A Prospective Evaluation of Pain After Non-complex Ventral Hernia Repair
The study aims to evaluate outcomes relating to pain and QOL after robotic-assisted or laparoscopic non-complex ventral hernia repair.
Conditions:
🦠 Ventral Hernia
🗓️ Study Start (Actual) 31 August 2021
🗓️ Primary Completion (Estimated) August 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 200
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Phoenix, Arizona, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Subject is between 18 and 80 years of age.
    • 2. Subject is a candidate for an elective primary (non-recurrent) ventral hernia repair.
    • 3. Ventral hernia repair that will require mesh placement

    Exclusion Criteria:

    • 1. Subject is contraindicated for general anesthesia or surgery.
    • 2. Subject with a ventral hernia that will require retromuscular mesh placement or employ a technique, including (but not limited to) external oblique release, Rives- Stoppa, eTEP Rives-Stoppa, transversus abdominis release, other component separation techniques (i.e. anterior component separation) or eTEP transversus abdominis release.
    • 3. Subject has a recurrent hernia.
    • 4. Subject who will have an emergent hernia repair.
    • 5. Subject with a history of chronic pain and/or taking daily pain medications for \>6 weeks.
    • 6. Subject with a history of substance abuse (excluding marijuana) and/or current (within 30 days) narcotic use.
    • 7. Current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery.
    • 8. Subject with a history of MRSA infection.
    • 9. Subject with HbA1c level \> 8.5%.
    • 10. Use of Exparel during the surgical procedure.
    • 11. Subject who will undergo a concomitant hernia repair or any other concomitant procedure.
    • 12. Current nicotine use (including vaping) within the past 30 days.
    • 13. Subject has a known bleeding or clotting disorder.
    • 14. Pregnant or suspected pregnancy.
    • 15. 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.
    • 16. Subject belonging to other vulnerable population, e.g, prisoner or ward of the state.
    • 17. Subject is currently participating in another interventional or investigational research study.
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 March 2021
  • First Submitted that Met QC Criteria 19 April 2021
  • First Posted 22 April 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 September 2023
  • Last Update Posted 28 September 2023
  • Last Verified September 2023