Ventral HerniaRECOVERNCT04487522
Pain and Quality of Life After Retromuscular Ventral Hernia Repair (RECOVER)
An observational study of Ventral Hernia, run by Intuitive Surgical at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Open retromuscular ventral hernia repair, Laparoscopic retromuscular ventral hernia repair and Robotic-assisted retromuscular ventral hernia repair
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 74 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Jul 2020to 19 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who will undergo an elective retromuscular ventral hernia repair procedure and who meet all eligibility criteria will be considered for enrollment.
Who may be able to join
- 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
Who cannot join
- 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%
Show all 16Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kaiser Foundation Research Institute, Oakland/Richmond
Oakland, California, 94612
Kaiser Foundation Research Institute, South Sacramento
Sacramento, California, 95825
Kaiser Foundation Research Institute, Santa Clara
Santa Clara, California, 95051
Kaiser Foundation Research Institute, Walnut Creek
Walnut Creek, California, 94596
About this study
Official title: RECOVER: a PRospECtive EvaluatiOn of Pain After Retromuscular VEntRal Hernia Repair
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.
Read the 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.
- Conditions
- Ventral Hernia
- Being tested
- Open retromuscular ventral hernia repair, Laparoscopic retromuscular ventral hernia repair, Robotic-assisted retromuscular ventral hernia repair
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open retromuscular ventral hernia repairProcedure or surgery
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.
Laparoscopic retromuscular ventral hernia repairProcedure or surgery
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.
Robotic-assisted retromuscular ventral hernia repairDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Retromuscular ventral hernia repair | These subjects will undergo an open, a laparoscopic, or a robotic-assisted retromuscular ventral hernia repair. Receives: Procedure: Open retromuscular ventral hernia repair; Procedure: Laparoscopic retromuscular ventral hernia repair; Device: 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. Receives: Procedure: Open retromuscular ventral hernia repair; Device: Robotic-assisted retromuscular ventral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.
Measured: 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.
Measured: 4 weeks
Non-opioid prescription pain medication usage
Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair
Measured: 4 weeks
Secondary outcomes (10)
Narcotic usage
Narcotic usage related to the retromuscular ventral hernia repair.
Measured: 3 months
Non-opioid prescription pain medication usage
Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair.
Measured: 3 months
Over the counter pain medication usage
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
Measured: 4 weeks
Need for refill prescription pain medication
Need for refill of prescription pain medication after the retromuscular ventral hernia repair
Measured: 4 weeks
PROMIS 3a pain scores
Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.
Measured: 4 weeks
Hospital length of stay
Duration of hospital stay
Measured: Start of procedure to discharge from the hospital (check out time), up to an approximate of one week
Incidence of intraoperative adverse events related to the retromuscular ventral hernia repair
Intra-operative adverse events related to the retromuscular ventral hernia repair
Measured: intraoperatve
Incidence of postoperative adverse events related to the retromuscular ventral hernia repair
Post-operative adverse events related to the retromuscular ventral hernia repair
Measured: 3 months
Hernia recurrence
Hernia recurrence after the retromuscular ventral hernia repair
Measured: 1 year
EQ-5D-3L QOL scores
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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start16 Jul 2020
- Primary completion9 Nov 2023
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487522
- Sponsor's protocol ID
- RECOVER
- Acronym
- RECOVER
- Status last verified
- Nov 2024
- First submitted
- 8 Jul 2020
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECOVER: a PRospECtive EvaluatiOn of Pain After Retromuscular VEntRal Hernia Repair
- ClinicalTrials.gov ID
- NCT04487522
- Acronym / sponsor ID
- RECOVER / RECOVER
- Conditions
- Ventral Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retromuscular ventral hernia repair | – | Procedure: Open retromuscular ventral hernia repair, Procedure: Laparoscopic retromuscular ventral hernia repair, Device: Robotic-assisted retromuscular ventral hernia repairThese subjects will undergo an open, a laparoscopic, or a robotic-assisted retromuscular ventral hernia repair. |
| Retromuscular TAR ventral hernia repair | – | Procedure: Open retromuscular ventral hernia repair, Device: Robotic-assisted retromuscular ventral hernia repairThese subjects will undergo an open or a robotic-assisted retromuscular transversus abdominis release (TAR) ventral hernia repair. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who will undergo an elective retromuscular ventral hernia repair procedure and who meet all eligibility criteria will be considered for enrollment.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open retromuscular ventral hernia repairWith 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 or surgery | Retromuscular TAR ventral hernia repair, Retromuscular ventral hernia repair |
| Laparoscopic retromuscular ventral hernia repairWith 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. | Procedure or surgery | Retromuscular ventral hernia repair |
| Robotic-assisted retromuscular ventral hernia repairWith 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. | Device | Retromuscular TAR ventral hernia repair, Retromuscular ventral hernia repair |
Primary outcome
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
10 secondary outcomes
Narcotic usage
Time frame: 3 months
Non-opioid prescription pain medication usage
Time frame: 3 months
Over the counter pain medication usage
Time frame: 4 weeks
Need for refill prescription pain medication
Time frame: 4 weeks
PROMIS 3a pain scores
Time frame: 4 weeks
Hospital length of stay
Time frame: Start of procedure to discharge from the hospital (check out time), up to an approximate of one week
Incidence of intraoperative adverse events related to the retromuscular ventral hernia repair
Time frame: intraoperatve
Incidence of postoperative adverse events related to the retromuscular ventral hernia repair
Time frame: 3 months
Hernia recurrence
Time frame: 1 year
EQ-5D-3L QOL scores
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernia, run by Intuitive Surgical at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.