Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-02-23 @ 8:18 AM
Study NCT ID:
NCT02616718
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2015-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incisional Hernia Progression Over Time
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2015-11-21', 'studyFirstSubmitQcDate': '2015-11-27', 'lastUpdatePostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fascial defect area', 'timeFrame': '28-32 weeks', 'description': 'Change fascial defect area from initial CT scan to follow-up CT scan'}], 'secondaryOutcomes': [{'measure': 'Hernia-related quality of life', 'timeFrame': '28-32 weeks', 'description': 'Change in Hernia-related quality of life'}, {'measure': 'Physical activity', 'timeFrame': '28-32 weeks', 'description': 'Change in physical activity, measured by International Physical Activity Questionnaire'}, {'measure': 'Hernia sac volume', 'timeFrame': '28-32 weeks', 'description': 'Change in hernia sac volume measured on repeated CT scans'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hernia, Ventral']}, 'descriptionModule': {'briefSummary': 'This is a prospective multicenter study of patients diagnosed with a medium to giant incisional hernia (transverse defect \\>7 cm). Patients referred to the surgical outpatient clinic are invited to participate in the study. As a standard, all patients who are examined for incisional hernia undergo CT scan according to a hernia protocol, before planning of surgical repair (baseline scan). After this CT scan, patients are seen in the out-patient clinic once again and either treated conservatively without surgery, or scheduled for elective surgical repair of the hernia.\n\nIf surgery is planned, the patients participating in the study undergo an additional CT scan in hernia protocol, within two weeks prior to surgery (follow-up scan).\n\nIf a conservative non-surgical approach is chosen, patients can still participate in the study and will undergo an additional CT scan after 28-32 weeks.', 'detailedDescription': "This is a prospective multicenter study of patients diagnosed with a medium to giant incisional hernia (transverse defect \\>7 cm). Patients referred to the surgical outpatient clinic are invited to participate in the study. As a standard, all patients who are examined for incisional hernia undergo CT scan according to a hernia protocol, before planning of surgical repair (baseline scan). After this CT scan, patients are seen in the out-patient clinic once again and either treated conservatively without surgery, or scheduled for elective surgical repair of the hernia.\n\nIf surgery is planned, the patients participating in the study undergo an additional CT scan in hernia protocol, within two weeks prior to surgery (follow-up scan). In case no baseline scan in hernia protocol exists, patients will undergo this scan immediately after inclusion in the study. Furthermore, patients will be asked to fill out a questionnaire on physical activity (IPAQ) and hernia-related quality of life (HerQLes) at the time of the baseline and follow-up scans. IPAQ is a well-validated questionnaire, which assesses patients' physical activity within the last 7 days. The outcome is metabolic minutes per week, a numerical value which places the responder in one of three categories: Low, moderate or high physical activity. HerQLes is a validated questionnaire assessing the hernia-related quality of life. This questionnaire has been translated into Danish using a standardized protocol. The outcome is a numerical score of 0-100, with 100 being the highest hernia-related quality of life. Currently, the time from planning of hernia repair to surgery is approximately 30 weeks. Thus, the mean time between the two CT scans should be around 28-32 weeks.\n\nIf a conservative non-surgical approach is chosen, patients can still participate in the study and will undergo an additional CT scan after 28-32 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected incisional hernia with a horizontal fascial defect \\> 7 cm\n\nExclusion Criteria:\n\n* Inability to read or speak Danish'}, 'identificationModule': {'nctId': 'NCT02616718', 'acronym': 'INPRO', 'briefTitle': 'Incisional Hernia Progression Over Time', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Incisional Hernia Progression Over Time', 'orgStudyIdInfo': {'id': 'H-15008340'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ventral incisional hernia', 'description': 'Repeated computed tomography scan of abdomen', 'interventionNames': ['Radiation: Repeated computed tomography scan of abdomen']}], 'interventions': [{'name': 'Repeated computed tomography scan of abdomen', 'type': 'RADIATION', 'description': 'Repeated computed tomography scan of abdomen within two weeks prior to surgery or 28-32 weeks after initial scan', 'armGroupLabels': ['Ventral incisional hernia']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2400', 'city': 'Copenhagen NV', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Digestive Disease Center, Bispebjerg Hospital'}], 'overallOfficials': [{'name': 'Kristian K Jensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Kristian Kiim Jensen', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}