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保留耻骨前列腺韧带的机器人辅助腹腔镜前列腺根治术学习曲线之外:≥1 年随访的前 200 例患者的肿瘤学和功能结果。

Beyond the learning curve of the Retzius-sparing approach for robot-assisted laparoscopic radical prostatectomy: oncologic and functional results of the first 200 patients with ≥ 1 year of follow-up.

机构信息

Department of Urology, Niguarda Ca' Granda Hospital, Milan, Italy.

出版信息

Eur Urol. 2013 Dec;64(6):974-80. doi: 10.1016/j.eururo.2013.06.046. Epub 2013 Jul 8.

DOI:10.1016/j.eururo.2013.06.046
PMID:23856036
Abstract

BACKGROUND

Robot-assisted laparoscopic radical prostatectomy (RARP) has become the main surgical option for localized prostate cancer. We recently developed a new approach for RARP, passing through the pouch of Douglas and avoiding all the Retzius structures involved in continence and potency preservation.

OBJECTIVE

To report the functional and oncologic results of our first 200 patients operated on using this new approach.

DESIGN, SETTING, AND PARTICIPANTS: This was a prospective, noncontrolled case series including the first 200 consecutive patients undergoing this kind of surgery (January the 1st, 2010 to December the 31st, 2011).

SURGICAL PROCEDURE

Retzius-sparing RARP.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

All perioperative, oncologic, and functional data were prospectively recorded. Potency was defined as an International Index of Erectile Function-5 questionnaire score >17; continence was defined as use of no pad or of one safety liner. Oncologic results were reported as positive surgical margins (PSM) and 1-yr biochemical disease-free survival (1y-bDFS). Recurrence was defined as a repeated prostate-specific antigen >0.2 ng/ml. Complications were graded according to the Clavien-Dindo system. The first 100 patients (group 1) were compared with the second 100 (group 2) to evaluate the learning curve effects.

RESULTS AND LIMITATIONS

The median patient age was 65 yr. Comparing the two groups, transfusions were needed in 8% versus 4% of cases in groups 1 and 2, respectively (p=0.02). There was one Clavien-Dindo grade 3b in group 1 versus one grade 3a complication in group 2. In patients with pT2 disease, PSMs were recorded in 22.4% of those in group 1 versus 10.1% in group 2 (p=0.045). 1y-bDFS was 89% in group 1 versus 92% in group 2. For groups 1 and 2, respectively, immediate continence was reached in 92% versus 90% of patients, and the 1-yr continence rate was 96% versus 96%. Considering the 77 potent patients aged <65 yr who underwent bilateral intrafascial nerve-sparing surgery, 40.4% of those in group 1 versus 40% of those in group 2 reached their first intercourse within 1 mo; at 1 yr of follow-up, these figures had increased to 81% versus 71%, respectively (p=0.162). The main limitation of this study is its noncontrolled nature.

CONCLUSIONS

We demonstrated Retzius-sparing RARP to be oncologically safe and to result in high early continence and potency rates. Long-term, prospective, comparative, and possibly randomized studies are needed.

摘要

背景

机器人辅助腹腔镜前列腺根治术(RARP)已成为治疗局限性前列腺癌的主要手术方法。我们最近开发了一种新的 RARP 方法,通过道格拉斯袋进入,避免了所有与控尿和保持勃起功能相关的耻骨后结构。

目的

报告我们使用这种新方法治疗的前 200 例患者的功能和肿瘤学结果。

设计、设置和参与者:这是一项前瞻性、非对照的病例系列研究,包括 200 例连续接受这种手术的患者(2010 年 1 月 1 日至 2011 年 12 月 31 日)。

手术步骤

保留耻骨后间隙的 RARP。

观察指标和统计分析

所有围手术期、肿瘤学和功能数据均前瞻性记录。勃起功能定义为国际勃起功能指数-5 问卷评分>17;控尿定义为不使用尿垫或仅使用一个安全衬垫。肿瘤学结果报告为阳性切缘(PSM)和 1 年生化无病生存率(1y-bDFS)。复发定义为前列腺特异性抗原再次>0.2ng/ml。并发症根据 Clavien-Dindo 系统分级。前 100 例患者(组 1)与后 100 例患者(组 2)进行比较,以评估学习曲线效应。

结果和局限性

中位患者年龄为 65 岁。比较两组患者,组 1 中有 8%的患者需要输血,而组 2 中有 4%的患者需要输血(p=0.02)。组 1 中有 1 例 Clavien-Dindo 3b 级并发症,而组 2 中有 1 例 3a 级并发症。在 pT2 疾病患者中,组 1 的 PSM 发生率为 22.4%,组 2 为 10.1%(p=0.045)。组 1 和组 2 的 1 年 bDFS 分别为 89%和 92%。对于组 1 和组 2,分别有 92%和 90%的患者术后即刻达到控尿,1 年控尿率分别为 96%和 96%。对于 77 名年龄<65 岁且接受双侧筋膜内神经保留手术的有勃起功能的患者,组 1 中有 40.4%的患者在 1 个月内恢复首次性交,而在 1 年随访时,这一比例分别增加到 81%和 71%(p=0.162)。本研究的主要局限性在于其非对照性质。

结论

我们证明保留耻骨后间隙的 RARP 在肿瘤学上是安全的,并且早期有较高的控尿和勃起功能恢复率。需要进行长期、前瞻性、对照和可能的随机研究。

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