Hernia Incisional, Hernia Incisional Ventral, Hernia, Ventral
Conditions
Keywords
Hernia Repair, Hernia Mesh Treatment, Ventral Hernia, Incisional Hernia, Intraperitoneal, Preperitoneal
Brief summary
The SYN 20-01 Study is a non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation looking into the assessment of GORE® SYNECOR Biomaterial in focused patient populations and in long-term application. Patients with ventral / incisional hernia amenable to hernia mesh repair will be enrolled into two cohorts (US and EU cohort) and followed-up over the period of 60 months.
Interventions
DEVICEHernia repair with mesh
Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery
Sponsors
W.L.Gore & Associates
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria - IP Cohort: * De-Novo ventral/incisional hernia amenable to repair with GORE® SYNECOR IP Biomaterial * Clean wound (CDC Wound Class I) * mVHWG Grade 1 or 2 (modified Ventral Hernia Working Group) Key
Exclusion criteria
- IP Cohort: \- Wound is either clean-contaminated, contaminated or dirty-infected Key Inclusion Criteria - PRE Cohort: * De-novo ventral/incisional hernia, with subject anatomy and surgical plan amenable to open surgical repair or minimally invasive surgery with the GORE® SYNECOR PRE Biomaterial placed in a sublay fashion within the preperitoneal space * Clean wound (CDC Wound Class I) * mVHWG Grade 1 or 2 (modified Ventral Hernia Working Group) Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia Recurrence | 24 Months | Hernia Recurrence Treated Location |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Re-Admission | 60 Months | Device or procedural-related |
| Thirty-Day Mortality | 30 Day | Mortality of all causes |
| SSO within 24 months post-procedure | 24 Months | Surgical Site Occurrence (SSO) |
| SSI (Surgical Site Infection) | 60 Months | Surgical Site Infection (SSI) |
| Freedom from mesh-involved events | 60 Months | Freedom from mesh-involved events |
| Major Seroma (clinically confirmed) | 60 Months | Major Seroma as clinically assessed (physiological parameters) and defined as seroma requiring treatment in the presence of infection, recurrence, mesh rejection or the need to be punctured/aspirated will be described without specific hypothesis or formal goal. Number of subjects with reported major seroma will be described as clinically confirmed by the investigator. |
| Change in Quality of Life (QoL) - SF 36 Questionnaire | 60 Months | SF 36 Questionnaire (36-Item Short Form Survey Instrument; possible score ranges from 0 to 100 points. 0 points represent the greatest possible limitation of health, while 100 points represent the absence of health restrictions) |
| Change in Quality of Life (QoL) - Carolinas Comfort Scale (CCS) | 60 Months | Carolinas Comfort Scale (CCS); CCS was designed that a lower score indicates a favorable health status; the total score is based on a scale of 0 - 115) |
| Ventral Hernia Recurrence Inventory sensitivity / specificity within 60 Month Follow-Up | 60 Months | VHRI Survey (Ventral Hernia Recurrence Inventory) |
| Adverse Events by Clavien Dindo Classification | 60 Months | Adverse Events by Clavien Dindo Classification |
| Surgical Site Occurrences (SSOPI) requiring Procedural Intervention | 24 Months | Surgical Site Occurrences (SSOPI) requiring Procedural Intervention |
Countries
Italy, Spain, United Kingdom, United States
Outcome results
None listed