Pain and Quality of Life After Inguinal Hernia Repair

Last updated: October 1, 2024
Sponsor: Intuitive Surgical
Overall Status: Completed

Phase

N/A

Condition

Hernia

Treatment

Open Inguinal Hernia Repair

Robotic-Assisted Inguinal Hernia Repair

Laparoscopic Inguinal Hernia Repair

Clinical Study ID

NCT04074200
ISI-IHP-2018
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is between 18 and 80 years of age.

  • Subject is a candidate for an elective primary inguinal hernia repair.

Exclusion

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 >6weeks.

  • Subject with a history of substance abuse and/or current (within 30 days) narcoticuse.

  • 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 concomitantprocedure.

  • Current marijuana use that the subject is unwilling to discontinue within the 14days 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 systemicillness that would preclude compliance with study requirements or ability to provideinformed consent.

  • Subject belonging to other vulnerable population, e.g, prisoner or ward of thestate.

  • Subject unable to comply with the follow-up visit schedule.

  • Subject is currently participating in another research study.

Study Design

Total Participants: 156
Treatment Group(s): 3
Primary Treatment: Open Inguinal Hernia Repair
Phase:
Study Start date:
August 26, 2019
Estimated Completion Date:
July 06, 2023

Study 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.

Connect with a study center

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

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