Pain and Quality of Life After Inguinal Hernia Repair

PREPARE: A PRospective Evaluation of Pain After Inguinal Hernia REpair

This study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted inguinal hernia repair.

This is a prospective, multi-center, observational pilot study comparing outcomes of pain and quality of life after inguinal hernia repair between open, laparoscopic, and robotic-assisted surgical approaches. The study will focus on short-term outcomes through 3 months post-operation. During the post-operative period through 3 months, pain medication intake, pill count, subject-reported pain (on post-operative days 1-3 and 14 days post-surgery), and quality of life (at 14 days, 30 days, and 3 months post-surgery), incidence of intra- and post-operative complications, and time to return to normal activity will be collected.

Inclusion Criteria:

• Subject is between 18 and 80 years of age.
• Subject is a candidate for an elective primary inguinal hernia repair.

Exclusion Criteria:

• Subject receiving a bilateral open repair.
• Subject who will have an emergent hernia repair.
• Subject with a history of chronic pain and/or taking daily pain medications for >6 weeks.
• Subject with a history of substance abuse and/or current (within 30 days) narcotic use.
• Subject with a history of methicillin-resistant Staphylococcus aureus (MRSA) infection.
• Diabetic subjects requiring insulin.
• Subject with recurrent hernias.
• Subject who will require the use of Exparel during the surgical procedure.
• Subject who will undergo a concomitant hernia repair or any other concomitant procedure.
• Current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery.
• Subject is contraindicated for surgery.
• Subject has a known bleeding or clotting disorder.
• Pregnant or suspect pregnancy.
• Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent.
• Subject belonging to other vulnerable population, e.g, prisoner or ward of the state.
• Subject unable to comply with the follow-up visit schedule.
• Subject is currently participating in another research study.