Health Condition 1: K439- Ventral hernia without obstructionor gangrene
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Intuitive Surgical Pvt. Ltd. India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject is between 18 and 65 years of age and who can understand, read, and write English. 2. Subject is a candidate for an elective ventral hernia repair (non-recurrent), with a ventral hernia defect size of 5 or less than 5 cms. 3. Ventral hernia repair that will require mesh placement.
Exclusion criteria
Exclusion criteria: 1. Subject is contraindicated for general anesthesia or surgery. 2. Subject has a recurrent hernia. 3. Subject who will have an emergent hernia repair. 4. Subject with a history of chronic pain and/or taking daily pain medications for more than 6 weeks. 5. Subject with HbA1c level greater than 8.5%. 6. Subject who will undergo a concomitant hernia repair or any other concomitant procedure. 7. Subject has a known bleeding or clotting disorder. 8. Pregnant or suspected pregnancy. 9. Subject has a psychological/psychiatric disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent. 10. Subject is currently participating in another interventional or investigational research study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient reported pain scores assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey and Numeric Rating Scale (NRS) Pain medication usage related to the ventral hernia repair through 14 days post-procedureTimepoint: Pre-Operative Assessment (-7 days), Intra-Operative Assessment, Post-Operative Assessment up to Discharge, Post-Operative Assessment at day 7+1 day, Post-Operative Assessment at day 14+3 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life AssessmentTimepoint: Pre-Operative Assessment, Post-Operative Assessment at day 14, Post-Operative Assessment at day 30;Length of hospital stay (LOS)Timepoint: Admission to discharge;Adverse events (AEs) related to the ventral hernia repair procedureTimepoint: Intraoperative and post-operative up to 30 days | — |
Countries
India
Contacts
Public ContactDr Akhil Dahiya
Intuitive Surgical Pvt. Ltd. India
Outcome results
None listed