CommunicationSPLICENCT03503487
Surgical Planning and Informed Consent
A study testing 3D informed consent in people with Communication and Feedback, Psychological, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Communication, Feedback, Psychological, Health Knowledge, Attitudes, Practice
- What is being tested?
- 3D informed consent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2016to 15 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having a cerebral tumor
- no visual/auditory deficit
- no psychiatric illness
- italian mother-tongue
Who cannot join
- younger than 18 or older than 70
- pre-existing perceptual deficit and/or psychiatric illness
- not italian mother-tongue
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Communication, Feedback, Psychological, Health Knowledge, Attitudes, Practice, Humans, Informed Consent, Neurosurgery
- Being tested
- 3D informed consent
- Medical subject headings
- Communication, Behavior, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D informed consentOther
Patients were given an informed consent with the aid of a 3D immersive surgical planner (either a Surgical Theater or Vesalius)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: 3D informed consent |
| Planner 2 | Experimental | Patients receiving 3D informed consent procedure before intervention with Vesalius Receives: Other: 3D informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start1 Jul 2016
- Primary completion15 Mar 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Orena, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Investigators
- Alessandro Perin, MD, PhD, Principal investigator, Foundation IRCCS Neurologic Institute Carlo Besta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503487
- Sponsor's protocol ID
- SPLICE
- Acronym
- SPLICE
- Status last verified
- Apr 2018
- First submitted
- 4 Apr 2018
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32242272
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Planning and Informed Consent
- ClinicalTrials.gov ID
- NCT03503487
- Acronym / sponsor ID
- SPLICE / SPLICE
- Conditions
- Communication, Feedback, Psychological, Health Knowledge, Attitudes, Practice, Humans, Informed Consent, Neurosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients receiving standard informed consent procedure before intervention |
| Planner 1 | Experimental | Other: 3D informed consentPatients receiving 3D informed consent procedure before intervention with Surgical Theater |
| Planner 2 | Experimental | Other: 3D informed consentPatients receiving 3D informed consent procedure before intervention with Vesalius |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- having a cerebral tumor
- no visual/auditory deficit
- no psychiatric illness
- italian mother-tongue
Key exclusion criteria (3 listed)
- younger than 18 or older than 70
- pre-existing perceptual deficit and/or psychiatric illness
- not italian mother-tongue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D informed consentPatients were given an informed consent with the aid of a 3D immersive surgical planner (either a Surgical Theater or Vesalius) | Other | Planner 1, Planner 2 |
Primary outcome
Evaluation of the comprehension of the benefits/risks of the intervention
Time frame: 1 year
Comprehension of the benefits/risks of the intervention evaluated through a ad hoc questionnaire
1 secondary outcome
Level of patient's anxiety
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Derived from this study: PubMed 32242272Perin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Perin, MD, PhD principal investigator
Foundation IRCCS Neurologic Institute Carlo Besta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D informed consent in people with Communication and Feedback, Psychological, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the comprehension of the benefits/risks of the intervention (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03503487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.