A Prospective Evaluation of Pain After Non-complex Ventral Hernia Repair

Stopped early

Conditions studied: Ventral Hernia

In brief

The study aims to evaluate outcomes relating to pain and QOL after robotic-assisted or laparoscopic non-complex ventral hernia repair.

Key facts

Study ID

NCT04855227

Run by

Intuitive Surgical

People needed

69

Starts

2021-08-31

Expected to finish

2024-11-19

Last updated by the study team

2024-12-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Subject is contraindicated for general anesthesia or surgery.
• 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.
• Subject has a recurrent hernia.
• 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 (excluding marijuana) and/or current (within 30 days) narcotic use.
• Current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery.
• Subject with a history of MRSA infection.
• Subject with HbA1c level > 8.5%.
• Use of Exparel during the surgical procedure.
• Subject who will undergo a concomitant hernia repair or any other concomitant procedure.
• Current nicotine use (including vaping) within the past 30 days.
• Subject has a known bleeding or clotting disorder.
• Pregnant or suspected 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 is currently participating in another interventional or investigational research study.

Where it is running

• Desert Surgical Specialists — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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