Surgical Planning and Informed Consent (SPLICE)

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.

Study Overview

• Status: Completed
• Conditions: Communication; Health Knowledge, Attitudes, Practice; Informed Consent; Patient Compliance; Patient-Centered Care; User-Computer Interface; Neurosurgery; Physician-Patient Relations; Humans; Feedback, Psychological
• Intervention / Treatment: Other: 3D informed consent

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20133
    • Foundation IRCCS Neurologic Institute Carlo Besta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients receiving standard informed consent procedure before intervention
Experimental: Planner 1; Patients receiving 3D informed consent procedure before intervention with Surgical Theater	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)
Experimental: Planner 2; Patients receiving 3D informed consent procedure before intervention with Vesalius	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of patient's anxiety	Anxiety score pre- and post- informed consent as assessed with the State-Trait Anxiety Inventory (STAI) Y-1 and Y-2	1 year

Collaborators and Investigators

• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Investigators: Principal Investigator: Alessandro Perin, MD, PhD, Foundation IRCCS Neurologic Institute Carlo Besta

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): March 15, 2018
• Study Completion (Actual): March 15, 2018

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: SPLICE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No