Trial document




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  DRKS00005448

Trial Description

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Title

Evaluation of depth of necrosis on histological material derived by standard bipolar TURis and by vaporisation with the Olympus PlasmaButton-electrode

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Proliferating prostatic tissue can be removed either by resection or vaporisation.
With both methods necrosis of cells occur due to high frequent electricity.
In the literature different information is given concerning the depth of the necrosis.
For clarification, vaporisation will be used on one side lobe and 2-5 tissue chips will be collected and evaluated for necrosis depth, on the other side lobe resection will be used and 2-5 tissue chips will be collected and evaluated for necrosis depth, as well.
The assignment of the method to the side lobe will be done randomly.

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Brief Summary in Scientific Language

Previous investigations concerning the depth of necrosis have been caried out on different organs / species and the determined values are not consistent.
This project aimed to clarify the inconsistencies by using a greater number of patients with BHP and directly compare both methods in one patient.
Deeper mecrosis can worse healing and may lead to inflammatory reactions.
In sides with contact to nerves/muscles the depth of necrosis may have influence on functional damage.
If necrosis depth can be clarified for both methods the best method can be chosen in the future with regard to the operated surroundings.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005448
  •   2013/11/12
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  •   yes
  •   Approved
  •   EK-BR-62/13-1, Ethikkommission bei der Sächsischen Landesärztekammer
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Secondary IDs

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Health Condition or Problem studied

  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   left side lobe: vaporisation (Olympus PlasmaButton: WA 22557C)
    right side lobe. resection (Olympus TURis loops medium: WA 22503D)
  •   right side lobe: vaporisation (Olympus PlasmaButton: WA 22557C)
    left side lobe. resection (Olympus TURis loops medium: WA 22503D)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

determination of necrosis depth of histological material, which is taken during two routinely operation methods

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Secondary Outcome

Not applicable

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/11/11
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

• patients with benign prostatic hypertrophy and indication for TURP on the basis of
- recurrent or refractory urinary retention, rest urine formation
- recurrent hematuria
- bladder stones
- recurrent urinary tract infections
• prostate volume > 30 cm3
• pre-treatment investigations completed according to currently accepted criteria for prostate surgery
- initial urologic evaluation
- indications for TURP
- pre-anaesthesia evaluation
• patients >= 18 years
• written informed consent signed by the patient

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Exclusion Criteria

• local treatments of prostate or preceding prostate surgery
• Known prostate carcinoma
• palliative TURP
• preoperative long-term catheter for more than 1 week
• contraindication for lithotomy position

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Addresses

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    • St. Elisabeth Krankenhaus Abteilung Urologie
    • Biedermannstr. 84
    • 04277  Leipzig
    • Germany
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    • Institut für Pathologie am Elsapark
    • Elsastr. 01
    • 04315  Leipzig
    • Germany
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    • St. Elisabeth Krankenhaus Abteilung Urologie
    • Mr.  Dr. med.  Jörg  Raßler 
    • Biedermannstr. 84
    • 04277  Leipzig
    • Germany
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    • St. Elisabeth Krankenhaus Abteilung Urologie
    • Mr.  Dr. med.  Jörg  Raßler 
    • Biedermannstr. 84
    • 04277  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Olympus Surgical Technologies EuropeOlympus Winter & Ibe GmbH
    • Kuehnstraße 61
    • 22045  Hamburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/11/20
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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.