An observational study in Hernia, Incisional Hernia and Laparoscopic, sponsored by Azienda Sanitaria Locale Napoli 2 Nord. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-18.
Sponsored by Azienda Sanitaria Locale Napoli 2 Nord · Observational
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.
Objective: To analyze extended-term outcomes of using the Intaperitoneal device for ventral and incisional hernia repair.
Methods: 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.
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.
In 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.
One 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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 272 is above the median of 120 across 327 observational studies indexed under Hernia.
Browse Hernia studies →Azienda Sanitaria Locale Napoli 2 Nord is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
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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.
Postoperative 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.
Exclusion Criteria:
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
Intraperitoneal Onlay Mesh(IPOM) standard (Group B) no defect closure will be performed.
Number of patients affected by Superficial surgical site infections
Superficial infections according to Clavien-Dindo criteria
Time frame: Within 30 days postoperatively
Number of patients affected by Deep surgical site infections
Deep surgical site infections according to Clavien-Dindo criteria
Time frame: Within 30 days postoperatively
Number of patients affected by organ space infections
Organ space infections according to Clavien-Dindo criteria
Time frame: Within 30 days postoperatively
Number of patients affected by Surgical Site Occurence
Surgical Site Occurence Reported according to the Ventral Hernia Working Group (VHWG) definitions
Time frame: Within 30 days postoperatively
Postoperative pain
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').
Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 1 month.
Postoperative pain
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').
Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 6 month.
Postoperative pain
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').
Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 12 month.
Rate of Incisional Hernia at Clinical examination
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated
Time frame: Patients are postoperatively examined at 1 months.
Rate of Incisional Hernia at Clinical examination
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated
Time frame: Patients are postoperatively examined at 6 months.
Rate of Incisional Hernia at Clinical examination
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated
Time frame: Patients are postoperatively examined at 12 months.
Rate of Incisional Hernia at ultrasonographic examination
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.
Time frame: Patients are postoperatively examined at 1 months.
Rate of Incisional Hernia at ultrasonographic examination
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.
Time frame: Patients are postoperatively examined at 6 months.
Rate of Incisional Hernia at ultrasonographic examination
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.
Time frame: Patients are postoperatively examined at 12 months.
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Azienda Sanitaria Locale Napoli 2 Nord