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Simulator Training for Gastrointestinal Endoscopy

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Terminated
CT.gov ID
NCT01405443
Collaborator
(none)
20
Enrollment
1
Location
35
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized controlled trial evaluating three training intervals using an endoscopy simulator for novices and comparing performance after training.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Randomized controlled trial evaluating different training intervals on an endoscopy simulator and comparing performance using a validated score (Global assessment of Gastrointestinal Endoscopic Skills). Physicians participating in the study are novices with no previous experience in flexible endoscopy. Subjects are randomized into three different training arms. Proficiency scores will be evaluated by a supervising physician blinded to group allocation.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Simulator Training for Gastrointestinal Endoscopy - How Much Simulator Training is Required to Acquire Proficiency in Gastrointestinal Endoscopy?
    Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Basic training

    Theory lecture esophagogastroduodenoscopy (EGD). One hour simulator training for EGD. 30 minutes supervised training. Supervised endoscopy. Theory lecture Colonoscopy. One hour simulator training for Colonoscopy. 30 minutes supervised training. Supervised endoscopy. Group will be followed up for 2 weeks training time.
    Intermediate training

    Theory lecture EGD. Three hours simulator training for EGD. 60 minutes supervised training. Supervised endoscopy. Theory lecture Colonoscopy. Three hours simulator training for Colonoscopy. 60 minutes supervised training. Supervised endoscopy. Group will be followed up for 4 weeks training time.
    Extended training

    Theory lecture EGD. Five hours simulator training for EGD. 90 minutes supervised training. Supervised endoscopy. Theory lecture Colonoscopy. Five hours simulator training for Colonoscopy. 90 minutes supervised training. Supervised endoscopy. Group will be followed up for 6 weeks training time.

    Outcome Measures

    Primary Outcome Measures

    1. Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group one [Score is evaluated after one week training]

      Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation.

    2. Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group three [Score is evaluated after three weeks of training]

      Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation.

    3. Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group two [Score is evaluated after two weeks of training]

      Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation.

    Secondary Outcome Measures

    1. Simulator score [Score is evaluated after the training period (at one week for group 1, at 2 weeks for group 2, and at three weeks for group 3)]

      Scores as evaluated by the Simbionix simulator software

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Physicians in residency or fellowship programs requiring training in flexible endoscopy (gastroenterology, internal medicine, surgery) with no experience in flexible endoscopy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitätsklinikum Hamburg-Eppendorf Hamburg Germany 20246

    Sponsors and Collaborators

    • Universitätsklinikum Hamburg-Eppendorf

    Investigators

    • Principal Investigator: Thomas Rösch, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. Thomas Rösch, Prof. Dr. Thomas Roesch, Universitätsklinikum Hamburg-Eppendorf, Endoscopy department, Universitätsklinikum Hamburg-Eppendorf
    ClinicalTrials.gov Identifier:
    NCT01405443
    Other Study ID Numbers:
    • UKE Hamburg Endoscopy PV3656
    First Posted:
    Jul 29, 2011
    Last Update Posted:
    Jun 6, 2019
    Last Verified:
    Jun 1, 2019
    Keywords provided by Prof. Dr. Thomas Rösch, Prof. Dr. Thomas Roesch, Universitätsklinikum Hamburg-Eppendorf, Endoscopy department, Universitätsklinikum Hamburg-Eppendorf
    Simulator training
    Flexible endoscopy
    Gastrointestinal endoscopy
    Colonoscopy
    Training
    Performance

    Study Results

    No Results Posted as of Jun 6, 2019