of the penis with completion of the anastomosis with the proximal meatus at the same session. the primary out come will be completion of the procedure and restoration of the urethral continuity. secondary out come will the cosmetic appearance

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 (Care Provider)

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

入选标准

  • all infants and children with proximal hypospadias

排除标准

  • disorders of sex developments
  • previous penile surgery
  • circumcised children
  • crippled penis
  • refusal of the plan of the management by the care givers

结局指标

主要结局

repair of proximal hypospadias without fistula

时间窗: six months post operative

strong strait stream of urine, no fistula formation, no urethral stricture

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

Mohammad Gharieb Mohammad Khirallah

professor of pediatric surgery

Tanta University

研究点 (2)

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