Trial document




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  DRKS00014930

Trial Description

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Title

The importance of the stereoscopic imaging in surgical patient education for understanding the patients of their disease and therapy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patients receiving brain tumor surgery are randomly divided into two groups. One group will receive conventional surgical patient education with the normal two-dimensional imaging of MRI imaging. The other group will receive an individualized three-dimensional image of the MRI imaging including an explanation of the surgical procedure.
The patients are questioned regarding the experience of surgical patient education.

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Brief Summary in Scientific Language

Prospective randomized study for the benefit of stereoscopic surgical patient education over conventional surgical patient education. One group of patients receive a conventional monoscopic surgical patient education and then fill in a questionnaire. The other group of patients receive a individual stereoscopic patient education. Then they fill out a similar questionnaire.

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Organizational Data

  •   DRKS00014930
  •   2018/06/29
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  •   yes
  •   Approved
  •   EA2/019/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   C71 -  Malignant neoplasm of brain
  •   D32 -  Benign neoplasm of meninges
  •   D44.3 -  Neoplasm of uncertain or unknown behaviour: Pituitary gland
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Interventions/Observational Groups

  •   conventional patient education
  •   stereoscopic patient education
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Questionnaire to determine the experience and understanding (objective and subjective) of the surgical education directly after the surgical education

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Secondary Outcome

Interview with a smaller number of patients concerning the experience of the three-dimensional presentation of selected patients after the three-dimensional surgical education

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/06/12
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

planned surgical intervention on the brain with a tumor

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Exclusion Criteria

Known mental disorder, lack of ability of stereoscopic perception, apoplexy within the last three days

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Addresses

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    • Charité Universitätsmedizin Berlin, Klinik für Neurochirurgie, Image Guidance Lab
    • Luisenstraße 64
    • 10117  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin, Klinik für Neurochirurgie, Image Guidance Lab
    • Mr.  Nicolas  Schlinkmann 
    • Luisenstraße 64
    • 10117  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin, Klinik für Neurochirurgie, Image Guidance Lab
    • Mr.  Nicolas  Schlinkmann 
    • Luisenstraße 64
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Universitätsmedizin Berlin, Klinik für Neurochirurgie, Image Guidance Lab
    • Luisenstraße 64
    • 10117  Berlin
    • Germany
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Status

  •   Enrolling by invitation
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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.