Simulation Based Training in Colonoscopy

January 21, 2014 updated by: Louise Preisler, Rigshospitalet, Denmark

Simulation-based Training for Colonoscopy: Establishing Criteria for Competency

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

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

25

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
      • Copenhagen, Denmark, 2100
        • Rigshospitalet; CEKU

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

28 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Experienced: 10 consultants of gastroenterology with experience in Colonoscopy (>350 procedures) Novices: 15 fellows of gastroenterology with limited experience in Colonoscopy (<2 procedures)

Description

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 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

  • Observational Models: Case-Control

Cohorts and Interventions

Group / Cohort
Experienced in Colonoscopy
two tests on two different modalities of colonoscopy simulators
Novices in colonoscopy
Two tests on each of trw colonoscopy simulators

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metrics with discriminatory ability measuring colonoscopy competence
Time Frame: tests were carried out in one day per participant
Each participant perform two tests on each model within the same day.
tests were carried out in one day per participant

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Louise Preisler, MD, Rigshospitalet, Copenhagen, University of Copenhagen

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

November 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Estimate)

January 23, 2014

Last Update Submitted That Met QC Criteria

January 21, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PassFailstudy

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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