Colonic PolypNCT03826069
Impact of Augmented Reality in Polypectomy Skills Acquisition in Simulation-based Endoscopy Training
A study testing Augmented reality-based curriculum and Conventional Simulation Curriculum in people with Colonic Polyp, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Simulation-based training (SBT) is a safe and effective strategy for improving skills development in gastrointestinal endoscopy. The use of curricula based on progressive learning, as well as comprehensive structured curricula, have been demonstrated to be effective in enhancing simulation-based training. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- Augmented reality-based curriculum and Conventional Simulation Curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jun 2019to Aug 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postgraduate trainees in the gastroenterology, general surgery, or internal medicine residency programs
- Performed 25 or less live or simulated endoscopic procedures
Who cannot join
- Performed more than 25 live or simulated endoscopic procedures
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B1W8
Nikko Gimpaya, 4168645628, gimpayan@smh.ca
About this study
Official title: Impact of Augmented Reality on Procedural Skills Acquisition in a Simulation-based Training Curriculum for Polypectomy: A Randomized Controlled Trial
Simulation-based training (SBT) is a safe and effective strategy for improving skills development in gastrointestinal endoscopy. The use of curricula based on progressive learning, as well as comprehensive structured curricula, have been demonstrated to be effective in enhancing simulation-based training. With current advancements in technologies, another possible enhancement to SBT is the use of augmented reality (AR). To date, no other studies have examined the benefits of AR technology in endoscopy training. This study aims to evaluate the effectiveness of a simulation-based AR curriculum in developing technical skills, self-assessment accuracy, and clinical performance; as compared to a conventional simulation curriculum.
Thirty six novice endoscopists will be recruited from the gastroenterology and general surgery programs at the University of Toronto. Participants will be randomized and assigned to two groups. The Conventional Simulation Training Curriculum group will receive 6 hours of simulated training, with expert feedback, and four 1-hour didactic teaching sessions. The AR Training Curriculum group will receive the same number of training hours and didactic sessions as the control group. The main difference is the use of superimposed videos to guide the intervention group through simulated polypectomy cases. During the didactic teaching sessions, the intervention group will also receive a brief introduction to principles of AR and its uses for endoscopy simulation. Participants will be trained to perform colonoscopies on two validated simulator models: (1) a bench-top colonoscopy simulator; and (2) the EndoVR® virtual reality simulator. Performance will be assessed before training (pre-test), immediately after training (acquisition post-test) and 4-6 weeks after training (retention test). On the same day as the retention test, the participants will perform two live colonoscopies and use a mechanical polypectomy simulation test (transfer tests), assessed by two blinded expert endoscopists.
The main hypothesis of this study is that novices trained under the AR-enhanced curriculum will have better technical skill performance during simulated polypectomies and live colonoscopies.
Read the detailed description
Simulation-based training (SBT) provides a safe and effective means to enhance skills development. Simulation-based curricula have been developed for a number of minimally invasive procedures, and more recently in gastrointestinal endoscopy. Previous studies have demonstrated the effectiveness of comprehensive structured curricula and curricula based on progressive learning in endoscopic simulation. However, as digital technologies evolve, other educational strategies using the latest innovations may aid to further enhance procedural skills training during simulation. One such strategy may lie in augmented reality (AR).
The use of AR involves the superimposition of a computer-generated image on a user's view of the real world, which enhances the user's perception of reality. There has been a recent, growing interest for the integration of AR in medical education, such as in the visualization of anatomical structures, training for various medical procedures and telemedicine guidance for remote procedural training. The real time interactive nature of AR provides immersion, immediate learner support, and has the ability to lower the complexity of learning new tasks by showing the content of the tasks using different perspectives, which is beneficial for both engagement and the learning process.
To date, there are only a few studies which have investigated the application of AR for medical education and procedural learning specifically. Some of the benefits demonstrated by these studies include decreased amount of practice needed, reduced failure rate, improved performance accuracy, accelerated learning, shortened learning curve and better understanding of spatial relationships. However, the majority of studies on the application of AR have been on training for laparoscopy, neurosurgical procedures, and echocardiography. There are currently no studies showing the benefits of AR in endoscopy training.
Furthermore, several studies have shown the importance of self-assessment for suitable lifelong learning of new techniques in minimally invasive surgery and gastrointestinal endoscopy. A study by our group showed that experienced endoscopists had better self-assessment accuracy compared to novice endoscopists, therefore, a targeted intervention to help novice endoscopists is needed so that they may seek appropriate preceptorship during their training. One such targeted intervention to improve self-assessment accuracy may be AR, as it provides immediate and repeated visual support of the perfect approach to perform a specific task, therefore, allowing the trainee to reflect on their performance.
In order to bridge the gap related to AR in endoscopy training, the investigators aim to determine the impact of a simulation-based AR curriculum on areas such as knowledge acquisition, technical performance during simulated polypectomies, non-technical skills during integrated scenarios, and self-assessment accuracy. The investigators hypothesize that AR is an instructional strategy with the potential to offer a highly realistic and meaningful learning experience for novice endoscopists with transferable skills to clinical practice.
- Conditions
- Colonic Polyp
- Being tested
- Augmented reality-based curriculum, Conventional Simulation Curriculum
- Keywords
- Augmented reality, Endoscopy, Polypectomy, Simulation training
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented reality-based curriculumOther
Participants in the Augmented Reality Group will be taught principles in augmented reality and training sessions will be enhanced by an augmented reality platform. This involves training on virtual reality simulators with superimposed videos and guides demonstrating correct procedure. In this study, the videos and guides will be on identifying and removing polyps.
Conventional Simulation CurriculumOther
Participants in this group will will train from low- to high-fidelity colonoscopy simulation. During training, the participants will receive guidance and feedback from expert endoscopists. In addition, there will be didactic sessions covering theory of colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Simulation Curriculum | Active comparator | Four, one-hour small-group sessions on the theory of colonoscopy including pathology, anatomy, and therapeutic technique. Following each session, a multiple choice test on topics covered will be administered. In addition, this group will be given a total of six hours of expert-assisted instruction on both the low-fidelity simulator (1 hour) and the high-fidelity VR simulator (5 hours). During the high-fidelity simulation, endoscopic procedures will be performed with instructor support. The difficulty of the therapeutic intervention (polypectomy) will rise after each successfully completed module. The last two hours of training on the high-fidelity simulator will consist of two integrated scenarios. Receives: Other: Conventional Simulation Curriculum |
| Augmented Reality Group | Experimental | This group will receive the same 4 hours of small group teaching and 6-hours of hands-on simulator training. The intervention is the augmented reality-based curriculum: (1) a brief explanation of the principles of AR and how it will be used during the VR simulations and (2) performance of the therapeutic procedure (polypectomy) as demonstrated by the real-time AR platform. Specific videos corresponding to the therapeutic intervention and pathology (e.g pedunculated vs non-pedunculated polyp) will be available every time a polypectomy is required. Each new module will come with increased technical challenges and will require adjustment to previously used technique by the learner. The last two hours of training on the high-fidelity simulator will consist of two integrated scenarios. Receives: Other: Augmented reality-based curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical performance during simulated polypectomies
The primary outcome measure is change in polypectomy technical performance between during the Integrated Scenario Tests and in Polypectomy Simulator Tests from pre-tests as assessed using the Direct Observation of Polypectomy Skills assessment tool (DOPyS; a validated task-specific polypectomy scoring tool) by two experienced endoscopists who will be blinded to group assignment. Range is scored from 0 to 100%; higher values represent a better outcome.
Measured: The change in DOPyS score will be assessed between pre-test and post-test done 6 weeks after the intervention.
Secondary outcomes (7)
Technical performance during simulated and live colonoscopies
Performance during simulated (pre, post, delayed) and two live clinical colonoscopies will be assessed using the Joint Advisory Group Direct Observation of Procedural Skills tool, a validated task-specific tool for performance in colonoscopy. Range is scored from 0 to 100%; higher values represent a better outcome.
Measured: The change in technical performance will be measured between a pre-test and post-test 6 weeks after the intervention.
Self-assessment of colonoscopy performance
Participants will be asked to assess their own colonoscopy performance using the Gastrointestinal Endoscopy Competency Assessment Tool (GiECAT). This will be compared with assessor evaluations. The purpose of this outcome measure is to investigate whether augmented reality helps improve self-assessment accuracy in novice endoscopists. The GiECAT is represented as a percentage from 0-100, with higher percentage score indicating greater self-assessment of performance, a better outcome.
Measured: The self-assessment will be at the time of the Integrated Scenario Tests 6 weeks after the intervention.
Non-technical skill performance during the Integrated Scenario Test
The non-technical skill performance will be measured using the Modified Objective Structured Assessment of Non-Technical Skills (MOSANTS) tool for colonoscopy. This is a score from 5-25, with higher scores indicating greater non-technical skill performance.
Measured: Participant non-technical skill performance will be measured during the integrated scenario six weeks after the intervention.
Patient Comfort during live colonoscopies
Assessed by the Nurse-Assessed Patient Comfort Score (NAPCOMS), a validated score for patient comfort in colonoscopy, ranging from 0-9, with higher scores indicating less comfort, a worse outcome.
Measured: This will be measured during colonoscopies performed 6 weeks after the intervention.
Self-Efficacy
Participants will be asked to complete a questionnaire using the adapted General Self-Efficacy Scale. This validated score of self-efficacy has a scale from 4-40, with higher scores indicating higher self-efficacy (a better outcome).
Measured: This will be measured at time of post-tests done 6 weeks after the intervention.
Cognitive Load
Participants will be asked to complete a questionnaire that includes the Cognitive Load Inventory for Colonoscopy (CLIC) Scale, a validated colonoscopy-specific cognitive load scale. This scale ranges from 0 to 150, with higher scores indicating greater cognitive load (a worse outcome).
Measured: This will be measured at time of post-tests done 6 weeks after the intervention.
Knowledge acquisition
Measured by the change in the colonoscopy-specific knowledge multiple choice test (a validated cognitive assessment tool for colonoscopy) between pre-test and post-test. This tool has been used in many prior studies in simulation in colonoscopy, is scored from 0-20 with higher scores indicating greater knowledge (a better outcome).
Measured: This will be measured as the difference in score between pre-test and post-test, administered 6 weeks after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start17 Jun 2019
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group, single-blinded, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Grover, MD, MEd, FRCPC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826069
- Sponsor's protocol ID
- 18-389
- Status last verified
- Nov 2022
- First submitted
- 28 Jan 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Augmented Reality on Procedural Skills Acquisition in a Simulation-based Training Curriculum for Polypectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03826069
- Acronym / sponsor ID
- 18-389
- Conditions
- Colonic Polyp
- Keywords
- Augmented reality, Endoscopy, Polypectomy, Simulation training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Simulation-based training (SBT) is a safe and effective strategy for improving skills development in gastrointestinal endoscopy. The use of curricula based on progressive learning, as well as comprehensive structured curricula, have been demonstrated to be effective in enhancing simulation-based training. With current advancements in technologies, another possible enhancement to SBT is the use of augmented reality (AR). To date, no other studies have examined the benefits of AR technology in endoscopy training. This study aims to evaluate the effectiveness of a simulation-based AR curriculum in developing technical skills, self-assessment accuracy, and clinical performance; as compared to a conventional simulation curriculum.
Thirty six novice endoscopists will be recruited from the gastroenterology and general surgery programs at the University of Toronto. Participants will be randomized and assigned to two groups. The Conventional Simulation Training Curriculum group will receive 6 hours of simulated training, with expert feedback, and four 1-hour didactic teaching sessions. The AR Training Curriculum group will receive the same number of training hours and didactic sessions as the control group. The main difference is the use of superimposed videos to guide the intervention group through simulated polypectomy cases. During the didactic teaching sessions, the intervention group will also receive a brief introduction to principles of AR and its uses for endoscopy simulation. Participants will be trained to perform colonoscopies on two validated simulator models: (1) a bench-top colonoscopy simulator; and (2) the EndoVR® virtual reality simulator. Performance will be assessed before training (pre-test), immediately after training (acquisition post-test) and 4-6 weeks after training (retention test). On the same day as the retention test, the participants will perform two live colonoscopies and use a mechanical polypectomy simulation test (transfer tests), assessed by two blinded expert endoscopists.
The main hypothesis of this study is that novices trained under the AR-enhanced curriculum will have better technical skill performance during simulated polypectomies and live colonoscopies.
Detailed description
Simulation-based training (SBT) provides a safe and effective means to enhance skills development. Simulation-based curricula have been developed for a number of minimally invasive procedures, and more recently in gastrointestinal endoscopy. Previous studies have demonstrated the effectiveness of comprehensive structured curricula and curricula based on progressive learning in endoscopic simulation. However, as digital technologies evolve, other educational strategies using the latest innovations may aid to further enhance procedural skills training during simulation. One such strategy may lie in augmented reality (AR).
The use of AR involves the superimposition of a computer-generated image on a user's view of the real world, which enhances the user's perception of reality. There has been a recent, growing interest for the integration of AR in medical education, such as in the visualization of anatomical structures, training for various medical procedures and telemedicine guidance for remote procedural training. The real time interactive nature of AR provides immersion, immediate learner support, and has the ability to lower the complexity of learning new tasks by showing the content of the tasks using different perspectives, which is beneficial for both engagement and the learning process.
To date, there are only a few studies which have investigated the application of AR for medical education and procedural learning specifically. Some of the benefits demonstrated by these studies include decreased amount of practice needed, reduced failure rate, improved performance accuracy, accelerated learning, shortened learning curve and better understanding of spatial relationships. However, the majority of studies on the application of AR have been on training for laparoscopy, neurosurgical procedures, and echocardiography. There are currently no studies showing the benefits of AR in endoscopy training.
Furthermore, several studies have shown the importance of self-assessment for suitable lifelong learning of new techniques in minimally invasive surgery and gastrointestinal endoscopy. A study by our group showed that experienced endoscopists had better self-assessment accuracy compared to novice endoscopists, therefore, a targeted intervention to help novice endoscopists is needed so that they may seek appropriate preceptorship during their training. One such targeted intervention to improve self-assessment accuracy may be AR, as it provides immediate and repeated visual support of the perfect approach to perform a specific task, therefore, allowing the trainee to reflect on their performance.
In order to bridge the gap related to AR in endoscopy training, the investigators aim to determine the impact of a simulation-based AR curriculum on areas such as knowledge acquisition, technical performance during simulated polypectomies, non-technical skills during integrated scenarios, and self-assessment accuracy. The investigators hypothesize that AR is an instructional strategy with the potential to offer a highly realistic and meaningful learning experience for novice endoscopists with transferable skills to clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group, single-blinded, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Conventional Simulation Curriculum | Active comparator | Other: Conventional Simulation CurriculumFour, one-hour small-group sessions on the theory of colonoscopy including pathology, anatomy, and therapeutic technique. Following each session, a multiple choice test on topics covered will be administered. In addition, this group will be given a total of six hours of expert-assisted instruction on both the low-fidelity simulator (1 hour) and the high-fidelity VR simulator (5 hours). During the high-fidelity simulation, endoscopic procedures will be performed with instructor support. The difficulty of the therapeutic intervention (polypectomy) will rise after each successfully completed module. The last two hours of training on the high-fidelity simulator will consist of two integrated scenarios. |
| Augmented Reality Group | Experimental | Other: Augmented reality-based curriculumThis group will receive the same 4 hours of small group teaching and 6-hours of hands-on simulator training. The intervention is the augmented reality-based curriculum: (1) a brief explanation of the principles of AR and how it will be used during the VR simulations and (2) performance of the therapeutic procedure (polypectomy) as demonstrated by the real-time AR platform. Specific videos corresponding to the therapeutic intervention and pathology (e.g pedunculated vs non-pedunculated polyp) will be available every time a polypectomy is required. Each new module will come with increased technical challenges and will require adjustment to previously used technique by the learner. The last two hours of training on the high-fidelity simulator will consist of two integrated scenarios. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Postgraduate trainees in the gastroenterology, general surgery, or internal medicine residency programs
- Performed 25 or less live or simulated endoscopic procedures
Key exclusion criteria (1 listed)
- Performed more than 25 live or simulated endoscopic procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented reality-based curriculumParticipants in the Augmented Reality Group will be taught principles in augmented reality and training sessions will be enhanced by an augmented reality platform. This involves training on virtual reality simulators with superimposed videos and guides demonstrating correct procedure. In this study, the videos and guides will be on identifying and removing polyps. | Other | Augmented Reality Group |
| Conventional Simulation CurriculumParticipants in this group will will train from low- to high-fidelity colonoscopy simulation. During training, the participants will receive guidance and feedback from expert endoscopists. In addition, there will be didactic sessions covering theory of colonoscopy. | Other | Conventional Simulation Curriculum |
Primary outcome
Technical performance during simulated polypectomies
Time frame: The change in DOPyS score will be assessed between pre-test and post-test done 6 weeks after the intervention.
The primary outcome measure is change in polypectomy technical performance between during the Integrated Scenario Tests and in Polypectomy Simulator Tests from pre-tests as assessed using the Direct Observation of Polypectomy Skills assessment tool (DOPyS; a validated task-specific polypectomy scoring tool) by two experienced endoscopists who will be blinded to group assignment. Range is scored from 0 to 100%; higher values represent a better outcome.
7 secondary outcomes
Technical performance during simulated and live colonoscopies
Time frame: The change in technical performance will be measured between a pre-test and post-test 6 weeks after the intervention.
Self-assessment of colonoscopy performance
Time frame: The self-assessment will be at the time of the Integrated Scenario Tests 6 weeks after the intervention.
Non-technical skill performance during the Integrated Scenario Test
Time frame: Participant non-technical skill performance will be measured during the integrated scenario six weeks after the intervention.
Patient Comfort during live colonoscopies
Time frame: This will be measured during colonoscopies performed 6 weeks after the intervention.
Self-Efficacy
Time frame: This will be measured at time of post-tests done 6 weeks after the intervention.
Cognitive Load
Time frame: This will be measured at time of post-tests done 6 weeks after the intervention.
Knowledge acquisition
Time frame: This will be measured as the difference in score between pre-test and post-test, administered 6 weeks after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Grover, MD, MEd, FRCPC principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented reality-based curriculum and Conventional Simulation Curriculum in people with Colonic Polyp, run by Unity Health Toronto at 1 site in Canada.
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 2 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikko Gimpaya, HBSc (416-864-5628, gimpayan@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical performance during simulated polypectomies (time frame: The change in DOPyS score will be assessed between pre-test and post-test done 6 weeks after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2022.