Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT01639118
Status:
TERMINATED
Last Update Posted:
2012-11-20
First Post:
2012-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006555', 'term': 'Hernia, Ventral'}, {'id': 'D006554', 'term': 'Hernia, Umbilical'}, {'id': 'D046449', 'term': 'Hernia, Abdominal'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Perception of an increased incidence of C-Qur V-patch mesh infection, with need for removal, compared to other meshes used for umbilical hernia repair.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-18', 'studyFirstSubmitDate': '2012-07-10', 'studyFirstSubmitQcDate': '2012-07-11', 'lastUpdatePostDateStruct': {'date': '2012-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['primary ventral hernia repair with mesh', 'umbilical hernia repair', 'epigastric hernia repair', 'C-Qur V-patch', 'Size tailored repair', 'preperitoneal repair', 'abdominal hernia', 'dual sided mesh'], 'conditions': ['Ventral Hernia', 'Umbilical Hernia', 'Epigastric Hernia']}, 'descriptionModule': {'briefSummary': 'Primary ventral hernias, such as umbilical and epigastric hernias, are best repaired with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh technology have been developed for the specific indication of small ventral hernias; this technique is very attractive because the mesh can be introduced through a nearly invisible scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No literature is available on the adequate size of mesh needed to repair a hernia defect of an umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a large mesh device. Small hernias might benefit of repair with a small mesh device so no enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size to have more overlap of the mesh beyond the hernia defect.\n\nWith this prospective cohort study the investigators want to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all adult patients that are planned for surgical repair of a primary umbilical or epigastric hernia will be considered to enter the study.\n\nExclusion Criteria:\n\n* patients refusing to participate at the follow up visits\n* pregnancy\n* age \\< 18 years\n* life expectancy less than 12 months\n* recurrent umbilical or epigastric hernia\n* incisional or trocar site hernias\n* emergency operations\n* liver cirrhosis or ascites\n* cancer patients\n* concomitant surgery'}, 'identificationModule': {'nctId': 'NCT01639118', 'acronym': 'SITUP', 'briefTitle': 'Prospective Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias', 'organization': {'class': 'OTHER', 'fullName': 'Algemeen Ziekenhuis Maria Middelares'}, 'officialTitle': 'Prospective Observational Cohort Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias', 'orgStudyIdInfo': {'id': 'SITUP-2012'}}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Oost Vlaanderen', 'country': 'Belgium', 'facility': 'AZ Maria Middelares', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Stijn De Sutter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Algemeen Ziekenhuis Maria Middelares'}, {'name': 'Filip Muysoms, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Algemeen Ziekenhuis Maria Middelares'}, {'name': 'Iris Kyle-Leinhase, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Algemeen Ziekenhuis Maria Middelares'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Algemeen Ziekenhuis Maria Middelares', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Stijn De Sutter', 'investigatorFullName': 'Stijn De Sutter', 'investigatorAffiliation': 'Algemeen Ziekenhuis Maria Middelares'}}}}