Simulation Based Training in Colonoscopy

Group Identification Clinical Trial

Official title:

Simulation-based Training for Colonoscopy: Establishing Criteria for Competency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043327
• Other study ID #: PassFailstudy
• Status: Completed
• Phase: N/A
• First received: January 10, 2014
• Last updated: January 21, 2014
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

The aim of this study is to create simulation-based tests with credible pass/fail-standards for two different fidelities of colonoscopy models

1. virtual reality simulator

2. physical model simulator To create pass/ fail standards for certification

Description:

Twenty-five physicians (10 consultants with endoscopic experience and 15 fellows in the first year of fellowship without endoscopic experience) will be tested twice on each of the two different simulator models.

Metrics with discriminatory ability will be identified for both modalities. Reliability will be determined A pass/ fail standard will be determined and the concequences explored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 28 Years to 64 Years

Eligibility

Inclusion Criteria: For the two groups

Experienced endoscopists :

Having performed >350 colonoscopy procedures

Novice endoscopists:

First or second year of fellowship in gastroenterology Having performed less than 3 colonoscopies

Exclusion Criteria: For the two groups

Experienced endoscopists:

Prior simulator training

Novice endoscopists:

Prior simulator training

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Group Identification

Locations

Country	Name	City	State
Denmark	Rigshospitalet; CEKU	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metrics with discriminatory ability measuring colonoscopy competence	Each participant perform two tests on each model within the same day.	tests were carried out in one day per participant	No