TERMINATED

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-08-31

Study Completion:2024-11-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT04855227

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Locations (Sites)

Desert Surgical Specialists

Phoenix, Arizona, 85027

United States

Collaborators and Investigators

Sponsor: Intuitive Surgical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-31

Study Completion Date2024-11-19

Study Record Updates

Study Start Date2021-08-31

Study Completion Date2024-11-19

Terms related to this study

Additional Relevant MeSH Terms

Ventral Hernia