Cholecystectomy with the Hugo™ robotic-assisted surgery system: the first general surgery clinical study in Korea.

Background: The Hugo™ Robotic-Assisted Surgery (RAS) System is an emergent device in the robotic surgery field. This study aims to describe the first general surgery-focused clinical study in Korea using the novel Hugo™ RAS System.

Methods: This study was a prospective, single-center, single-arm, confirmatory clinical study conducted at Seoul National University Hospital where 20 cholecystectomies were performed. To evaluate the safety and performance of the Hugo™ RAS System the incidence of conversion to laparoscopy or open surgery, major complication (Clavien-Dindo Grade ≥ III) rate, overall complication rate, readmission rate, and reoperation rate were evaluated. All parameters were assessed within 30 days post-procedure. Any device deficiencies encountered during our initial experience and device data such as setup, console, and operative times were also reported.

Results: We confirmed that our trial achieved the primary objective with a success rate of at least 95%. This was accomplished with no conversions to other types of surgery due to serious system malfunction and with only one major complication within 24 h post-procedure. The 20 consecutively enrolled patients had a median age and BMI of 58 years old and 23.9 kg/m, respectively. The major complication rate was 10% (2/20 patients), the overall complication rate was 15% (3/20 patients), the readmission rate was 15% (3/20 patients), and the reoperation rate was 0% (0/20 patients). None of the complications were definitively device related. The median setup, console, and operative times were 16, 17, and 55 min, respectively. The device deficiency rate was 15% (3/20 patients), but all device deficiencies were minor, occurred before the first incision, and did not present a risk to the patient.

Conclusion: Based on our initial experience with the Hugo™ RAS System, cholecystectomy is feasible and safe. This trial is registered with ClinicalTrials.gov (NCT05715827).