Prospective Comparative Trial to Assess the Role of Local Long Acting Steroid Injection After Hypospadias Surgery in Decreasing Complications and Preserving Better Cosmesis
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Failure rate
研究概览
简要总结
Post-operative tissue oedema is one of the main causes of failure of hypospadias repair. Severe oedema may disrupt the suture line, invite infection and result in repair failure. Thus, we suggested that local injection of corticosteroids in just below coronal sulcus into dartos and buck's fascia may limit this oedema thus improving the outcome of hypospadias repair.
详细描述
This is a prospective comparative trial : comparing the use of local steroids injection to reduce tissue edema after hypospadias and to preserve the final cosmesis after tissue repair.
The patients will be divided into 2 groups(each group 20 patients): one group will be injected steroids just after hypospadias surgery while the other will not.
The short and long term outcomes between both groups will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Hypospadias Patient
- •Recurrent Cases
- •6 months or more
- •Distal, and mid penile hypospadias
排除标准
- 未提供
研究组 & 干预措施
Steroid injection
Steroid (betamethasone) 2 ml is injected subcutaneously after finishing the operation at the repair site.
干预措施: steroid betamethasone (Drug)
结局指标
主要结局
Failure rate
时间窗: 2 weeks
次要结局
- Final cosmesis(3 days, 5 days, 10 days, 2 weeks)
- incidence of Tissue edema(3 days, 5 days, 10 days, 2 weeks)
- Infection Rate(3 days, 5 days, 10 days, 2 weeks)
- Fistula rate(2 weeks)
研究者
Ahmed Abozamel
Doctor Lecturer in Urology department
Cairo University