Pain and Quality of Life After Retromuscular Ventral Hernia Repair (RECOVER)
RECOVER
RECOVER: a PRospECtive EvaluatiOn of Pain After Retromuscular VEntRal Hernia Repair
1 other identifier
observational
74
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2020
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2020
CompletedStudy Start
First participant enrolled
July 16, 2020
CompletedFirst Posted
Study publicly available on registry
July 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2024
CompletedNovember 26, 2024
November 1, 2024
3.3 years
July 8, 2020
November 22, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Pain scores
Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.
7 days
Narcotic usage
Narcotic usage (in hospital and out of hospital) taken for the purpose of managing abdominal pain after the ventral hernia repair.
4 weeks
Non-opioid prescription pain medication usage
Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair
4 weeks
Secondary Outcomes (10)
Narcotic usage
3 months
Non-opioid prescription pain medication usage
3 months
Over the counter pain medication usage
4 weeks
Need for refill prescription pain medication
4 weeks
PROMIS 3a pain scores
4 weeks
- +5 more secondary outcomes
Study Arms (2)
Retromuscular ventral hernia repair
These subjects will undergo an open, a laparoscopic, or a robotic-assisted retromuscular ventral hernia repair.
Retromuscular TAR ventral hernia repair
These subjects will undergo an open or a robotic-assisted retromuscular transversus abdominis release (TAR) ventral hernia repair.
Interventions
With the subject under general anesthesia, a single incision is made in the abdomen. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.
With the subject under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope are inserted to complete the repair. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.
With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the subject and used to complete the procedure. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.
Eligibility Criteria
Subjects who will undergo an elective retromuscular ventral hernia repair procedure and who meet all eligibility criteria will be considered for enrollment.
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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Kaiser Foundation Research Institute, Oakland/Richmond
Oakland, California, 94612, United States
Kaiser Foundation Research Institute, South Sacramento
Sacramento, California, 95825, United States
Kaiser Foundation Research Institute, Santa Clara
Santa Clara, California, 95051, United States
Kaiser Foundation Research Institute, Walnut Creek
Walnut Creek, California, 94596, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2020
First Posted
July 27, 2020
Study Start
July 16, 2020
Primary Completion
November 9, 2023
Study Completion
September 19, 2024
Last Updated
November 26, 2024
Record last verified: 2024-11