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随机对照试验比较腹腔镜和机器人辅助根治性前列腺切除术。

Randomised controlled trial comparing laparoscopic and robot-assisted radical prostatectomy.

机构信息

Division of Urology, San Luigi Gonzaga Hospital-Orbassano (Turin), University of Turin, Turin, Italy.

出版信息

Eur Urol. 2013 Apr;63(4):606-14. doi: 10.1016/j.eururo.2012.07.007. Epub 2012 Jul 20.

DOI:10.1016/j.eururo.2012.07.007
PMID:22840353
Abstract

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, χ(2) test, Pearson χ(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.

摘要

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)的优势在随机对照试验中很少被研究。

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。本研究的主要终点是术后 3 个月时的控尿情况变化。

设计、地点和参与者:2010 年 1 月至 2011 年 1 月,纳入 120 例局限性前列腺癌患者,并根据手术方式(随机分组方案)随机分为 RARP 组和 LRP 组。

干预

所有 RARP 和 LRP 干预均由同一位经验丰富的外科医生采用相同的技术进行。

观察指标和统计分析

记录和比较患者的人口统计学、围手术期和病理结果,如并发症和前列腺特异性抗原(PSA)测量。在拔除导尿管时和 48 小时后评估控尿情况,并在 1、3、6 和 12 个月后评估控尿和勃起功能。采用学生 t 检验、Mann-Whitney 检验、χ²检验、Pearson χ²检验和多元回归分析进行统计学分析。

结果和局限性

两组(RARP 组:n=60;LRP 组:n=60)在人口统计学数据方面具有可比性。两组在围手术期和病理结果、并发症发生率或 PSA 测量方面无差异。RARP 组在各个时间点的控尿率均较高:RARP 组术后 3 个月的控尿率为 80%,LRP 组为 61.6%(p=0.044),术后 1 年的控尿率分别为 95.0%和 83.3%(p=0.042)。在接受神经保留技术治疗的术前有勃起功能的患者中,勃起功能恢复率分别为 80.0%和 54.2%(p=0.020)。局限性包括患者数量较少。

结论

RARP 在恢复控尿和勃起功能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。

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