Ignite Creation Date:
2025-12-24 @ 6:57 PM
Ignite Modification Date:
2025-12-29 @ 3:28 PM
Study NCT ID:
NCT02425657
Status:
UNKNOWN
Last Update Posted:
2019-07-05
First Post:
2015-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040261', 'term': 'Harm Reduction'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2015-04-10', 'studyFirstSubmitQcDate': '2015-04-21', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MCSAT (Mayo Clinical Skills Assessment Tool)', 'timeFrame': '12 weeks', 'description': 'Measured at day 0,5,10,15 and 20.'}], 'secondaryOutcomes': [{'measure': 'Endoscopy training computer generated data - Percentage of colon visualized', 'timeFrame': '12 weeks', 'description': 'Computer generated score (Simulator test performed at day 0, 10 and 20)'}, {'measure': 'Endoscopy training computer generated data - Time to cecum', 'timeFrame': '12 weeks', 'description': 'Computer generated score (Simulator test performed at day 0, 10 and 20)colonoscopies)'}, {'measure': 'Endoscopy training computer generated data - Estimated patient pain', 'timeFrame': '12 weeks', 'description': 'Computer generated score (Simulator test performed at day 0, 10 and 20)'}, {'measure': 'Endoscopy training computer generated data: Percentage spent with clear view', 'timeFrame': '12 weeks', 'description': 'Computer generated score (Simulator test performed at day 0, 10 and 20)'}, {'measure': 'Endoscopy training computer generated data - Total score', 'timeFrame': '12 weeks', 'description': 'Computer generated score (Simulator test performed at day 0, 10 and 20)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Education', 'Training', 'Fast track', 'Colonoscopy'], 'conditions': ['Harm Reduction', 'Perforation During Colonoscopy', 'Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '25034851', 'type': 'BACKGROUND', 'citation': "Fried GM, Marks JM, Mellinger JD, Trus TL, Vassiliou MC, Dunkin BJ. ASGE's assessment of competency in endoscopy evaluation tools for colonoscopy and EGD. Gastrointest Endosc. 2014 Aug;80(2):366-7. doi: 10.1016/j.gie.2014.03.019. No abstract available."}, {'pmid': '25634177', 'type': 'BACKGROUND', 'citation': 'Preisler L, Svendsen MBS, Nerup N, Svendsen LB, Konge L. Simulation-based training for colonoscopy: establishing criteria for competency. Medicine (Baltimore). 2015 Jan;94(4):e440. doi: 10.1097/MD.0000000000000440.'}, {'pmid': '21514931', 'type': 'BACKGROUND', 'citation': 'Sedlack RE. Training to competency in colonoscopy: assessing and defining competency standards. Gastrointest Endosc. 2011 Aug;74(2):355-366.e1-2. doi: 10.1016/j.gie.2011.02.019. Epub 2011 Apr 23.'}, {'pmid': '25670810', 'type': 'BACKGROUND', 'citation': 'Kaminski MF, Anderson J, Valori R, Kraszewska E, Rupinski M, Pachlewski J, Wronska E, Bretthauer M, Thomas-Gibson S, Kuipers EJ, Regula J. Leadership training to improve adenoma detection rate in screening colonoscopy: a randomised trial. Gut. 2016 Apr;65(4):616-24. doi: 10.1136/gutjnl-2014-307503. Epub 2015 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'Specially educated trainers will be responsible for colonoscopy training of junior doctors. The educated trainers will have attended seminars held by Valori et al.\n\nThe following fast track colonoscopy training program for junior doctors will consist of: 1) Endoscopy simulation training and theory course 2) supervised and partly supervised lower endoscopy. 3) Directly observed practical skills according graded by MCSAT (Mayo Clinical Skills Assessment Tool) .', 'detailedDescription': 'Initially a "train the trainers" program will begin with 3 sessions held by Valori et al. at Aalborg University Hospital. 6 Trainers are expected to be trained during the "train the trainers" program. The doctors selected for the "train the trainers" program are doctors specialized in abdominal surgery with an extensive lower GI-endoscopy experience and who is considered to have an excellent teaching ability to educate junior doctor.\n\nThe training program for junior doctors consist of the following:\n\n* Initial 1 day endoscopy simulation and theory at Nordsim. Endoscopy simulation scores will be monitored.\n* 20 days of fully supervised colonoscopies (max booking of 6 colonoscopies pr day). Trainer is always present in the endoscopy room\n* MCSAT (Mayo Clinical Skills Assessment Tool) will be used to grade the trainee multiple times and planned at day 0,5,10,15 and 20. Multiple graders will be used.\n* Simulator test will be held at day 0, 10 and 20 colonoscopies to validate progress and compare simulator generated measures with MCSAT. Both the AccuTouch and Symbionix simulator will be used,'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Junior doctors in North Jutland Surgical Departments defined as PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Doctors currently enrolled in PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2.\n* Able to arrange colonoscopy training in such a way that the total program can be completed in 12 weeks.\n* Able to perform supervised upper endoscopy.\n\nExclusion Criteria:\n\n* Less than 4 months left at current job position.'}, 'identificationModule': {'nctId': 'NCT02425657', 'briefTitle': 'Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments', 'orgStudyIdInfo': {'id': 'AalborgH1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Junior Doctors', 'description': 'Surgical trainees (PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2).', 'interventionNames': ['Behavioral: Training of junior doctors']}], 'interventions': [{'name': 'Training of junior doctors', 'type': 'BEHAVIORAL', 'description': 'Training program', 'armGroupLabels': ['Junior Doctors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9500', 'city': 'Hobro', 'state': 'Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lasse Pedersen, m.d.', 'role': 'CONTACT', 'email': 'lasse.pedersen@rn.dk', 'phone': '+45 97661212'}], 'facility': 'Aalborg University Hospital:Hobro', 'geoPoint': {'lat': 56.64306, 'lon': 9.79029}}, {'zip': '9000', 'city': 'Aalborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lasse L Pedersen, m.d.', 'role': 'CONTACT', 'email': 'lasse.pedersen@rn.dk', 'phone': '+4597661212'}, {'name': 'Inge Bernstein, PhD, MHM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NordSim, Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '9800', 'city': 'Hjørring', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lasse Pedersen, m.d.', 'role': 'CONTACT', 'email': 'lasse.pedersen@rn.dk', 'phone': '+45 97661212'}], 'facility': 'Hjörring Hospial', 'geoPoint': {'lat': 57.46417, 'lon': 9.98229}}], 'centralContacts': [{'name': 'Lasse Pedersen, m.d.', 'role': 'CONTACT', 'email': 'lasse.pedersen@rn.dk', 'phone': '(+45) 97661212'}], 'overallOfficials': [{'name': 'Lasse Pedersen, m.d.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aaborg University Surgical Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nordsim', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Ph.D.-student', 'investigatorFullName': 'Lasse Pedersen', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}