Surgical Planning and Informed Consent
Condition: Communication; Feedback, Psychological; Health Knowledge, Attitudes, Practice; Humans; Informed Consent; Neurosurgery; Patient Compliance; Patient-Centered Care; Physician-Patient Relations; User-Computer Interface
Study type: Interventional

Summary: 
      New devices for anatomic studies and 3-D visualization have proven to be useful for
      pre-operative surgical planning and intra-operative procedures; the hypothesis of our study
      is that, in this specific case scenario, Surgical Theater and Vesalius (two devices available
      at the Besta NeuroSim Center, Foundation I.R.C.C.S. Neurological Institute Carlo Besta) can
      improve doctor-patient communication during the process of obtaining informed consent:
      through tridimensional representation of anatomic structures of the brain, these devices are
      able to help patients understand better their own anatomy and the surgical approach to their
      disease.

      The aim of our study is therefore to understand whether this high-technology 3D planning,
      used as a tool to optimize patient-doctor communication, can effectively improve patients'
      understanding of the disease and the surgical procedure they will be going through (for which
      they are supposed to sign the consent), as well as the benefits, the risks and all the
      possible complications that can derive form surgery.

      Surgical Theater and Vesalius may be of great help: thanks to the case-specific 3D
      reconstruction of the patient's anatomy, the explanation of the surgical procedure could be
      customized for each different person, considering that anyone has certain unique individual
      features that a regular standardized system could not possibly take into account.
    

Detailed description: 
      Informed consent is the authorisation of an activity based on the understanding of what that
      activity entails in the absence of control by others. In surgery this process needs the
      comprehension of the benefits and the risks of the operation. Despite this, it has been
      argued that most surgeons do not devote adequate importance and time to this step in their
      daily practice; sometimes they are just afraid of scaring the patients with too many
      unnecessary details. Surgeons then might hide themselves behind legal booklets that should
      provide all information; too often though, patients do not fully realise their diseases and
      the possible outcomes.

      New devices for anatomical studies and 3D visualization have proven to be useful for
      preoperative surgical planning and intra-operative procedures; the hypothesis of our study is
      that Surgical Theater and Vesalius (two new-generation, immersive, 3D imaging visualizers)
      can improve doctor-patient communication during the process of obtaining informed consent:
      through the tridimensional representation of anatomic structures of the brain, these devices
      are able to help patients better understand their anatomy, the surgical approach for their
      disease and possible complications.

      In a prospective, randomized controlled pilot study, 40 patients undergoing neurosurgery for
      intracranial tumours were enrolled. Patients' cognitive function, verbal comprehension and
      memory were assessed before being enrolled. All groups initially underwent the standard
      informed consent process. Then the experimental groups received a second informed consent
      process with the aid of surgical planners, while the control group went through to a second
      round of standard informed consent. Questionnaires about appreciation, anxiety, and perceived
      and objective comprehension (on pathology, surgery, complications) were given.

      Tridimensional surgical planners may be of great help in improving how technical information
      is conveyed to patients when consented for surgery. Considering that every individual has
      unique features, a standardised method cannot be taken into account, therefore, thanks to the
      case-specific 3D reconstruction of the patient's anatomy, the explanation of the surgical
      procedure can be customized for every patient. Using new 3D technologies is expected to
      reduce patients' anxiety and to improve the understanding of their conditions and the
      possible consequences related to any treatment options.
    

Intervention name(s): 3D informed consent
Intervention type(s): Other
Intervention description(s): Patients were given an informed consent with the aid of a 3D immersive surgical planner (either a Surgical Theater or Vesalius)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care