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.
Study Type
OBSERVATIONAL
Enrollment
320
Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Tufts Medical Center
Boston, Massachusetts, United States
Hernia Recurrence
Hernia Recurrence Treated Location
Time frame: 24 Months
Hernia Recurrence
Hernia Recurrence Treated Location
Time frame: 60 Months
Hospital Re-Admission
Device or procedural-related
Time frame: 60 Months
Thirty-Day Mortality
Mortality of all causes
Time frame: 30 Day
SSO within 24 months post-procedure
Surgical Site Occurrence (SSO)
Time frame: 24 Months
SSI (Surgical Site Infection)
Surgical Site Infection (SSI)
Time frame: 60 Months
Freedom from mesh-involved events
Freedom from mesh-involved events
Time frame: 60 Months
Major Seroma (clinically confirmed)
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.
Time frame: 60 Months
Change in Quality of Life (QoL) - SF 36 Questionnaire
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Corewell Health
Grand Rapids, Michigan, United States
Lovelace Women's Hospital
Albuquerque, New Mexico, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, United States
Ospedale Civile di Baggiovara
Baggiovara, Italy
Vincenzo Monaldi Hospital
Naples, Italy
...and 5 more locations
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)
Time frame: 60 Months
Change in Quality of Life (QoL) - Carolinas Comfort Scale (CCS)
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)
Time frame: 60 Months
Ventral Hernia Recurrence Inventory sensitivity / specificity within 60 Month Follow-Up
VHRI Survey (Ventral Hernia Recurrence Inventory)
Time frame: 60 Months
Adverse Events by Clavien Dindo Classification
Adverse Events by Clavien Dindo Classification
Time frame: 60 Months
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Time frame: 24 Months
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Time frame: 60 Months