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临床试验/NCT06284135
NCT06284135已完成不适用

Prospective Randomised Study to Examine the Influence of a Modification of the DaVinci Prostatectomy on the Frequency of Postoperative Lymphoceles Requiring Treatment and Postoperative Complications

Martini-Klinik am UKE GmbH2 个研究点 分布在 1 个国家目标入组 1,080 人开始时间: 2017年6月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,080
试验地点
2
主要终点
rate of lymphoceles requiring intervention after RARP

研究概览

简要总结

A two-armed prospective randomised, controlled, single-centre trial on 1080 patients with prostate cancer who underwent robot-assisted radical prostatectomy with bilateral pelvic lymph node dissection was carried out. Patients in the intervention arm received fixation of the peritoneal flap of the bladder to the plexus Santorini at the end of surgery (Michl-technique, MT); in the control group, surgery was performed without this modification. The primary endpoint was the rate of lymphoceles requiring intervention.

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
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

  • Declaration of consent signed
  • Minimum age 18 years
  • localised prostate carcinoma
  • planned DVRP with bilateral lymphadenectomy

排除标准

  • patient's lack of capacity to consent
  • no planned PLND
  • metastatic prostate cancer
  • ASA status >3

研究组 & 干预措施

Michl-stitch

Experimental

干预措施: Michl-stitch (Other)

control

No Intervention

结局指标

主要结局

rate of lymphoceles requiring intervention after RARP

时间窗: one year follow-up

Clavien-Dindo \>2°

次要结局

  • total lymphocele rate after RARP(one year follow-up)
  • other complications ≥ grade IIIa according to Clavien-Dindo after RARP(one year follow-up)
  • continence rates after RARP(one year folow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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