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NCT Number: NCT05472987

Robotic Versus Open Ventral Hernia Repair

This is a randomized trial comparing open retromuscular ventral hernia repair to robotic 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Health, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Ventral Hernia Repair

Procedure

Patients will undergo retromuscular ventral hernia repair

Primary outcomes

  1. Length of Stay

    Time frame: 30 days

    Time in the hospital after the surgery

Secondary outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alvaro Carvalho

CONTACT

[email protected]

Lucas Beffa, MD

CONTACT

[email protected]

216-445-5975

Sponsors and collaborators

Lead sponsor

Lucas Beffa

Other

Registry information

Official study title

Robotic Versus Open Ventral Hernia Repair: A Randomized Controlled Trial

Acronym: ROVHR

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 25, 2022
Registry last updated
Oct 7, 2025

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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