Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-03 @ 11:10 PM
Study NCT ID:
NCT01665859
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2012-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for Poor Outcome After Epigastric and Umbilical Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006554', 'term': 'Hernia, Umbilical'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006555', 'term': 'Hernia, Ventral'}, {'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6783}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2012-08-13', 'studyFirstSubmitQcDate': '2012-08-13', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'readmission', 'timeFrame': '30 days', 'description': 'Riskfactors for readmission within 30 days after umbilical or epigastric hernia repair'}], 'secondaryOutcomes': [{'measure': 'reoperation for recurrence', 'timeFrame': 'up to 4 years', 'description': 'Risk factors for recurrence repair after umbilical or epigastric hernia repair'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['readmission', 'recurrence', 'umbilical', 'epigastric', 'hernia', 'outcome', 'morbidity'], 'conditions': ['Umbilical Hernia', 'Epigastric Hernia']}, 'descriptionModule': {'briefSummary': 'Umbilical and epigastric hernia repairs are common and performed by numerous surgical techniques. Considering that the hernia repairs in general are relatively small and simple procedures there are disproportionate poor results.\n\nThe aim of present study is to determine surgical risk factors for readmission after umbilical and epigastric hernia repair and to report risk factors for later reoperation for recurrence.', 'detailedDescription': 'All elective umbilical or epigastric hernias registered in the Danish Ventral Hernia Database are included in the study. The included patients will be followed in up to 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All elective umbilical or epigastric hernia repairs registered in tha Danish National Hernia Database from January 1st 2007 to December 31st 2010', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Umbilical or epigastric hernia repair\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01665859', 'briefTitle': 'Risk Factors for Poor Outcome After Epigastric and Umbilical Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Nationwide Prospective Study of Surgical Risk Factors for Poor Outcome After Epigastric and Umbilical Hernia Repair', 'orgStudyIdInfo': {'id': 'FH09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Danish Ventral 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 Hospital', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}], 'overallOfficials': [{'name': 'Frederik Helgstrand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'dept. surgery, Køge sygehus, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Frederik Helgstrand', 'investigatorAffiliation': 'Zealand University Hospital'}}}}