Pain and Quality of Life After Retromuscular Ventral Hernia Repair (RECOVER)

Completed

Conditions studied: Ventral Hernia

In brief

The study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted retromuscular ventral hernia repair.

Key facts

Study ID

NCT04487522

Run by

Intuitive Surgical

People needed

74

Starts

2020-07-16

Expected to finish

2024-09-19

Last updated by the study team

2024-11-26

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is between 18 and 89 years of age
• Subject is a candidate for an elective retromuscular ventral hernia repair under general anesthesia
• Subject has access to complete study assessments electronically and agrees to comply with all follow-up requirements
• Ventral hernia is >= 4cm

You may not qualify if…

• Subject who will have an emergent hernia repair
• Subject has a parastomal hernia (i.e. hernia related to ostomy formation)
• Subject with a history of chronic pain and/or taking daily pain medication for >6 weeks
• Subject wtih a history of substance abuse (excluding marijuana) and/or current (within 30 days) narcotic use
• Subject with a history of MRSA infection
• Subject with HbA1c level > 8.5%
• Subject undergoing a minimally invasive (MIS) repair who will require the use of Exparel during the surgical procedure
• Subject who will undergo a concomitant hernia repair or any other concomitant procedure
• Subject has cirrhosis
• Current nicotine use (including vaping) within the past 30 days
• Subject is contraindicated for general anesthesia or surgery
• 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 the study requirements or ability to provide informed consent
• Subject belonging to other vulnerable population, e.g., prisoner or ward of state
• Subject is currently participating in another interventional research study

Where it is running

• Kaiser Foundation Research Institute, Oakland/Richmond — Oakland, California, United States
• Kaiser Foundation Research Institute, South Sacramento — Sacramento, California, United States
• Kaiser Foundation Research Institute, Santa Clara — Santa Clara, California, United States
• Kaiser Foundation Research Institute, Walnut Creek — Walnut Creek, California, United States

Full record on ClinicalTrials.gov

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