Robot-assisted ureteral reimplantation using the KangDuo surgical Robot-01 system: a prospective, single-center, single-arm pilot study.

Abstract

Background: Ureteral reimplantation plays a crucial role in distal ureteral reconstruction, and the integration of robotic systems has greatly enhanced minimally invasive surgical techniques. This pilot study aims to evaluate the technically feasibility and safety of the newly developed KangDuo Surgical Robot-01 (KD-SR-01) system in performing robot-assisted ureteral reimplantation.

Methods: This prospective, single-center, single-arm pilot study was conducted from February 2022 to June 2024. Thirty-one ureteral reimplantation procedures were performed using the KD-SR-01 system. We collected the patients' characteristics, perioperative data and follow-up findings prospectively. We used the NASA-TLX (National Aeronautics and Space Administration Task Load Index) to assess ergonomics.

Results: All 31 procedures were completed successfully without conversion. The median operative time was 153 min (IQR, 136-178.5 min). The median estimated blood loss was 20 mL (IQR, 15-35 mL). No patients needed blood transfusions during the operation. No severe complications occurred either intraoperatively or postoperatively. The median postoperative hospital stay was 4 days (IQR, 4-4 days). At a median follow-up of 22 months (IQR, 13-35 months), the subjective success rate was 96.8% (95% confidence interval: 83.3-99.9%). The surgeon indicated a high level of comfort, with a NASA-TLX global score of 9.47 ± 4.97.

Conclusions: The KD-SR-01 system is technically feasible and safe for robot-assisted ureteral reimplantation.

Trial registration: This study was registered at www.chictr.org.cn (ChiCTR2200056553) on February 7, 2022.