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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ventral Hernia
• Intervention / Treatment: Procedure: Open retromuscular ventral hernia repair; Procedure: Laparoscopic retromuscular ventral hernia repair; Device: Robotic-assisted retromuscular ventral hernia repair

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

• Study Contact: Name: Jennifer Mueller; Phone Number: 15105529880; Email: jennifer.mueller@intusurg.com

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Recruiting
      • Kaiser Foundation Research Institute, Oakland/Richmond
      • Contact: Jennifer Yip; Email: Jennifer.Yip@kp.org
      • Principal Investigator: Rouzbeh Mostaedi, MD
      • Sub-Investigator: Francisca Maertens, MD
      • Sub-Investigator: David Nguyen, MD
    • Sacramento, California, United States, 95825
      • Recruiting
      • Kaiser Foundation Research Institute, South Sacramento
      • Contact: Tashia Orr, MBA; Phone Number: 916-628-1668; Email: Tashia.Orr@kp.org
      • Principal Investigator: Sharon Shiraga, MD
    • Santa Clara, California, United States, 95051
      • Recruiting
      • Kaiser Foundation Research Institute, Santa Clara
      • Contact: Nancy Mendelssohn; Phone Number: 650-450-3459; Email: Nancy.D.Mendelssohn@kp.org
      • Principal Investigator: Elliott Brill, MD
      • Sub-Investigator: Maureen Tedesco, MD
      • Sub-Investigator: Jong-Ping Lu, MD
      • Sub-Investigator: Amid Keshavarzi, MD
    • Walnut Creek, California, United States, 94596
      • Recruiting
      • Kaiser Foundation Research Institute, Walnut Creek
      • Contact: Richard M Joven; Email: Richard.M.Joven@kp.org
      • Principal Investigator: Jacob Spivak, MD
      • Sub-Investigator: Robert Bell, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 87 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects who will undergo an elective retromuscular ventral hernia repair procedure and who meet all eligibility criteria will be considered for enrollment.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retromuscular ventral hernia repair; These subjects will undergo an open, a laparoscopic, or a robotic-assisted retromuscular ventral hernia repair.	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.; Procedure: 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.
Retromuscular TAR ventral hernia repair; These subjects will undergo an open or a robotic-assisted retromuscular transversus abdominis release (TAR) ventral hernia repair.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.	7 days
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
Non-opioid prescription pain medication usage	Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Narcotic usage	Narcotic usage related to the retromuscular ventral hernia repair.	3 months
Non-opioid prescription pain medication usage	Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair.	3 months
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
Need for refill prescription pain medication	Need for refill of prescription pain medication after the retromuscular ventral hernia repair	4 weeks
PROMIS 3a pain scores	Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.	4 weeks
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
Incidence of intraoperative adverse events related to the retromuscular ventral hernia repair	Intra-operative adverse events related to the retromuscular ventral hernia repair	intraoperatve
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
Hernia recurrence	Hernia recurrence after the retromuscular ventral hernia repair	1 year
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

Collaborators and Investigators

• Sponsor: Intuitive Surgical

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2020
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: RECOVER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No