Robot-assisted single-port radical prostatectomy: A phase 1 clinical study.

ABSTRACT

OBJECTIVE: To investigate the safety and feasibility of robot-assisted single-port radical prostatectomy using the da Vinci single-port surgical system. METHODS: This was a prospective phase 1 clinical study of prostate cancer patients undergoing robot-assisted single-port radical prostatectomy using the da Vinci single-port surgical system. Primary outcome measures included the conversion rate and 30-day complications after surgery. Secondary outcome measures included operative time, blood loss, hospital stay, duration of catheterization, final pathological outcomes and number of lymph nodes yielded at pelvic lymphadenectomy. RESULTS: From February to August 2017, 20 patients were included in the present study. The mean age was 67.7 ± 6.0 years. The mean preoperative prostate-specific antigen level was 15.3 ± 11.3 ng/mL, and the mean prostate size was 36.6 ± 15.5 mL. Preoperatively, 12 (60%) patients had a Gleason score of 6, four (20%) had a Gleason score of 7 and four (20%) had a Gleason score of 8-10. The mean operative time was 208.9 ± 35.2 min, and the mean blood loss was 296.3 ± 220.7 mL. None of the patients required conversion. The mean hospital stay was 5.0 ± 1.7 days. Among the patients, six (15%) had T2a disease, one (5%) had T2b disease, seven (35%) had T2c disease and nine (45%) had T3a disease on final pathology. A mean number of 8.3 ± 7.1 lymph nodes were yielded at pelvic lymphadenectomy. There were no intraoperative complications. The observed postoperative complications were Clavien grade I-II, and all resolved with conservative management. CONCLUSION: Robot-assisted single-port radical prostatectomy using the da Vinci surgical system is safe and technically feasible.