Using Simulation to Ensure Basic Competence in Gastroscopy

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.

Study Overview

• Status: Completed
• Conditions: Simulation; Endoscopy; Education; Gastroscopy
• Intervention / Treatment: Other: Simulation training in gastroscopy

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Simulation gastroscopy test score	Test score based on time usage, landmark and pathology recognition	1-hour test

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: OP_971

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No