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临床试验/NCT03787823
NCT03787823Unknown不适用

Robotic Retzius-sparing Radical Prostatectomy- a Randomized Controlled Trial Evaluating Transdouglas-RARP

Heidelberg University1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2018年8月27日最近更新:
适应症

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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanne N. Nyarangi-Dix, M.D.

Chief senior physician and Vice chairlady of the Dept. of Urology

Heidelberg University

研究点 (1)

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