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

NCT04855227 | Terminated

• 1 other identifier: ASPIRE
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  14 days

Secondary Outcomes (8)

• Change in narcotic usage from 1 day post-procedure to 30 days post-procedure

  30 days

• Change in OTC pain medication usage from 1 day post-procedure to 30 days post-procedure

  30 days

• Need for refill prescription pain medication usage from 1 day post-procedure to 30 days post-procedure

  30 days

• Change in Quality of Life assessment: EQ-5D-3L (EQ) from baseline to 14 days

  14 days

• Change in Quality of Life assessment: EuraHS-QOL from baseline to 30 days

  30 days

Study Arms (2)

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.

Procedure: robotic-assisted ventral hernia repair

Interventions

robotic-assisted ventral hernia repair PROCEDURE

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.

Also known as: laparoscopic ventral hernia repair

Robotic-assisted ventral hernia repair

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (1)

Desert Surgical Specialists

Phoenix, Arizona, 85027, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 22, 2021
• Study Start: August 31, 2021
• Primary Completion: November 4, 2024
• Study Completion: November 19, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

US (1)