A Prospective Evaluation of Pain After Non-complex Ventral Hernia Repair (ASPIRE)

Intuitive Surgical

Status

Terminated

Conditions

Ventral Hernia

Treatments

Procedure: robotic-assisted ventral hernia repair

Study type

Observational

Funder types

Industry

Identifiers

NCT04855227

ASPIRE

Details and patient eligibility

About

The study aims to evaluate outcomes relating to pain and QOL after robotic-assisted or laparoscopic non-complex ventral hernia repair.

Full 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.

Enrollment

69 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.