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临床试验/NCT05528276
NCT05528276尚未招募不适用

Does Preputial Inlay Graft Improves the Outcome of Tubularized Incised Plate Repair for Primary Distal Hypospadias? a Prospective Randomized Controlled Trial.

Assiut University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
2
主要终点
Operation time.

研究概览

简要总结

Hypospadias is a common congenital anomalies in male children affecting 1 in 200-300 male births, the penis urethral opening is found ventrally, penile curvature and a lack of foreskin (1). Multiple operations are described , Tubularised incised-plate is the preferred option for distal hypospadias and with trial to extend the operation indication to proximal and redo hypospadias (2). Its simple operative technique made TIP repair gain worldwide acceptance in addition to the low complication rate & good cosmetic outcome (3).It has several complication as stenosis meatus, fistula formation , uretheral stricture and failed repair (4). Objective scoring systems were introduced to allow better judgment and identification of the postoperative results, depending on pre-operative and intra-operative criteria (5). Modifications of the T.I.P operation was done to reduce complication and allow better results by using a graft , Snodgraft vs Snodgrass operation are nearly equal regarding the outcomes (6). To our knowledge there is no definite recommendation.

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
1 Year 至 12 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Children age more than 12 months to 12 years.
  • De-novo penile hypospadias after degloving of penis intraoperative (fresh, not previously operated)

排除标准

  • Circumcised
  • Ventral Penile curvature ≥30° after penile degloving & artificial erection, (requiring transection of urethral plate).
  • Uretheral plate less than 6mm
  • Megameatus intact prepuce
  • Albumin less than 3.5 g/dL

结局指标

主要结局

Operation time.

时间窗: intraoperative

the duration of the operation will be measured from the start of anesthesia to end.

site of the meatus

时间窗: 6 months from the operation

the meatal position will be measured in centimeters from the original position .

blood loss.

时间窗: one hour postoperatively

the amount of blood loss will be measured by CBC

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

Abdelrahman Mohamed Abdelkader

teaching assistant of urology & andrology

Assiut University

研究点 (2)

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