Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-23 @ 3:01 PM
Study NCT ID:
NCT05750368
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2023-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3031}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-05', 'studyFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'operation for recurrence', 'timeFrame': '4 year', 'description': 'operation for recurrence during the observation period'}], 'secondaryOutcomes': [{'measure': 'Readmittance', 'timeFrame': '90 days', 'description': 'readmittance within 90 days after repair'}, {'measure': 'operation for complications', 'timeFrame': '90 days', 'description': '90 days operation for complications'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epigastric Hernia', 'Women With Epigastric Hernias']}, 'descriptionModule': {'briefSummary': 'The aim was to evaluate outcomes after epigastric hernia repair in women on a nationwide basis. The primary outcome iss recurrence - secondary outcomes are readmission, operation for complication, risk factors for recurrence, and readmittance.', 'detailedDescription': 'Aim Outcomes after epigastric hernia repair are rarely reported independently. Furthermore, women have the highest prevalence of epigastric hernia repair in the age of 41-50 years.\n\nThe aim of this study was to evaluate long-term outcomes after epigastric hernia repairs in women on a nationwide basis.\n\nMethods Nationwide database cohort study using prospectively recorded data from the Danish Hernia Database from women undergoing elective repair for epigastric hernias, during a 4-year period (2018-2021). A 100% follow-up was obtained by combining intra-operative data with data from the National Civil Register (NRC). The primary outcome was operation for recurrence, secondary outcomes were readmission and operation for complications. We compared open vs. laparoscopic repairs, and subgroup analysis were made for open repairs (sutured vs. mesh).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients undergoing ventral hernia repair in Denmark.', 'genderDescription': 'all women undergoing repair', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All female patients undergoing elective repair with a laparoscopic or open technique for an epigastric hernia were included.\n\nExclusion Criteria:\n\n* umbilical or incisional hernias, male patients, recurrent hernia repairs, and hernia repairs performed in relation to other surgical procedures.'}, 'identificationModule': {'nctId': 'NCT05750368', 'acronym': 'EPI-WOMEN', 'briefTitle': 'Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study', 'orgStudyIdInfo': {'id': 'women-epigastric'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women undergoing epigastric hernia repair', 'description': 'all women who have undergone epigastric hernia repair open or laparoscopic in Denmark during af 4-year period from January 1st, 2018, to Dec 31st, 2021.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Herlev Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, ph.d.', 'investigatorFullName': 'Mette Willaume', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}