Abstract
The DAVINCI SP system is an advanced robotic surgery platform allowing an endoscope and three articulated instruments to enter the body through a single incision while maintaining workspace triangulation. This open-label, single-arm clinical trial (ClinicalTrials.gov Identifier: NCT05403190 18/05/2022) evaluates the feasibility of using the DAVINVI SP system for extraperitoneal-approach robot-assisted radical prostatectomy (RaRP) in Taiwan. Two surgical techniques, the conventional anterior approach and the Hood technique, were used for RaRP. The primary endpoint was the success rate of RaRP with the DAVINCI SP system without conversion to multiport RaRP or open surgery. Secondary endpoints included perioperative variables, oncological outcomes, and functional outcomes. The study achieved a 100% success rate for the primary endpoint. Patients who underwent RaRP with the DAVINCI SP system had lower postoperative pain scores and shorter hospital stays. Additionally, 93.33% did not require a drain tube post-surgery, 80% achieved undetectable PSA levels at six months, and 96.67% regained continence within three months. The oncologic and continence outcomes are comparable between patients receiving conventional anterior approach or Hood technique. In conclusion, the DAVINCI SP system allows an effective extraperitoneal-approach RaRP, offering reduced pain, shorter hospital stays, and low drain tube placement rates.Trial registration: ClinicalTrials.gov (Identifier: NCT05403190 18/05/2022).