A study to evaluate Pain after non-complex ventral hernia repair
- Conditions
- Health Condition 1: K439- Ventral hernia without obstructionor gangrene
- Registration Number
- CTRI/2024/03/064267
- Lead Sponsor
- Intuitive Surgical Pvt. Ltd. India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient reported pain scores assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey and Numeric Rating Scale (NRS) <br/ ><br> <br/ ><br>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 Outcome Measures
Name Time Method Adverse events (AEs) related to the ventral hernia repair procedureTimepoint: Intraoperative and post-operative up to 30 days;Length of hospital stay (LOS)Timepoint: Admission to discharge;Quality of Life AssessmentTimepoint: Pre-Operative Assessment, Post-Operative Assessment at day 14, Post-Operative Assessment at day 30