Early Surgical Outcomes in the Use of Hybrid Mesh for Incisional Hernia Repair: Results From a Multicenter Italian Study (SHIELD)

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.

Study Overview

• Status: Completed
• Conditions: Hernia; Incisional Hernia; Laparoscopic

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 272

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • francesco Pizza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• age > 18 years
• Clean wounds
• Informed consent
• Patients affected by Incisional and Ventral Hernia
• Elective surgery
• Hernia size between 3 e 10 cm

Exclusion Criteria:

• age < 18 years;
• Life expectancy < 24 months (as estimated by the operating surgeon), -
• Pregnancy
• Immunosuppressant therapy within 2 weeks before surgery
• Clean-contaminated and contaminated, dirty wounds
• Cirrhosis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
A; 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
B; Intraperitoneal Onlay Mesh(IPOM) standard (Group B) no defect closure will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients affected by Superficial surgical site infections	Superficial infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Number of patients affected by Deep surgical site infections	Deep surgical site infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Number of patients affected by organ space infections	Organ space infections according to Clavien-Dindo criteria	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	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').	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').	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').	Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 12 month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	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.	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.	Patients are postoperatively examined at 12 months.

Collaborators and Investigators

• Sponsor: Azienda Sanitaria Locale Napoli 2 Nord

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): November 18, 2023

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Hernia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: 202318

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No