Status:
COMPLETED
Pain and Quality of Life After Inguinal Hernia Repair
Lead Sponsor:
Intuitive Surgical
Conditions:
Inguinal Hernia
Eligibility:
All Genders
18-80 years
Brief Summary
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.
Detailed 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 app...
Eligibility Criteria
Inclusion
- Subject is between 18 and 80 years of age.
- Subject is a candidate for an elective primary inguinal hernia repair.
Exclusion
- 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.
Key Trial Info
Start Date :
August 26 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 6 2023
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04074200
Start Date
August 26 2019
End Date
July 6 2023
Last Update
October 3 2024
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232