Pain and Quality of Life After Inguinal Hernia Repair (PREPARE)

Intuitive Surgical

Status

Completed

Conditions

Inguinal Hernia

Treatments

Procedure: Open Inguinal Hernia Repair

Device: Robotic-Assisted Inguinal Hernia Repair

Procedure: Laparoscopic Inguinal Hernia Repair

Study type

Observational

Funder types

Industry

Identifiers

NCT04074200

ISI-IHP-2018

Details and patient eligibility

About

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.

Full description

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.

Enrollment

156 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.