A Prospective Evaluation of Pain After Non-complex Ventral Hernia Repair
NCT ID: NCT04855227
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
69 participants
OBSERVATIONAL
2021-08-31
2024-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Laparoscopic ventral hernia repair
These subjects will undergo a laparoscopic primary umbilical or incisional hernia repair.
No interventions assigned to this group
Robotic-assisted ventral hernia repair
These subjects will undergo a robotic-assisted primary umbilical or incisional hernia repair.
robotic-assisted 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.
Interventions
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robotic-assisted 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Intuitive Surgical
INDUSTRY
Responsible Party
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Locations
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Desert Surgical Specialists
Phoenix, Arizona, United States
Countries
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Other Identifiers
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ASPIRE
Identifier Type: -
Identifier Source: org_study_id