Randomised Controlled Trial Comparing Laparoscopic and Robot-assisted Radical Prostatectomy

Randomised Controlled Trial Comparing Laparoscopic and Robot-assisted Radical Prostatectomy
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DOI:
10.1016/j.eururo.2012.07.007
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发表时间:
2013-04-01
期刊:
影响因子:
23.4
通讯作者:
Fiori, Cristian
Fiori, Cristian
中科院分区:
医学1区
文献类型:
--
作者:
Porpiglia, Francesco;Morra, Ivano;Fiori, Cristian

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背景:机器人辅助根治性前列腺切除术(RARP)相对于腹腔镜根治性前列腺切除术(LRP)的优势很少在随机对照试验中进行研究。目的:比较 RARP 和 LRP 在功能、围手术期和肿瘤学结果方面的差异。该研究的主要终点是手术后 3 个月失禁的变化。设计、设置和参与者:从 2010 年 1 月到 2011 年 1 月,招募了 120 名器官局限性前列腺癌患者,并根据手术方法随机分配(使用随机化计划)到两组中的一组:RARP 组和 LRP 组。干预:所有 RARP 和 LRP 干预均由同一位外科医生采用相同的技术进行。结果测量和统计分析:记录并比较人口统计、围手术期和病理结果,例如并发症和前列腺特异性抗原(PSA)测量。在拔除导管时和 48 小时后评估自制力,并在 1、3、6 和 12 个月后评估自制力和效力。采用student t检验、Mann-Whitney检验、chi(2)检验、Pearson chi(2)检验和多元回归分析进行统计。 结果和局限性:两组(RARP:n = 60;LRP:n = 60)在人口统计数据方面具有可比性。围手术期和病理结果、并发症发生率或 PSA 测量结果没有差异。 RARP 组在每个时间点的节制率均较高:3 个月后,RARP 组的节制率为 80%,LRP 组为 61.6%(p = 0.044),1 年后,节制率分别为 95.0% 和 83.3%(p = 0.042)。在术前接受神经保留技术治疗的有效患者中,勃起恢复率分别为 80.0% 和 54.2% (p = 0.020)。局限性包括患者数量较少。结论:RARP 在失禁和效能恢复方面提供了更好的功能结果。需要进一步的研究来证实我们的结果。 (c) 2012 年由 Elsevier B.V. 代表欧洲泌尿外科协会出版。
Background: The advantages of robot-assisted radical prostatectomy (RARP) over laparoscopic radical prostatectomy (LRP) have rarely been investigated in randomised controlled trials.Objective: To compare RARP and LRP in terms of the functional, perioperative, and oncologic outcomes. The main end point of the study was changes in continence 3 mo after surgery.Design, setting, and participants: From January 2010 to January 2011, 120 patients with organ-confined prostate cancer were enrolled and randomly assigned (using a randomisation plan) to one of two groups based on surgical approach: the RARP group and the LRP group.Intervention: All RARP and LRP interventions were performed with the same technique by the same single surgeon.Outcome measurements and statistical analysis: The demographic, perioperative, and pathologic results, such as the complications and prostate-specific antigen (PSA) measurements, were recorded and compared. Continence was evaluated at the time of catheter removal and 48 h later, and continence and potency were evaluated after 1, 3, 6, and 12 mo. The student t test, Mann-Whitney test, chi(2) test, Pearson chi(2) test, and multiple regression analysis were used for statistics.Results and limitations: The two groups (RARP: n = 60; LRP: n = 60) were comparable in terms of demographic data. No differences were recorded in terms of perioperative and pathologic results, complication rate, or PSA measurements. The continence rate was higher in the RARP group at every time point: Continence after 3 mo was 80% in the RARP group and 61.6% in the LRP group (p = 0.044), and after 1 yr, the continence rate was 95.0% and 83.3%, respectively (p = 0.042). Among preoperative potent patients treated with nerve-sparing techniques, the rate of erection recovery was 80.0% and 54.2%, respectively (p = 0.020). The limitations included the small number of patients.Conclusions: RARP provided better functional results in terms of the recovery of continence and potency. Further studies are needed to confirm our results. (c) 2012 Published by Elsevier B.V. on behalf of European Association of Urology.