A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Prospective, Multicenter Post-Market Study to Evaluate and Compare the Clinical Outcomes, Pain and Patient Quality of Life After Open, Laparoscopic or Robotic Assisted Hernia (Incisional and Inguinal) Repair

Conditions
-----------------
Hernia, Incisional Hernia, Hernia, Inguinal, Indirect, Hernia, Inguinal, Direct, Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: Hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years and older All patients undergoing either an open, laparoscopic or robotic-assisted Incisional or Inguinal Hernia repair procedure Non-Emergent Incisional or Inguinal Hernia Repair cases Exclusion Criteria: Emergent Cases for both Incisional and Inguinal Hernia Incisional Hernia related to ostomy formation Incisional Hernia requiring component separation (determined pre-operatively or intraoperatively)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open Hernia Repair<br>A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia open repair surgical procedure | Procedure: Hernia repair<br>* Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice<br>|
| Laparoscopic Hernia Repair<br>A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia laparoscopic repair surgical procedure | Procedure: Hernia repair<br>* Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice<br>|
| Robotic Hernia Repair<br>A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia robotic-assisted laparoscopic repair surgical procedure | Procedure: Hernia repair<br>* Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of complications observed intraoperatively through 30 days | Number of intraoperative and short-term complications related to hernia repair. | 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 | 30 days post-procedure to 3 years post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 2-4 weeks post-procedure through 3 years post-procedure |