Robotic Retzius-sparing Radical Prostatectomy- a Randomized Controlled Trial Evaluating Transdouglas-RARP
试验速览
- 阶段
- 不适用
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Urinary continence
研究概览
简要总结
Prospective randomized blinded RCT comparing Transdouglas Prostatectomy to classical transperitoneal anterior radical prostatectomy
详细描述
We will evaluate functional urinary and sexual recovery, oncologic outcomes and postoperative complications in patients over a follow up period of 12 months
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Indication for radical prostatectomy
- •>18 years old
- •Preoperatively continent
- •informed signed consent for study
排除标准
- •cT4-Cancer
- •Withdrawl of consent to study
研究组 & 干预措施
Retzius-sparing RARP
Arm B randomizes men with an indication for radical robotic Prostatectomy (RARP) to retzius-sparing transdouglas RARP
干预措施: robotic Prostatectomy (RARP) (Procedure)
anterior transperitoneal RARP
Arm A randomizes men with an indication for radical robotic Prostatectomy (RARP) to anterior transperitoneal RARP
干预措施: robotic Prostatectomy (RARP) (Procedure)
结局指标
主要结局
Urinary continence
时间窗: 1 Week after Prostatectomy
Pad use
次要结局
- Resection margine(pathology report, approximately 1 week postoperatively)
- postoperative PSA(12 months)
- Urinary continence(3, 6 and 12 months after Prostatectomy)
- Postoperative complications(First 12 months after Prostatectomy)
研究者
Joanne N. Nyarangi-Dix, M.D.
Chief senior physician and Vice chairlady of the Dept. of Urology
Heidelberg University