Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT03833856
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2019-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Clinical Course of Colonoscopy Related Perforation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-08', 'studyFirstSubmitDate': '2019-02-06', 'studyFirstSubmitQcDate': '2019-02-06', 'lastUpdatePostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operation', 'timeFrame': '1 month', 'description': 'Number of participants who take surgical treatment after perforation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perforation Colon']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the incidence and clinical course of colonoscopy related perforation based on the result of a prospective registry.', 'detailedDescription': 'In each endoscopy unit from participating hospital, there is a alarm system focusing on the development of perforation. Therefore, perforation cases will not be missed from the registry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patients undergoing colonoscopy who end up with perforation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have a perforation after colonoscopy\n\nExclusion Criteria:\n\n* Patients who refuse to be registered.'}, 'identificationModule': {'nctId': 'NCT03833856', 'briefTitle': 'Incidence and Clinical Course of Colonoscopy Related Perforation', 'organization': {'class': 'OTHER', 'fullName': 'Kyungpook National University Hospital'}, 'officialTitle': 'Incidence and Risk of Poor Outcomes After Colonoscopy Related Perforation: Result From a Prospective Data Registry', 'orgStudyIdInfo': {'id': 'KNUH2019'}}, 'armsInterventionsModule': {'interventions': [{'name': 'colonoscopy perforation', 'type': 'PROCEDURE', 'description': 'The development of perforation after colonoscopy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41944', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Eun Soo Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eun Soo Kim, MD, PhD', 'investigatorAffiliation': 'Kyungpook National University Hospital'}}}}