Trial document




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  DRKS00007138

Trial Description

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Title

Randomized, multicenter study comparing robot-assisted and conventional laparoscopic radical prostatectomy

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Trial Acronym

LAP-01

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The objective of the study is the comparison of two surgical techniques for localized prostate cancer (robot-assisted versus non-robot-assisted). Bring the robot-assisted method benefits for the patient. Analyzed are men with localized prostate cancer.

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Brief Summary in Scientific Language

Robot-Assisted Laparoscopic Radical Prostatectomy compared to conventional laparoscopic radical prostatectomy in terms of functional, clinical and oncological parameters and quality of life and patient satisfaction.

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Organizational Data

  •   DRKS00007138
  •   2014/11/13
  •   [---]*
  •   yes
  •   Approved
  •   079-12-05032012, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   conventional laparoscopic radical prostatectomy
  •   robot-assisted laparoscopic radical prostatectomy
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

continence 3 months postoperative (ICIQ=Urinary Incontinence Form, pads, diary)

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Secondary Outcome

- Continence (ICIQ-SF): 1, 3, 6, 12 months p.o.
- Continence (Pads-per day): 1, 6, 12 months p.o.
- Erectile function (IIEF-5): 3, 6, 12 months p.o.
- Quality of life (EORTC QLQ-C30): 1, 3, 6, 12 months p.o.
- Anxiety and depression (HADS): 1, 3, 6, 12 months p.o.
- Satisfaction: 1, 3, 6, 12 months p.o.
- PSA: 3, 6, 12, 24, 36


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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Planned
  •   2014/11/17
  •   782
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- Histologically confirmed prostate cancer (diagnosis)
- Indication for primary-curative radical prostatectomy
- Patients aged ≤ 75 years (at the time of surgery)

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Exclusion Criteria

- Obese patients with a BMI> 35
- Currently present severe concomitant disease (eg,
Liver cirrhosis, secondary malignancy or recurrence of any kind)
- Tumor stage: T4
- Previous malignancy (≤ 3 years before inclusion in this study)
- Neoadjuvant therapy (≤ 3 months prior to inclusion in this study)
- Immune Compromised Patients
- Intermittent self-catheterization (in the year prior consent)
- The following treatments in the past 3 months: Operations at Sigma, extensive Hämorrhoidalresektion, Transurethral needle ablation of the prostate (TUNA), osteosynthesis supplies the pelvic area, salvage prostatectomy
- Patients with chronic urinary tract infection (proven more than 5 antibiotic-requiring infection episodes in last year)
- Requiring dialysis patients

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Addresses

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    • Universität Leipzig
    • Ritterstraße 26
    • 04109  Leipzig
    • Germany
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    • Universitätsklinikum LeipzigKlinik und Poliklinik für Urologie
    • Ms.  Dr.  Sigrun  Holze 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum LeipzigKlinik und Poliklinik für Urologie
    • Ms.  Dr.   Sigrun  Holze 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Krebshilfe e.V.
    • Buschstr. 32
    • 53113  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.