Section of Urology, Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden; Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden.
Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Eur Urol. 2021 Nov;80(5):650-660. doi: 10.1016/j.eururo.2021.07.025. Epub 2021 Sep 15.
Radical prostatectomy reduces mortality among patients with localised prostate cancer. Evidence on whether different surgical techniques can affect mortality rates is lacking.
To evaluate functional and oncological outcomes 8 yr after robot-assisted laparoscopic prostatectomy (RALP) and open retropubic radical prostatectomy (RRP).
DESIGN, SETTING, AND PARTICIPANTS: We enrolled 4003 patients in a prospective, controlled, nonrandomised trial comparing RALP and RRP in 14 Swedish centres between 2008 and 2011. Data for functional outcomes were assessed via validated patient questionnaires administered preoperatively and at 12 and 24 mo and 8 yr after surgery.
The primary endpoint was urinary incontinence. Functional outcomes at 8 yr were analysed using the modified Poisson regression approach.
Urinary incontinence was not significantly different at 8 yr after surgery between RALP and RRP (27% vs 29%; adjusted risk ratio [aRR] 1.05, 95% confidence interval [CI] 0.90-1.23). Erectile dysfunction was significantly lower in the RALP group (66% vs 70%; aRR 0.93, 95% CI 0.87-0.99). Prostate cancer-specific mortality (PCSM) was significantly lower in the RALP group at 8 yr after surgery (40/2699 vs 25/885; aRR 0.56, 95% CI 0.34-0.93). Differences in oncological outcomes were mainly seen in the group with high D'Amico risk, with a lower risk of positive surgical margins (21% vs 34%), biochemical recurrence (51% vs 69%), and PCSM (14/220 vs 11/77) for RALP versus RRP. The main limitation is the nonrandomised design.
In this prospective multicentre controlled trial, PCSM at 8 yr after surgery was lower for RALP in comparison to RRP. A causal relationship between surgical technique and mortality cannot be inferred, but the result confirms that RALP is oncologically safe. Taken together with better short-term results reported elsewhere, our findings confirm that implementation of RALP may continue.
Our study comparing two surgical techniques for removal of the prostate for localised prostate cancer shows that a robot-assisted minimally invasive technique is safe in the long term. Together with previous results showing some better short-term effects with this approach, our findings support continued use of robot-assisted surgery.
根治性前列腺切除术可降低局限性前列腺癌患者的死亡率。目前缺乏不同手术技术是否会影响死亡率的证据。
评估机器人辅助腹腔镜前列腺切除术(RALP)和开放式经耻骨后根治性前列腺切除术(RRP)术后 8 年的功能和肿瘤学结果。
设计、地点和参与者:我们在 2008 年至 2011 年间在瑞典的 14 个中心前瞻性地比较了 RALP 和 RRP,共纳入了 4003 名患者。通过术前、术后 12 个月、24 个月和 8 年的有效患者问卷调查评估功能结局。
主要终点是尿失禁。采用校正泊松回归分析方法分析术后 8 年的功能结局。
RRP 和 RALP 术后 8 年尿失禁的发生率无显著差异(27%比 29%;校正风险比[aRR]为 1.05,95%置信区间[CI]为 0.90-1.23)。RALP 组勃起功能障碍显著较低(66%比 70%;aRR 为 0.93,95%CI 为 0.87-0.99)。RRP 组术后 8 年前列腺癌特异性死亡率(PCSM)显著较低(40/2699 比 25/885;aRR 为 0.56,95%CI 为 0.34-0.93)。在高 D'Amico 风险组中,肿瘤学结局的差异更为显著,RALP 组的阳性切缘率(21%比 34%)、生化复发率(51%比 69%)和 PCSM(14/220 比 11/77)均较低。主要局限性在于非随机设计。
在这项前瞻性多中心对照试验中,与 RRP 相比,RALP 术后 8 年的 PCSM 较低。不能推断手术技术和死亡率之间存在因果关系,但结果证实 RALP 在肿瘤学上是安全的。结合其他地方报道的短期结果更好,我们的发现证实了 RALP 的实施可以继续。
我们对两种用于治疗局限性前列腺癌的前列腺切除术的研究表明,机器人辅助微创技术是安全的。与以前的结果一起表明这种方法有一些更好的短期效果,我们的研究结果支持继续使用机器人辅助手术。