NCT03468387Unknown不适用
Primary Urethral Realignment vs. Suprapubic Cystostomy for Initial Management of Pelvic Fracture Urethral Injury in Children: Randomized Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 主要终点
- The success rate after initial intervention (realignment or suprapubic cystostomy).
研究概览
简要总结
It is prospective randomized comparative clinical trial comparing primary urethral realignment vs. suprapubic cystostomy in initial management of pediatric pelvic fracture urethral injury regarding:
- The success rate after initial intervention.
- The need for urethroplasty in the failed realignment group and cystostomy group.
- The success rate of urethroplasty in the failed realignment group and cystostomy group.
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 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male children less than 18 years presenting with pelvic fracture urethral injury
排除标准
- •Associated bladder neck injury.
- •Associated rectal injury.
- •Late presentation >2weeks since trauma.
- •History of previous urethral intervention.
研究组 & 干预措施
Primary realignment
Active Comparator
干预措施: Primary realignment (Procedure)
Suprapubic cystostomy
Active Comparator
干预措施: Suprapubic cystostomy (Procedure)
结局指标
主要结局
The success rate after initial intervention (realignment or suprapubic cystostomy).
时间窗: 3 months after initial intervention.
The fulfillment of success criteria after initial intervention which includes good stream, no postvoid residual urine, normal Qmax for age and free retrograde urethrogram
次要结局
- The need for urethroplasty in both groups.(3 months after initial intervention)
- The success rate of urethroplasty in both groups.(3 months after urethroplasty.)
研究者
Mohamed Osama
Principal Investigator
Assiut University
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