Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 11:50 PM
Study NCT ID:
NCT01388634
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2011-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prolonged Hospital Stay and Readmission After Elective Ventral Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006555', 'term': 'Hernia, Ventral'}], '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': 2258}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2011-06-27', 'studyFirstSubmitQcDate': '2011-07-05', 'lastUpdatePostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 1 week', 'description': 'analyse factors associated with prolonged length of hospital stay (minimum 5 days).'}], 'secondaryOutcomes': [{'measure': 'Readmission', 'timeFrame': '30 days', 'description': 'reasons for readmission after a ventral hernia repair'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Length of hospital stay', 'readmission', 'ventral hernia'], 'conditions': ['Ventral Hernia']}, 'referencesModule': {'references': [{'pmid': '21975153', 'type': 'DERIVED', 'citation': 'Helgstrand F, Rosenberg J, Kehlet H, Bisgaard T. Nationwide analysis of prolonged hospital stay and readmission after elective ventral hernia repair. Dan Med Bull. 2011 Oct;58(10):A4322.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to analyse factors associated with prolonged length of hospital stay, readmission and death in a nationwide group of patients undergoing elective ventral hernia repair in search for areas of interest to improve outcome after ventral hernia surgery', 'detailedDescription': 'Detailed analysis of reasons for prolonged hospital stay and readmission in patients undergoing a ventral hernia repair'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients registered in The Danish Ventral Hernia Database in 2008', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with elective ventral hernia repair in Denmark 2008\n\nExclusion Criteria:\n\n* emergency repairs'}, 'identificationModule': {'nctId': 'NCT01388634', 'acronym': 'LOSHERNIA', 'briefTitle': 'Prolonged Hospital Stay and Readmission After Elective Ventral Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Nationwide Analysis of Prolonged Hospital Stay and Readmission After Elective Ventral Hernia Repair', 'orgStudyIdInfo': {'id': 'Køge hospital'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study cohort', 'description': 'Patients with prolonged length of hospital stay (\\>5 days) or readmission after ventral hernia repair'}, {'label': 'control group', 'description': 'Patients without prolonged length of hospital stay (\\>5 days) or readmission after ventral hernia repair'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4600', 'city': 'Køge', 'country': 'Denmark', 'facility': 'Dept. of surgery, Køge Hospital', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}], 'overallOfficials': [{'name': 'Frederik Helgstrand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. surgery Køge hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Frederik Helgstrand', 'investigatorAffiliation': 'Zealand University Hospital'}}}}