Surgical Planning and Informed Consent (SPLICE)

April 11, 2018 updated by: Eleonora Orena, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Level of patient's anxiety
Time Frame: 1 year
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alessandro Perin, MD, PhD, Foundation IRCCS Neurologic Institute Carlo Besta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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