Clinical trial NCT04487522: Pain and Quality of Life After Retromuscular Ventral Hernia Repair (RECOVER)
Official title: RECOVER: a PRospECtive EvaluatiOn of Pain After Retromuscular VEntRal Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernia
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2020-07-27
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who will undergo an elective retromuscular ventral hernia repair procedure and who meet all eligibility criteria will be considered for enrollment.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Pain scores
timeFrame: 7 days
measure: Narcotic usage
timeFrame: 4 weeks
measure: Non-opioid prescription pain medication usage
timeFrame: 4 weeks
Secondary outcomes:
measure: Narcotic usage
timeFrame: 3 months
measure: Non-opioid prescription pain medication usage
timeFrame: 3 months
measure: Over the counter pain medication usage
timeFrame: 4 weeks
measure: Need for refill prescription pain medication
timeFrame: 4 weeks
measure: PROMIS 3a pain scores
timeFrame: 4 weeks
measure: Hospital length of stay
timeFrame: Start of procedure to discharge from the hospital (check out time), up to an approximate of one week
measure: Incidence of intraoperative adverse events related to the retromuscular ventral hernia repair
timeFrame: intraoperatve
measure: Incidence of postoperative adverse events related to the retromuscular ventral hernia repair
timeFrame: 3 months
measure: Hernia recurrence
timeFrame: 1 year
measure: EQ-5D-3L QOL scores
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Foundation Research Institute, Oakland/Richmond
state: California
city: Sacramento
country: United States
facility: Kaiser Foundation Research Institute, South Sacramento
state: California
city: Santa Clara
country: United States
facility: Kaiser Foundation Research Institute, Santa Clara
state: California
city: Walnut Creek
country: United States
facility: Kaiser Foundation Research Institute, Walnut Creek
state: California
Study officials:
References: