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

Incisional Hernia Clinical Trial

— SHIELD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06166069
• Other study ID #: 202318
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: November 18, 2023

Study information

• Verified date: December 2023
• Source: Azienda Sanitaria Locale Napoli 2 Nord
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: November 18, 2023
• Est. primary completion date: October 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Laparoscopic

Locations

Country	Name	City	State
Italy	francesco Pizza	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale Napoli 2 Nord

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients affected by Superficial surgical site infections	Superficial infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Primary	Number of patients affected by Deep surgical site infections	Deep surgical site infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Primary	Number of patients affected by organ space infections	Organ space infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Primary	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
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.