NCT03503487

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

April 4, 2018

Last Update Submit

April 11, 2018

Conditions

CommunicationFeedback, PsychologicalHealth Knowledge, Attitudes, PracticeHumansInformed ConsentNeurosurgeryPatient CompliancePatient-Centered CarePhysician-Patient RelationsUser-Computer Interface

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the comprehension of the benefits/risks of the intervention

    Comprehension of the benefits/risks of the intervention evaluated through a ad hoc questionnaire

    1 year

Secondary Outcomes (1)

  • Level of patient's anxiety

    1 year

Study Arms (3)

Control

NO INTERVENTION

Patients receiving standard informed consent procedure before intervention

Planner 1

EXPERIMENTAL

Patients receiving 3D informed consent procedure before intervention with Surgical Theater

Other: 3D informed consent

Planner 2

EXPERIMENTAL

Patients receiving 3D informed consent procedure before intervention with Vesalius

Other: 3D informed consent

Interventions

3D informed consentOTHER

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

Planner 1Planner 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • having a cerebral tumor
  • no visual/auditory deficit
  • no psychiatric illness
  • italian mother-tongue

You may not qualify if:

  • younger than 18 or older than 70
  • pre-existing perceptual deficit and/or psychiatric illness
  • not italian mother-tongue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation IRCCS Neurologic Institute Carlo Besta

Milan, 20133, Italy

Location

Related Publications (1)

  • Perin A, Galbiati TF, Ayadi R, Gambatesa E, Orena EF, Riker NI, Silberberg H, Sgubin D, Meling TR, DiMeco F. Informed consent through 3D virtual reality: a randomized clinical trial. Acta Neurochir (Wien). 2021 Feb;163(2):301-308. doi: 10.1007/s00701-020-04303-y. Epub 2020 Apr 3.

    PMID: 32242272DERIVED

MeSH Terms

Conditions

CommunicationBehaviorPatient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Alessandro Perin, MD, PhD

    Foundation IRCCS Neurologic Institute Carlo Besta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist, Neuroscientist researcher

Study Record Dates

First Submitted

April 4, 2018

First Posted

April 19, 2018

Study Start

July 1, 2016

Primary Completion

March 15, 2018

Study Completion

March 15, 2018

Last Updated

April 19, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)