腹腔镜与机器人辅助根治性前列腺切除术的前瞻性随机对照试验的 5 年结果。
Five-year Outcomes for a Prospective Randomised Controlled Trial Comparing Laparoscopic and Robot-assisted Radical Prostatectomy.
机构信息
Division of Urology, San Luigi Gonzaga Hospital-Orbassano, University of Turin, Turin, Italy.
Division of Urology, San Luigi Gonzaga Hospital-Orbassano, University of Turin, Turin, Italy.
出版信息
Eur Urol Focus. 2018 Jan;4(1):80-86. doi: 10.1016/j.euf.2016.11.007. Epub 2016 Nov 23.
BACKGROUND
The literature is lacking randomised controlled trials comparing robot-assisted (RARP) and laparoscopic (LRP) radical prostatectomy, especially for follow-up >1 yr.
OBJECTIVE
To report 5-yr outcomes for our previously published prospective randomised study comparing RARP and LRP.
DESIGN, SETTING, AND PARTICIPANTS: From January 2010 to January 2011, 120 patients with organ-confined prostate cancer were enrolled and randomly assigned to RARP or LRP.
INTERVENTION
A single surgeon performed all interventions using the same transperitoneal anterograde technique.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Continence, potency, and serum prostate-specific antigen were assessed postoperatively at 1, 3, 6, and 12 mo, and then every 6 mo until 60 mo. At the end of the follow-up period, patients were administered questions 1 and 46 of the Expanded Prostate Cancer Index Composite questionnaire to assess their satisfaction with the intervention and general health status. A generalised estimating equations model was used to compare time series data for functional results, and Kaplan-Meier and Cox models were used to analyse oncologic outcomes.
RESULTS AND LIMITATIONS
The probability of achieving continence (odds ratio [OR] 2.47, p<0.021) and potency (OR 2.35, p<0.028) over time was more than doubled for the RARP compared to the LRP group. There was no difference between the two approaches in terms of patient survival. Pathologic Gleason score, positive surgical margins, and pT stage were associated with significantly higher biochemical recurrence in Cox multivariate models. Patient satisfaction with the intervention and their general health status was significantly higher in the RARP group.
CONCLUSIONS
Throughout the 5-yr follow-up, RARP yielded better functional results compared to LRP, without compromising oncologic outcomes.
PATIENT SUMMARY
In this report we looked at 5-yr outcomes for a study comparing robot-assisted radical prostatectomy (RARP) and laparascopic radical prostatectomy for the treatment of prostate cancer. We found that continence and potency are better among patients treated with RARP, while oncologic results are comparable.
背景
目前缺乏比较机器人辅助(RARP)和腹腔镜(LRP)根治性前列腺切除术的随机对照试验,尤其是在随访时间>1 年的情况下。
目的
报告我们之前发表的一项前瞻性随机研究比较 RARP 和 LRP 的 5 年结果。
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,并随机分为 RARP 或 LRP 组。
干预
由同一位外科医生采用相同的经腹顺行技术进行所有手术。
结局测量和统计分析
术后 1、3、6 和 12 个月,以及 60 个月时,评估尿控、勃起功能和血清前列腺特异性抗原,并每 6 个月评估一次。随访结束时,采用前列腺癌指数综合问卷的扩展部分第 1 题和第 46 题评估患者对干预的满意度和一般健康状况。采用广义估计方程模型比较功能结果的时间序列数据,采用 Kaplan-Meier 和 Cox 模型分析肿瘤学结果。
结果和局限性
与 LRP 组相比,RARP 组的尿控(优势比[OR]2.47,p<0.021)和勃起功能(OR 2.35,p<0.028)的时间概率增加了一倍以上。两种方法在患者生存率方面没有差异。在 Cox 多变量模型中,病理 Gleason 评分、阳性切缘和 pT 分期与生化复发显著相关。RARP 组患者对干预的满意度和一般健康状况显著更高。
结论
在 5 年随访期间,RARP 组与 LRP 组相比,功能结果更好,而肿瘤学结果无差异。
患者总结
在本报告中,我们观察了一项比较机器人辅助根治性前列腺切除术(RARP)和腹腔镜根治性前列腺切除术治疗前列腺癌的 5 年结果。我们发现,接受 RARP 治疗的患者尿控和勃起功能更好,而肿瘤学结果相当。