DRKS00015720招募中未知
ProLy-Study: Preventing lymphoceles using a peritoneal flap fixation in robot-assisted radical prostatectomies – a prospective multicenter RCT - ProLy
Klinik für Urologie und Zentrum für minimal-invasive und robotisch-assistierte Urologie Augusta Bochum Akad. Lehrkrankenhaus der Univ. Essen/Duisburg Chefarzt Prof. Dr. med. B. Ubrig für die Deutsche Gesellschaft für roboter-assistierte Urologie e.V.0 个研究点目标入组 828 人开始时间: 2019年9月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 828
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 99 Years（—）
- 性别
- Male
入选标准
- •Adult men with diagnosed localized non-metastatic prostate cancer (max. T2, cN0, cM0) undergoing transperitoneal radical prostatectomy with pelvic lymph node dissection as proposed in German national guidelines, who are able and willing to give written informed consent and to participate in the follow up appointments.
排除标准
- •Incapacity to give informed consent (language barrier, cognitive impairment/mental disorders, prisoners)
- •Inadequate compliance for follow up visits
- •Current participation in other clinical trials
- •Previous radiation of abdomen or pelvis (percutaneous/brachy therapy)
- •Previous transurethral treatment of benign prostate hyperplasia
- •Previous chemotherapy within last 5 years
- •Previous abdominal surgery with high risk of adhesions, especially colon surgery, vascular surgery. Uncomplicated cholecystectomy, appendectomy, endoluminal vascular therapie are not excluded
- •Current or previous deep vein thrombosis within 12 months
- •Previous PLND
- •Planned simultaneously hernia surgery
- •Diagnosed coagulation disorder
- •Unexplained pathological lab values or unexplained pathological results in physical exanimation
- •Staff members and their relatives
研究者
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