Abstract
ObjectiveThis study aimed to assess the feasibility and safety of the SHURUI single-port robotic surgical system for a range of major urological surgeries. MethodsIn this prospective, multicenter clinical trial, we examined the effectiveness of the SHURUI 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 system. The study's primary endpoints focused on the success of surgeries, gauging this by the absence of deviations from planned procedures, the need for additional ports, or re-operations within a 24-hour period post-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 following discharge. ResultsThe 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 (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. ConclusionThe SHURUI single-port robotic 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.
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