Robotic versus open ventral hernia repair (ROVHR): a randomized controlled trial protocol

Area of Science:

• Minimally Invasive Surgery
• Surgical Oncology
• Robotic Surgery

Background:

• Robotic retromuscular hernia repair is feasible and safe, but lacks robust randomized data for clinical benefit.
• Existing comparative studies are limited by bias, including retrospective designs and registry data.
• Previous research shows inconsistent outcomes, creating knowledge gaps for surgical decision-making.

Purpose of the Study:

• To test the hypothesis that robotic retromuscular hernia repair reduces hospital length of stay by at least 24 hours compared to open repair.
• To provide high-level, evidence-based outcomes to guide clinical decisions in hernia repair surgery.
• To compare direct operating room costs between robotic and open retromuscular hernia repair.

Main Methods:

• A registry-based, multicenter, double-blinded randomized trial (ROVHR trial, NCT: 05472987).
• Primary endpoint: reduction in length of stay by at least 24 hours.
• Secondary outcomes: 30-day wound morbidity, readmissions, opioid consumption, pain scores (NRS-11, PROMIS-3a), and patient-reported outcomes (HerQLes, EuraHS).

Main Results:

• Data not yet available as the study is designed to generate new evidence.

Conclusions:

• This randomized trial is designed to address the lack of high-level evidence comparing robotic and open retromuscular hernia repair.
• The study's primary endpoint focuses on reducing length of hospital stay, a key metric for patient recovery and healthcare efficiency.
• Findings will contribute crucial evidence-based data to inform clinical practice and decision-making in hernia surgery.