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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hernia
- Sponsor
- Intuitive Surgical
- Enrollment
- 944
- Locations
- 17
- Primary Endpoint
- Number of patient reported complications post 30-days through 3 years post procedure
- Status
- Completed
- Last Updated
- 3 years ago
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.
Investigators
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)
Outcomes
Primary Outcomes
Number of patient reported complications post 30-days through 3 years post procedure
Time Frame: 30 days post-procedure to 3 years post-procedure
Number of long-term complications related to hernia repair directly reported by patients
Number of complications observed intraoperatively through 30 days
Time Frame: 30 days
Number of intraoperative and short-term complications related to hernia repair.
Secondary Outcomes
- Incisional or Inguinal Hernia Recurrence through 3 years(30 days post-procedure through 3 years)
- Patient reported outcomes on post-procedure pain through 3 years(2-4 weeks post-procedure through 3 years post-procedure)
- Patient reported outcomes on Quality of Life through 1 year(Pre-procedure (baseline) and 30 days through 1 year for Qualify of Life)