Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-01-13 @ 10:46 PM
Study NCT ID:
NCT02263612
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2014-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Late Mesh Complications After 3258 Incisional Hernia Operations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3258}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2014-09-20', 'studyFirstSubmitQcDate': '2014-10-08', 'lastUpdatePostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Death', 'timeFrame': 'Up to 7 years', 'description': 'Riskfactors for death later than 30 days after incisional hernia repair'}], 'primaryOutcomes': [{'measure': 'Reoperation', 'timeFrame': 'Up to 7 years', 'description': 'Riskfactors for reoperation (any procedure) more than 30 days after incisional hernia repair'}], 'secondaryOutcomes': [{'measure': 'Readmission', 'timeFrame': 'Up to 7 years', 'description': 'Riskfactors for readmission later than 30 days after incisional hernia repair'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Incisional Hernia', 'Complications', 'Long-term'], 'conditions': ['Incisional Hernia']}, 'descriptionModule': {'briefSummary': 'The Danish Hernia Database (DHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DHD to uncover risk factors for long-term (30 days postoperative and later) readmission, reoperation, death and reoperation for recurrence after incisional hernia repair with use of a synthetic mesh.', 'detailedDescription': 'All principal incisional hernias registered in the Danish Hernia Database are included in the study. The included patients have been followed for more than 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All incisional hernia repairs registered in tha Danish National Hernia Database from January 1st 2007 to December 31st 2010', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Incisional Hernia Repair'}, 'identificationModule': {'nctId': 'NCT02263612', 'briefTitle': 'Late Mesh Complications After 3258 Incisional Hernia Operations', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Late Mesh Complications After 3258 Incisional Hernia Operations', 'orgStudyIdInfo': {'id': 'DK_02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Danish Hernia Database', 'description': 'Patients registered in the Danish Ventral Hernia Database during January 1st 2007 to december 31st 2010'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4600', 'city': 'Køge', 'country': 'Denmark', 'facility': 'Køge Sygehus', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}], 'overallOfficials': [{'name': 'Dunja Kokotovic, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'dept. of surgery, Køge University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Frederik Helgstrand', 'investigatorAffiliation': 'Zealand University Hospital'}}}}