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保留 Retzius 间隙的机器人辅助根治性前列腺切除术可改善早期尿控恢复:一项随机、对照、单盲临床试验,随访 1 年。

Retzius-sparing robot-assisted radical prostatectomy improves early recovery of urinary continence: a randomized, controlled, single-blind trial with a 1-year follow-up.

机构信息

Department of Urology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.

Institute of Urology, Nanjing University, Nanjing, China.

出版信息

BJU Int. 2020 Nov;126(5):633-640. doi: 10.1111/bju.15195. Epub 2020 Aug 17.

DOI:10.1111/bju.15195
PMID:32741099
Abstract

OBJECTIVE

To evaluate the impact of Retzius-sparing robot-assisted radical prostatectomy (posterior approach) on early recovery of urinary continence (UC) compared to the conventional approach (anterior approach) for the treatment of clinically localized prostate cancer (PCa).

METHODS

A total of 110 consecutive patients with clinically localized PCa were prospectively randomized in a 1:1 ratio to an anterior group (n = 55) or a posterior group (n = 55). The primary outcome was immediate UC, defined as freedom from any pad use within 1 week after removal of the urinary catheter. The UC rate following surgery was also calculated with Kaplan-Meier curves, and the log-rank test was used for statistical comparison. Intra-operative outcomes, pathological data and oncological outcomes, including positive surgical margin (PSM) status and biochemical recurrence-free survival (BCRFS), were also compared between the two groups. The comparison of the two approaches was also analysed in subgroups after risk stratification.

RESULTS

Of the patients who underwent the posterior approach, 69.1% achieved immediate UC compared with 30.9% in the anterior group (relative risk 2.24, 95% confidence interval [CI] 1.48-3.51; P = 0.000). The relative Kaplan-Meier curves for UC during the 12-month follow-up revealed statistically better recovery in the posterior group when compared with the anterior group (hazard ratio [HR] 1.51, 95% CI 1.01-2.24; log-rank P = 0.007). No statistically significant differences were observed between the groups regarding complications (P = 0.399), PSM status (P = 0.225) or BCRFS (HR 4.80, 95% CI 0.97-23.78; log-rank P = 0.111). In sub-analyses, no significant difference between the two approaches with regard to UC recovery in patients with high-risk PCa was observed (HR 1.26, 95% CI 0.63-2.51; log-rank P = 0.415).

CONCLUSIONS

The Retzius-sparing approach significantly improved early recovery of UC compared to the conventional approach. Further prospective studies are needed to confirm the benefits of the Retzius-sparing approach for clinically localized PCa, especially for high-risk cases.

摘要

目的

评估保留耻骨后间隙的机器人辅助根治性前列腺切除术(后入路)与传统前入路治疗局限性前列腺癌(PCa)在早期尿控恢复方面的影响。

方法

前瞻性纳入 110 例局限性 PCa 患者,采用 1:1 比例随机分为前组(n=55)和后组(n=55)。主要结局为即刻尿控,定义为导尿管拔除后 1 周内无需使用任何尿垫。采用 Kaplan-Meier 曲线计算术后尿控率,并采用对数秩检验进行统计学比较。比较两组患者的术中结果、病理数据和肿瘤学结果,包括切缘阳性(PSM)状态和生化无复发生存率(BCRFS)。还对两组患者进行风险分层后进行亚组分析。

结果

后入路组中,69.1%的患者实现即刻尿控,而前入路组为 30.9%(相对风险 2.24,95%置信区间[CI] 1.48-3.51;P=0.000)。在 12 个月的随访期间,UC 的相对 Kaplan-Meier 曲线显示后入路组的恢复情况明显优于前入路组(风险比[HR] 1.51,95%CI 1.01-2.24;对数秩 P=0.007)。两组患者在并发症(P=0.399)、PSM 状态(P=0.225)或 BCRFS(HR 4.80,95%CI 0.97-23.78;对数秩 P=0.111)方面无统计学差异。在亚组分析中,在后入路组中,高危 PCa 患者的 UC 恢复方面,两种方法之间无显著差异(HR 1.26,95%CI 0.63-2.51;对数秩 P=0.415)。

结论

与传统方法相比,保留耻骨后间隙的方法可显著改善早期尿控恢复。需要进一步的前瞻性研究来证实保留耻骨后间隙的方法对局限性 PCa 的益处,尤其是对高危病例。

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