Pain and Quality of Life After Inguinal Hernia Repair
Purpose
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.
Condition
- Inguinal Hernia
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Open Inguinal Hernia Repair | These subjects will undergo an inguinal hernia repair using an open surgical approach. |
|
Laparoscopic Inguinal Hernia Repair | These subjects will undergo an inguinal hernia repair using a laparoscopic surgical approach. |
|
Robotic-assisted Inguinal Hernia Repair | These subjects will undergo an inguinal hernia repair using a robotic-assisted surgical approach. |
|
Recruiting Locations
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Intuitive Surgical
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 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.