跳至主要内容
临床试验/NCT06565286
NCT06565286招募中不适用

Inlay Inner Preputial Graft Versus Transverse Preputial Island Flap in Management of Proximal Penile Hypospadias

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月18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
50
试验地点
1
主要终点
measure complications after staged repair of proximal penile hypospadias using different techniques.

研究概览

简要总结

Proximal hypospadias (penoscrotal, scrotal, and perineal types) account for approximately 20% of all cases . The management of hypospadias has greatly improved over the past two decades since the introduction of tubularized incisized plate urethroplasty. However, obtaining a favorable cosmetic outcome and functional straight penis is a major surgical challenge for such patients, and the ideal repair of proximal hypospadias remains the Holy Grail for hypospadias specialists.

详细描述

The surgical plan for proximal hypospadias can be divided into single and staged operations. Single stage operations are often associated with high rates of complications and reoperations. Reportedly, complications occur in 20-50% of patients. Therefore, many pediatric surgeons are selecting staged procedures. Staged surgical repair of proximal forms of hypospadias has been proven to achieve successful both functional and cosmetic results. Although staged repair with inner preputial layer graft has regained popularity in the repair of proximal hypospadias; but Choosing between flaps or grafts to substitute the urethral plate in 2-stage hypospadias repair has been a matter of debate with no consensus in the literature.

Flaps have reliable blood supply that may be theoretically less liable for strictures or contractures. Grafts are more versatile, which can be used in primary and recurrent cases when healthy local skin is deficient.

In this study, our aim is to compare outcomes of grafts and flaps when used to substitute the urethral plate in two-stage repair of primary proximal penile hypospadias (penoscrotal and scrotal types).

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
Double (Participant, Care Provider)

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

入选标准

  • Age: more than 6 months.
  • Type of hypospadias: proximal penile hypospadias (scrotal and penoscrotal variants)

排除标准

  • Age: less than 6 months.
  • Perineal hypospadias.
  • circumcised patients.
  • Previous hypospadias repair
  • Raised serum creatinine, coagulopathy.

结局指标

主要结局

measure complications after staged repair of proximal penile hypospadias using different techniques.

时间窗: 6 month after end of treatment

urinary fistulas, urethral strictures, diverticula and failed repair.

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 Shabaan Abohamady

assistant lecturer- urology departement - faculty of medicine -sohag university

Sohag University

研究点 (1)

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