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NCT05191550
Comparing Expert and Trainee Levels of Surgical Technical Skills
NA trial testing Virtual reality brain tumor simulation in Training Groups in 50 participants. Completed in 31 May 2016.
31 May 2016
Quick facts
| Lead sponsor | McGill University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 50 |
| Start date | 1 March 2015 |
| Primary completion | 31 May 2016 |
| Estimated completion | 31 May 2016 |
Drugs / interventions tested
- Virtual reality brain tumor simulation
Conditions studied
- Training Groups — all drugs for Training Groups →
Sponsor
McGill University
Who can join
18 and older, any sex, with Training Groups. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 .
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05191550 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by McGill University
- Last refreshed: 25 March 2022
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