Robotic Versus Open Ventral Hernia Repair
ROVHR
1 other identifier
interventional
200
1 country
4
Brief Summary
This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2022
CompletedFirst Posted
Study publicly available on registry
July 25, 2022
CompletedStudy Start
First participant enrolled
July 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
October 7, 2025
October 1, 2025
5 years
July 20, 2022
October 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of Stay
Time in the hospital after the surgery
30 days
Secondary Outcomes (9)
Post-operative wound complications
30 day and one year
Other post operative complications
30 days
Readmission rate
30 days
Opioid consumption
30 days and one year
Acute pain scores
5 days after surgery
- +4 more secondary outcomes
Study Arms (2)
Open Ventral Hernia Repair
ACTIVE COMPARATORThese patients will undergo open retromuscular ventral hernia repairs
Robotic Ventral Hernia Repair
ACTIVE COMPARATORThese patients will undergo robotic retromuscular ventral hernia repairs.
Interventions
Patients will undergo retromuscular ventral hernia repair
Eligibility Criteria
You may qualify if:
- years and older
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lucas Beffalead
Study Sites (4)
University of Florida Health
Gainesville, Florida, 32608, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
University of Tennessee Medical Center, Knoxville
Knoxville, Tennessee, 37920, United States
Related Publications (1)
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.
PMID: 40035894DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucas Beffa, MD
The Cleveland Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor of Surgery
Study Record Dates
First Submitted
July 20, 2022
First Posted
July 25, 2022
Study Start
July 25, 2022
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
October 7, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share