Trial document





This trial has been registered retrospectively.
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  DRKS00015720

Trial Description

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Title

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

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Trial Acronym

ProLy

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URL of the Trial

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Brief Summary in Lay Language

Lymphoceles, the accumulation of lymph fluids in leg and pelvis, are the most common complications after radical prostatectomy and lymph node dissection to treat prostate cancer. This study examines the effect of modifying the operation technique at the end of the radical prostatectomy, whether it changes the appearance of lymphoceles or not. In this study, 828 patients will be divided in two even groups: in the first group the surgical fixation of the peritoneum which separates the abdominal from the pelvic cavity will be done in a modified way as a so called peritoneal flap, a procedure which is used in an increasing number of hospitals in Germany. The second group receives the standard treatment without a special fixation.
Both groups receive the standard treatment in accordance with the German guidelines on prostate cancer, which is in this study a transperitoneal robot-assisted radical prostatectomy, which is a minimal invasive surgical technique using an access through the abdominal cavity. There will be a random allocation in two groups, the patients and the follow-up doctors don’t know the specific allocation (blinding). Despite the routine care in the hospital there are no additional invasive procedures like additional blood samples or additional diagnostic procedures using x-ray planned.
After discharge there are two follow up visits including recent medical history, physical examination and a sonographic examination.

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Brief Summary in Scientific Language

Prostate cancer is with 24% of new diagnosed cancer per year the most common solid tumor in adult men in Germany. Regarding cancer mortality statistics, prostate-cancer related deaths are second (Robert Koch Institut (RKI), Gesellschaft der epidemiologischen Krebsregister in Deutschland (GEKID),2017). Depending on age and comorbidities, robotic-assisted radical prostatectomy (RARP) is a common treatment option in intermediate risk prostate cancer patientens (localized, non-metastatic prostate cancer, depending on initial biopsy (grading) and prostate specific antigen of the patient). European and German guidelines recommend pelvic lymph node dissection (PLND) for staging and adjuvant therapy planning, the recommended template contains the areas of the external and internal iliac artery and the Fossa obturatoria (Leitlinienprogramm Onkologie (Deutsche Krebsgesellschaft, Deutsche Krebshilfe, AWMF), 2018). With the extend of the PLND many patients develop lymphoceles in the pelvis and lower extremities which is the most frequent complication following RARP (Heidenreich & Deutz, 2015; Heidenreich, Ohlmann & Polyakov, 2007; Lattouf et al., 2007; Mottet et al., 2017).

Previously, Lebeis et al. (2015) introduced a technique using a peritoneal-flap to reduced lymphocele formation in RARP-patients. In this prospective randomized, single-blinded multicenter-study, this technique is compared to a control group:
In Group A, study subjects receive a RARP with PLND and the standardized peritoneal-flap-fixation, in Group B (control) the subject also receives RARP with PNLD without peritoneal flap-fixation.

Recruiting of 828 patients in 5 German centers is planned (1:1 randomisation). The study subject and any other physicians in the follow up process remain blinded.

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Organizational Data

  •   DRKS00015720
  •   2019/09/26
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  •   yes
  •   Approved
  •   2018-451-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   I89.8 -  Other specified noninfective disorders of lymphatic vessels and lymph nodes
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   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
  •   RARP with PLND (control)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

90-days prevalence of lymphoceles

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/11/01
  •   828
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   99   Years
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Additional 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.

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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

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Addresses

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    • 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.
    • Bergstr. 26
    • 44791  Bochum
    • Germany
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    • Universitätsklinikums Leipzig, Klinik und Poliklinik für Urologie
    • Liebigstraße 20
    • 04103  Leipzig
    • Germany
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    • Klinik für Urologie und Zentrum für minimal-invasive und robotisch-assistierte Urologie Augusta Bochum Akad. Lehrkrankenhaus der Univ. Essen/Duisburg
    • Mr.  Anselm  Boy 
    • Bergstr. 26
    • 4479  Bochum
    • Germany
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    • Klinik für Urologie und Zentrum für minimal-invasive und robotisch-assistierte Urologie Augusta Bochum Akad. Lehrkrankenhaus der Univ. Essen/Duisburg
    • Mr.  Anselm  Boy 
    • Bergstr. 26
    • 4479  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Gesellschaft für Roboter-assistierte Urologie e.V. c/o Prof. Dr. med. Stefan Siemer Stellv. Klinikdirektor Klinik und Poliklinik für Urologie und Kinderurologie Universitätsklinikum des Saarlandes
    • Kirrberger Straße
    • 66424  Homburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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