Surgical Planning and Informed Consent

Communication Clinical Trial

— SPLICE  

Official title:

Surgical Planning and Informed Consent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503487
• Other study ID #: SPLICE
• Status: Completed
• Phase: N/A
• First received: April 4, 2018
• Last updated: April 11, 2018
• Start date: July 1, 2016
• Est. completion date: March 15, 2018

Study information

• Verified date: April 2018
• Source: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 15, 2018
• Est. primary completion date: March 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
Italy	Foundation IRCCS Neurologic Institute Carlo Besta	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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