Robotic-assisted Urological Minimally Invasive Cancer Surgeries using the MicroHand S Surgical Robot System.

OBJECTIVE

To evaluate the safety and feasibility of the enhanced MicroHand S surgical robot system in urological minimally invasive cancer surgeries, in alignment with the IDEAL-D Framework Stage 2a.

METHODS

Procedures were performed by an experienced urologist from the Affiliated Hospital of Qingdao University using the MicroHand S surgical robot system. Patients requiring radical cystectomy, partial nephrectomy, or radical prostatectomy were enrolled. The primary endpoint was the rate of unplanned conversion from robot-assisted surgery to conventional laparoscopic or open surgery. An independent Clinical Expert Committee reviewed the study to adjudicate the occurrence of adverse events (AEs) and serious adverse events (SAEs). All patients were followed for 1 year postoperatively.

RESULTS

These procedures included 12 radical cystectomies, 8 radical prostatectomies, and 3 partial nephrectomies. All procedures were completed successfully without the need for conversion to conventional laparoscopic or open surgery. No robotic devices or surgical instruments related AEs were recorded during the procedure. All patients had a postoperative Clavien-Dindo classification of grade Ⅰ before discharge (100%). No patients returned to the operating room within 24 hours of surgery. At 1- year follow-up none patient presented a tumor recurrence.

CONCLUSIONS

The MicroHand S system is safe and feasible for complex urological MICS, supporting further clinical trial recruitment.

CLINICAL TRIAL REGISTRATION: The study was registered at Clinicaltrials.gov (https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05462392), registration number: NCT05462392.