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

Completed

• Conditions: Ventral Hernia
• Interventions: Procedure: Open retromuscular ventral hernia repair; Procedure: Laparoscopic retromuscular ventral hernia repair; Device: Robotic-assisted retromuscular ventral hernia repair

• Registration Number: NCT04487522
• Lead Sponsor: Intuitive Surgical

Brief 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.

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 Timeline

• Study First Submitted: 2020-07-08
• Study Start: 2020-07-16
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Primary Completion: 2023-11-09
• Study Completion: 2024-09-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retromuscular ventral hernia repair	Open retromuscular ventral hernia repair	These subjects will undergo an open, a laparoscopic, or a robotic-assisted retromuscular ventral hernia repair.
Retromuscular ventral hernia repair	Robotic-assisted retromuscular ventral hernia repair	These subjects will undergo an open, a laparoscopic, or a robotic-assisted retromuscular ventral hernia repair.
Retromuscular TAR ventral hernia repair	Open retromuscular ventral hernia repair	These subjects will undergo an open or a robotic-assisted retromuscular transversus abdominis release (TAR) ventral hernia repair.
Retromuscular ventral hernia repair	Laparoscopic retromuscular ventral hernia repair	These subjects will undergo an open, a laparoscopic, or a robotic-assisted retromuscular ventral hernia repair.
Retromuscular TAR ventral hernia repair	Robotic-assisted retromuscular ventral hernia repair	These subjects will undergo an open or a robotic-assisted retromuscular transversus abdominis release (TAR) ventral hernia repair.

Primary Outcome Measures

Name	Time	Method
Non-opioid prescription pain medication usage	4 weeks	Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair
Pain scores	7 days	Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.
Narcotic usage	4 weeks	Narcotic usage (in hospital and out of hospital) taken for the purpose of managing abdominal pain after the ventral hernia repair.

Secondary Outcome Measures

Name	Time	Method
Narcotic usage	3 months	Narcotic usage related to the retromuscular ventral hernia repair.
Non-opioid prescription pain medication usage	3 months	Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair.
Over the counter pain medication usage	4 weeks	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
Hospital length of stay	Start of procedure to discharge from the hospital (check out time), up to an approximate of one week	Duration of hospital stay
Need for refill prescription pain medication	4 weeks	Need for refill of prescription pain medication after the retromuscular ventral hernia repair
PROMIS 3a pain scores	4 weeks	Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.
Incidence of postoperative adverse events related to the retromuscular ventral hernia repair	3 months	Post-operative adverse events related to the retromuscular ventral hernia repair
Incidence of intraoperative adverse events related to the retromuscular ventral hernia repair	intraoperatve	Intra-operative adverse events related to the retromuscular ventral hernia repair
EQ-5D-3L QOL scores	4 weeks	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).
Hernia recurrence	1 year	Hernia recurrence after the retromuscular ventral hernia repair

Trial Locations

Locations (4)

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, United States