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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2022
  • participants needed
    125
  • sponsor
    Intuitive Surgical
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Updated on 13 August 2020
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Investigator
Jennifer Mueller
Primary Contact
Kaiser Foundation Research Institute, Walnut Creek (2.8 mi away) Contact
+3 other location
anesthesia
herniorrhaphy
repair of ventral hernia

Summary

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.

Description

This is a prospective, multicenter, observational study assessing outcomes relating to pain and quality of life for subjects undergoing open, laparoscopic, or robotic-assisted retromuscular ventral hernia repair. The study will focus on short-term post-operative outcomes through 3 months. The study will also collect recurrence data through 1 year. During the post-operative period through 3 months, pain medication intake, subject reported pain (on post-operative day 7, 14, 21, 28, and 3 months) and quality of life (on day 28, 3 months, and 1 year) and incidence of intra-operative and post-operative adverse events related to the ventral hernia repair will be collected.

Details
Treatment Open retromuscular ventral hernia repair, Laparoscopic retromuscular ventral hernia repair, Robotic-assisted retromuscular ventral hernia repair
Clinical Study IdentifierNCT04487522
SponsorIntuitive Surgical
Last Modified on13 August 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 89 yrs?
Gender: Male or Female
Do you have Ventral Hernia?
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

Exclusion Criteria

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
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