Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-01 @ 6:25 AM
Study NCT ID:
NCT04898803
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2021-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How Effective Can a Simulator-Based Training Course For Beginners In Endoscopy Be Made?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-05-18', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Assessment of Gastrointestinal Endoscopic Skills (GAGES) competence score competence score', 'timeFrame': 'one to five weeks after training course', 'description': '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.'}, {'measure': 'Non-inferiority of the new training procedure', 'timeFrame': 'through study completion, approximately 1 year', 'description': 'Non-inferiority of the new training procedure in the final exams according to DGVS criteria'}], 'secondaryOutcomes': [{'measure': 'competence assessment Direct Observation of Procedural Skills (DOPS) by Joint Advisory Group on Gastrointestinal Endoscopy (JAG)', 'timeFrame': 'one to five weeks after training course', 'description': 'Comparison of the JAG DOPS competence level of the video-based observations of the first two patient examinations, each assessed by two endoscopists. Assession of trainee\'s needed level of supervision at pre- and post procedure, insertion and withdrawal, visualisation, management of findings, and non-technical skills. Each has 4 values, best is "Competent for independent practice", worst is "maximal supervision"'}, {'measure': 'Assessment of Competency in Endoscopy (ACE)', 'timeFrame': 'one to five weeks after training course', 'description': 'Comparison of the ACE competence evaluation of the video-based observations of the first two patient examinations, each assessed by two endoscopists.'}, {'measure': 'mean self-assessment by Visual Analog Scale (VAS)', 'timeFrame': 'one to five weeks after training course', 'description': 'VAS after the first two patient examinations. This enables an assessment of the stress level and ultimately a measurement of the cognitive load of the subject. To be evaluated on a non-scaled line from "do not agree at all" to "totally agree".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['simulator training', 'gastroscopy training', 'physicians training'], 'conditions': ['Physicians Gastroscopy Training']}, 'referencesModule': {'references': [{'pmid': '28927657', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25303910', 'type': 'BACKGROUND', 'citation': '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. 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Epub 2017 Feb 22.'}, {'pmid': '24770972', 'type': 'BACKGROUND', 'citation': 'Thompson CC, Jirapinyo P, Kumar N, Ou A, Camacho A, Lengyel B, Ryan MB. Development and initial validation of an endoscopic part-task training box. Endoscopy. 2014 Sep;46(9):735-44. doi: 10.1055/s-0034-1365463. Epub 2014 Apr 25.'}, {'pmid': '25475901', 'type': 'BACKGROUND', 'citation': 'Koch AD, Ekkelenkamp VE, Haringsma J, Schoon EJ, de Man RA, Kuipers EJ. Simulated colonoscopy training leads to improved performance during patient-based assessment. Gastrointest Endosc. 2015 Mar;81(3):630-6. doi: 10.1016/j.gie.2014.09.014. Epub 2014 Dec 2.'}, {'pmid': '20112113', 'type': 'BACKGROUND', 'citation': 'Vassiliou MC, Kaneva PA, Poulose BK, Dunkin BJ, Marks JM, Sadik R, Sroka G, Anvari M, Thaler K, Adrales GL, Hazey JW, Lightdale JR, Velanovich V, Swanstrom LL, Mellinger JD, Fried GM. Global Assessment of Gastrointestinal Endoscopic Skills (GAGES): a valid measurement tool for technical skills in flexible endoscopy. 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No abstract available."}, {'pmid': '21416186', 'type': 'BACKGROUND', 'citation': 'van Dongen KW, Verleisdonk EJ, Schijven MP, Broeders IA. Will the Playstation generation become better endoscopic surgeons? Surg Endosc. 2011 Jul;25(7):2275-80. doi: 10.1007/s00464-010-1548-2. Epub 2011 Mar 17.'}, {'pmid': '28859953', 'type': 'BACKGROUND', 'citation': 'Scaffidi MA, Grover SC, Carnahan H, Yu JJ, Yong E, Nguyen GC, Ling SC, Khanna N, Walsh CM. A prospective comparison of live and video-based assessments of colonoscopy performance. Gastrointest Endosc. 2018 Mar;87(3):766-775. doi: 10.1016/j.gie.2017.08.020. Epub 2017 Aug 30.'}, {'pmid': '27170086', 'type': 'BACKGROUND', 'citation': "Sewell JL, Boscardin CK, Young JQ, Ten Cate O, O'Sullivan PS. Measuring cognitive load during procedural skills training with colonoscopy as an exemplar. Med Educ. 2016 Jun;50(6):682-92. doi: 10.1111/medu.12965."}, {'pmid': '28445213', 'type': 'BACKGROUND', 'citation': "Sewell JL, Boscardin CK, Young JQ, Ten Cate O, O'Sullivan PS. Learner, Patient, and Supervisor Features Are Associated With Different Types of Cognitive Load During Procedural Skills Training: Implications for Teaching and Instructional Design. Acad Med. 2017 Nov;92(11):1622-1631. doi: 10.1097/ACM.0000000000001690."}, {'pmid': '16116532', 'type': 'BACKGROUND', 'citation': 'Thomas-Gibson S, Saunders BP. Development and validation of a multiple-choice question paper in basic colonoscopy. Endoscopy. 2005 Sep;37(9):821-6. doi: 10.1055/s-2005-870202.'}, {'pmid': '12518123', 'type': 'BACKGROUND', 'citation': 'Bini EJ, Firoozi B, Choung RJ, Ali EM, Osman M, Weinshel EH. Systematic evaluation of complications related to endoscopy in a training setting: A prospective 30-day outcomes study. Gastrointest Endosc. 2003 Jan;57(1):8-16. doi: 10.1067/mge.2003.15.'}, {'pmid': '31040624', 'type': 'BACKGROUND', 'citation': 'Fudman DI, Falchuk KR, Feuerstein JD. Complication rates of trainee- versus attending-performed upper gastrointestinal endoscopy. Ann Gastroenterol. 2019 May-Jun;32(3):273-277. doi: 10.20524/aog.2019.0372. Epub 2019 Mar 28.'}], 'seeAlsoLinks': [{'url': 'http://www.dgvs.de/fortbildung-aktuell/zertifizierung-endoskopischer-trainingskurse/', 'label': 'certification of endoscopic training by DGVS'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Training in interventional medicine, including surgery and endoscopy, is usually still done on the patient, under more or less qualified supervision. Previous exercises on models or simulators are still the exception and only reach around 40% of colleagues in countries with defined curricula and guidelines.The simulator-based training, however, offers a protected area in which, without risk to the patient, initial learning successes in flexible endoscopy can be achieved according to the "trial and error" principle. Various studies have shown that initial training on the simulator is beneficial: Physicians trained on the simulator require less support during the first examinations on the patient, less examination time, can reach and identify anatomical landmarks better and have better hand-eye coordination.If the simulator training is embedded in a structured curriculum, greater successes seem to be achieved in comparison to unstructured training. The feedback during the training is also a positive influencing factor; this should ideally take place at the end of each unit. It is also possible to use a simulator to train defined partial performances and to repeat these in the required amount. A step-by-step structure with defined intermediate goals, in the sense of mastery learning, also increases effectiveness.There is little data on the optimal duration or the saturation of the learning curve in simulator training. In one study the learning curve flattened after 60 simulated colonoscopies. Another study showed a gradual improvement up to 6 hours on the simulator. It also used threshold values for the performance score to define the optimal point in time for transition to patient-based training.\n\nThe current certification for the standardization of the nationwide endoscopy training courses by the German Gastroenterological Society (DGVS), provides for 4 hours of training on the simulator, including one hour of introduction. With an also recommended maximum group size of 4 participants per simulator, this corresponds to a duration of only 1 hour of effective simulator training per trainee. There are no recommendations for structuring simulator trainings or the type of simulators used.\n\nThe main aim of the present study is to find out whether it is possible to improve this situation without unrealistically extending the training and course times.\n\nTrainees will randomly attend either a conventional training or an extended simulator training. Immediately after the course, in accordance with the DGVS guidelines, an examination of the same content for both groups to inquire the theoretical knowledge is done.1-5 weeks after completion of the training course, an evaluation of the endoscopic skills of the participants takes place. It is done on the patient, under supervision, as is currently customary in everyday clinical training. After a one-day introduction through observation of routine gastroscopies, two gastroscopies are then carried out. Two endoscopists independently assess the performance based on a Video record of the examination. All endoscopists involved in supervision or assessment are blinded to the trainee\'s group membership..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'see above', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nTrainees:\n\n* licensed physicians in internal medicine, surgery or gastroenterology,\n* no endoscopic or laparoscopic experience\n* informed consent\n\nPatient's endoscopies:\n\n* all patients \\> 18 years of age who are capable of being informed and have a clinical indication for esophagogastroduodenoscopy\n* informed consent\n* simple examination expected\n\nExclusion Criteria:\n\nPatient's endoscopies:\n\n\\- difficult examination expected"}, 'identificationModule': {'nctId': 'NCT04898803', 'acronym': 'EFFEKTRA', 'briefTitle': 'How Effective Can a Simulator-Based Training Course For Beginners In Endoscopy Be Made?', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'How Effective Can a Simulator-Based Training Course For Beginners In Endoscopy Be Made?', 'orgStudyIdInfo': {'id': 'PV7217'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'conventional gastroscopy training course', 'description': 'physicians receive the DGVS-recommended training, consisting of a 2-day course with 1 hour of simulator training', 'interventionNames': ['Other: conventional DGVS training']}, {'label': 'extended simulator course', 'description': '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.', 'interventionNames': ['Other: extended simulator training']}], 'interventions': [{'name': 'conventional DGVS training', 'type': 'OTHER', 'description': 'see above', 'armGroupLabels': ['conventional gastroscopy training course']}, {'name': 'extended simulator training', 'type': 'OTHER', 'description': 'see above', 'armGroupLabels': ['extended simulator course']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Hospital Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22457', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Albertinen Krankenhaus', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Thomas Rösch, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'Olympus Deutschland GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Director, Department of Interdisciplinary Endoscopy', 'investigatorFullName': 'Prof. Dr. Thomas Rösch', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}