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临床试验/NCT04043637
NCT04043637已完成不适用

Complete Puborectalis, Puboperinealis Muscle and Urethral Rhabdomyosphincter Preservation in Laparoscopic Radical Prostatectomy: Anatomic Landmarks to Achieving Early Urinary Continence

Consorci Sanitari Integral0 个研究点目标入组 120 人开始时间: 2012年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
主要终点
change in the proportion of patients with of urinary incontinence

研究概览

简要总结

This study describes how to perform a correct prostatic apex and membranous urethra in order to preserve all anatomical elements that are necessary to achieve a very fast urinary continence after open/laparoscopic/robotic radical prostatectomy, avoiding positive surgical margins at this level.

详细描述

This study describes a simple technical variation, aimed at the sparing of the muscle systems and neurovascular bundles in order to achieve high rates of urinary continence in the early postoperative period ( the first two months after surgery) in prostate cancer patients undergoing radical prostatectomy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age between 40 and 75 years
  • A Body Mass Index lower than 35 Hg/m2
  • Patients with organ-confined prostate cancer
  • Signed informed consent

排除标准

  • Contraindications for Laparoscopy

结局指标

主要结局

change in the proportion of patients with of urinary incontinence

时间窗: The follow-up was at 2 weeks, 4 weeks and 8 weeks after removal of the urethral catheter (one week after surgery), and, thereafter, once a month over the first year after surgery

Assessment of the proportion of patients with urinary incontinence after laparoscopic radical prostatectomy

次要结局

  • change in the proportion of patients with recovery of the erectile function(every month during the first year after surgery)
  • number of patients with overall positive surgical margins(immediate postoperative period)
  • biochemical recurrence rate(until the completion of the study, with a mean follow-up of 72 months)

研究者

申办方类型
Other
责任方
Sponsor

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