Intuitive Surgical is hosting a clinical trial on levels of pain and quality of life after different surgical approaches to inguinal hernia repairs. Researchers will examine the difference between open, laparoscopic, and robotic-assisted surgical approaches. This study’s estimated completion date is February 1, 2021.
There will be an estimated 200 participants in this study. Some will be placed into a group where an open inguinal hernia repair will be performed. Others will undergo a laparoscopic hernia repair, and the last group will have a hernia repair using the robotic-assisted approach. Researchers will observe pain medication intake, pill count, pain reported by participants, and quality of life after the operation at time points of 14 days, 30 days, and 3 months after surgery.
All sexes, ages 18 to 80 years old, are allowed to participate. They must be a candidate for an elective primary inguinal hernia repair.
Those not allowed to participate include:
- Subject who will have an emergency hernia repair.
- Subject with a history of chronic pain and/or taking daily pain medications for less than 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 who require insulin.
- Subject with repeated 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 nicotine or marijuana use within the past 30 days.
- Subject who will be put in danger if they undergo any of the researched surgeries (contraindicated) .
- 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 prevent compliance with study requirements or ability to provide informed consent.
- Subject belongs to vulnerable population (e.g, prisoner or ward of the state).
- Subject is unable to comply with the follow-up visit schedule.
- Subject is currently participating in another research study
Those interested may participate in this study at Vanderbilt University Medical Center in Nashville, Tennessee, 37232. Feel free to contact Alison Gorski at 408-523-1855 or at firstname.lastname@example.org with any questions or concerns.
This clinical trial is sponsored by Intuitive Surgical. Richard Pierce, M.D. as the Principal Investigator.
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