Pain and Quality of Life After Retromuscular Ventral Hernia Repair (RECOVER)

RECOVER: a PRospECtive EvaluatiOn of Pain After Retromuscular VEntRal Hernia Repair

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.

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