Hernia, Incisional Hernia, Hernia, Inguinal, Indirect, Hernia, Inguinal, Direct, Inguinal Hernia
Conditions
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.
Interventions
PROCEDUREHernia repair
Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice
Sponsors
Accelovance
Intuitive Surgical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years and older 2. All patients undergoing either an open, laparoscopic or robotic-assisted 3. Incisional or Inguinal Hernia repair procedure 4. Non-Emergent Incisional or Inguinal Hernia Repair cases
Exclusion criteria
1. Emergent Cases for both Incisional and Inguinal Hernia 2. Incisional Hernia related to ostomy formation 3. Incisional Hernia requiring component separation (determined pre-operatively or intraoperatively)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of complications observed intraoperatively through 30 days | 30 days | Number of intraoperative and short-term complications related to hernia repair. |
| Number of patient reported complications post 30-days through 3 years post procedure | 30 days post-procedure to 3 years post-procedure | Number of long-term complications related to hernia repair directly reported by patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported outcomes on Quality of Life through 1 year | Pre-procedure (baseline) and 30 days through 1 year for Qualify of Life | 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. |
| Incisional or Inguinal Hernia Recurrence through 3 years | 30 days post-procedure through 3 years | Number of hernia recurrences for each patient will be patient reported through 3 years post-procedure. |
| Patient reported outcomes on post-procedure pain through 3 years | 2-4 weeks post-procedure through 3 years post-procedure | 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 |
Countries
United States
Outcome results
None listed