A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients
Purpose
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.
Conditions
- Hernia
- Incisional Hernia
- Hernia, Inguinal, Indirect
- Hernia, Inguinal, Direct
- Inguinal Hernia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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)
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Open Hernia Repair | A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia open repair surgical procedure |
|
| Laparoscopic Hernia Repair | A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia laparoscopic repair surgical procedure |
|
| Robotic Hernia Repair | A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia robotic-assisted laparoscopic repair surgical procedure |
|
More Details
- Status
- Completed
- Sponsor
- Intuitive Surgical