Simulator Training for Gastrointestinal Endoscopy

This study has been terminated.
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Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01405443
First received: April 15, 2011
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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


Condition
Performance of Inappropriate Operation

Study Type: Observational
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group one [ Time Frame: Score is evaluated after one week training ] [ Designated as safety issue: No ]
    Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation.

  • Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group three [ Time Frame: Score is evaluated after three weeks of training ] [ Designated as safety issue: No ]
    Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation.

  • Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group two [ Time Frame: Score is evaluated after two weeks of training ] [ Designated as safety issue: No ]
    Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation.


Secondary Outcome Measures:
  • Simulator score [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Scores as evaluated by the Simbionix simulator software


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405443

Locations
Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Thomas Rösch, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
  More Information

No publications provided

Responsible Party: Prof. Dr. Thomas Rösch, Prof. Dr. Thomas Roesch, Universitätsklinikum Hamburg-Eppendorf, Endoscopy department, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01405443     History of Changes
Other Study ID Numbers: UKE Hamburg Endoscopy PV3656
Study First Received: April 15, 2011
Last Updated: April 15, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Simulator training
Flexible endoscopy
Gastrointestinal endoscopy
Colonoscopy
Training
Performance

ClinicalTrials.gov processed this record on July 26, 2014