NCT04898803|Completed
How Effective Can a Simulator-Based Training Course For Beginners In Endoscopy Be Made?
EFFEKTRA
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EFFEKTRA
Sponsor study identifier
observational
32
1 country
2
Study Start
August 3, 2020
Actual (reported)Primary Completion
December 14, 2022
Actual (reported)Study Completion
December 14, 2022
Actual (reported)The aim of the study is to clarify whether physicians training for gastroscopies benefit from a modified training course. The duration and type of optimized use of training simulators as part of a basic gastroscopy course can lead to a higher level of competence in patient examinations (main target parameters) than conventional use. Further goals are the comparison of the theoretical knowledge gained through the modified versus conventional course, as well as the self-assessment of the participants.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 14, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 3, 2020
Actual (reported)January 25, 2021
Actual (reported)May 24, 2021
Actual (reported)December 14, 2022
Actual (reported)December 14, 2022
Actual (reported)Global Assessment of Gastrointestinal Endoscopic Skills (GAGES) competence score competence score
Comparison of the GAGES competence score of the video-based observations of the first two patient examinations, each assessed by two endoscopists. To be valuated: intubation of esophagus, scope navigation, ability to keep a clear endoscope field, instrumentation, quality of examination. Best score each question 5 pts, worst 1 pt.
one to five weeks after training course
Non-inferiority of the new training procedure
Non-inferiority of the new training procedure in the final exams according to DGVS criteria
through study completion, approximately 1 year
competence assessment Direct Observation of Procedural Skills (DOPS) by Joint Advisory Group on Gastrointestinal Endoscopy (JAG)
one to five weeks after training course
Assessment of Competency in Endoscopy (ACE)
one to five weeks after training course
mean self-assessment by Visual Analog Scale (VAS)
one to five weeks after training course
physicians receive the DGVS-recommended training, consisting of a 2-day course with 1 hour of simulator training
physicians receive a two-day simulator course with a minimum of 6 hours of simulator training per trainee, structured in stages in the sense of progressive or mastery learning. The initial part of the training will be part-task training.
see above
see above
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
see above
University Hospital Eppendorf
Hamburg, 20246, Germany
Albertinen Krankenhaus
Hamburg, 22457, Germany
Amiot A, Conroy G, Le Baleur Y, Winkler J, Palazzo M, Treton X. Endoscopic training: A nationwide survey of French fellows in gastroenterology. Clin Res Hepatol Gastroenterol. 2018 Apr;42(2):160-167. doi: 10.1016/j.clinre.2017.08.005. Epub 2017 Sep 18.
Jirapinyo P, Thompson CC. Current status of endoscopic simulation in gastroenterology fellowship training programs. Surg Endosc. 2015 Jul;29(7):1913-9. doi: 10.1007/s00464-014-3884-0. Epub 2014 Oct 11.
Thomas Rösch, Prof. Dr.
Universitätsklinikum Hamburg-Eppendorf
32 participants (actual enrollment reported by the registry).
First Submitted
January 25, 2021
First Posted
May 24, 2021
Study Start
August 3, 2020
Actual (reported)Contact the study team to confirm eligibility.
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A Simulation-Based Training Curriculum of Progressive Fidelity and Complexity Improves Technical and Non-Technical Skills in Colonoscopy: a Blinded, Randomized Trial
Harewood GC, Murray F, Winder S, Patchett S. Evaluation of formal feedback on endoscopic competence among trainees: the EFFECT trial. Ir J Med Sci. 2008 Sep;177(3):253-6. doi: 10.1007/s11845-008-0161-z. Epub 2008 Jun 27.
IMPACT OF A GAME-BASED LEARNING INTERVENTION IN SIMULATION-BASED ENDOSCOPY TRAINING ON COLONOSCOPY PERFORMANCE IN NOVICE ENDOSCOPISTS - A RANDOMIZED CONTROLLED TRIAL
Hashimoto DA, Petrusa E, Phitayakorn R, Valle C, Casey B, Gee D. A proficiency-based virtual reality endoscopy curriculum improves performance on the fundamentals of endoscopic surgery examination. Surg Endosc. 2018 Mar;32(3):1397-1404. doi: 10.1007/s00464-017-5821-5. Epub 2017 Aug 15.
Ritter EM, Taylor ZA, Wolf KR, Franklin BR, Placek SB, Korndorffer JR Jr, Gardner AK. Simulation-based mastery learning for endoscopy using the endoscopy training system: a strategy to improve endoscopic skills and prepare for the fundamentals of endoscopic surgery (FES) manual skills exam. Surg Endosc. 2018 Jan;32(1):413-420. doi: 10.1007/s00464-017-5697-4. Epub 2017 Jul 11.
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ASGE Training Committee; Sedlack RE, Coyle WJ, Obstein KL, Al-Haddad MA, Bakis G, Christie JA, Davila RE, DeGregorio B, DiMaio CJ, Enestvedt BK, Jorgensen J, Mullady DK, Rajan L. ASGE's assessment of competency in endoscopy evaluation tools for colonoscopy and EGD. Gastrointest Endosc. 2014 Jan;79(1):1-7. doi: 10.1016/j.gie.2013.10.003. Epub 2013 Nov 14. No abstract available.
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Primary Completion
December 14, 2022
Actual (reported)Study Completion
December 14, 2022
Actual (reported)Last Updated
June 28, 2023
Record last verified: 2023-06
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