Ventral HerniaROVHRNCT05472987
Robotic Versus Open Ventral Hernia Repair
A study testing Ventral Hernia Repair in people with Ventral Hernia, run by Lucas Beffa at 5 sites in United States.
Trial summary
This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Ventral Hernia Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Jul 2022to 1 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Riley Wilkinson, MD contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University Hospitals
Cleveland, Ohio, 44106
Samuel Zolin, MD, 216-844-8741, samuel.zolin@uhhospitals.org
Neha Pervez, neha.pervez@uhhospitals.org
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Lucas Beffa, MD, 216-445-5975, Beffal@ccf.org
- Recruiting
University of Florida Health
Gainesville, Florida, 32608
Mazen Al-Mansour, MBBS
- Recruiting
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Abby Birrell, 864-522-2100, abby.birrell@prismahealth.org
Jeremy Warren, MD
- Recruiting
University of Tennessee Medical Center, Knoxville
Knoxville, Tennessee, 37920
Kaela Blake, MD, kblake@utmck.edu
Tiffany Johnson, thjohnson@utmck.edu
About this study
Official title: Robotic Versus Open Ventral Hernia Repair: A Randomized Controlled Trial
This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair.
Read the 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.
- Conditions
- Ventral Hernia
- Being tested
- Ventral Hernia Repair
- Keywords
- Robotic, Hernia, Ventral hernia, Open hernia, Mesh
- Medical subject headings
- Hernia, Ventral, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventral Hernia RepairProcedure or surgery
Patients will undergo retromuscular ventral hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Open Ventral Hernia Repair | Active comparator | These patients will undergo open retromuscular ventral hernia repairs Receives: Procedure: Ventral Hernia Repair |
| Robotic Ventral Hernia Repair | Active comparator | These patients will undergo robotic retromuscular ventral hernia repairs. Receives: Procedure: Ventral Hernia Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Time in the hospital after the surgery
Measured: 30 days
Secondary outcomes (9)
Post-operative wound complications
any abnormal wound healing
Measured: 30 day and one year
Other post operative complications
Heart attacks, acute kidney injury, admissions to ICU, respiratory failure
Measured: 30 days
Readmission rate
Readmission to the hospital within 30 days of the surgery
Measured: 30 days
Opioid consumption
Opioid prescribed and consumed
Measured: 30 days and one year
Acute pain scores
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
Measured: 5 days after surgery
Hernia Related Specific Quality of Life Score
Score of 0-100 with lower scores indicating worse quality of life
Measured: 30 days and one year
Direct cost
Cost to the hospital
Measured: 30 days
Hernia recurrence
Hernia recurrence
Measured: 30 days and one year
Quality of life scores using European Hernia Society (EuraHS) scale
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.
Measured: 30 day and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start25 Jul 2022
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lucas Beffa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lucas Beffa, The Cleveland Clinic
- Investigators
- Lucas Beffa, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472987
- Sponsor's protocol ID
- 22-591
- Acronym
- ROVHR
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carvalho AC, Woo KP, Ellis RC, Tu C, Miller BT, Prabhu AS, Rosen MJ, Krpata DM, Petro CC, Beffa LR. Robotic versus open ventral hernia repair (ROVHR): a randomized controlled trial protocol. Hernia. 2025 Mar 4;29(1):109. doi: 10.1007/s10029-025-03299-7.
PubMed 40035894