Hybrid Duckett Urethroplasty Versus Modified Single Stage Duckett Uteothroplasty for Management of Proximal Hypospadias: a Randomized Clinical Trial
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
- 否
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
Mohammad Gharieb Mohammad Khirallah
professor of pediatric surgery
Tanta University
