Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-03 @ 6:55 PM
Study NCT ID:
NCT03105895
Status:
UNKNOWN
Last Update Posted:
2017-04-11
First Post:
2017-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-08', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-04-04', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incisional Hernia', 'timeFrame': '24 months', 'description': 'Development of an incisional hernia diagnosed clinically or radiologically'}], 'secondaryOutcomes': [{'measure': 'Surgical site infection', 'timeFrame': '30 days', 'description': 'Wound infection according to CDC guidelines'}, {'measure': 'Surgical site seroma', 'timeFrame': '30 days', 'description': 'Seroma ocurrence in the wound'}, {'measure': 'Surgical site hematoma', 'timeFrame': '30 days', 'description': 'Hematoma occurrence in the wound'}, {'measure': 'Mesh exposition', 'timeFrame': '30 days', 'description': 'Mesh that can be seen during postoperative recovery without skin covarage'}, {'measure': 'Evisceration', 'timeFrame': '30 days', 'description': 'Postoperative wound dehiscence'}, {'measure': 'Systemic complications', 'timeFrame': '30 days', 'description': 'Any systemic complication occurred in the postoperative period'}, {'measure': 'Chronic mesh infection', 'timeFrame': 'up to 2 years postoperative', 'description': 'Mesh chronically infected that need removal to solve'}, {'measure': 'Abdominal wall pain', 'timeFrame': 'Up to 2 years', 'description': 'VAS score in the follow-up'}, {'measure': 'Length of mesh at MRI 6 weeks', 'timeFrame': '6 weeks', 'description': 'Length of the mesh calculated at the MRI planned at 6 weeks'}, {'measure': 'Width of mesh at MRI 6 weeks', 'timeFrame': '6 weeks', 'description': 'Width of the mesh calculated at the MRI planned at 6 weeks'}, {'measure': 'Length of mesh at MRI 1 year', 'timeFrame': '1 year', 'description': 'Length of the mesh calculated at the MRI planned at 1 year'}, {'measure': 'Width of mesh at MRI 1 year', 'timeFrame': '1 year', 'description': 'Width of the mesh calculated at the MRI planned at 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Incisional hernia', 'Mesh prevention', 'Mesh augmentation'], 'conditions': ['Incisional Hernia']}, 'referencesModule': {'references': [{'pmid': '38652308', 'type': 'DERIVED', 'citation': 'Rodicio Miravalles JL, Mendez CSM, Lopez-Monclus J, Moreno Gijon M, Lopez Quindos P, Amoza Pais S, Lopez Lopez A, Garcia Bear I, Menendez de Llano Ortega R, Diez Perez de Las Vacas MI, Garcia-Urena MA. Short-term outcomes of a multicentre prospective study using a "visible" polyvinylidene fluoride onlay mesh for the prevention of midline incisional hernia. Langenbecks Arch Surg. 2024 Apr 23;409(1):136. doi: 10.1007/s00423-024-03307-x.'}]}, 'descriptionModule': {'briefSummary': 'It has been demonstrated that incisional hernia incidence after laparotomy can be safely reduced with the addition of a mesh to the conventional closure of the abdominal wall. There still some debate about which is the best position to place this mesh: onlay or sublay. In Europe we have now meshes with CEE approval to be used as reinforcement of abdominal wall closure. The investigators have planned to include 200 patients in a multi center study using an onlay PDVF mesh that can be tracked by magnetic resonance. The patients included will be patients with risk factors for the development of an incisional hernia. The incidence of incisional hernia will be assessed clinically and radiologically after 1 and 2 years follow-up. The incidence of surgical sites occurrences and pain will be also assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing midline laparotomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Any known risk factor for development of incisional hernia\n\n* \\> 60 years\n* BMI \\> 30\n* DM\n* Chronic bronquitis\n* Smoking\n* Neoplasia\n* Renal failure\n* Liver failure\n* Immnusupression\n* Urgent operation\n\nExclusion Criteria:\n\n* Previous supraumbilical midline laparotomy\n* Previous incisional hernia\n* Emergency surgery\n* Life expectancy of less than 12 months\n* Patient´s rejection to participate\n* Unable to understand and participate'}, 'identificationModule': {'nctId': 'NCT03105895', 'acronym': 'VISIBLE', 'briefTitle': 'Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI', 'organization': {'class': 'OTHER', 'fullName': 'Henares University Hospital'}, 'officialTitle': 'Multicenter Study on Prevention of Incisional Hernia After Laparotomy With an Onlay Mesh Visible on MRI', 'orgStudyIdInfo': {'id': 'HH 02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mesh group', 'type': 'PROCEDURE', 'description': 'An onlay PDVF mesh will be placed as abdominal wall reinforcement'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Puerto Real', 'state': 'Cádiz', 'country': 'Spain', 'facility': 'Puerto Real University Hospital', 'geoPoint': {'lat': 36.52819, 'lon': -6.19011}}, {'city': 'Arganda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Sureste Hospital', 'geoPoint': {'lat': 40.30076, 'lon': -3.43722}}, {'city': 'Avilés', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'San Agustín University Hospital', 'geoPoint': {'lat': 43.55473, 'lon': -5.92483}}, {'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'University Central Hospital of Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'Talavera de la Reina', 'state': 'Toledo', 'country': 'Spain', 'facility': 'Nuestra Señora del Prado University Hospital', 'geoPoint': {'lat': 39.96348, 'lon': -4.83076}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Puerta de Hierro University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'This is study to watch the behavior of an onlay mesh for incisional hernia prevention after laparotomy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henares University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'CARDIOLINK', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Miguel A ngel Garci-a Urena', 'investigatorAffiliation': 'Henares University Hospital'}}}}