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Robotic Versus Open Ventral Hernia Repair (ROVHR)

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ClinicalTrials.gov Identifier: NCT05472987
Recruitment Status : Recruiting
First Posted : July 25, 2022
Last Update Posted : August 25, 2023
Sponsor:
Information provided by (Responsible Party):
Lucas Beffa, The Cleveland Clinic

Study Description
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Brief Summary:
This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair.

Condition or disease Intervention/treatment Phase
Ventral Hernia Procedure: Ventral Hernia Repair Not Applicable

Detailed Description:
This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair. This is a superiority trial with a primary outcome of length of stay in the hospital, theorizing that robotic retromuscular ventral hernia repairs are superior to open ventral hernia repairs by reducing length of stay by 24 hours. Patients will be blinded to the intervention, groups will be in parallel, and the primary outcome (when the patient is discharged) will be determined by a blinded assessor.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Patients will be blinded to the intervention. The primary outcome will be determined by a surgeon other than the operating surgeon who is blinded to the intervention. Patients will also receive the same dressings over their wounds and an abdominal binder will be placed over the abdomen in attempts to limit the unblinding of the patient.
Primary Purpose: Treatment
Official Title: Robotic Versus Open Ventral Hernia Repair: A Randomized Controlled Trial
Actual Study Start Date : July 25, 2022
Estimated Primary Completion Date : August 1, 2025
Estimated Study Completion Date : August 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Open Ventral Hernia Repair
These patients will undergo open retromuscular ventral hernia repairs
 Procedure: Ventral Hernia Repair
Patients will undergo retromuscular ventral hernia repair
Active Comparator: Robotic Ventral Hernia Repair
These patients will undergo robotic retromuscular ventral hernia repairs.
 Procedure: Ventral Hernia Repair
Patients will undergo retromuscular ventral hernia repair


Outcome Measures
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Primary Outcome Measures :
  1. Length of Stay [ Time Frame: 30 days ]
    Time in the hospital after the surgery


Secondary Outcome Measures :
  1. Post-operative wound complications [ Time Frame: 30 day and one year ]
    any abnormal wound healing

  2. Other post operative complications [ Time Frame: 30 days ]
    Heart attacks, acute kidney injury, admissions to ICU, respiratory failure

  3. Readmission rate [ Time Frame: 30 days ]
    Readmission to the hospital within 30 days of the surgery

  4. Opioid consumption [ Time Frame: 30 days and one year ]
    Opioid prescribed and consumed

  5. Acute pain scores [ Time Frame: 5 days after surgery ]
    Numeric Rating Scale-11 pain scores daily, 0-10 with 0 being no pain and 10 being the worst pain for first five days after surgery

  6. Hernia Related Specific Quality of Life Score [ Time Frame: 30 days and one year ]
    Score of 0-100 with lower scores indicating worse quality of life

  7. Direct cost [ Time Frame: 30 days ]
    Cost to the hospital

  8. Hernia recurrence [ Time Frame: 30 days and one year ]
    Hernia recurrence

  9. Quality of life scores using European Hernia Society (EuraHS) scale [ Time Frame: 30 day and one year ]
    EuraHS is a hernia specific quality of life scale with three domains: pain, restrictions of activity, and cosmesis. 0-30 with higher scores indicating a worse quality of life.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years and older
  • 7 cm to 15 cm wide hernia midline defects
  • BMI less than or equal to 45
  • Patient deemed both an open and robotic candidate by operating surgeon

Exclusion Criteria:

  • 17 years old or younger
  • prisoners
  • pregnant patients
  • Emergent patients
  • BMI greater than 45
  • Hernia defects less than 7 cm or greater than 15 cm in width
Contacts and Locations
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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): NCT05472987


Contacts
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Contact: Lucas Beffa, MD 216-445-5975 beffal@ccf.org
Contact: Ryan Ellis ellisr2@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Lucas Beffa, MD    216-445-5975    Beffal@ccf.org   
Contact: Ryan Ellis       ellisr2@ccf.org   
Sponsors and Collaborators
Lucas Beffa
Investigators
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Principal Investigator: Lucas Beffa, MD The Cleveland Clinic
More Information
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Responsible Party: Lucas Beffa, Assistant Professor of Surgery, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT05472987    
Other Study ID Numbers: 22-591
First Posted: July 25, 2022    Key Record Dates
Last Update Posted: August 25, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lucas Beffa, The Cleveland Clinic:
Robotic
Hernia
Ventral hernia
Open hernia
Mesh
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal