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CompletedNCT05191550Updated Mar 25, 2022

Comparing Expert and Trainee Levels of Surgical Technical Skills

An interventional study of Virtual reality brain tumor simulation in Training Groups, sponsored by McGill University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-25.

Sponsored by McGill University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 6 years 5 months after the study started (first participant enrolled Mar 2015, registered Aug 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.
02

Conditions studied

  • Training Groups

Keywords

  • Virtual reality
  • Simulation
03

In context

Lead sponsor

McGill University is the lead sponsor of 244 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Neurosurgeons

Neurosurgical fellows

Neurosurgical residents

Medical students

Exclusion criteria

Exclusion Criteria:

Experience with previous similar brain tumor simulation

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Neurosurgeons, fellows, residents and medical students

    Neurosurgeons (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.

    Behavioral: Virtual reality brain tumor simulation

Interventions

  • BehavioralVirtual reality brain tumor simulation

    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.

06

What researchers measure

Primary outcomes

  1. Simulated bipolar and simulated ultrasonic aspirator separation distance

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

    Time frame: 1 day

  2. Simulated bipolar force application

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

    Time frame: 1 day

  3. Simulated ultrasonic aspirator force application

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

    Time frame: 1 day

07

Study locations

No study locations are listed for this record.

08

References and documents

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. Erratum In: JAMA Surg. 2020 Oct 1;155(10):1002. doi: 10.1001/jamasurg.2020.4676. JAMA Surg. 2021 Jul 1;156(7):694. doi: 10.1001/jamasurg.2021.1953. 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05191550
Lead sponsor
McGill University
Responsible party
Sponsor
First posted
Jan 13, 2022
Start date
Mar 1, 2015
Primary completion
May 31, 2016
Completion
May 31, 2016
Last update
Mar 25, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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