Robot‐assisted versus three‐dimensional laparoscopic radical prostatectomy: 12‐month outcomes of a randomised controlled trial.

Objectives: To compare functional and oncological outcomes of robot‐assisted laparoscopic prostatectomy (RALP) to three‐dimensional laparoscopic radical prostatectomy (3D‐LRP) at 12 months after surgery. Patients and methods: Prospective randomised single‐centre study of 145 consecutive men referred to radical prostatectomy in a tertiary referral centre in Finland. Patients were randomised 1:1 to the RALP (N = 75) and 3D‐LRP (N = 70) groups. The primary outcome was urinary continence evaluated with the Expanded Prostate Cancer Index Composite 26‐item version (EPIC‐26) incontinence domain score at 12 months after surgery. Secondary outcomes included the use of protective pads at 12 months after surgery, EPIC‐26 domain scores of irritative/obstructive, bowel, sexual and hormonal symptoms, positive surgical margin (PSM) rate, and biochemical recurrence (BCR). Complication frequency within the 3‐month period after surgery was evaluated according to Clavien–Dindo classification. Statistical significance between groups was analysed using Mann–Whitney, chi‐square and Fisher's exact tests. The trial was terminated after interim analysis based on no statistically significant difference in EPIC‐26 urinary incontinence domain scores. Altogether 145 patients of the target accrual of 280 patients were recruited. Results: Postoperative continence at 12 months after surgery according to the EPIC‐26 incontinence domain was 79.25 in both groups (P = 0.4). Between group difference was −5.8 (95% confidence interval –15.2 to 3.6). There was no statistically significant difference in the rates of PSM or BCR between the two surgical modality groups. Conclusion: We were unable to demonstrate a difference between the RALP and 3D‐LRP groups for functional and oncological outcomes at 12 months after surgery. [ABSTRACT FROM AUTHOR]