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临床试验/NCT06405763
NCT06405763招募中不适用

Snodgrass Versus Grafted Snodgrass Repair in Narrow Urethral Plate in Distal Penile Hypospadias

Sohag University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年12月11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
2
主要终点
Functional outcome

研究概览

简要总结

We aime to compare between Snodgrass and grafted Snodgrass repair in the outcome in distal penile hypospadias with urethral plate less than 8mm

详细描述

The main goal for hypospadias repair is to achieve both cosmetic and functional normality.

Several surgical techniques for hypospadias repair have been developed that depend on the site of the urethral meatus in children The effect of the urethral plate characteristics on the surgical outcome of Snodgrass repair has been studied in many series. Some documented that urethral plate width has a significant impact on the complication rates Holland and Smith reported a high complication rate in Snodgrass repair with a urethral plate width of less than 8 mm 7 The augmentation of the urethral plate either with inlay graft (DIGU, Snodgraft, or G-TIP), Onlay preputial flap, or other flaps carries a better outcome than the original TIP in many studies Others denied any effect of the narrow urethral plate on the success rate We aim in this study to determine which is better in narrow urethral plate in distal penile hypospadias, as regarding surgical and cosmetic outcomes; Snodgrass or combined inner preputial graft with Snodgrass

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 16 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Children age: > 6m up to 16y
  • Distal penile hypospadias(distal shaft,coronal,subcoronal )
  • mid penile hypospadias with mild chordae les 30 degree
  • Urethral plate <8 mm in maximum transverse diameter before the midline urethral plate incision .Primary non-circumcised cases of hypospadias

排除标准

  • Proximal and mid penile hypospadias with marked chordae
  • previous hypospadias repair

结局指标

主要结局

Functional outcome

时间窗: 12 months

Investigators want to compare between Snodgrass and combined inner preputial graft with Snodgrass in functional outcome by evaluation of the stream an ideal stream of urine (single, compact, rifled, non-dispersed urinary stream of adequate caliber) without straining.

Cosmetic outcome

时间窗: 12 months

Investigators want to compare between Snodgrass and combined inner preputial graft with Snodgrass in cosmetic outcome By Hypospadias Objective penile Evaluation (HOPE) Score 1.meatus position 2.meatus shape 3.glans shape 4.penile skin shape 5.penile axis secreal 6.Torsion

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 Shawky Gebaly

Resident doctor at urology department, Sohag university hospitals

Sohag University

研究点 (2)

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