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

Ventral Hernia Clinical Trial

— ASPIRE  

Official title:

ASPIRE: A proSpective Evaluation of PaIn After Non-complex ventRal hErnia Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04855227
• Other study ID #: ASPIRE
• Status: Recruiting
• Start date: August 31, 2021
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Intuitive Surgical
• Contact: Smruthi Srinivasa Murthy, MS
• Phone: 682-552-6131
• Email: smruthi.srinivasamurthy[@]intusurg.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Desert Surgical Specialists	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change in narcotic usage from 1 day post-procedure to 30 days post-procedure	Narcotic usage after the ventral hernia repair as determined through use of a patient reported pain medication log.	30 days
Secondary	Change in OTC pain medication usage from 1 day post-procedure to 30 days post-procedure	Over the counter (OTC) pain medication usage after the ventral hernia repair as determined through use of a patient reported pain medication log.	30 days
Secondary	Need for refill prescription pain medication usage from 1 day post-procedure to 30 days post-procedure	Need for refill narcotic prescription pain medication usage	30 days
Secondary	Change in Quality of Life assessment: EQ-5D-3L (EQ) from baseline to 14 days	Quality of life assessment using the EQ-5D-3L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)	14 days
Secondary	Change in Quality of Life assessment: EuraHS-QOL from baseline to 30 days	Quality of life using the EuraHS-QOL assessment tool, with scores on questions relating to pain, restrictions of movement, and cosmetic discomfort; with a scale ranging from 0 (no pain/no restriction/very beautiful) to 10 (worst pain/completely restricted/extremely ugly).	30 days
Secondary	Length of hospital stay (LOS)	How long the patient was admitted to the hospital	Procedure start time to discharge from the hospital (check out time), up to an approximate of one week
Secondary	Incidence of intraoperative adverse events related to the ventral hernia repair	Intraoperative adverse events related to the ventral hernia repair	Intraoperative
Secondary	Incidence of postoperative adverse events related to the ventral hernia repair through 30 days post-procedure	Post-operative adverse events related to the ventral hernia repair	30 days