Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-02-19 @ 1:39 PM
Study NCT ID:
NCT03796169
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2018-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intervention for Colonoscopy Quality is Associated With the Personal Characteristics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-07', 'studyFirstSubmitDate': '2018-12-16', 'studyFirstSubmitQcDate': '2019-01-04', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of overall adenoma detection rate', 'timeFrame': '9 months', 'description': 'Primary outcome measures include overall adenoma detection rate.'}, {'measure': 'Measurement of adenoma detection rate after personal notification', 'timeFrame': '3 months after personal notification', 'description': 'Primary outcome measures include adenoma detection rate after personal notification'}, {'measure': 'Measurement of adenoma detection rate after open notification', 'timeFrame': '3 months after open notification', 'description': 'Primary outcome measures include adenoma detection rate after open notification'}, {'measure': 'Measurement of adenoma detection rate after education', 'timeFrame': '3 months after education', 'description': 'Primary outcome measures include adenoma detection rate after education'}], 'secondaryOutcomes': [{'measure': 'Measurement of overall polyp detection rate', 'timeFrame': '9 months', 'description': 'Secondary outcome measures include overall polyp detection rate.'}, {'measure': 'Measurement of overall withdrawal time', 'timeFrame': '9 months', 'description': 'Secondary outcome measures include overall withdrawal time.'}, {'measure': 'Measurement of overall adenomas per colonoscopy', 'timeFrame': '9 months', 'description': 'Secondary outcome measures include overall adenomas per colonoscopy.'}, {'measure': 'Measurement of polyp detection rate after personal notification', 'timeFrame': '3 months after personal notification', 'description': 'Primary outcome measures include polyp detection rate after personal notification'}, {'measure': 'Measurement of polyp detection rate after open notification', 'timeFrame': '3 months after open notification', 'description': 'Primary outcome measures include polyp detection rate after open notification'}, {'measure': 'Measurement of polyp detection rate after education', 'timeFrame': '3 months after education', 'description': 'Primary outcome measures include polyp detection rate after education'}, {'measure': 'Measurement of withdrawal time after personal notification', 'timeFrame': '3 months after personal notification', 'description': 'Primary outcome measures include withdrawal time after personal notification'}, {'measure': 'Measurement of withdrawal time after open notification', 'timeFrame': '3 months after open notification', 'description': 'Primary outcome measures include withdrawal time after open notification'}, {'measure': 'Measurement of withdrawal time after education', 'timeFrame': '3 months after education', 'description': 'Primary outcome measures include withdrawal time after education'}, {'measure': 'Measurement of adenomas per colonoscopy after personal notification', 'timeFrame': '3 months after personal notification', 'description': 'Primary outcome measures include adenomas per colonoscopy after personal notification.'}, {'measure': 'Measurement of adenomas per colonoscopy after open notification', 'timeFrame': '3 months after open notification', 'description': 'Primary outcome measures include adenomas per colonoscopy after open notification'}, {'measure': 'Measurement of adenomas per colonoscopy after education', 'timeFrame': '3 months after education', 'description': 'Primary outcome measures include adenoma detection rate after education'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonoscopy', 'Human Characteristics']}, 'referencesModule': {'references': [{'pmid': '23295274', 'type': 'BACKGROUND', 'citation': 'Coe SG, Crook JE, Diehl NN, Wallace MB. An endoscopic quality improvement program improves detection of colorectal adenomas. Am J Gastroenterol. 2013 Feb;108(2):219-26; quiz 227. doi: 10.1038/ajg.2012.417. Epub 2013 Jan 8.'}, {'pmid': '19665583', 'type': 'BACKGROUND', 'citation': 'Shaukat A, Oancea C, Bond JH, Church TR, Allen JI. Variation in detection of adenomas and polyps by colonoscopy and change over time with a performance improvement program. Clin Gastroenterol Hepatol. 2009 Dec;7(12):1335-40. doi: 10.1016/j.cgh.2009.07.027. Epub 2009 Aug 7.'}, {'pmid': '26845473', 'type': 'BACKGROUND', 'citation': 'Jover R, Zapater P, Bujanda L, Hernandez V, Cubiella J, Pellise M, Ponce M, Ono A, Lanas A, Seoane A, Marin-Gabriel JC, Chaparro M, Cacho G, Herreros-de-Tejada A, Fernandez-Diez S, Peris A, Nicolas-Perez D, Murcia O, Castells A, Quintero E; COLONPREV Study Investigators. Endoscopist characteristics that influence the quality of colonoscopy. Endoscopy. 2016 Mar;48(3):241-7. doi: 10.1055/s-0042-100185. Epub 2016 Feb 4.'}, {'pmid': '37158042', 'type': 'DERIVED', 'citation': 'Choi HH, Sung SY, Lee BI, Cho H, Jung Y, Park JM, Cho YS, Lee KM, Kim SW, Choi H, Chae HS, Choi MG. The Effect of Intervention for Improving Colonoscopy Quality Is Associated with the Personality Traits of Endoscopists. Gut Liver. 2024 Mar 15;18(2):265-274. doi: 10.5009/gnl220280. Epub 2023 May 9.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate whether the personal characteristics of the endoscopist is associated with effect of interventions for colonoscopy quality improvement.\n\nThis is a prospective, 9-month, multicenter, single-blind study. Baseline quality indicators including adenoma detection rate, polyp detection rate, withdrawal time and adenomas per colonoscopy of each endoscopist were measured in the health promotion centers of academic hospitals for 3 months. Follow-up measurements of quality indicators were repeated every 3 months after each interventions (personal notification of quality indicators, open notification of quality indicators, and colonoscopy quality education by a GI faculty. At the end of the study, personal characteristics of each endoscopist was evaluated using fear of negative evaluation scale, cognitive flexibility inventory, and almost perfect scale.', 'detailedDescription': "Suboptimal colonoscopy quality is associated with development of interval colorectal cancer and colorectal cancer-related death. It is uncertain how to improve colonoscopy quality effectively. The quality of screening colonoscopy for colorectal cancer depends on the endoscopist who performed the examination. The aim of this study was to investigate the impact of endoscopists' personal characteristics on the quality of colonoscopy and effectiveness of intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Highly experienced board-certified gastroenterologists performed colonoscopies in health screening endoscopy centers.\n* Endoscopists who sign the consent\n* Patients for quality indicators of endoscopists\n\n * routinely perform outpatient screening, surveillance and diagnostic colonoscopy (first-time screening colonoscopies performed and had no previous colonoscopy within 3 years).\n\nExclusion Criteria:\n\n* endoscopists who refuse to sign the consent\n* Patients for quality indicators of endoscopists\n\n * Known hereditary polyposis syndrome, Inflammatory bowel disease, those with surgically altered anatomy, undergone previous colonoscopy within 3 years'}, 'identificationModule': {'nctId': 'NCT03796169', 'briefTitle': 'Effect of Intervention for Colonoscopy Quality is Associated With the Personal Characteristics', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'Effect of Intervention for Improving Colonoscopy Quality is Associated With the Personal Characteristics of the Endoscopist', 'orgStudyIdInfo': {'id': 'XC15FIMI0020K'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endoscopist', 'description': 'Intervention for personal notification, open notification and colonoscopy quality education by a GI faculty', 'interventionNames': ['Behavioral: Personal notification', 'Behavioral: Open notification', 'Behavioral: Education']}], 'interventions': [{'name': 'Personal notification', 'type': 'BEHAVIORAL', 'description': 'Baseline quality indicators of each endoscopist were measured and those were notified individually.', 'armGroupLabels': ['Endoscopist']}, {'name': 'Open notification', 'type': 'BEHAVIORAL', 'description': 'Quality indicators were measured for 3 months after 1st interventions and those were notified openly', 'armGroupLabels': ['Endoscopist']}, {'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'Quality indicators were measured for 3 months after 2nd interventions and educated the importance of colonoscopy quality by a GI faculty', 'armGroupLabels': ['Endoscopist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Division of Gastroenterology; Seoul St. Mary's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Bo-In Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Division of Gastroenterology; Seoul St. Mary's hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': "Saint Vincent's Hospital, Korea", 'class': 'OTHER'}, {'name': 'Uijeongbu St. Mary Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD', 'investigatorFullName': 'Bo-In Lee', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}