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临床试验/NCT06165120
NCT06165120招募中不适用

Preputial Graft Versus Preputial Flap in Treatment of Proximal Hypospadias With Marked Ventral Curvature (a Comparative Study)

Sohag University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年11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
20
试验地点
2
主要终点
Incidence of residual ventral curvature

研究概览

简要总结

Hypospadias is a male congenital anomaly characterized by the abnormally located urethral meatus being displaced along the ventral side of the penis along a line from the tip of glans penis to the perineum.

Hypospadias is one of the most common congenital malformations of the male genitourinary system, with a reported global incidence of 0.6-34.2 per 10,000 live births. There is more than one classification for hypospadias. Most commonly, hypospadias is classified into proximal & distal hypospadias which mainly affects the decision for the corrective procedure.

Correction of proximal hypospadias remains a surgical challenge, which is mainly due to the pathological features of proximal hypospadias including a more proximal meatus, severe ventral chordee, and the need to transect the urethral plate during the operation.

The use of a 2-stage repair was found to achieve more satisfactory functional and cosmetic outcomes for proximal hypospadias with severe ventral chordee . Bracka repair, first described in 1995 by Bracka, is a 2-stage repair which uses grafts. This procedure has been improved over time, and recently it has been associated with satisfactory outcomes in proximal hypospadias with severe ventral curvature. Staged transverse preputial island flap urethroplasty (STPIF), first reported by Chen et al., is another 2-stage repair using flaps based on the traditional transverse preputial island flap (TPIF). STPIF has been shown to reduce the difficulty of surgery and the complication rate in management of proximal hypospadias. Thus, both Bracka repair and STPIF are valuable 2-stage methods, and both have achieved promising results. However, there are no available clear comparative data for determination which method has a better outcome and less complications in treating proximal hypospadias.

This study compares Bracka's procedure using preputial grafts and STPIF (Staged Preutial Island Flap) procedure using preputial flaps in surgical correction of proximal hypospadias with marked ventral curvtaure.

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 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • All patients with proximal hypospadias with marked ventral curvature (>30 degrees) who presented to the outpatient clinic of Department of Pediatric Surgery in Sohag University Hospital.

排除标准

  • Patients with insufficient follow up data or those who are non-compliant on follow up.
  • Previously circumcised patients.
  • Patients with complex urogenital malformations or DSD.
  • Patients with ventral curvature less than 30 degrees.
  • Patients with crippled hypospadias.

结局指标

主要结局

Incidence of residual ventral curvature

时间窗: 1 year

measured in degrees; if less than 15 degrees it's acceptable, if more than 15 degrees it will need further correction

Incidence of urethral diverticula formation

时间窗: 1 year

evaluated by voiding problems

Incidence of urethral stricture

时间窗: 1 year

calibrated by urethral Hegar's dilators according to the age

Incidence of meatal stenosis

时间窗: 1 year

calibrated by urethral Hegar's dilators according to the age

Incidence of graft/flap fibrosis after the first stage

时间窗: 1 year

evaluated objectively by signs of inflammation, necrosis and fibrosis

Incidence of glans dehiscence

时间窗: 1 year

evaluated subjectively by the patients or the parents using questionnaires and objectively by the surgeons

Incidence of urethro-cutaneous fistula

时间窗: 1 year

measured in millimeters; if less than 3 millimeters it's a micro-fistula, if it's more than 3 millimeters it's a macro-fistula

Percentage of patients with accepted cosmetic appearance

时间窗: 1 year

assessed by questionnaires obtained from the patients and/or the parents

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 Mohamed Ahmed Mahmoud

Resident at Pediatric Surgery Departemt at Sohag University Hospitals

Sohag University

研究点 (2)

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