Comparing Expert and Trainee Levels of Surgical Technical Skills

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trial of Proficiency- Based Simulation Training for General Surgical Trainees

NCT00712387

Education Training Computer Simulation

UNKNOWN NA

Individualized Deliberate Practice on a Virtual Reality Simulator

NCT01753947

Education General Surgery

COMPLETED NA

Documenting a Learning Curve and Test-retest Reliability of a Virtual Reality Training Simulator in Laparoscopic Surgery

NCT00435630

Education

COMPLETED NA

Virtual Reality Training Simulator for Cesarean Section

NCT05604924

Virtual Reality

COMPLETED NA

VR-Live Hybrid Neurosurgery Clerkship:Boosting Neurosurgical Presence & Decisions

NCT07304570

Virtual Reality Telemedicine

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Training Groups

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Virtual Reality Simulated practice and realistic brain tumor simulation

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

All participants are provided a number and only the principal investigator has access to this information

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Virtual reality brain tumor simulation

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Virtual 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.

Intervention Type BEHAVIORAL