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HerniaSHIELDNCT06166069

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

An observational study of Hernia and Incisional Hernia, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hernia, Incisional Hernia, Laparoscopic
How many people
272 participants
Where
1 siteItaly
Study dates
1 Jan 2021to 18 Nov 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • francesco Pizza

    Naples, 80131

Other trials in Italy

About this 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.

Read the 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.

Keywords
Hernia
Medical subject headings
Hernia, Incisional Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06166069
Study groupRoleWhat they receive
AIntraperitoneal 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
BIntraperitoneal Onlay Mesh(IPOM) standard (Group B) no defect closure will be performed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients affected by Superficial surgical site infections

    Superficial infections according to Clavien-Dindo criteria

    Measured: Within 30 days postoperatively

  2. Number of patients affected by Deep surgical site infections

    Deep surgical site infections according to Clavien-Dindo criteria

    Measured: Within 30 days postoperatively

  3. Number of patients affected by organ space infections

    Organ space infections according to Clavien-Dindo criteria

    Measured: Within 30 days postoperatively

  4. Number of patients affected by Surgical Site Occurence

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

    Measured: Within 30 days postoperatively

  5. 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').

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

  6. 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').

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

  7. 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').

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

Secondary outcomes (6)

  1. 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

    Measured: Patients are postoperatively examined at 1 months.

  2. 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

    Measured: Patients are postoperatively examined at 6 months.

  3. 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

    Measured: Patients are postoperatively examined at 12 months.

  4. 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.

    Measured: Patients are postoperatively examined at 1 months.

  5. 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.

    Measured: Patients are postoperatively examined at 6 months.

  6. 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.

    Measured: Patients are postoperatively examined at 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2023
  2. Study start1 Jan 2021
  3. Primary completion30 Oct 2022
  4. Study completion18 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06166069
Sponsor's protocol ID
202318
Acronym
SHIELD
Status last verified
Dec 2023
First submitted
1 Dec 2023
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39966208

Questions about this trial

What is this clinical trial studying?

An observational study of Hernia and Incisional Hernia, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients affected by Superficial surgical site infections (time frame: Within 30 days postoperatively). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06166069, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.

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