The objective of this prospective, multi-center post-market study is to prospectively collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic assisted hernia repair. The outcomes that will be collected include various routine clinical parameters, short term patient reported outcomes (quality of life, pain scores) and long term hernia recurrence information. Patients will be treated according to standard of care at the surgeon's institution and patients will be followed up to collect information related to complications information and patient satisfaction associated with the hernia repair procedure.
Study Type
OBSERVATIONAL
Enrollment
944
Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice
Beverly Hills Hernia Center
Beverly Hills, California, United States
Vanderbilt University Medical Center
Nashville, California, United States
Kaiser Foundation Research Institute
Oakland, California, United States
Florida Hospital - Celebration Health
Celebration, Florida, United States
Baptist Health South Florida
South Miami, Florida, United States
Southern Illinois Healthcare
Carbondale, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Progressive Surgical Associates
New Lenox, Illinois, United States
Louisville Surgical Associates
Louisville, Kentucky, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
...and 7 more locations
Number of complications observed intraoperatively through 30 days
Number of intraoperative and short-term complications related to hernia repair.
Time frame: 30 days
Number of patient reported complications post 30-days through 3 years post procedure
Number of long-term complications related to hernia repair directly reported by patients
Time frame: 30 days post-procedure to 3 years post-procedure
Patient reported outcomes on Quality of Life through 1 year
Use of quality of life questionnaires (Carolinas Comfort Scale or HerQles Abdominal Questionnaire) will be used to assess patient qualify of life pre-procedure and post-procedure through 1 year.
Time frame: Pre-procedure (baseline) and 30 days through 1 year for Qualify of Life
Incisional or Inguinal Hernia Recurrence through 3 years
Number of hernia recurrences for each patient will be patient reported through 3 years post-procedure.
Time frame: 30 days post-procedure through 3 years
Patient reported outcomes on post-procedure pain through 3 years
Pain medication taken by patient (type, dosage and quantity of pills) will also be captured through patient reported methods. Unit of measure will be numerical count of pills take
Time frame: 2-4 weeks post-procedure through 3 years post-procedure
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