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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retromuscular ventral hernia repair | These subjects will undergo an open, a laparoscopic, or a robotic-assisted retromuscular ventral hernia repair. |
| |
| Retromuscular TAR ventral hernia repair | These subjects will undergo an open or a robotic-assisted retromuscular transversus abdominis release (TAR) ventral hernia repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open retromuscular ventral hernia repair | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey. | 7 days |
| Narcotic usage | Narcotic usage (in hospital and out of hospital) taken for the purpose of managing abdominal pain after the ventral hernia repair. | 4 weeks |
| Non-opioid prescription pain medication usage | Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic usage | Narcotic usage related to the retromuscular ventral hernia repair. | 3 months |
| Non-opioid prescription pain medication usage | Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who will undergo an elective retromuscular ventral hernia repair procedure and who meet all eligibility criteria will be considered for enrollment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Foundation Research Institute, Oakland/Richmond | Oakland | California | 94612 | United States | ||
| Kaiser Foundation Research Institute, South Sacramento |
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| Laparoscopic retromuscular ventral hernia repair | Procedure | 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. |
|
| Robotic-assisted retromuscular ventral hernia repair | Device | 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. |
|
| 3 months |
| Over the counter pain medication usage | 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 | 4 weeks |
| Need for refill prescription pain medication | Need for refill of prescription pain medication after the retromuscular ventral hernia repair | 4 weeks |
| PROMIS 3a pain scores | Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey. | 4 weeks |
| Hospital length of stay | Duration of hospital stay | Start of procedure to discharge from the hospital (check out time), up to an approximate of one week |
| Incidence of intraoperative adverse events related to the retromuscular ventral hernia repair | Intra-operative adverse events related to the retromuscular ventral hernia repair | intraoperatve |
| Incidence of postoperative adverse events related to the retromuscular ventral hernia repair | Post-operative adverse events related to the retromuscular ventral hernia repair | 3 months |
| Hernia recurrence | Hernia recurrence after the retromuscular ventral hernia repair | 1 year |
| EQ-5D-3L QOL scores | 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). | 4 weeks |
| Sacramento |
| California |
| 95825 |
| United States |
| Kaiser Foundation Research Institute, Santa Clara | Santa Clara | California | 95051 | United States |
| Kaiser Foundation Research Institute, Walnut Creek | Walnut Creek | California | 94596 | United States |
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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