Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-02-24 @ 5:30 PM
Study NCT ID:
NCT02564757
Status:
COMPLETED
Last Update Posted:
2017-01-31
First Post:
2015-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Pregnancy Increase Risk of Ventral Hernia Recurrence?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}], 'ancestors': [{'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': 3578}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2015-09-29', 'lastUpdatePostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence', 'timeFrame': '0-7 years', 'description': 'Clinical ventral hernia recurrence will be defined as clinical recurrence retrieved from the Danish National Patient Registry.'}, {'measure': 'Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence Repair', 'timeFrame': '0-8 years', 'description': 'Ventral hernia recurrence repair will be defined as reoperation retrieved from the Danish National Patient Registry.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Recurrent Hernia of Anterior Abdominal Wall']}, 'descriptionModule': {'briefSummary': 'The investigators will examine if pregnancy increases risk of ventral hernia recurrence', 'detailedDescription': 'The investigators will establish a cohort of female fertile patients who underwent ventral hernia repair (Umbilical, Epigastric and Incisional hernia repair) registered in the Danish Hernia Database. The investigators will link these data at an individual level with the Danish National Patient Registry (DNPR), Danish Medical Birth Registry (DMBR) and the Danish Civil Registry (CPR).\n\nFrom DMBR, subsequent pregnancies in the study cohort will be noted. From DNPR, ventral hernia recurrence, defined as clinical recurrence and/or reoperation for recurrence will be noted. Cases registered with both clinical recurrence and reoperation for recurrence, the date of the earliest registration will be defined as the date of ventral hernia recurrence.\n\nFrom CPR, date of death or emigration will be noted.\n\nThrough an extended Cox regression analysis, handling pregnancy as a time-dependent variable, the investigators will examine whether pregnancy is associated with an increased risk of ventral hernia recurrence.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fertile female patients who have undergone ventral hernia repair', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fertile female patient\n\nExclusion Criteria:\n\n* non-Danish citizen'}, 'identificationModule': {'nctId': 'NCT02564757', 'briefTitle': 'Does Pregnancy Increase Risk of Ventral Hernia Recurrence?', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Does Pregnancy Increase Risk of Ventral Hernia Recurrence?', 'orgStudyIdInfo': {'id': 'eoma2'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lars N Jorgensen, MD, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Bispebjerg Hospital, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research scholar', 'investigatorFullName': 'Erling Oma', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}