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Completed

NCT Number: NCT04487522

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

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.

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Foundation Research Institute, Oakland/Richmond, Oakland, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open retromuscular ventral hernia repair

Procedure

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

Procedure

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 retromuscular ventral hernia repair

Device

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.

Primary outcomes

  1. Pain scores

    Time frame: 7 days

    Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.

  2. Narcotic usage

    Time frame: 4 weeks

    Narcotic usage (in hospital and out of hospital) taken for the purpose of managing abdominal pain after the ventral hernia repair.

  3. Non-opioid prescription pain medication usage

    Time frame: 4 weeks

    Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair

Secondary outcomes

  1. Narcotic usage

    Time frame: 3 months

    Narcotic usage related to the retromuscular ventral hernia repair.

  2. Non-opioid prescription pain medication usage

    Time frame: 3 months

    Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair.

  3. Over the counter pain medication usage

    Time frame: 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

  4. Need for refill prescription pain medication

    Time frame: 4 weeks

    Need for refill of prescription pain medication after the retromuscular ventral hernia repair

  5. PROMIS 3a pain scores

    Time frame: 4 weeks

    Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.

  6. Hospital length of stay

    Time frame: Start of procedure to discharge from the hospital (check out time), up to an approximate of one week

    Duration of hospital stay

  7. Incidence of intraoperative adverse events related to the retromuscular ventral hernia repair

    Time frame: intraoperatve

    Intra-operative adverse events related to the retromuscular ventral hernia repair

  8. Incidence of postoperative adverse events related to the retromuscular ventral hernia repair

    Time frame: 3 months

    Post-operative adverse events related to the retromuscular ventral hernia repair

  9. Hernia recurrence

    Time frame: 1 year

    Hernia recurrence after the retromuscular ventral hernia repair

  10. EQ-5D-3L QOL scores

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

RECOVER: a PRospECtive EvaluatiOn of Pain After Retromuscular VEntRal Hernia Repair

Acronym: RECOVER

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jul 27, 2020
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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