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#HERNIA FREE CLINICAL TRIALS TRIAL#

This clinical trial is sponsored by Intuitive Surgical. Researchers will examine the difference between open, laparoscopic, and robotic-assisted surgical approaches. Feel free to contact Alison Gorski at 40 or at with any questions or concerns. Intuitive Surgical is hosting a clinical trial on levels of pain and quality of life after different surgical approaches to inguinal hernia repairs. Those interested may participate in this study at Vanderbilt University Medical Center in Nashville, Tennessee, 37232. Subject is currently participating in another research study.

Subject is unable to comply with the follow-up visit schedule. The aim of the study was prospectively to compare the early results and outcome in 105 patients randomly allocated to undergo tension-free laparoscopic hernia repair (LHR) with transabdominal preperitoneal technique (53 patients) or open hernia repair (OHR) with mesh apposition (52 patients).

Subject belongs to vulnerable population (e.g, prisoner or ward of the state).

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 has a known bleeding or clotting disorder.

Subject who will be put in danger if they undergo any of the researched surgeries (contraindicated).

Current nicotine or marijuana use within the past 30 days. Study population is Waitemata Health (Auckland New Zealand) patients presenting to clinic with unilateral primary inguinal hernia aged less than 60 years, fit for surgery and able to consent for the study.

Subject who will undergo a concomitant hernia repair or any other concomitant procedure.

Subject who will require the use of Exparel during the surgical procedure.Subject with a history of methicillin-resistant Staphylococcus aureus (MRSA) infection.Subject with a history of substance abuse and/or current (within 30 days) narcotic use.Subject with a history of chronic pain and/or taking daily pain medications for less than 6 weeks.Subject who will have an emergency hernia repair.Those not allowed to participate include: They must be a candidate for an elective primary inguinal hernia repair. 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.Īll sexes, ages 18 to 80 years old, are allowed to participate. Others will undergo a laparoscopic hernia repair, and the last group will have a hernia repair using the robotic-assisted approach. Some will be placed into a group where an open inguinal hernia repair will be performed. There will be an estimated 200 participants in this study. This study’s estimated completion date is February 1, 2021. Intuitive Surgical is hosting a clinical trial on levels of pain and quality of life after different surgical approaches to inguinal hernia repairs.