Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-02-24 @ 8:30 AM
Study NCT ID:
NCT02694120
Status:
UNKNOWN
Last Update Posted:
2016-02-29
First Post:
2016-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Complications, EfficAcy and Costs of Large Polypectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2016-01-29', 'studyFirstSubmitQcDate': '2016-02-23', 'lastUpdatePostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complications of large polypectomy', 'timeFrame': '15 days', 'description': 'incidence of polypectomy-related adverse events'}], 'secondaryOutcomes': [{'measure': 'costs of large polypectomy', 'timeFrame': '15 days', 'description': 'assessment of the average cost per procedure, including devices and staff costs'}, {'measure': 'efficacy of large polypectomy', 'timeFrame': '6 months', 'description': 'assessment of residual adenoma at follow-up'}]}, 'conditionsModule': {'conditions': ['Polypectomy']}, 'referencesModule': {'references': [{'pmid': '31839962', 'type': 'DERIVED', 'citation': 'Amato A, Radaelli F, Correale L, Di Giulio E, Buda A, Cennamo V, Fuccio L, Devani M, Tarantino O, Fiori G, De Nucci G, De Bellis M, Hassan C, Repici A; Bowell Group. Intra-procedural and delayed bleeding after resection of large colorectal lesions: The SCALP study. United European Gastroenterol J. 2019 Dec;7(10):1361-1372. doi: 10.1177/2050640619874176. Epub 2019 Sep 23.'}]}, 'descriptionModule': {'briefSummary': 'Colonoscopy has been shown to reduce the incidence and mortality of colorectal cancer, through the recognition and removal of pre-cancerous lesions, which in most cases evolve with a sequence that goes through formation of high-grade dysplasia (HGD).\n\nThe probability of HGD increases with the increase of the lesion of the polyp itself. Lesions\\> 2 cm are present in 1% of colonoscopy screening. The resection of these lesions presents a greater technical difficulty and consequently a decrease in the efficiency. The rate of incomplete resection reported in the literature reaches 10% while that of recurrence / residual adenoma 16.4 / 31.7%.\n\nThe aim of the study SCALP is to evaluate the incidence of complications, efficacy and cost of endoscopic resection of colic lesions\\> 2cm in a setting of clinical practice in an unselected population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population undergoing large endoscopic polypectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients undergoing large endoscopic polypectomy\n\nExclusion Criteria:\n\n* pregnancy\n* incapacity to give informed consent'}, 'identificationModule': {'nctId': 'NCT02694120', 'acronym': 'SCALP', 'briefTitle': 'Study on Complications, EfficAcy and Costs of Large Polypectomy', 'organization': {'class': 'OTHER', 'fullName': 'Valduce Hospital'}, 'orgStudyIdInfo': {'id': '2016.2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'colonoscopy population'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valduce Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Arnaldo Amato', 'investigatorAffiliation': 'Valduce Hospital'}}}}