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

Background: Robotic retromuscular hernia repair has proven to be feasible and safe but lacks randomized data to demonstrate significant clinical benefit. The majority of current comparative studies published have been case series, retrospective studies, systematic reviews, or large registry data, all of which have significant limitations and bias (Bittner et al. in Surg Endosc 32:727–734. https://doi.org/10.1007/s00464-017-5729-0, 2018; Bracale et al in Hernia 25:1471–1480. https://doi.org/10.1007/s10029-021-02487-5, 2021; Carbonell in Ann Surg 267:210–217. https://doi.org/10.1097/SLA.0000000000002244, 2018; (Warren et al. in Surg Endosc. https://doi.org/10.1007/s00464-024-11202-1, 2024; Dewulf et al in BJS Open 6:zrac057. https://doi.org/10.1093/bjsopen/zrac057, 2022; Maskal and Beffa in Surg Clin N Am 103:977–991. https://doi.org/10.1016/j.suc.2023.04.007, 2023). It was only recently that the first randomized trial was conducted by Warren et al. comparing open and robotic retromuscular hernia repairs with synthetic mesh (Warren et al. in Surg Endosc. https://doi.org/10.1007/s00464-024-11202-1, 2024). The data currently available has yielded inconsistent outcomes leaving significant knowledge gaps for clinical decision making. Reduced length of stay for robotic retromuscular repairs has been a consistently proven outcome, however, and therefore, we hypothesized that robotic retromuscular hernia repairs would be superior to open retromuscular hernia repair by reducing length of stay in the hospital by 24 h (Carbonell in Ann Surg 267:210–217. https://doi.org/10.1097/SLA.0000000000002244, 2018). Methods: The Institutional Review Board at all participating sites has approved this protocol. This trial has been registered on clinicaltrials.gov (NCT: 05472987). The ROVHR trial is a registry-based, multicenter, double-blinded randomized trial. The primary hypothesis is robotic retromuscular hernia repairs is superior to open retromuscular hernia repairs by reducing length of stay by at least 24 h. Secondary outcomes include 30-day wound morbidity, readmissions, opioids prescribed and consumed, NRS-11 pain scores obtained daily for the 5 first days after surgery, PROMIS-3a Pain Intensity survey, and patient reported outcomes including Hernia-Related Quality of Life (HerQLes), and EuraHS. Additionally, direct operating room costs will be compared. Discussion: Based existing literature, we designed a randomized trial with a primary endpoint to determine if robotic retromuscular hernia repairs reduce length of in hospital stay by at least 24 h compared to open retromuscular hernia repairs. This study will add high-level of evidence providing evidence-based outcomes for clinical decision making. Trial registration: NCT05472987. Registered on July 20, 2022.