Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04397120
Status:
COMPLETED
Last Update Posted:
2020-05-21
First Post:
2020-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Factors Affecting ADR of Screening Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13495}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-19', 'studyFirstSubmitDate': '2020-05-16', 'studyFirstSubmitQcDate': '2020-05-19', 'lastUpdatePostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma detection rate', 'timeFrame': 'After histopathologically examined, reviewed, and confirmed, an average of 7 days.', 'description': 'the proportion of colonoscopies in which at least one adenoma was detected'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adenoma Detection Rate', 'Colonoscopy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the impact of multilevel factors on the quality of screening colonoscopy, reflected mainly by adenoma detection rate (ADR).', 'detailedDescription': 'The subjects will include patients who need to screening colonoscopies by 21 endoscopists between January 2019 and December 2019 were retrospectively enrolled in this unit. Multilevel factors, including patient-, proceduralist-, and procedure-level characteristics were analyzed for the relationship with ADR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Endoscopy Department of a university Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were retrospectively included in this study if they had undergone a completed colonoscopy.\n\nExclusion Criteria:\n\n* prior colonoscopy within 3 years;\n* medical history of inflammatory bowel disease (IBD), CRC, or abdominal surgery;\n* fair or poor quality of bowel preparation (fair quality: some semisolid stool that could be suctioned or washed away but \\>90% of mucosal surface seen; poor quality: semisolid stool that could not be suctioned or washed away with \\<90% of mucosal surface seen);\n* failure in cecal intubation;\n* withdrawal time without removing\\<6 min.'}, 'identificationModule': {'nctId': 'NCT04397120', 'briefTitle': 'The Factors Affecting ADR of Screening Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhejiang Chinese Medical University'}, 'officialTitle': 'Comprehensive Analysis of Multilevel Factors Affecting Adenoma Detection Rates of Screening Colonoscopy', 'orgStudyIdInfo': {'id': 'CADR-HuY-2005'}}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'First Affiliated Hospital of Zhejiang Chinese Medical University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Bin Lu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Zhejiang Chinese Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data sharing will be consider after study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhejiang Chinese Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}