A comparison of digital, visual, and visuospatial automated feedback systems in simulated bimanual surgical skills training
| ISRCTN | ISRCTN17590019 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17590019 |
- Submission date
- 21/10/2022
- Registration date
- 01/11/2022
- Last edited
- 01/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Virtual reality simulation training platforms provide realistically simulated operative procedures, objective computer-assisted performance assessment, and tailored feedback. Trainees enhance their skills by practising risk-free realistically simulated operative procedures. This study explores the efficiency of feedback in technical skills learning by comparing digital, visual, and visuospatial feedback protocols to practice alone without feedback.
Who can participate?
Students who are currently enrolled in medical schools
What does the study involve?
Participants do a total of six tumor resection tasks with and without feedback depending on their group allocation.
What are the possible benefits and risks of participating?
The study allows students to practice their surgical bimanual skills using a cutting-edge simulation technology with haptic feedback, the NeuroVR neurosurgical simulator. The study involves no risks to participants.
Where is the study run from?
The Neurosurgical Simulation and Artificial Intelligence Learning Centre, McGill University which is located at the Montreal Neurological Institute and Hospital (Canada)
When is the study starting and how long is it expected to run for?
September 2018 to November 2020
Who is funding the study?
1. Brain Tumour Foundation of Canada (Canada)
2. Royal College of Physicians and Surgeons of Canada (Canada)
3. Franco Di Giovanni Foundation (Canada)
4. Montreal Neurological Institute and Hospital (Canada)
5. Fonds de recherche du Quebec–Sante (Canada)
6. McGill University Internal Studentships (Canada)
7. National Research Council of Canada (Canada)
Who is the main contact?
1. Dr Recai Yilmaz, recai.yilmaz@mail.com
2. Dr Rolando Del Maestro, rolando.del_maestro@mcgill.ca
Contact information
Principal Investigator
300 Leo Pariseau, Suite 2210
Montreal
H2X 4B3
Canada
 ORCID ID |
0000-0003-3733-8921 |
|---|---|
| Phone | +1 (0)519 708 0346 |
| rolando.del_maestro@mcgill.ca |
Scientific
300 Leo Pariseau, Suite 2210
Montreal
H2X 4B3
Canada
| ORCID ID |
0000-0003-0521-3227 |
|---|---|
| Phone | +1 (0)438 979 1299 |
| recai.yilmaz@mail.com |
Public
300 Leo Pariseau, Suite 2210
Montreal
H2X 4B3
Canada
| ORCID ID |
0000-0003-0521-3227 |
|---|---|
| Phone | +1 (0)438 979 1299 |
| recai.yilmaz@mail.com |
Study information
| Study design | Multicenter interventional four-arm randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effect of feedback modality on simulated surgical skills learning using automated educational systems |
| Study acronym | FeedbackEffect |
| Study objectives | 1. Students who are provided with feedback information will achieve a higher learning rate in simulated bimanual surgical skills learning than students who practice without feedback 2. Visual and visuospatial feedback will achieve a higher learning rate than providing feedback without visual and visuospatial information |
| Ethics approval(s) | Approved 22/11/2021, McGill University Health Centre Research Ethics Board (Neurosciences-Psychiatry, 3801 University Street, #686, Montreal, Quebec, H3A 2B4, Canada; +1 (0)514 398 1046; reb.neuro@mcgill.ca), ref: 2010-270, NEU-09-042 |
| Health condition(s) or problem(s) studied | Training bimanual surgical skills of medical students using virtual reality simulation and feedback |
| Intervention | This is a four-arm randomized controlled trial. Google online random number generator is used to determine participant group allocation between the four groups. Participants perform six simulated tumor resections, a practice subpial tumor resection five times, and a complex realistic brain tumor resection once. The first group acts as the control group that is doing the tasks without any feedback. The participants in the remaining groups receive digital, visual, and visuospatial feedback after completing each task based on their group allocation in three feedback groups. Each session of the simulation trial takes an hour and a half, and data are collected in a single session with no follow-up. |
| Intervention type | Other |
| Primary outcome measure | Learning measured using the total number of expert benchmarks achieved on previously validated 14 performance metrics with expert-level benchmarks, on a scale of 1 to 14, across five repetitions of the simulated task, assessed after the completion of each task |
| Secondary outcome measures | Performance improvement measured using participant scores, across the five repetitions of the simulated task, on the 14 performance metrics, assessed after the completion of each task: 1. Brain volume removed (cc) 2. Amount of blood loss (cc) 3. Maximum force applied with the dominant hand (Newton) 4. Maximum force applied with a non-dominant hand (Newton) 5. Sum of forces applied with the dominant hand (Newton) 6. Sum of forces applied with a non-dominant hand (Newton) 7. Tumour percentage removed (%) 8. Total tip path length dominant hand (mm) 9. Total tip path length non-dominant hand (mm) 10. Path length index 11. Efficiency index 12. Average instrument tips separation distance (mm) 13. Coordination index 14. Bimanual forces ratio |
| Overall study start date | 01/09/2018 |
| Completion date | 01/11/2020 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 120 |
| Key inclusion criteria | Students who are currently enrolled in medical schools. |
| Key exclusion criteria | There are no exclusion criteria |
| Date of first enrolment | 01/07/2019 |
| Date of final enrolment | 31/10/2020 |
Locations
Countries of recruitment
- Canada
Study participating centre
Montreal Neurological Institute
3801 University Street
Room E2.89
Montreal
H3A 2B4
Canada
Sponsor information
Hospital/treatment centre
845 Sherbrooke Street West
Montreal
H3A 0G4
Canada
| Phone | +1 (0)514 398 1046 |
|---|---|
| reb.neuro@mcgill.ca | |
| Website | https://muhc.ca/ |
"ROR" |
https://ror.org/01pxwe438 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Fondation canadienne des tumeurs cérébrales
- Location
- Canada
Government organisation / Universities (academic only)
- Alternative name(s)
- Collège royal des médecins et chirurgiens du Canada, Royal College, The Royal College of Physicians and Surgeons of Canada, RCPSC
- Location
- Canada
No information available
Government organisation / Research institutes and centers
- Alternative name(s)
- Institut et Hôpital Neurologiques de Montréal, Neuro, Montreal Neurological Institute-Hospital, Montreal Neuro, The Neuro, MNI
- Location
- Canada
No information available
Government organisation / Universities (academic only)
- Alternative name(s)
- McGill, Université McGill, Universitas McGill, MGU
- Location
- Canada
Government organisation / National government
- Alternative name(s)
- Conseil national de recherches Canada, NRC, CNRC
- Location
- Canada
Results and Publications
| Intention to publish date | 30/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal with a broad audience. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Recai Yilmaz (recai.yilmaz@mail.com), Dr Rolando Del Maestro (rolando.del_maestro@mcgill.ca). Institution: Neurosurgical Simulation and Artificial Intelligence Learning Centre, McGill University, 300 Rue Léo Pariseau, Suite 2210, H2X 4B3, Montreal, Quebec, Canada, neurosimlab@gmail.com. The raw simulation performance dataset collected in this study is available from the contact people on a reasonable request. With the approval of both Dr Recai Yilmaz and Dr Rolando Del Maestro, this dataset or any data derived from the raw simulation performance data can be made available to a researcher or a research group that works or will work in collaboration with the research group at the Neurosurgical Simulation and Artificial Intelligence Learning Centre. Data would become available during this time of collaboration and may be used only for scientific research purposes. Participant consent was obtained to use this data for scientific research purposes. Participant data were anonymized, and the data was stored using participant ID numbers without any personal information. Participant re-identification is not allowed. |
Editorial Notes
31/10/2022: Trial's existence confirmed by McGill University Health Centre Research Ethics Board.
