Clinical trial NCT06166069: Early Surgical Outcomes in the Use of Hybrid Mesh for Incisional Hernia Repair: Results From a Multicenter Italian Study
Official title: Early Surgical Outcomes in the Use of Hybrid Mesh for Incisional Hernia Repair: Results From a Multicenter Italian Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia
Incisional Hernia
Laparoscopic
Keywords: Hernia
Lead sponsor: Azienda Sanitaria Locale Napoli 2 Nord
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients affected by Superficial surgical site infections
timeFrame: Within 30 days postoperatively
measure: Number of patients affected by Deep surgical site infections
timeFrame: Within 30 days postoperatively
measure: Number of patients affected by organ space infections
timeFrame: Within 30 days postoperatively
measure: Number of patients affected by Surgical Site Occurence
timeFrame: Within 30 days postoperatively
measure: Postoperative pain
timeFrame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 1 month.
measure: Postoperative pain
timeFrame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 6 month.
measure: Postoperative pain
timeFrame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 12 month.
Secondary outcomes:
measure: Rate of Incisional Hernia at Clinical examination
timeFrame: Patients are postoperatively examined at 1 months.
measure: Rate of Incisional Hernia at Clinical examination
timeFrame: Patients are postoperatively examined at 6 months.
measure: Rate of Incisional Hernia at Clinical examination
timeFrame: Patients are postoperatively examined at 12 months.
measure: Rate of Incisional Hernia at ultrasonographic examination
timeFrame: Patients are postoperatively examined at 1 months.
measure: Rate of Incisional Hernia at ultrasonographic examination
timeFrame: Patients are postoperatively examined at 6 months.
measure: Rate of Incisional Hernia at ultrasonographic examination
timeFrame: Patients are postoperatively examined at 12 months.
Other outcomes:
Locations:
city: Naples
country: Italy
facility: francesco Pizza
Study officials:
References: