I89.8 C61
Conditions
Interventions
Group 1: Robotic-assisted radical prostatectomy (RARP) with extended pelvic lymph node dissection (PLND) with bilateral standardized formation of a peritoneal-flap next to the field of PLND
Group 2: R
Sponsors
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.
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-days prevalence of lymphoceles | — |
Secondary
| Measure | Time frame |
|---|---|
| size and extend of detected lymphoceles prevalence of symptomatic lymphoceles prevalence of treatment of lymphoceles prevalence of postoperative complications (Clavien-Dindo-Classification) length of procedure | — |
Countries
Germany
Contacts
Public ContactAnselm Boy
Klinik für Urologie und Zentrum für minimal-invasive und robotisch-assistierte Urologie Augusta Bochum Akad. Lehrkrankenhaus der Univ. Essen/Duisburg
Outcome results
None listed