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
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
- 否
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
研究点 (2)
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