Trial document




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  DRKS00016794

Trial Description

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Title

Peritoneal flap as Lymphocele prophylaxis following robotic-assisted (DaVinci ® System, Intuitive Surgical®), laparoscopic radical prostatectomy with pelvic lymph node dissection

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Trial Acronym

PELYCAN

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URL of the Trial

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Brief Summary in Lay Language

The robotic-assisted (DaVinci ® System, Intuitive Surgical®), laparoscopic radical prostatectomy with pelvic lymph node dissection bares surgical risks and complications, one of which is the formation of lymphatic fluid in the pelvic area. This complication is called pelvic lymphocele and might cause different symptoms, e.g. pain, infection including fever and chills, signs of a thrombosis or thrombosis itself. Due to these complications an admission to the ward may be necessary once again.
By creating and using a flap made of the part of the membrane, that covers the abdominal cavity from the inside (= peritoneum), next to and above the bladder, we aim to achieve a reduction in the formation of lymphoceles. Using that technique, on the one side, the lymphatic fluid can be reabsorbed in a more natural way. On the other side, that technique, in theory, protects the area, where the lymphatic nodes have been removed. Thus an encapsulation of lymphatic fluid is prevented.
Mannheim University Hospital’s Department of Urology aims to enhance the surgical technique and clinical outcome after laparoscopic radical prostatectomy with pelvic lymph node dissection. Therefore, the benefit of performing the above-mentioned, so-called peritoneal flap, regarding a reduction in the rate of lymphoceles will be assessed.

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Brief Summary in Scientific Language

Symptomatic pelvic lymphoceles are a major procedure related complication after robotic-assisted, laparoscopic radical prostatectomy with pelvic lymph node dissection in patients with prostatic cancer. The rate of this complication is currently around 1-5%. Asymptomatic lymphoceles have a rate of 10-18%. Lymphoceles can become symptomatic by causing pain or being a focus of infection. Furthermore, lymphoceles can develop hemodynamic relevance when in contact with the iliac vein and cause signs of a deep vein thrombosis or a thrombosis itself. This may lead to venous thromboembolism. Hence lymphoceles should be treated if they are symptomatic or impair venous flow. The gold standard is the sonographically steered drainage. Recent data ([Lebeis C, Urology 2015] and [Stolzenburg J.-U., European Urology Oncology, 2018]) suggest that a peritoneal flap could decrease the risk for both, asymptomatic as well as symptomatic lymphoceles. Due to methodical limitations (partial retrospective, no randomization) further studies are required.

Hypothesis: Using a peritoneal flap decreases the rate of lymphoceles and thereby morbidity. This might lead to a higher quality of life after robotic-assisted (DaVinci ® System, Intuitive Surgical®), laparoscopic radical prostatectomy with pelvic lymph node dissection in patients with prostatic cancer.

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Organizational Data

  •   DRKS00016794
  •   2019/05/13
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  •   yes
  •   Approved
  •   2019-1127N, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

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

  •   robotic-assisted (DaVinci ® System, Intuitive Surgical®), laparoscopic radical prostatectomy with pelvic lymph node dissection WITH peritoneal flap
  •   robotic-assisted (DaVinci ® System, Intuitive Surgical®), laparoscopic radical prostatectomy with pelvic lymph node dissection WITHOUT peritoneal flap
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Characteristics

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

Symptomatic pelvic lymphocele within 6 months after robotic-assisted (DaVinci ® System, Intuitive Surgical®), laparoscopic radical prostatectomy with pelvic lymph node dissection

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Secondary Outcome

Asymptomatic lymphocele at the time of discharge;
Asymptomatic lymphocele within 6 months after surgical treatment;
Rehospitalization rate within 6 months after surgical treatment;
Quality of Life (QLQ-C30, EORTC)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/05/13
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

patients undergoing robotic-assisted, laproscopic prostatectomy with pelvic lymph node dissection;

Low, intermediate and high-risk (D’Amico);

age ≥ 18 years;

written informed consent

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Exclusion Criteria

- former transperitoneal hernia repair

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Addresses

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    • Universitätsklinikum Mannheim
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsklinik für Urologie der UMM Mannheim
    • Theodor-Kutzer-Ufer 1-3/Haus 28, Ebene 1
    • 68167  Mannheim
    • Germany
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    • Klinik für Urologie
    • Mr.  Univ.-Prof. Dr. med.  Philipp  Nuhn 
    • Theodor-Kutzer-Ufer 1-3/ Haus 28, Ebene 1
    • 68167  Mannheim
    • Germany
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    • Studienzentrale der Klinik für Urologie
    • Ms.  Simone  Zendler 
    • Theodor-Kutzer-Ufer 1-3/Haus 28, Ebene 1
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik für Urologie der UMM Mannheim
    • Theodor-Kutzer-Ufer 1-3/Haus 28, Ebene 1
    • 68167  Mannheim
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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