Pain and Quality of Life After Retromuscular Ventral Hernia Repair (RECOVER)

Ventral Hernia Clinical Trial

— RECOVER  

Official title:

RECOVER: a pRospECtive evaluatiOn of Pain After Retromuscular VEntRal Hernia Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04487522
• Other study ID #: RECOVER
• Status: Recruiting
• Start date: July 16, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2023
• Source: Intuitive Surgical
• Contact: Jennifer Mueller
• Phone: 15105529880
• Email: jennifer.mueller[@]intusurg.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted retromuscular ventral hernia repair.

Description:

This is a prospective, multicenter, observational study assessing outcomes relating to pain and quality of life for subjects undergoing open, laparoscopic, or robotic-assisted retromuscular ventral hernia repair. The study will focus on short-term post-operative outcomes through 3 months. The study will also collect recurrence data through 1 year. During the post-operative period through 3 months, pain medication intake, subject reported pain (on post-operative day 7, 14, 21, 28, and 3 months) and quality of life (on day 28, 3 months, and 1 year) 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: 125
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Subject is between 18 and 89 years of age

• Subject is a candidate for an elective retromuscular ventral hernia repair under general anesthesia

• Subject has access to complete study assessments electronically and agrees to comply with all follow-up requirements

• Ventral hernia is >= 4cm

Exclusion Criteria:

• Subject who will have an emergent hernia repair

• Subject has a parastomal hernia (i.e. hernia related to ostomy formation)

• Subject with a history of chronic pain and/or taking daily pain medication for >6 weeks

• Subject wtih a history of substance abuse (excluding marijuana) and/or current (within 30 days) narcotic use

• Subject with a history of MRSA infection

• Subject with HbA1c level > 8.5%

• Subject undergoing a minimally invasive (MIS) repair who will require the use of Exparel during the surgical procedure

• Subject who will undergo a concomitant hernia repair or any other concomitant procedure

• Subject has cirrhosis

• Current nicotine use (including vaping) within the past 30 days

• Subject is contraindicated for general anesthesia or surgery

• 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 the study requirements or ability to provide informed consent

• Subject belonging to other vulnerable population, e.g., prisoner or ward of state

• Subject is currently participating in another interventional research study

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Procedure:
• Open retromuscular ventral hernia repair
With the subject under general anesthesia, a single incision is made in the abdomen. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.
• Laparoscopic retromuscular 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.

Device:
• Robotic-assisted retromuscular 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	Kaiser Foundation Research Institute, Oakland/Richmond	Oakland	California
United States	Kaiser Foundation Research Institute, South Sacramento	Sacramento	California
United States	Kaiser Foundation Research Institute, Santa Clara	Santa Clara	California
United States	Kaiser Foundation Research Institute, Walnut Creek	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores	Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.	7 days
Primary	Narcotic usage	Narcotic usage (in hospital and out of hospital) taken for the purpose of managing abdominal pain after the ventral hernia repair.	4 weeks
Primary	Non-opioid prescription pain medication usage	Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair	4 weeks
Secondary	Narcotic usage	Narcotic usage related to the retromuscular ventral hernia repair.	3 months
Secondary	Non-opioid prescription pain medication usage	Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair.	3 months
Secondary	Over the counter pain medication usage	Over the counter (OTC) pain medication usage after the retromuscular ventral hernia repair procedure as determined by patient reporting of OTC pain medication usage at follow-ups	4 weeks
Secondary	Need for refill prescription pain medication	Need for refill of prescription pain medication after the retromuscular ventral hernia repair	4 weeks
Secondary	PROMIS 3a pain scores	Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.	4 weeks
Secondary	Hospital length of stay	Duration of hospital stay	Start of procedure to discharge from the hospital (check out time), up to an approximate of one week
Secondary	Incidence of intraoperative adverse events related to the retromuscular ventral hernia repair	Intra-operative adverse events related to the retromuscular ventral hernia repair	intraoperatve
Secondary	Incidence of postoperative adverse events related to the retromuscular ventral hernia repair	Post-operative adverse events related to the retromuscular ventral hernia repair	3 months
Secondary	Hernia recurrence	Hernia recurrence after the retromuscular ventral hernia repair	1 year
Secondary	EQ-5D-3L QOL scores	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).	4 weeks