Status:
TERMINATED
A Prospective Evaluation of Pain After Non-complex Ventral Hernia Repair
Lead Sponsor:
Intuitive Surgical
Conditions:
Ventral Hernia
Eligibility:
All Genders
18-80 years
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
August 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 19 2024
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT04855227
Start Date
August 31 2021
End Date
November 19 2024
Last Update
December 19 2024
Active Locations (1)
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1
Desert Surgical Specialists
Phoenix, Arizona, United States, 85027