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

摘要

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.