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Simulation Based Training in Colonoscopy

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT02043327
Collaborator
(none)
25
Enrollment
1
Location
12
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    25 participants
    Observational Model:
    Case-Control
    Official Title:
    Simulation-based Training for Colonoscopy: Establishing Criteria for Competency
    Study Start Date :
    Nov 1, 2012
    Actual Primary Completion Date :
    Mar 1, 2013
    Actual Study Completion Date :
    Nov 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Experienced in Colonoscopy

    two tests on two different modalities of colonoscopy simulators
    Novices in colonoscopy

    Two tests on each of trw colonoscopy simulators

    Outcome Measures

    Primary Outcome Measures

    1. Metrics with discriminatory ability measuring colonoscopy competence [tests were carried out in one day per participant]

      Each participant perform two tests on each model within the same day.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    28 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rigshospitalet; CEKU Copenhagen Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Louise Preisler, MD, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT02043327
    Other Study ID Numbers:
    • PassFailstudy
    First Posted:
    Jan 23, 2014
    Last Update Posted:
    Jan 23, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by Louise Preisler, MD, Rigshospitalet, Denmark
    Colonoscopy
    assessment
    certification,
    simulation,
    standard setting

    Study Results

    No Results Posted as of Jan 23, 2014