ProLy-Study: Preventing lymphoceles using a peritoneal flap fixation in robot-assisted radical prostatectomies – a prospective multicenter RCT

Not Applicable

Recruiting

Conditions: I89.8
C61
Other specified noninfective disorders of lymphatic vessels and lymph nodes
Malignant neoplasm of prostate

Registration Number: DRKS00015720

Lead Sponsor: 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.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 828

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
90-days prevalence of lymphoceles

Secondary Outcome Measures

Name	Time	Method
size and extend of detected lymphoceles<br>prevalence of symptomatic lymphoceles<br>prevalence of treatment of lymphoceles<br>prevalence of postoperative complications (Clavien-Dindo-Classification)<br>length of procedure