Using Simulation to Ensure Basic Competence in Gastroscopy
1 other identifier
observational
35
1 country
1
Brief Summary
The main purpose of this study is to develop and gather validity evidence for a simulation-based test to ensure learning basic competence in gastroscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 29, 2019
CompletedFirst Posted
Study publicly available on registry
November 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedOctober 1, 2021
September 1, 2021
2 months
October 29, 2019
September 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Simulation gastroscopy test score
Test score based on time usage, landmark and pathology recognition
1-hour test
Secondary Outcomes (3)
Total time for the diagnostic exercises
1-hour test
Total time for the tool exercises
1-hour test
Total landmark and pathology recognition for the diagnostic exercises
1-hour test
Study Arms (3)
Novices
Medical students
Intermediates
Endoscopy (EGD) assisting nurses. No prior self-performed endoscopies
Experienced
Medical doctors in medical Gastroenterology or surgery, who have self-performed more than 500 EGD
Interventions
Simulation-based training with virtual reality simulation at a Simbionix GI-mentor II endoscopy simulator and procedure training on a phantom.
Eligibility Criteria
The medical students will be recruited after passing their anatomy exam at the University of Southern Denmark. The endoscopy nurses will be recruited at Odense University Hospital. Medical doctors in medical gastroenterology and surgery will be recruited at the Odense University Hospital, Denmark.
You may qualify if:
- Medical students enrolled at the University of Southern Denmark who have passed their anatomy exam.
- Experienced endoscopy nurses, who have assisted to more than 100 gastroscopies and with no prior self-performed gastroscopies.
- Experienced medical doctors in medical gastroenterology or surgery, who have self-performed more than 500 gastroscopies.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Odense University Hospital
Odense, 5000, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
October 29, 2019
First Posted
November 4, 2019
Study Start
October 1, 2019
Primary Completion
November 30, 2019
Study Completion
January 1, 2020
Last Updated
October 1, 2021
Record last verified: 2021-09