Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT04801394
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2021-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Analysis on Large Incisional Hernia in High Risk Patients
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-14', 'studyFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2021-03-15', 'lastUpdatePostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early surgical outcome of FLaPp® prosthesis classified according to Clavien Dindo Classification', 'timeFrame': 'one month', 'description': 'evaluation of feasibility of FLaPp® prosthesis in patients affected by LIH by the assessment of postoperative morbidity classified according to Clavien Dindo Classification'}, {'measure': 'Evaluation of pain after FLaPp® prosthesis', 'timeFrame': 'one month', 'description': 'Evaluation of postoperative pain through Visual Analague Scale'}, {'measure': 'Mortality after FLaPp® prosthesis', 'timeFrame': 'One month', 'description': 'Rate of posoperative mortality after FLaPp® prosthesis'}], 'secondaryOutcomes': [{'measure': 'incisional hernia recurrence at medium term', 'timeFrame': '36 months', 'description': 'assessment of postoperative recurrence after 36 months evaluated with clinical outcpatient control and CT scan'}, {'measure': "Patients' satisfatcion after FLaPp® prosthesis", 'timeFrame': '36 months', 'description': 'Evaluated through the so-called 36 items Short-Form health survey'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Incisional Hernia', 'Large Incisional Hernia']}, 'descriptionModule': {'briefSummary': 'Large incisional hernia (LIH) is a challenging condition where the abdominal wall is hopelessly compromised. Nowadays the best treatment option in this particularly frail subset of patients is a major issue. The Auhtors proposed the clinical experience with an innovative approach with the composite Free Lateral Polypropylene prosthesis (FLaPp®) mesh fashioned as "neoperitoneum" analyzing its feasibility and short/medium term results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic patients with midline Large incisional hernia\n\nExclusion Criteria:\n\n* lateral incisional hernias\n* collagen diseases\n* patients who recently have undergone chemotherapy and/or radiation therapy\n* patients with acquired immunodeficiency'}, 'identificationModule': {'nctId': 'NCT04801394', 'briefTitle': 'Retrospective Analysis on Large Incisional Hernia in High Risk Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Retrospective Analysis on Large Incisional Hernia in High Risk Patients: the Innovative "Neo-peritoneum" Approach With a Composite Mesh', 'orgStudyIdInfo': {'id': 'Combined mesh'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesh Group', 'description': 'Patient with large incisional hernia treated with FLaPp® mesh as neoperineium', 'interventionNames': ['Procedure: hernioplastic and insertion of FLaPp® composite mesh']}], 'interventions': [{'name': 'hernioplastic and insertion of FLaPp® composite mesh', 'type': 'PROCEDURE', 'description': 'After the reduction of the large incisional hernia, the polypropylene transparent film of this mesh (lower flap) was sutured to the margins of the residual peritoneum and posterior rectus sheath as a "neo-peritoneum"; the macroporous light polypropylene layer (upper flap) was then sutured circumferentially with full-thickness transabdominal stitches in the retromuscular space.', 'armGroupLabels': ['Mesh Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Claudio Gambardella', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}