Robotic versus open ventral hernia repair (ROVHR): a randomized controlled trial protocol.
Alvaro C Carvalho, Kimberly P Woo, Ryan C Ellis...
https://pubmed.ncbi.nlm.nih.gov/40035894Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05472987
Robotic Versus Open Ventral Hernia Repair: A Randomized Controlled Trial
Led by Lucas Beffa · Updated on 2025-10-07
200
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two surgical methods for ventral hernia repair: open retromuscular repair and robotic retromuscular repair. This randomized trial aims to determine whether the robotic approach can reduce hospital length of stay by 24 hours compared to the open method. The study is designed to assess superiority with patients and outcome assessors blinded to the treatment group. Participants will undergo either open or robotic retromuscular ventral hernia repair. The study groups run in parallel, and the main treatment difference is the surgical approach used. The trial will evaluate hospital stay length as the primary outcome, with several secondary outcomes including post-operative complications, readmission rates, opioid use, pain scores, quality of life, costs, and hernia recurrence measured at various times up to one year. During the study, participants will be closely monitored for hospital length of stay and various health outcomes related to the surgery. Assessments include wound and other post-operative complications, pain levels within five days of surgery, quality of life questionnaires, opioid consumption, and recurrence of hernia over 30 days and one year. The total participation time includes follow-up assessments up to one year after surgery to monitor recovery and quality of life.
CONDITIONS
Brief Title
Robotic Versus Open Ventral Hernia Repair
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults 18 years and older
- Ventral hernia midline defects between 7 cm and 15 cm wide
- Body mass index (BMI) less than or equal to 45
- Deemed suitable for both open and robotic hernia repair by the operating surgeon
You will not qualify if you...
- Age 17 years or younger
- Prisoners
- Pregnant individuals
- Patients requiring emergency surgery
- Body mass index (BMI) greater than 45
- Hernia defects smaller than 7 cm or larger than 15 cm in width
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Up to hospital discharge
Participants undergo either open or robotic retromuscular ventral hernia repair and receive immediate post-operative care.
1 surgery visit and post-operative hospital stay
Post-operative Follow-up
Duration - Up to 1 year
Participants are monitored for wound complications, pain, opioid consumption, quality of life, and hernia recurrence after surgery.
Multiple visits up to 1 year after surgery
Trial Site Locations
Total: 4 locations
1
University of Florida Health
Gainesville, Florida, United States, 32608
Actively Recruiting
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
3
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Actively Recruiting
4
University of Tennessee Medical Center, Knoxville
Knoxville, Tennessee, United States, 37920
Actively Recruiting
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Research Team
L
Lucas Beffa, MD
A
Alvaro Carvalho
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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