Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2025-12-30 @ 5:32 PM
Study NCT ID:
NCT01323361
Status:
COMPLETED
Last Update Posted:
2013-01-28
First Post:
2011-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D000072836', 'term': 'Surgical Wound'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-25', 'studyFirstSubmitDate': '2011-03-24', 'studyFirstSubmitQcDate': '2011-03-24', 'lastUpdatePostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of variation in inflammatory markers related to "trauma" impact', 'timeFrame': '6 weeks post surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['inflammation', 'laparoscopy', 'hernia', 'incisional', 'trauma'], 'conditions': ['Hernia']}, 'descriptionModule': {'briefSummary': 'The study aims to show variation in CA-125 and other inflammatory markers assumed to be a response to trauma and peritoneal inflammation in the perioperative period of laparoscopic ventral hernia repair', 'detailedDescription': 'CA-125 and other inflammatory markers as body temperature, CRP, PCT, leucocytes and neutrophils measured pre- and post-operatively - correlated to trauma size i.e. area of dissection, mesh size, number of fixation points etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults admitted for ventral or incisional hernia repair\n\nExclusion Criteria:\n\n* Loss-of-domain\n* ASA above III\n* Liver failure\n* Abnormal CA-125 prior to surgery'}, 'identificationModule': {'nctId': 'NCT01323361', 'briefTitle': 'CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Multi-centre Observational Pilot-study for Evaluation of Variation in CA-125 and Other Inflammatory Markers in the Perioperative Period of Laparoscopic Ventral Hernia Repair', 'orgStudyIdInfo': {'id': '2010/3264-1 (REK)'}, 'secondaryIdInfos': [{'id': '2010/29472', 'type': 'OTHER', 'domain': 'Datainspectorate, Norway'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Non-immunosupressed', 'description': 'Normal population', 'interventionNames': ['Procedure: Laparoscopic ventral hernia repair']}], 'interventions': [{'name': 'Laparoscopic ventral hernia repair', 'type': 'PROCEDURE', 'description': 'Patients operated with laparoscopic repair of ventral or incisional hernia', 'armGroupLabels': ['Non-immunosupressed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'state': 'Akershus', 'country': 'Norway', 'facility': 'Oslo University Hospital, Rikshospitalet'}, {'zip': '2819', 'city': 'Gjøvik', 'state': 'Oppland', 'country': 'Norway', 'facility': 'Sykehuset Innlandet HF', 'geoPoint': {'lat': 60.79574, 'lon': 10.69155}}], 'overallOfficials': [{'name': 'jan r lambrecht, md', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sykehuset Innlandet HF'}, {'name': 'ole m øyen, Dr. Med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Oslo University Hospital'}, {'name': 'erik trondsen, Dr. Med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sykehuset Innlandet HF', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jan Lambrecht', 'investigatorAffiliation': 'Oslo University Hospital'}}}}