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).