Inguinal and Ventral Hernia Repair with the Hugo Robotic-Assisted Surgery System: A Prospective, Single-arm, Clinical Trial

Objective: – To determine the safety and efficacy of the Hugo robotic-assisted surgery (RAS) platform in the repair of inguinal and ventral hernias. Summary Background Data: – Robotic-assisted surgery has increasingly been utilized in inguinal and ventral hernia repair. Here, we share the results of the first trial of the Hugo RAS platform for use in inguinal and ventral hernia repair in the US. Methods: – This was a prospective, multi-center, single-arm, FDA-approved, investigational device exemption study. Adult patients (N=206) eligible for minimally invasive repair of uncomplicated, non-emergent, and non-recurrent inguinal or ventral hernias were enrolled across 7 sites. Surgeries were performed on 193 patients over 11 months. The primary effectiveness and safety endpoints were the rate of surgical success, defined as the procedure not being converted from the use of the Hugo RAS system to another approach, and the rate of patients with one or more procedure- and/or device-related surgical-site events (SSEs) through 30 days post-procedure, respectively. Results: – The mean (standard deviation) age and body-mass index were 57.4 (13.6) years and 28.4 (4.8) kg/m², respectively, and 78.8% (152/193) of patients were male. There were 97 patients treated in the inguinal hernia cohort and 96 treated in the ventral hernia cohort. The surgical success rate was 100% (193/193), with no conversions, and the SSE rates for the inguinal and ventral cohorts were 0% (0/97) and 2.1% (2/96), respectively. Conclusions: – The Hugo RAS system was found to be safe and effective in the repair of inguinal and ventral hernias in a US patient population.