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

Intuitive Surgical

Status

Completed

Conditions

Ventral Hernia

Treatments

Procedure: Open retromuscular ventral hernia repair

Device: Robotic-assisted retromuscular ventral hernia repair

Procedure: Laparoscopic retromuscular ventral hernia repair

Study type

Observational

Funder types

Industry

Identifiers

NCT04487522

RECOVER

Details and patient eligibility

About

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.

Full 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.

Enrollment

74 patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

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