Retzius-sparing versus standard robot-assisted radical prostatectomy: a prospective randomized comparison on immediate continence rates
Retzius-sparing versus standard robot-assisted radical prostatectomy: a prospective randomized comparison on immediate continence rates
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DOI：
10.1007/s00464-018-6499-z
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发表时间：
2019-07-01
影响因子：
3.1
通讯作者：
Annino, Filippo
中科院分区：
文献类型：
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作者：
Asimakopoulos, Anastasios D.;Topazio, Luca;Annino, Filippo
背景前列腺切除术后尿失禁是一种导致严重痛苦的不良事件。我们的目的是在一项单外科医生前瞻性随机比较研究中评估传统机器人辅助腹腔镜根治性前列腺切除术 (TR-RALP) 和保留 Retzius 的 RALP (RS-RALP) 治疗临床局限性前列腺癌 (PCa) 的即刻尿失禁 (UC) 恢复情况。方法 102 名连续 PCa 患者前瞻性随机接受 TR-RALP (57) 或 RS-RALP (45)。术后失禁定义为患者报告没有渗漏或每天使用 0 个护垫。计算每次治疗的立即节制率和 95% 置信区间 (CI 95%)。单变量和多变量逻辑回归用于评估 RALP 后立即失禁的预测因素。通过Kaplan-Meier曲线计算1至6个月的失禁率；对数秩检验用于曲线比较。进行了两项分析，考虑了所有接受神经保留 RALP 的随机患者的符合方案 (PP) 人群和所有接受 RALP 的随机患者的意向治疗 (ITT) 人群。结果在 PP 分析中，TR-RALP 的立即失禁率为 12/40 (30%) (CI 95% 17-47%)，TR-RALP 的立即失禁率为 20/39 (51.3%) (CI)。 RS-RALP 为 95% 35-68% (p=0.05)。在 ITT 分析中，TR-RALP 的相应比率为 12/57 (21%) (CI 95% 11-34%)，RS-RALP 的相应比率为 23/45 (51%) (CI 95% 36-66%) (p=0.001)。 TR-RALP 的中位节制时间为 21 天，RS-RALP 的中位节制时间为 1 天（p=0.02）。与对数秩检验相比，关于节制的相对 Kaplan-Meier 曲线结果有统计学差异 (p=0.02)。在多变量分析中，较低的年龄和 Retzius 保留方法与较早的失禁恢复显着相关。结论 Retzius 保留方法显着缩短了 RALP 后达到失禁的时间。需要进一步的研究来确认我们的结果的可重复性，并调查 RS-RALP 作为老年人术后节制的额外保护因素的作用。
BackgroundPost-prostatectomy urinary incontinence is an adverse event leading to significant distress. Our aim was to evaluate immediate urinary continence (UC) recovery in a single-surgeon prospective randomized comparative study between the traditional robot-assisted laparoscopic radical prostatectomy (TR-RALP) and the Retzius-sparing RALP (RS-RALP), for the treatment of the clinically localized prostate cancer (PCa).Methods102 consecutive PCa patients were prospectively randomized to TR-RALP (57) or RS-RALP (45). Postoperative continence was defined as patient-reported absence of leakage or use of 0 pads/day. The immediate continence rate and 95% confidence interval (CI 95%) were calculated for each treatment. Univariable and multivariate logistic regressions were used to assess predictors of immediate continence following RALP. Continence rates from 1 to 6 months were calculated by Kaplan-Meier curves; log-rank test was used for the curve comparison. Two analyses were performed, considering a per-protocol (PP) population regarding all randomized patients that received nerve-sparing RALP and an Intention-To-Treat (ITT) population regarding all randomized patients that received RALP.ResultsIn the PP analysis, the rates of immediate continence were 12/40 (30%) (CI 95% 17-47%) for the TR-RALP and 20/39 (51.3%) (CI 95% 35-68%) for the RS-RALP (p=0.05). In the ITT analysis, the corresponding rates were 12/57 (21%) (CI 95% 11-34%) for the TR-RALP and 23/45 (51%) (CI 95% 36-66%) for the RS-RALP (p=0.001). Median time to continence was 21 days for the TR-RALP and 1day for RS-RALP, respectively (p=0.02). The relative Kaplan-Meier curves regarding continence resulted statistically different when compared with the log rank test (p=0.02). In the multivariate analysis, lower age and the Retzius-sparing approach were significantly associated to earlier continence recovery.ConclusionsThe Retzius-sparing approach significantly reduces time to continence following RALP. Further studies are required to confirm the reproducibility of our results and investigate the role of the RS-RALP as an additional protective factor for postoperative continence in the elderly population.