Minimally Invasive Scrotal Incision for Penile Prosthesis Implantation, Novel Technique.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Objective cure rate
研究概览
简要总结
The main goals of this study are to examine the superiority of this novel technique and its acceptance by patients with ED candidate for PPI and compare these results with data available in the literature for ordinary peno-scrotal incision.
详细描述
Rational for the expected superiority of scrotal approach over peno-scrotal approach in penile prosthesis implant (PPI):
A- Expected to have all the previously mentioned pros of the traditional approach.
B- Expected lower incidence of post-operative pain with our novel approach owing to lower sensitivity of scrotal skin and tension free wound closure compared to traditional peno-scrotal approach.
C- Expected lower incidence of infection owing to multilevel wound closure done in our novel approach.
D- Expected rapid wound closure and wound healing than traditional peno-scrotal approach owing to difference in embryologic origin of penile and scrotal skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The study participants are male patients who are candidate for penile prosthesis implantation and will accept to do minimal scrotal incision procedure for treatment of ED.
排除标准
- •male patients with active scrotal infection.
- •contraindicaions to anasthesia.
结局指标
主要结局
Objective cure rate
时间窗: 4-12 weaks
should include rate of complications as fistula, scar, extensive fibrosis, infection rate, incidence of prosthetic removal.
Subjective cure rate
时间窗: 3 to 4 weaks
will be judged according to rate of wound healing, cosmotic final results, scar tension and scar pain.
次要结局
未报告次要终点
研究者
Mohamed Ibrahim Almetwally Algammal,MD
clinical professor
Al-Azhar University