Simulation-assisted Teaching in Learning Gastroscopy

May 30, 2022 updated by: Anders Bo Nielsen
This project is a single-blinded randomized controlled trial investigating the effect of simulation-based teaching in learning gastroscopy for medical doctors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Of Southern Denmark
      • Odense, Region Of Southern Denmark, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medical doctors in medical gastroenterology or surgery

Exclusion Criteria:

  • prior experience with gastroscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Simulation-based learning + clinical training
Other: Simulation-based learning
Pre-clinical simulation-based learning at Simbionix GI-mentor II virtual reality simulator and OGI CLA 4 phantom.
NO_INTERVENTION: Clinical training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of procedures before declared unassisted
Time Frame: 1 year
Number of gastroscopies before the supervisor declare the participant ready to do unassisted upper GI endoscopies
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 1 year
Survey using "Gastrointestinal Endoscopy Satisfaction Questionnaire" a validated questionnaire using a scale from 1-5 (5 is the best).
1 year
Complication rate
Time Frame: 1 year
1 year
Mucosa visualization percent of the upper gastrointestinal tract
Time Frame: 1 year
Assessed by endoscopy experts at video documented endoscopies
1 year
Duration of intubation
Time Frame: 1 year
Duration of time that the patient is intubated with the endoscope
1 year
Time
Time Frame: 1 year
Total time for the procedure
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anders Bo Nielsen

Investigators

  • Principal Investigator: Anders Bo Nielsen, MD, Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2020

Primary Completion (ACTUAL)

January 30, 2022

Study Completion (ACTUAL)

May 1, 2022

Study Registration Dates

First Submitted

December 19, 2019

First Submitted That Met QC Criteria

January 28, 2020

First Posted (ACTUAL)

January 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 30, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • OP_972

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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