Ventral Hernia
Conditions
Brief summary
The study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted retromuscular ventral hernia repair.
Detailed description
This is a prospective, multicenter, observational study assessing outcomes relating to pain and quality of life for subjects undergoing open, laparoscopic, or robotic-assisted retromuscular ventral hernia repair. The study will focus on short-term post-operative outcomes through 3 months. The study will also collect recurrence data through 1 year. During the post-operative period through 3 months, pain medication intake, subject reported pain (on post-operative day 7, 14, 21, 28, and 3 months) and quality of life (on day 28, 3 months, and 1 year) and incidence of intra-operative and post-operative adverse events related to the ventral hernia repair will be collected.
Interventions
PROCEDUREOpen retromuscular ventral hernia repair
With the subject under general anesthesia, a single incision is made in the abdomen. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.
PROCEDURELaparoscopic retromuscular ventral hernia repair
With the subject under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope are inserted to complete the repair. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.
DEVICERobotic-assisted retromuscular ventral hernia repair
With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the subject and used to complete the procedure. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.
Sponsors
Intuitive Surgical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Subject is between 18 and 89 years of age * Subject is a candidate for an elective retromuscular ventral hernia repair under general anesthesia * Subject has access to complete study assessments electronically and agrees to comply with all follow-up requirements * Ventral hernia is \>= 4cm
Exclusion criteria
* Subject who will have an emergent hernia repair * Subject has a parastomal hernia (i.e. hernia related to ostomy formation) * Subject with a history of chronic pain and/or taking daily pain medication for \>6 weeks * Subject wtih a history of substance abuse (excluding marijuana) and/or current (within 30 days) narcotic use * Subject with a history of MRSA infection * Subject with HbA1c level \> 8.5% * Subject undergoing a minimally invasive (MIS) repair who will require the use of Exparel during the surgical procedure * Subject who will undergo a concomitant hernia repair or any other concomitant procedure * Subject has cirrhosis * Current nicotine use (including vaping) within the past 30 days * Subject is contraindicated for general anesthesia or surgery * Subject has a known bleeding or clotting disorder * Pregnant or suspected pregnancy * Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with the study requirements or ability to provide informed consent * Subject belonging to other vulnerable population, e.g., prisoner or ward of state * Subject is currently participating in another interventional research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | 7 days | Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey. |
| Narcotic usage | 4 weeks | Narcotic usage (in hospital and out of hospital) taken for the purpose of managing abdominal pain after the ventral hernia repair. |
| Non-opioid prescription pain medication usage | 4 weeks | Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for refill prescription pain medication | 4 weeks | Need for refill of prescription pain medication after the retromuscular ventral hernia repair |
| PROMIS 3a pain scores | 4 weeks | Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey. |
| Hospital length of stay | Start of procedure to discharge from the hospital (check out time), up to an approximate of one week | Duration of hospital stay |
| Narcotic usage | 3 months | Narcotic usage related to the retromuscular ventral hernia repair. |
| Incidence of postoperative adverse events related to the retromuscular ventral hernia repair | 3 months | Post-operative adverse events related to the retromuscular ventral hernia repair |
| Hernia recurrence | 1 year | Hernia recurrence after the retromuscular ventral hernia repair |
| EQ-5D-3L QOL scores | 4 weeks | Quality of life assessment using the EQ-5D-3L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine). |
| Incidence of intraoperative adverse events related to the retromuscular ventral hernia repair | intraoperatve | Intra-operative adverse events related to the retromuscular ventral hernia repair |
| Non-opioid prescription pain medication usage | 3 months | Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair. |
| Over the counter pain medication usage | 4 weeks | Over the counter (OTC) pain medication usage after the retromuscular ventral hernia repair procedure as determined by patient reporting of OTC pain medication usage at follow-ups |
Countries
United States
Outcome results
None listed