Status:
COMPLETED
Pain and Quality of Life After Retromuscular Ventral Hernia Repair (RECOVER)
Lead Sponsor:
Intuitive Surgical
Conditions:
Ventral Hernia
Eligibility:
All Genders
18-89 years
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 he...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 19 2024
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04487522
Start Date
July 16 2020
End Date
September 19 2024
Last Update
November 26 2024
Active Locations (4)
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1
Kaiser Foundation Research Institute, Oakland/Richmond
Oakland, California, United States, 94612
2
Kaiser Foundation Research Institute, South Sacramento
Sacramento, California, United States, 95825
3
Kaiser Foundation Research Institute, Santa Clara
Santa Clara, California, United States, 95051
4
Kaiser Foundation Research Institute, Walnut Creek
Walnut Creek, California, United States, 94596