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Completed

NCT Number: NCT06166069

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

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.

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Key information

Conditions

Hernia Incisional Hernia Laparoscopic Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

francesco Pizza

Naples, 80131, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of patients affected by Superficial surgical site infections

    Time frame: Within 30 days postoperatively

    Superficial infections according to Clavien-Dindo criteria

  2. Number of patients affected by Deep surgical site infections

    Time frame: Within 30 days postoperatively

    Deep surgical site infections according to Clavien-Dindo criteria

  3. Number of patients affected by organ space infections

    Time frame: Within 30 days postoperatively

    Organ space infections according to Clavien-Dindo criteria

  4. Number of patients affected by Surgical Site Occurence

    Time frame: Within 30 days postoperatively

    Surgical Site Occurence Reported according to the Ventral Hernia Working Group (VHWG) definitions

  5. Postoperative pain

    Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 1 month.

    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').

  6. Postoperative pain

    Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 6 month.

    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').

  7. Postoperative pain

    Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 12 month.

    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').

Secondary outcomes

  1. Rate of Incisional Hernia at Clinical examination

    Time frame: Patients are postoperatively examined at 1 months.

    Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated

  2. Rate of Incisional Hernia at Clinical examination

    Time frame: Patients are postoperatively examined at 6 months.

    Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated

  3. Rate of Incisional Hernia at Clinical examination

    Time frame: Patients are postoperatively examined at 12 months.

    Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated

  4. Rate of Incisional Hernia at ultrasonographic examination

    Time frame: Patients are postoperatively examined at 1 months.

    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.

  5. Rate of Incisional Hernia at ultrasonographic examination

    Time frame: Patients are postoperatively examined at 6 months.

    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.

  6. Rate of Incisional Hernia at ultrasonographic examination

    Time frame: Patients are postoperatively examined at 12 months.

    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.

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale Napoli 2 Nord

Other

Registry information

Acronym: SHIELD

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 12, 2023
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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