Surgical Planning and Informed Consent

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.

Conditions

• Communication
• Feedback, Psychological
• Health Knowledge, Attitudes, Practice
• Humans
• Informed Consent
• Neurosurgery
• Patient Compliance
• Patient-Centered Care
• Physician-Patient Relations
• User-Computer Interface

Interventions

OTHER

3D informed consent

Patients were given an informed consent with the aid of a 3D immersive surgical planner (either a Surgical Theater or Vesalius)

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

  lead OTHER

Principal Investigators

• Alessandro Perin, MD, PhD · Foundation IRCCS Neurologic Institute Carlo Besta

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-01

Primary Completion

2018-03-15

Completion

2018-03-15

Countries

• Italy

Study Locations