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/40035894/Actively Recruiting
Led by Lucas Beffa · Updated on 2025-10-07
200
Participants Needed
4
Research Sites
N/A
Total Duration
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
Robotic Versus Open Ventral Hernia Repair
L
Lucas Beffa, MD
A
Alvaro Carvalho
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Lucas Beffa
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Robotic retromuscular ventral hernia repair | Open retromuscular ventral hernia repair | Laparoscopic ventral hernia repair |
|---|---|---|---|
| What this involves | Surgical repair of midline ventral hernias using a robot-assisted retromuscular approach as tested in the trial. | Conventional open retromuscular ventral hernia repair as the comparator arm in the trial. | Minimally invasive laparoscopic ventral hernia repair commonly used in current practice. |
| Role in the study | Investigational surgical technique being evaluated in the randomized trial. | Active comparator surgical technique, representing standard open surgery. | Widely accepted minimally invasive option used outside the trial setting. |
| Main clinical purpose | To repair ventral hernia using a robotic platform in a retromuscular plane. | To repair ventral hernia using a conventional open retromuscular approach. | To repair ventral hernias via laparoscopic access with mesh placement. |
| Procedure approach | Performed with robotic-assisted instruments for retromuscular mesh placement. | Delivered via open surgical incision into retromuscular space for mesh repair. | Using laparoscopic instruments through small incisions with mesh placement. |
| Evidence & clinical context | No published results yet; trial is still ongoing as of study registry (completion mid-2027). | Well-established open technique with known clinical outcomes over years of use. | Strong clinical acceptance supported by trials showing less hospital stay and fewer wound infections compared to open repair; similar recurrence and complication rates. |
| Limitations to consider | Results are not yet available from the trial to assess outcomes. | Open surgery is associated with higher wound infection risk than minimally invasive methods. | May not be suitable for very large defects and surgical resources or expertise may vary. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Alvaro C Carvalho, Kimberly P Woo, Ryan C Ellis...
https://pubmed.ncbi.nlm.nih.gov/40035894/Lucas Beffa
Lead Sponsor