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

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

ArmDescriptionAssigned Intervention
Open Inguinal Hernia Repair These subjects will undergo an inguinal hernia repair using an open surgical approach.
  • Procedure: Open Inguinal Hernia Repair
    With the patient under anesthesia, a single incision is made in the groin area. The hernia defect may be closed, as per the operating surgeon's standard of care (SOC). Mesh may be used to repair the hernia, as per SOC. The specific open approach may vary due to surgeon preference and patient characteristics. After the repair, the patient will be prescribed a 5 day supply of pain medication, as per SOC.
Laparoscopic Inguinal Hernia Repair These subjects will undergo an inguinal hernia repair using a laparoscopic surgical approach.
  • Procedure: Laparoscopic Inguinal Hernia Repair
    With the patient under general anesthesia, several small incisions are made in the groin area. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope (a lighted scope used to visualize the hernia) are inserted to complete the repair. The hernia defect may be closed, as per the operating surgeon's standard of care (SOC). Mesh may be used to repair the hernia, as per SOC. The specific laparoscopic approach may vary due to surgeon preference and patient characteristics. After the repair, the patient will be prescribed a 5 day supply of pain medication, as per SOC.
Robotic-assisted Inguinal Hernia Repair These subjects will undergo an inguinal hernia repair using a robotic-assisted surgical approach.
  • Device: Robotic-Assisted Inguinal Hernia Repair
    With the patient under general anesthesia, several small incisions are made in the groin area. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the patient and used to complete the procedure. The hernia defect may be closed, as per the operating surgeon's standard of care (SOC). Mesh may be used to repair the hernia, as per SOC. The specific robotic-assisted approach may vary due to surgeon preference and patient characteristics. After the repair, the patient will be prescribed a 5 day supply of pain medication, as per SOC.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Jill Janssen
615-343-8010
clinicaltrialscenter@vanderbilt.edu

More Details

Status
Recruiting
Sponsor
Intuitive Surgical

Study Contact

Alison Gorski
4085231855
alison.gorski@intusurg.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.