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Training GroupsNCT05191550

Comparing Expert and Trainee Levels of Surgical Technical Skills

A study testing Virtual reality brain tumor simulation in people with Training Groups, run by McGill University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: The use of virtual reality surgical simulators has been explored as a means of providing objective assessments in surgery. The enormous data generated by simulators can provide an objective and novel insight into the technical composites of expertise. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Training Groups
What is being tested?
Virtual reality brain tumor simulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
1 Mar 2015to 31 May 2016
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Neurosurgeons
  • Neurosurgical fellows
  • Neurosurgical residents
  • Medical students

Who cannot join

  • Experience with previous similar brain tumor simulation

About this study

Official title: Comparing Expert and Trainee Levels of Surgical Technical Skills in Virtual Reality Surgical Simulation - A Case Series Study

Background:

The use of virtual reality surgical simulators has been explored as a means of providing objective assessments in surgery. The enormous data generated by simulators can provide an objective and novel insight into the technical composites of expertise.

Read more

The objective of this work to form a data repository from expert and trainee levels of surgical performance data using the NeuroVR surgical simulation platform with haptic feedback, which will be used to assess face, content and construct validity of the simulated surgical tasks and develop intelligent systems in future studies.

Specific Aims: 1) Construct a data repository including expert and trainee levels of surgical performance data on virtual reality simulation. 2) Outline the face and content validity of the simulated tasks.

Design: 50 participants from a single university were recruited in this consecutive retrospective case series study.

Setting: Neurosurgical Simulation and Artificial Intelligence Learning Centre, McGill University Participants: Neurosurgeons (14), neurosurgical fellows and neurosurgical residents (24) from Montreal Neurological Institute and Hospital along with medical studies (12).

Task: Complete removal of a simulated tumor with minimal bleeding and damage to surrounding healthy brain using two surgical instruments of the NeuroVR (CAE Healthcare) surgical simulator.

Intervention: A single 28-minute simulation session, including 5 practice scenarios (3 minutes per task) and one complex realistic scenario (13 minutes). Pre- and post-questionnaires to obtain participant demographics and assess face and content validity of the simulated tasks.

Main Outcomes and Measures:

Primary outcome are surgical performance metrics recorded during the simulated tasks including.

  1. Simulated bipolar and simulated ultrasonic aspirator separation distance Mean instrument tip separation distance in mm
  2. Simulated bipolar force application Mean bipolar force application in Newtons
  3. Simulated ultrasonic aspirator force application Mean ultrasonic aspirator force application in Newtons

Secondary outcomes include:

1.Rating of face validity of simulation

Questionnaire using 5 point Likert scale will assess face validity

2 Rating of content validity of simulation

Questionnaire using 5 point Likert scale will assess content validity

.

Read the detailed description

Detailed Description:

Background Technological means are being increasingly used in education; however surgical technical skills training is still heavily dependent on expert-trainee relationship. This apprenticeship model faces limitations with the availability of expert surgeons, patient-safety concerns, lack of objectivity, standardization, and quantitation. Surgical interventions carry substantive risks to patients and high costs to health care systems. Consequently, surgical education transforms into more competency-based frameworks by implementing technological means to increase data collection, enable quantification, and objective analysis. Virtual reality simulators have been developed to provide standardized realistic simulated operative environments with the detailed performance data recorded, enabling to explore the composites of technical expertise, and offering new methodologies for surgical training.

Rationale A technically challenging operation in neurosurgery involves the subpial resection of brain tumors adjacent to critical structures. Two simulated tumor resection tasks were developed previously to simulate this procedure using the NeuroVR platform with haptic feedback. The face, content and construct validity of these simulations and methodologies to assess surgical performance in these tasks qualitatively and quantitatively are yet to be explored.

Research Objectives To form a data repository of simulated surgical performance across different expertise levels to allow future studies and to explore face, content and construct validity to develop expert benchmarks and intelligent systems to provide feedback to learners.

Participants do not know about the performance metrics recorded, only that they will be practicing technical skills used in neurosurgery for subpial tumor resection procedures.

Primary Purpose:

Official Title: Comparing Expert and Trainee Levels of Surgical Technical Skills in Virtual Reality Surgical Simulation - A Case Series Study Study Start Date: March 1, 2015

Study Completion Date:

May 31, 2016

Arms and Interventions

Arm Intervention/treatment Single arm, consecutive case series study

All participants performed two simulated tasks: a practice subpial tumor resection five times and a complex brain tumor resection once. Participants were instructed to remove the tumor completely while minimizing injury to the adjacent critical tissues and bleeding. Practice and complex tumor resection tasks were to be completed within three- and 13-minutes time limits, respectively. Participants received no feedback during or after the trials. Performance data was recorded at 0.02 second intervals by the NeuroVR platform.

Contacts and Locations Locations Canada, Quebec Neurosurgical Simulation and Artificial Intelligence Learning Centre, Montreal Neurological Institute, McGill University, Montreal, H3A 2B4 Quebec, Canada Investigators Principal Investigator: Rolando F. Del Maestro, MD PhD McGill University

More Information Responsible Party: Rolando F. Del Maestro, William Feindel Professor Emeritus in Neuro-Oncology, McGill University

ClinicalTrials.gov Identifier:

Human Subjects Ethics Review Board Status: Approved Ethics Review Board Project Number: 2010-270 NEU-09-042 Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No

Data Analysis Plan This study aims to form a data repository to enable future studies to explore the composites of surgical expertise in virtual reality surgical simulation performance by both qualitative and quantitative analyses. Participant rating of the simulated tasks will be used to assess face and content validity of the simulated tasks. A median score of >=3 is deemed sufficient for validation.

References:

  1. Stulberg JJ, Huang R, Kreutzer L, Ban K, Champagne BJ, Steele SE, et al. Association Between Surgeon Technical Skills and Patient Outcomes. JAMA Surgery. 2020.DOI: 10.1001/jamasurg.2020.3007.
  2. Delorme S, Laroche D, DiRaddo R, Del Maestro RF. NeuroTouch: A Physics-Based Virtual Simulator for Cranial Microneurosurgery Training. Operative Neurosurgery. 2012;71(suppl_1):ons32-ons42.DOI: 10.1227/NEU.0b013e318249c744.
  3. Gélinas-Phaneuf N, Del Maestro RF. Surgical Expertise in Neurosurgery: Integrating Theory Into Practice. Neurosurgery. 2013;73(suppl_1):S30-S8.DOI: 10.1227/NEU.0000000000000115.
  4. Anderson O, Davis R, Hanna GB, Vincent CA. Surgical adverse events: a systematic review. The American Journal of Surgery. 2013;206(2):253-62.DOI: 10.1016/j.amjsurg.2012.11.009.
  5. Brightwell A, Grant J. Competency-based training: who benefits? Postgraduate Medical Journal. 2013;89(1048):107.DOI: 10.1136/postgradmedj-2012-130881.
  6. Sabbagh AJ, Bajunaid KM, Alarifi N, Winkler-Schwartz A, Alsideiri G, Al-Zhrani G, et al. Roadmap for Developing Complex Virtual Reality Simulation Scenarios: The Subpial Neurosurgical Tumor Resection Model. World Neurosurgery. 2020.DOI: https://doi.org/10.1016/j.wneu.2020.03.187.
Conditions
Training Groups
Being tested
Virtual reality brain tumor simulation
Keywords
Virtual reality, Simulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual reality brain tumor simulationBehavioural

    Task: Complete removal of a simulated tumour - distinguishable by colour and haptic properties - with minimal bleeding and damage to surrounding healthy brain using two surgical instruments (Cavitron Ultrasonic Aspirator and Bipolar pincers) of the NeuroVR (CAE Healthcare) surgical simulator.

    Intervention: A single 28-minute simulation session, including six virtual subpial tumour resection attempts. Five simple practice scenarios (3 minutes per task) and one complex realistic scenario (13 minutes). Pre- and post-questionnaires to obtain participant demographics and assess face and content validity of the simulated tasks.

Study groups in NCT05191550
Study groupRoleWhat they receive
Neurosurgeons, fellows, residents and medical studentsExperimentalNeurosurgeons (14), neurosurgical fellows and neurosurgical residents (24) from Montreal Neurological Institute and Hospital along with medical students (12) who are enrolled in first to fourth year of McGill medical school.
Receives: Behavioral: Virtual reality brain tumor simulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Simulated bipolar and simulated ultrasonic aspirator separation distance

    Measured in millimeters (range 0-30mm) values > 5mm poor performance

    Measured: 1 day

  2. Simulated bipolar force application

    Measured in Newtons (range 0-1.5N) values > 0.5 N poor performance

    Measured: 1 day

  3. Simulated ultrasonic aspirator force application

    Measured in Newtons (range 0-1.5N) values > 0.5 N poor performance

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2022
  2. Study start1 Mar 2015
  3. Primary completion31 May 2016
  4. Study completion31 May 2016

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Virtual Reality Simulated practice and realistic brain tumor simulation
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05191550
Sponsor's protocol ID
2010-270, NEU-09-042-Trial 2
Status last verified
Mar 2022
First submitted
20 Aug 2021
Last updated
25 Mar 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Stulberg JJ, Huang R, Kreutzer L, Ban K, Champagne BJ, Steele SR, Johnson JK, Holl JL, Greenberg CC, Bilimoria KY. Association Between Surgeon Technical Skills and Patient Outcomes. JAMA Surg. 2020 Oct 1;155(10):960-968. doi: 10.1001/jamasurg.2020.3007.

    PubMed 32838425
  • Delorme S, Laroche D, DiRaddo R, Del Maestro RF. NeuroTouch: a physics-based virtual simulator for cranial microneurosurgery training. Neurosurgery. 2012 Sep;71(1 Suppl Operative):32-42. doi: 10.1227/NEU.0b013e318249c744.

    PubMed 22233921
  • Gelinas-Phaneuf N, Del Maestro RF. Surgical expertise in neurosurgery: integrating theory into practice. Neurosurgery. 2013 Oct;73 Suppl 1:30-8. doi: 10.1227/NEU.0000000000000115.

    PubMed 24051880
  • Anderson O, Davis R, Hanna GB, Vincent CA. Surgical adverse events: a systematic review. Am J Surg. 2013 Aug;206(2):253-62. doi: 10.1016/j.amjsurg.2012.11.009. Epub 2013 May 1.

    PubMed 23642651
  • Brightwell A, Grant J. Competency-based training: who benefits? Postgrad Med J. 2013 Feb;89(1048):107-10. doi: 10.1136/postgradmedj-2012-130881. Epub 2012 Sep 27.

    PubMed 23019588
  • Sabbagh AJ, Bajunaid KM, Alarifi N, Winkler-Schwartz A, Alsideiri G, Al-Zhrani G, Alotaibi FE, Bugdadi A, Laroche D, Del Maestro RF. Roadmap for Developing Complex Virtual Reality Simulation Scenarios: Subpial Neurosurgical Tumor Resection Model. World Neurosurg. 2020 Jul;139:e220-e229. doi: 10.1016/j.wneu.2020.03.187. Epub 2020 Apr 11.

    PubMed 32289510

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality brain tumor simulation in people with Training Groups, run by McGill University.

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 1 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 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Simulated bipolar and simulated ultrasonic aspirator separation distance (time frame: 1 day). The study lists 3 primary outcomes in all. 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 NCT05191550, which also lists 6 linked publications.

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 25 Mar 2022.

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