Pain and Quality of Life After Retromuscular Ventral Hernia Repair (RECOVER) (RECOVER)
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| ClinicalTrials.gov Identifier: NCT04487522 |
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Recruitment Status :
Recruiting
First Posted : July 27, 2020
Last Update Posted : September 28, 2023
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Sponsor:
Intuitive Surgical
Information provided by (Responsible Party):
Intuitive Surgical
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Ventral Hernia | Procedure: Open retromuscular ventral hernia repair Procedure: Laparoscopic retromuscular ventral hernia repair Device: Robotic-assisted retromuscular ventral hernia repair |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 125 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | RECOVER: a pRospECtive evaluatiOn of Pain After Retromuscular VEntRal Hernia Repair |
| Actual Study Start Date : | July 16, 2020 |
| Estimated Primary Completion Date : | September 1, 2024 |
| Estimated Study Completion Date : | December 1, 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Retromuscular ventral hernia repair
These subjects will undergo an open, a laparoscopic, or a robotic-assisted retromuscular ventral hernia repair.
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Procedure: Open retromuscular ventral hernia repair
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. Procedure: Laparoscopic retromuscular ventral hernia repair 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. Device: Robotic-assisted retromuscular ventral hernia repair 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. |
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Retromuscular TAR ventral hernia repair
These subjects will undergo an open or a robotic-assisted retromuscular transversus abdominis release (TAR) ventral hernia repair.
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Procedure: Open retromuscular ventral hernia repair
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. Device: Robotic-assisted retromuscular ventral hernia repair 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. |
Primary Outcome Measures :
- Pain scores [ Time Frame: 7 days ]Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.
- Narcotic usage [ Time Frame: 4 weeks ]Narcotic usage (in hospital and out of hospital) taken for the purpose of managing abdominal pain after the ventral hernia repair.
- Non-opioid prescription pain medication usage [ Time Frame: 4 weeks ]Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair
Secondary Outcome Measures :
- Narcotic usage [ Time Frame: 3 months ]Narcotic usage related to the retromuscular ventral hernia repair.
- Non-opioid prescription pain medication usage [ Time Frame: 3 months ]Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair.
- Over the counter pain medication usage [ Time Frame: 4 weeks ]Over the counter (OTC) pain medication usage after the retromuscular ventral hernia repair procedure as determined by patient reporting of OTC pain medication usage at follow-ups
- Need for refill prescription pain medication [ Time Frame: 4 weeks ]Need for refill of prescription pain medication after the retromuscular ventral hernia repair
- PROMIS 3a pain scores [ Time Frame: 4 weeks ]Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.
- Hospital length of stay [ Time Frame: Start of procedure to discharge from the hospital (check out time), up to an approximate of one week ]Duration of hospital stay
- Incidence of intraoperative adverse events related to the retromuscular ventral hernia repair [ Time Frame: intraoperatve ]Intra-operative adverse events related to the retromuscular ventral hernia repair
- Incidence of postoperative adverse events related to the retromuscular ventral hernia repair [ Time Frame: 3 months ]Post-operative adverse events related to the retromuscular ventral hernia repair
- Hernia recurrence [ Time Frame: 1 year ]Hernia recurrence after the retromuscular ventral hernia repair
- EQ-5D-3L QOL scores [ Time Frame: 4 weeks ]Quality of life assessment using the EQ-5D-3L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
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| Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04487522
Contacts
| Contact: Jennifer Mueller | 15105529880 | jennifer.mueller@intusurg.com |
Locations
| United States, California | |
| Kaiser Foundation Research Institute, Oakland/Richmond | Recruiting |
| Oakland, California, United States, 94612 | |
| Contact: Jennifer Yip Jennifer.Yip@kp.org | |
| Principal Investigator: Rouzbeh Mostaedi, MD | |
| Sub-Investigator: Francisca Maertens, MD | |
| Sub-Investigator: David Nguyen, MD | |
| Kaiser Foundation Research Institute, South Sacramento | Recruiting |
| Sacramento, California, United States, 95825 | |
| Contact: Tashia Orr, MBA 916-628-1668 Tashia.Orr@kp.org | |
| Principal Investigator: Sharon Shiraga, MD | |
| Kaiser Foundation Research Institute, Santa Clara | Recruiting |
| Santa Clara, California, United States, 95051 | |
| Contact: Nancy Mendelssohn 650-450-3459 Nancy.D.Mendelssohn@kp.org | |
| Principal Investigator: Elliott Brill, MD | |
| Sub-Investigator: Maureen Tedesco, MD | |
| Sub-Investigator: Jong-Ping Lu, MD | |
| Sub-Investigator: Amid Keshavarzi, MD | |
| Kaiser Foundation Research Institute, Walnut Creek | Recruiting |
| Walnut Creek, California, United States, 94596 | |
| Contact: Richard M Joven Richard.M.Joven@kp.org | |
| Principal Investigator: Jacob Spivak, MD | |
| Sub-Investigator: Robert Bell, MD | |
Sponsors and Collaborators
Intuitive Surgical
| Responsible Party: | Intuitive Surgical |
| ClinicalTrials.gov Identifier: | NCT04487522 |
| Other Study ID Numbers: |
RECOVER |
| First Posted: | July 27, 2020 Key Record Dates |
| Last Update Posted: | September 28, 2023 |
| Last Verified: | September 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Hernia Hernia, Ventral Pathological Conditions, Anatomical Hernia, Abdominal |