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

NCT06166069 | Completed

• 1 other identifier: 202318
• Study Type: observational
• Target: 272
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hernia; Incisional Hernia; Laparoscopic

Keywords

Hernia

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• Rate of Incisional Hernia at Clinical examination

  Patients are postoperatively examined at 1 months.

• Rate of Incisional Hernia at Clinical examination

  Patients are postoperatively examined at 6 months.

• Rate of Incisional Hernia at Clinical examination

  Patients are postoperatively examined at 12 months.

• Rate of Incisional Hernia at ultrasonographic examination

  Patients are postoperatively examined at 1 months.

• Rate of Incisional Hernia at ultrasonographic examination

  Patients are postoperatively examined at 6 months.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead

Study Sites (1)

francesco Pizza

Naples, 80131, Italy

Location

Related Publications (1)

• 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.

  PMID: 39966208 DERIVED

MeSH Terms

Conditions

Hernia; Incisional Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Md

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 12, 2023
• Study Start: January 1, 2021
• Primary Completion: October 30, 2022
• Study Completion: November 18, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

IT (1)