Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-01-03 @ 9:02 PM
Study NCT ID:
NCT02007395
Status:
COMPLETED
Last Update Posted:
2013-12-10
First Post:
2013-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study on Polypectomy Complications: SPoC.
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': 5170}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-05', 'studyFirstSubmitDate': '2013-12-05', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complications of endoscopic polypectomy', 'timeFrame': '3 months'}]}, 'conditionsModule': {'conditions': ['Endoscopic Polypectomy']}, 'descriptionModule': {'briefSummary': 'Colonoscopy has been shown to reduce both the colo-rectal cancer incidence and mortality, due to its capability to detect and remove precancerous lesions. However, polypectomy is associated with complications, such as bleeding and perforation, with an estimated overall incidence of about 10%, with polyp size and right-sided location considered as major risk factors. Aim of present study was to prospectively evaluate the early and delayed (30-days follow-up) complications of polypectomy in a multicenter regional Italian real practice setting'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population undergoing endoscopic polypectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients undergoing endoscopic polypectomy\n\nExclusion Criteria:\n\n* pregnancy\n* incapacity to give informed consent'}, 'identificationModule': {'nctId': 'NCT02007395', 'briefTitle': 'Prospective Study on Polypectomy Complications: SPoC.', 'organization': {'class': 'OTHER', 'fullName': 'Valduce Hospital'}, 'orgStudyIdInfo': {'id': '5/2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'colonoscopy population'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valduce Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Arnaldo Amato', 'investigatorAffiliation': 'Valduce Hospital'}}}}