Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT06166069
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2023-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Surgical Outcomes in the Use of Hybrid Mesh for Incisional Hernia Repair: Results From a Multicenter Italian Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2023-12-08', 'lastUpdatePostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients affected by Superficial surgical site infections', 'timeFrame': 'Within 30 days postoperatively', 'description': 'Superficial infections according to Clavien-Dindo criteria'}, {'measure': 'Number of patients affected by Deep surgical site infections', 'timeFrame': 'Within 30 days postoperatively', 'description': 'Deep surgical site infections according to Clavien-Dindo criteria'}, {'measure': 'Number of patients affected by organ space infections', 'timeFrame': 'Within 30 days postoperatively', 'description': 'Organ space infections according to Clavien-Dindo criteria'}, {'measure': 'Number of patients affected by Surgical Site Occurence', 'timeFrame': 'Within 30 days postoperatively', 'description': 'Surgical Site Occurence Reported according to the Ventral Hernia Working Group (VHWG) definitions'}, {'measure': 'Postoperative pain', 'timeFrame': 'Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 1 month.', 'description': "Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')."}, {'measure': 'Postoperative pain', 'timeFrame': 'Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 6 month.', 'description': "Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')."}, {'measure': 'Postoperative pain', 'timeFrame': 'Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 12 month.', 'description': "Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')."}], 'secondaryOutcomes': [{'measure': 'Rate of Incisional Hernia at Clinical examination', 'timeFrame': 'Patients are postoperatively examined at 1 months.', 'description': "Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated"}, {'measure': 'Rate of Incisional Hernia at Clinical examination', 'timeFrame': 'Patients are postoperatively examined at 6 months.', 'description': "Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated"}, {'measure': 'Rate of Incisional Hernia at Clinical examination', 'timeFrame': 'Patients are postoperatively examined at 12 months.', 'description': "Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated"}, {'measure': 'Rate of Incisional Hernia at ultrasonographic examination', 'timeFrame': 'Patients are postoperatively examined at 1 months.', 'description': "An abdominal ultrasonography with the patient lying prone, will be performed in in all patients (symptomatic or asymptomatic) providing any valuable information about Hernia Recurrence onset. Valsalva maneuver will be performed during the ultrasonography scan. Size and location of all imaging detected Hernia Recurrence will be recorded, as well as any other patient's complaint."}, {'measure': 'Rate of Incisional Hernia at ultrasonographic examination', 'timeFrame': 'Patients are postoperatively examined at 6 months.', 'description': "An abdominal ultrasonography with the patient lying prone, will be performed in in all patients (symptomatic or asymptomatic) providing any valuable information about Hernia Recurrence onset. Valsalva maneuver will be performed during the ultrasonography scan. Size and location of all imaging detected Hernia Recurrence will be recorded, as well as any other patient's complaint."}, {'measure': 'Rate of Incisional Hernia at ultrasonographic examination', 'timeFrame': 'Patients are postoperatively examined at 12 months.', 'description': "An abdominal ultrasonography with the patient lying prone, will be performed in in all patients (symptomatic or asymptomatic) providing any valuable information about Hernia Recurrence onset. Valsalva maneuver will be performed during the ultrasonography scan. Size and location of all imaging detected Hernia Recurrence will be recorded, as well as any other patient's complaint."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hernia'], 'conditions': ['Hernia', 'Incisional Hernia', 'Laparoscopic']}, 'referencesModule': {'references': [{'pmid': '39966208', 'type': 'DERIVED', 'citation': "Pizza F, Iuppa A, Maida P, Pilone V, Crucitti A, Carmen TPM, Morini L, Marin JN, Petitti T, Bertoglio C, Marte G, Sordelli I, Gili S, Lucido FS, Busciano L, D'Antonio D, Docimo L, Gambardella C. Postoperative outcomes and wound events in incisional hernia repair using hybrid mesh: results from a prospective multicenter italian study. Hernia. 2025 Feb 18;29(1):94. doi: 10.1007/s10029-025-03285-z."}]}, 'descriptionModule': {'briefSummary': 'Background: Ventral hernia repair poses challenges for surgeons due to controversies in approach, patient selection, and mesh selection. The GORE® SYNECOR Intraperitoneal (IP) Biomaterial, a hybrid mesh, aims to balance durability and infection risk.\n\nObjective: To analyze extended-term outcomes of using the Intaperitoneal device for ventral and incisional hernia repair.\n\nMethods: Retrospective analysis of patients undergoing surgery in eight Italian Surgery Centers, evaluating pIPOM and sIPOM techniques with GORE® SYNECOR IP Biomaterial. Preoperative evaluations included anthropometric measurements, comorbidities, CT scans, and GIQLI assessments. Surgical procedures and interventions were recorded. Postoperative complications, GIQLI changes, cosmesis, hernia recurrence, and mesh bulging were assessed.', 'detailedDescription': 'The management of ventral hernias, whether they are primary or incisional, presents a significant challenge for abdominal wall surgeons. Laparoscopic ventral hernia repair has become a widely accepted technique on a global scale, with literature reporting favorable outcomes, even over the long term. Nevertheless, various substantial controversies have emerged concerning the ideal approach and patient selection and "ideal mesh". Permanent mesh materials with a macro-porous structure have demonstrated excellent durability, a low risk of infection in ventral hernia repair. Nevertheless, hernia recurrences and complications can still occur. The use of absorbable mesh materials may reduce the risk of infectious complications and the need for mesh removal. However, it might be associated with a higher likelihood of long-term recurrence when compared to permanent materials.\n\nIn response to these challenges, hybrid mesh materials, combining both absorbable and permanent components, have been developed to strike a balance between achieving long-term durability and minimizing the risk of infection or "Mesh removal". These hybrid meshes can be utilized either intraperitoneally or extra-peritoneally depending on their composition.\n\nOne example of such a hybrid mesh is the GORE® SYNECOR Intraperitoneal Biomaterial (referred to as the device), manufactured by W.L. Gore \\& Associates, Inc. in Flagstaff, AZ. This composite mesh comprises a bioabsorbable 3D web scaffold and a permanent dense polytetrafluoroethylene (PTFE) monofilament macro-porous knit. The device is specifically designed for intraperitoneal placement, using either an underlay or intraperitoneal onlay technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Enrolled participants were allocated to either the pIPOM or sIPOM Groups based on the routine surgical practices of each center. In Group A, (IH) repairs were performed with the closure of the fascia using sutures (pIPOM). In Group B, laparoscopic IH repairs were carried out without closing the fascia (sIPOM). The choice of prosthesis dimensions was customized, with a minimum requirement of at least a 5 cm overlap.\n\nPostoperative complications, including morbidity (assessed according to the Clavien-Dindo classification \\[9\\]), mortality, length of hospital stay, and surgical reinterventions, were documented. All patients underwent regular follow-up at 1, 3, 6, and 12 months. During these follow-up visits, anthropometric measurements were conducted.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* Clean wounds\n* Informed consent\n* Patients affected by Incisional and Ventral Hernia\n* Elective surgery\n* Hernia size between 3 e 10 cm\n\nExclusion Criteria:\n\n* age \\< 18 years;\n* Life expectancy \\< 24 months (as estimated by the operating surgeon), -\n* Pregnancy\n* Immunosuppressant therapy within 2 weeks before surgery\n* Clean-contaminated and contaminated, dirty wounds\n* Cirrhosis'}, 'identificationModule': {'nctId': 'NCT06166069', 'acronym': 'SHIELD', 'briefTitle': 'Early Surgical Outcomes in the Use of Hybrid Mesh for Incisional Hernia Repair: Results From a Multicenter Italian Study', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Sanitaria Locale Napoli 2 Nord'}, 'officialTitle': 'Early Surgical Outcomes in the Use of Hybrid Mesh for Incisional Hernia Repair: Results From a Multicenter Italian Study', 'orgStudyIdInfo': {'id': '202318'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Intraperitoneal Onlay Mesh(IPOM) Plus (GroupA) the laparoscopic closure of the hernia defect will be then performed with detached stitches, non-resorbable 1/0 suture with running intracorporeal suture or intra/extracorporeal interrupted suture'}, {'label': 'B', 'description': 'Intraperitoneal Onlay Mesh(IPOM) standard (Group B) no defect closure will be performed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'francesco Pizza', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Sanitaria Locale Napoli 2 Nord', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Md', 'investigatorFullName': 'Francesco Pizza', 'investigatorAffiliation': 'Azienda Sanitaria Locale Napoli 2 Nord'}}}}