Using Simulation to Ensure Basic Competence in Gastroscopy

Sponsor

Odense University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04150237

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endoscopy Simulation Education Gastroscopy	Other: Simulation training in gastroscopy

Study Design

Study Type:

Observational

Actual Enrollment :

35 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Using Simulation to Ensure Basic Competence in Gastroscopy

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Nov 30, 2019

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Novices Medical students	Other: Simulation training in gastroscopy Simulation-based training with virtual reality simulation at a Simbionix GI-mentor II endoscopy simulator and procedure training on a phantom.
Intermediates Endoscopy (EGD) assisting nurses. No prior self-performed endoscopies	Other: Simulation training in gastroscopy Simulation-based training with virtual reality simulation at a Simbionix GI-mentor II endoscopy simulator and procedure training on a phantom.
Experienced Medical doctors in medical Gastroenterology or surgery, who have self-performed more than 500 EGD	Other: Simulation training in gastroscopy Simulation-based training with virtual reality simulation at a Simbionix GI-mentor II endoscopy simulator and procedure training on a phantom.

Arm

Intervention/Treatment

Novices

Medical students

Other: Simulation training in gastroscopy

Simulation-based training with virtual reality simulation at a Simbionix GI-mentor II endoscopy simulator and procedure training on a phantom.

Intermediates

Endoscopy (EGD) assisting nurses. No prior self-performed endoscopies

Other: Simulation training in gastroscopy

Simulation-based training with virtual reality simulation at a Simbionix GI-mentor II endoscopy simulator and procedure training on a phantom.

Experienced

Medical doctors in medical Gastroenterology or surgery, who have self-performed more than 500 EGD

Other: Simulation training in gastroscopy

Simulation-based training with virtual reality simulation at a Simbionix GI-mentor II endoscopy simulator and procedure training on a phantom.

Outcome Measures

Primary Outcome Measures

Simulation gastroscopy test score [1-hour test]
Test score based on time usage, landmark and pathology recognition

Secondary Outcome Measures

Total time for the diagnostic exercises [1-hour test]
A total time for two diagnostic virtual reality tests and a test on a phantom
Total time for the tool exercises [1-hour test]
A total time of virtual reality tests and two tests on a phantom
Total landmark and pathology recognition for the diagnostic exercises [1-hour test]
Recognition of a total number of 48 landmarks and pathologies

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odense University Hospital	Odense		Denmark	5000

Sponsors and Collaborators

Odense University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anders Bo Nielsen, Medical Doctor, Odense University Hospital

ClinicalTrials.gov Identifier:

NCT04150237

Other Study ID Numbers:

OP_971

First Posted:

Nov 4, 2019

Last Update Posted:

Oct 1, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 1, 2021