Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-01-22 @ 4:07 PM
Study NCT ID:
NCT01760395
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2012-12-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complications in Inguinal Hernia Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 335}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-11', 'studyFirstSubmitDate': '2012-12-31', 'studyFirstSubmitQcDate': '2012-12-31', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgical complication', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inguinal Hernia']}, 'referencesModule': {'references': [{'pmid': '25762240', 'type': 'DERIVED', 'citation': 'Kouhia S, Vironen J, Hakala T, Paajanen H. Open Mesh Repair for Inguinal Hernia is Safer than Laparoscopic Repair or Open Non-mesh Repair: A Nationwide Registry Study of Complications. World J Surg. 2015 Aug;39(8):1878-84; discussion 1885-6. doi: 10.1007/s00268-015-3028-2.'}]}, 'descriptionModule': {'briefSummary': 'Inguinal hernia repair is the most common procedure in general surgery. Even with acceptable complication rates, thousands of patients worldwide suffer from inguinal hernia surgery complications every year. In Finland, the Finnish Patient Insurance Centre (FPIC) receives reports from surgical complications. In this study, the database of FPIC is used to compare the complication profiles of open and laparoscopic inguinal hernia surgery with mesh.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Finnish patients having had complicated inguinal hernia surgery 2002-2010.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* surgery between 2002 and 2010\n* complicated inguinal hernia surgery reported to FPIC\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01760395', 'briefTitle': 'Complications in Inguinal Hernia Surgery', 'organization': {'class': 'OTHER', 'fullName': 'North Karelia Central Hospital'}, 'officialTitle': 'Complications in Inguinal Hernia Surgery - a Nationwide Registry Study', 'orgStudyIdInfo': {'id': 'NKCH-surg-010'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Karelia Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sanna Kouhia', 'investigatorAffiliation': 'North Karelia Central Hospital'}}}}