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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04487522
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Ventral Hernia 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.

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: RECOVER: a pRospECtive evaluatiOn of Pain After Retromuscular VEntRal Hernia Repair
Actual Study Start Date : July 16, 2020
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04487522


Contacts
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Contact: Jennifer Mueller 15105529880 jennifer.mueller@intusurg.com

Locations
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United States, California
Kaiser Foundation Research Institute, Oakland/Richmond Recruiting
Oakland, California, United States, 94612
Contact: Jennifer Yip       Jennifer.Yip@kp.org   
Principal Investigator: Rouzbeh Mostaedi, MD         
Sub-Investigator: Francisca Maertens, MD         
Sub-Investigator: David Nguyen, MD         
Kaiser Foundation Research Institute, South Sacramento Recruiting
Sacramento, California, United States, 95825
Contact: Tashia Orr, MBA    916-628-1668    Tashia.Orr@kp.org   
Principal Investigator: Sharon Shiraga, MD         
Kaiser Foundation Research Institute, Santa Clara Recruiting
Santa Clara, California, United States, 95051
Contact: Nancy Mendelssohn    650-450-3459    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         
Kaiser Foundation Research Institute, Walnut Creek Recruiting
Walnut Creek, California, United States, 94596
Contact: Richard M Joven       Richard.M.Joven@kp.org   
Principal Investigator: Jacob Spivak, MD         
Sub-Investigator: Robert Bell, MD         
Sponsors and Collaborators
Intuitive Surgical
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Responsible Party: Intuitive Surgical
ClinicalTrials.gov Identifier: NCT04487522    
Other Study ID Numbers: RECOVER
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal