Ventral HerniaASPIRENCT04855227
A Prospective Evaluation of Pain After Non-complex Ventral Hernia Repair
An observational study of Ventral Hernia, run by Intuitive Surgical at 1 site in United States.
Trial summary
The study aims to evaluate outcomes relating to pain and QOL after robotic-assisted or laparoscopic non-complex ventral hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- robotic-assisted ventral hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2021to 19 Nov 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 80 years
- All sexes
- Adult, Older adult
Study population: Subjects who will undergo an elective non-complex 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 80 years of age.
- Subject is a candidate for an elective primary (non-recurrent) ventral hernia repair.
- Ventral hernia repair that will require mesh placement
Who cannot join
- Subject is contraindicated for general anesthesia or surgery.
- Subject with a ventral hernia that will require retromuscular mesh placement or employ a technique, including (but not limited to) external oblique release, Rives- Stoppa, eTEP Rives-Stoppa, transversus abdominis release, other component separation techniques (i.e. anterior component separation) or eTEP transversus abdominis release.
- Subject has a recurrent hernia.
- Subject who will have an emergent hernia repair.
- Subject with a history of chronic pain and/or taking daily pain medications for >6 weeks.
- Subject with a history of substance abuse (excluding marijuana) and/or current (within 30 days) narcotic use.
Show all 17Show fewer
- Current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery.
- Subject with a history of MRSA infection.
- Subject with HbA1c level > 8.5%.
- Use of Exparel during the surgical procedure.
- Subject who will undergo a concomitant hernia repair or any other concomitant procedure.
- Current nicotine use (including vaping) within the past 30 days.
- 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 study requirements or ability to provide informed consent.
- Subject belonging to other vulnerable population, e.g, prisoner or ward of the state.
- Subject is currently participating in another interventional or investigational research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASPIRE: A proSpective Evaluation of PaIn After Non-complex ventRal hErnia Repair
The study aims to evaluate outcomes relating to pain and QOL after robotic-assisted or laparoscopic non-complex ventral hernia repair.
Read the detailed description
This is a prospective, observational, study across robotic-assisted and laparoscopic primary (non-recurrent) umbilical and incisional hernia repair. The study aims to evaluate pain and QOL outcomes through 30 days. During the post-operative period through 30 days, pain medication intake, subject reported pain and quality of life and incidence of intra-operative and post-operative adverse events related to the ventral hernia repair will be collected.
- Conditions
- Ventral Hernia
- Being tested
- robotic-assisted 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.
robotic-assisted ventral hernia repairProcedure or surgery
Also called laparoscopic ventral hernia repair
Laparoscopic 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.
Robotic-assisted 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.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic ventral hernia repair | These subjects will undergo a laparoscopic primary umbilical or incisional hernia repair. | |
| Robotic-assisted ventral hernia repair | These subjects will undergo a robotic-assisted primary umbilical or incisional hernia repair. Receives: Procedure: robotic-assisted ventral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain score assessed by the PROMIS 3a from baseline to 14 days
Change in patient reported pain scores assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey, with a scale from 1-5; 1 meaning no pain and 5 meaning severe pain.
Measured: 14 days
Change in narcotic usage from 1 day post-procedure to 14 days post-procedure
Narcotic usage after the ventral hernia repair as determined through use of a patient reported pain medication log.
Measured: 14 days
Change in pain score assessed by the NRS from baseline to 14 days
Change in patient reported pain scores assessed by the Numeric Rating Scale (NRS) from 1-10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Measured: 14 days
Secondary outcomes (8)
Change in narcotic usage from 1 day post-procedure to 30 days post-procedure
Narcotic usage after the ventral hernia repair as determined through use of a patient reported pain medication log.
Measured: 30 days
Change in OTC pain medication usage from 1 day post-procedure to 30 days post-procedure
Over the counter (OTC) pain medication usage after the ventral hernia repair as determined through use of a patient reported pain medication log.
Measured: 30 days
Need for refill prescription pain medication usage from 1 day post-procedure to 30 days post-procedure
Need for refill narcotic prescription pain medication usage
Measured: 30 days
Change in Quality of Life assessment: EQ-5D-3L (EQ) from baseline to 14 days
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: 14 days
Change in Quality of Life assessment: EuraHS-QOL from baseline to 30 days
Quality of life using the EuraHS-QOL assessment tool, with scores on questions relating to pain, restrictions of movement, and cosmetic discomfort; with a scale ranging from 0 (no pain/no restriction/very beautiful) to 10 (worst pain/completely restricted/extremely ugly).
Measured: 30 days
Length of hospital stay (LOS)
How long the patient was admitted to the hospital
Measured: Procedure start time to discharge from the hospital (check out time), up to an approximate of one week
Incidence of intraoperative adverse events related to the ventral hernia repair
Intraoperative adverse events related to the ventral hernia repair
Measured: Intraoperative
Incidence of postoperative adverse events related to the ventral hernia repair through 30 days post-procedure
Post-operative adverse events related to the ventral hernia repair
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start31 Aug 2021
- Primary completion4 Nov 2024
- Study completion19 Nov 2024
Why it stopped: Slow rate of enrollment . Additionally it was observed during the course of the trial that changes to the standard of care pain management protocols at some of the institutions, which are not aligned with the study protocol requirements
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 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
- NCT04855227
- Sponsor's protocol ID
- ASPIRE
- Acronym
- ASPIRE
- Status last verified
- Dec 2024
- First submitted
- 30 Mar 2021
- Last updated
- 19 Dec 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 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASPIRE: A proSpective Evaluation of PaIn After Non-complex ventRal hErnia Repair
- ClinicalTrials.gov ID
- NCT04855227
- Acronym / sponsor ID
- ASPIRE / ASPIRE
- Conditions
- Ventral Hernia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow rate of enrollment . Additionally it was observed during the course of the trial that changes to the standard of care pain management protocols at some of the institutions, which are not aligned with the study protocol requirements
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 22 Apr 2021 (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 evaluate outcomes relating to pain and QOL after robotic-assisted or laparoscopic non-complex ventral hernia repair.
Detailed description
This is a prospective, observational, study across robotic-assisted and laparoscopic primary (non-recurrent) umbilical and incisional hernia repair. The study aims to evaluate pain and QOL outcomes through 30 days. During the post-operative period through 30 days, pain medication intake, subject reported pain and quality of life and incidence of intra-operative and post-operative adverse events related to the ventral hernia repair will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic ventral hernia repair | – | –These subjects will undergo a laparoscopic primary umbilical or incisional hernia repair. |
| Robotic-assisted ventral hernia repair | – | Procedure: robotic-assisted ventral hernia repairThese subjects will undergo a robotic-assisted primary umbilical or incisional hernia repair. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects who will undergo an elective non-complex ventral hernia repair procedure and who meet all eligibility criteria will be considered for enrollment.
Key inclusion criteria (3 listed)
- Subject is between 18 and 80 years of age.
- Subject is a candidate for an elective primary (non-recurrent) ventral hernia repair.
- Ventral hernia repair that will require mesh placement
Key exclusion criteria (17 listed)
- Subject is contraindicated for general anesthesia or surgery.
- Subject with a ventral hernia that will require retromuscular mesh placement or employ a technique, including (but not limited to) external oblique release, Rives- Stoppa, eTEP Rives-Stoppa, transversus abdominis release, other component separation techniques (i.e. anterior component separation) or eTEP transversus abdominis release.
- Subject has a recurrent hernia.
- Subject who will have an emergent hernia repair.
- Subject with a history of chronic pain and/or taking daily pain medications for >6 weeks.
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 |
|---|---|---|
| robotic-assisted ventral hernia repairAlso: laparoscopic ventral hernia repairLaparoscopic 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. Robotic-assisted 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. | Procedure or surgery | Robotic-assisted ventral hernia repair |
Primary outcome
Change in pain score assessed by the PROMIS 3a from baseline to 14 days
Time frame: 14 days
Change in patient reported pain scores assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey, with a scale from 1-5; 1 meaning no pain and 5 meaning severe pain.
Change in narcotic usage from 1 day post-procedure to 14 days post-procedure
Time frame: 14 days
Narcotic usage after the ventral hernia repair as determined through use of a patient reported pain medication log.
Change in pain score assessed by the NRS from baseline to 14 days
Time frame: 14 days
Change in patient reported pain scores assessed by the Numeric Rating Scale (NRS) from 1-10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
8 secondary outcomes
Change in narcotic usage from 1 day post-procedure to 30 days post-procedure
Time frame: 30 days
Change in OTC pain medication usage from 1 day post-procedure to 30 days post-procedure
Time frame: 30 days
Need for refill prescription pain medication usage from 1 day post-procedure to 30 days post-procedure
Time frame: 30 days
Change in Quality of Life assessment: EQ-5D-3L (EQ) from baseline to 14 days
Time frame: 14 days
Change in Quality of Life assessment: EuraHS-QOL from baseline to 30 days
Time frame: 30 days
Length of hospital stay (LOS)
Time frame: Procedure start time to discharge from the hospital (check out time), up to an approximate of one week
Incidence of intraoperative adverse events related to the ventral hernia repair
Time frame: Intraoperative
Incidence of postoperative adverse events related to the ventral hernia repair through 30 days post-procedure
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Slow rate of enrollment . Additionally it was observed during the course of the trial that changes to the standard of care pain management protocols at some of the institutions, which are not aligned with the study protocol requirements). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 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.
1 site 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 1 site 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 3 inclusion and 17 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: stopped early, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Slow rate of enrollment . Additionally it was observed during the course of the trial that changes to the standard of care pain management protocols at some of the institutions, which are not aligned with the study protocol requirements). Results are not available in the source record.
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?
Change in pain score assessed by the PROMIS 3a from baseline to 14 days (time frame: 14 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 19 Dec 2024.