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.
Study Type
OBSERVATIONAL
Enrollment
74
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.
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.
Kaiser Foundation Research Institute, Oakland/Richmond
Oakland, California, United States
Kaiser Foundation Research Institute, South Sacramento
Sacramento, California, United States
Kaiser Foundation Research Institute, Santa Clara
Santa Clara, California, United States
Kaiser Foundation Research Institute, Walnut Creek
Walnut Creek, California, United States
Pain scores
Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.
Time frame: 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.
Time frame: 4 weeks
Non-opioid prescription pain medication usage
Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair
Time frame: 4 weeks
Narcotic usage
Narcotic usage related to the retromuscular ventral hernia repair.
Time frame: 3 months
Non-opioid prescription pain medication usage
Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair.
Time frame: 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
Time frame: 4 weeks
Need for refill prescription pain medication
Need for refill of prescription pain medication after the retromuscular ventral hernia repair
Time frame: 4 weeks
PROMIS 3a pain scores
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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.
Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.
Time frame: 4 weeks
Hospital length of stay
Duration of hospital stay
Time frame: 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
Time frame: intraoperatve
Incidence of postoperative adverse events related to the retromuscular ventral hernia repair
Post-operative adverse events related to the retromuscular ventral hernia repair
Time frame: 3 months
Hernia recurrence
Hernia recurrence after the retromuscular ventral hernia repair
Time frame: 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).
Time frame: 4 weeks