A novel single-port robotic system in urology: A prospective multicenter single-arm clinical trial evaluating feasibility and efficacy of first 50 cases.

OBJECTIVE

This study aimed to assess the feasibility and safety of the SHURUI single-port robotic surgical system for a range of major urological surgeries.

METHODS

In this prospective, multicenter clinical trial, we examined the effectiveness of the SHURUI single-port robotic surgical system in urological interventions. The first 50 patients from four centers in China underwent single-port surgeries including partial nephrectomy, radical prostatectomy, partial adrenalectomy, and pyeloureteroplasty, exclusively by the SHURUI single-port robotic surgical system. The study's primary endpoints focused on the success of surgeries, defined as no deviations from planned procedures, no need for more than one port, and no re-operations within 24 h after surgery. Secondary endpoints encompassed a range of surgical metrics, functional outcomes, and patient demographic data. Clinical assessments were conducted before surgery, before discharge, and 1 month after discharge.

RESULTS

The surgical procedures were executed successfully without requiring intraoperative conversions or transfusions. Both estimated blood loss and operation durations were maintained within satisfactory limits. For each type of surgery, the mean console times and estimated blood loss were 179.8 (standard deviation [SD] 39.4) min and 125.6 (SD 126.0) mL for radical prostatectomy, 126.7 (SD 47.8) min and 39.2 (SD 54.4) mL for partial nephrectomy, 112.6 (SD 37.4) min and 20.0 (SD 13.2) mL for partial adrenalectomy, and 148.0 (SD 18.2) min and 18.0 (SD 17.9) mL for pyeloureteroplasty, respectively. Across the cohort, 17 patients experienced a total of 25 adverse events, while 10 postoperative complications, all rated as Clavien-Dindo grade I, were encountered by eight patients. All patients had shown recovery or improvement from these events before the end of this trial.

CONCLUSION

The SHURUI single-port robotic surgical system demonstrated feasibility and safety in the performance of major urological surgeries. These initial findings highlight the system's potential, though further research and longer follow-up are required to assess long-term outcomes.