Background

Radical prostatectomy reduces mortality among patients with localised prostate cancer. Evidence on whether different surgical techniques can affect mortality rates is lacking.

Objective

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.

Outcome measurements and statistical analysis

The primary endpoint was urinary incontinence. Functional outcomes at 8 yr were analysed using the modified Poisson regression approach.

Results and limitations

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.

Conclusions

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.

Patient summary

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.

中文翻译：

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开放与机器人辅助腹腔镜根治性前列腺切除术治疗局限性前列腺癌后的功能和肿瘤学结果：8 年随访

背景

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。缺乏不同手术技术是否会影响死亡率的证据。

客观的

评估机器人辅助腹腔镜前列腺切除术 (RALP) 和开放性耻骨后根治性前列腺切除术 (RRP) 8 年后的功能和肿瘤学结果。

设计、设置和参与者

我们在 2008 年至 2011 年期间在 14 个瑞典中心招募了 4003 名患者参加一项比较 RALP 和 RRP 的前瞻性、对照、非随机试验。功能结果的数据通过术前和术后 12 个月、24 个月和 8 年进行的经过验证的患者问卷进行评估。

结果测量和统计分析

主要终点是尿失禁。使用改进的泊松回归方法分析 8 岁时的功能结果。

结果和局限性

RALP 和 RRP 手术后 8 年的尿失禁没有显着差异（27% 对 29%；调整后的风险比 [aRR] 1.05，95% 置信区间 [CI] 0.90–1.23）。RALP 组的勃起功能障碍显着降低（66% 对 70%；aRR 0.93，95% CI 0.87–0.99）。手术后 8 年，RALP 组的前列腺癌特异性死亡率 (PCSM) 显着降低（40/2699 vs 25/885；aRR 0.56，95% CI 0.34–0.93）。肿瘤学结果的差异主要见于 D'Amico 风险高的组，手术切缘阳性（21% 对 34%）、生化复发（51% 对 69%）和 PCSM（14/220 对11/77) 用于 RALP 与 RRP。主要限制是非随机设计。

结论

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。无法推断手术技术与死亡率之间的因果关系，但结果证实 RALP 在肿瘤学上是安全的。结合其他地方报告的更好的短期结果，我们的研究结果证实 RALP 的实施可能会继续。

患者总结

我们的研究比较了两种用于切除局部前列腺癌的前列腺手术技术，表明机器人辅助微创技术在长期内是安全的。加上之前的结果显示这种方法有更好的短期效果，我们的研究结果支持继续使用机器人辅助手术。