Clinical trial NCT04855227: A Prospective Evaluation of Pain After Non-complex Ventral Hernia Repair
Official title: ASPIRE: A proSpective Evaluation of PaIn After Non-complex ventRal hErnia Repair
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ventral Hernia
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2021-04-22
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Subject is between 18 and 80 years of age.
2. Subject is a candidate for an elective primary (non-recurrent) ventral hernia repair.
3. Ventral hernia repair that will require mesh placement

Exclusion Criteria:

1. Subject is contraindicated for general anesthesia or surgery.
2. 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.
3. Subject has a recurrent hernia.
4. Subject who will have an emergent hernia repair.
5. Subject with a history of chronic pain and/or taking daily pain medications for \>6 weeks.
6. Subject with a history of substance abuse (excluding marijuana) and/or current (within 30 days) narcotic use.
7. Current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery.
8. Subject with a history of MRSA infection.
9. Subject with HbA1c level \> 8.5%.
10. Use of Exparel during the surgical procedure.
11. Subject who will undergo a concomitant hernia repair or any other concomitant procedure.
12. Current nicotine use (including vaping) within the past 30 days.
13. Subject has a known bleeding or clotting disorder.
14. Pregnant or suspected pregnancy.
15. 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.
16. Subject belonging to other vulnerable population, e.g, prisoner or ward of the state.
17. Subject is currently participating in another interventional or investigational research study.

Primary outcomes:
measure: Change in pain score assessed by the PROMIS 3a from baseline to 14 days
timeFrame: 14 days
measure: Change in narcotic usage from 1 day post-procedure to 14 days post-procedure
timeFrame: 14 days
measure: Change in pain score assessed by the NRS from baseline to 14 days
timeFrame: 14 days
Secondary outcomes:
measure: Change in narcotic usage from 1 day post-procedure to 30 days post-procedure
timeFrame: 30 days
measure: Change in OTC pain medication usage from 1 day post-procedure to 30 days post-procedure
timeFrame: 30 days
measure: Need for refill prescription pain medication usage from 1 day post-procedure to 30 days post-procedure
timeFrame: 30 days
measure: Change in Quality of Life assessment: EQ-5D-3L (EQ) from baseline to 14 days
timeFrame: 14 days
measure: Change in Quality of Life assessment: EuraHS-QOL from baseline to 30 days
timeFrame: 30 days
measure: Length of hospital stay (LOS)
timeFrame: Procedure start time to discharge from the hospital (check out time), up to an approximate of one week
measure: Incidence of intraoperative adverse events related to the ventral hernia repair
timeFrame: Intraoperative
measure: Incidence of postoperative adverse events related to the ventral hernia repair through 30 days post-procedure
timeFrame: 30 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Desert Surgical Specialists
state: Arizona
Study officials:
References: