Robotic Versus Open Ventral Hernia Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ventral Hernia Repair.
- Who it may be relevant to
- Registry conditions: Ventral Hernia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Robotic Versus Open Ventral Hernia Repair: A Randomized Controlled Trial
Overview
This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair.
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.
Interventions
- Procedure Ventral Hernia Repair
Patients will undergo retromuscular ventral hernia repair
Primary outcome measures
- Length of Stay [Time frame: 30 days]
Secondary outcome measures (9)
- Post-operative wound complications [Time frame: 30 day and one year]
- Other post operative complications [Time frame: 30 days]
- Readmission rate [Time frame: 30 days]
- Opioid consumption [Time frame: 30 days and one year]
- Acute pain scores [Time frame: 5 days after surgery]
- Hernia Related Specific Quality of Life Score [Time frame: 30 days and one year]
- Direct cost [Time frame: 30 days]
- Hernia recurrence [Time frame: 30 days and one year]
- Quality of life scores using European Hernia Society (EuraHS) scale [Time frame: 30 day and one year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- University of Florida Health — Gainesville
- Cleveland Clinic — Cleveland
- Prisma Health Greenville Memorial Hospital — Greenville
- University of Tennessee Medical Center, Knoxville — Knoxville
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. PMID 40035894
Identifiers
NCT: NCT05472987 · 22-591