Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT05162560
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2021-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Outcome of Acute Diverticulitis in Finland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2021-10-25', 'studyFirstSubmitQcDate': '2021-12-03', 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of annual incidence and prevalence of acute diverticulitis', 'timeFrame': 'January 2009-December 2019', 'description': 'how many patients with acute diverticulitis are treated in all hospitals in Finland'}], 'secondaryOutcomes': [{'measure': 'Number of patients with surgical or conservative treatment', 'timeFrame': 'January 2009-December 2019', 'description': 'Number of patients with conservative or surgical treatment of acute diverticulitis in two hospitals'}, {'measure': 'Number of treatment complications and survival of patients with acute diverticulitis', 'timeFrame': 'January 2009-December 2019', 'description': 'outcome of patients with acute diverticulitis in two hospitals'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Diverticulitis']}, 'descriptionModule': {'briefSummary': 'The incidence of acute diverticulitis (AD), conservative vs. surgical treatment and outcome of patients are studied using national registries and patient charts from two hospitals between years 2009-19.', 'detailedDescription': 'Acute diverticulitis (AD) of colon is increasing in Finland. Incidence, prevalence and mortality of AD of colon are investigated during 10-year period (2009-2019) in whole country. Epidemiological data is compared to data of acute appendicitis. Nationwide data of patients with AD are asked from Finnish Institute for Health and Welfare (THL). To compare registry-based nationwide data, patient charts from electronic database of two hospitals (Mikkeli Central Hospital and Tampere University Hospital) are reviewed from same study period. Patient characteristics, medication, treatment (conservative vs surgery), recurrence of AD and long-term outcome are recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with acute diverticulitis is whole Finland and in two study hospitals during years 2009-2019', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients with acute diverticulitis (K57) in Finland and in two hospitals\n\nExclusion Criteria:\n\n* other reasons for acute or chronic abdominal pain'}, 'identificationModule': {'nctId': 'NCT05162560', 'briefTitle': 'Incidence and Outcome of Acute Diverticulitis in Finland', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'Incidence of Acute Diverticulitis in Finland: Nationwide Register Study of Epidemiology and Outcome of Treatment Between 2009-19', 'orgStudyIdInfo': {'id': '5200661'}}, 'armsInterventionsModule': {'interventions': [{'name': 'patients with acute diverticulitis', 'type': 'OTHER', 'description': 'registry and hospital charts of patients with acute diverticulitis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50100', 'city': 'Mikkeli', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Hannu EK Paajanen, MD', 'role': 'CONTACT', 'email': 'paajanen@surffi.fi', 'phone': '+358405263101'}], 'facility': 'Mikkeli Central Hospital', 'geoPoint': {'lat': 61.68857, 'lon': 27.27227}}], 'centralContacts': [{'name': 'Hannu EK Paajanen, MD', 'role': 'CONTACT', 'email': 'paajanen@surffi.fi', 'phone': '+358405263101'}, {'name': 'Tuomo Rantanen, MD', 'role': 'CONTACT', 'email': 'tuomo.rantanen@kuh.fi', 'phone': '+358504028461'}], 'overallOfficials': [{'name': 'Hannu EK Paajanen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Univerisity of Finland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tampere University Hospital', 'class': 'OTHER'}, {'name': 'Mikkeli Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}