Impact of Augmented Reality in Polypectomy Skills Acquisition in Simulation-based Endoscopy Training

NCT03826069 | Unknown

• 1 other identifier: 18-389
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colonic Polyp

Keywords

Augmented reality; Endoscopy; Polypectomy; Simulation training

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  Participant non-technical skill performance will be measured during the integrated scenario six weeks after the intervention.

• Patient Comfort during live colonoscopies

  This will be measured during colonoscopies performed 6 weeks after the intervention.

• Self-Efficacy

  This will be measured at time of post-tests done 6 weeks after the intervention.

Study Arms (2)

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.

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.

Other: Augmented reality-based curriculum

Interventions

Augmented reality-based curriculum OTHER

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.

Augmented Reality Group

Conventional Simulation Curriculum OTHER

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.

Conventional Simulation Curriculum

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Postgraduate trainees in the gastroenterology, general surgery, or internal medicine residency programs
• Performed 25 or less live or simulated endoscopic procedures

You may not qualify if:

• Performed more than 25 live or simulated endoscopic procedures

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Samir Grover, MD, MEd, FRCPC

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikko Gimpaya, HBSc

CONTACT

416-864-5628; gimpayan@smh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Expert endoscopists will assess the performance of the participants during simulated colonoscopy, simulated polypectomies, simulated scenarios, and two live colonoscopy procedures. Assessors will have no knowledge of the group assignments and assessments will be done by viewing video recordings of the participants. The videos will be edited to remove the faces and other identifiable characteristics of the participants and patients.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group, single-blinded, randomized controlled trial

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 1, 2019
• Study Start: June 17, 2019
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)