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一项在病例数有限的中心内,对连续的开放性经耻骨后前列腺切除术和机器人辅助腹腔镜根治性前列腺切除术进行的前瞻性比较试验。

A prospective trial comparing consecutive series of open retropubic and robot-assisted laparoscopic radical prostatectomy in a centre with a limited caseload.

机构信息

Klinik für Urologie, Luzerner Kantonsspital, Lucerne, Switzerland.

出版信息

Eur Urol. 2011 Jan;59(1):1-6. doi: 10.1016/j.eururo.2010.10.026. Epub 2010 Oct 21.

DOI:10.1016/j.eururo.2010.10.026
PMID:21035248
Abstract

BACKGROUND

Robot-assisted radical prostatectomy (RALP) is performed worldwide, even in institutions with limited caseloads. However, although the results of large RALP series are available, oncologic and functional outcomes as well as complications from low-caseload centres are lacking.

OBJECTIVE

To compare perioperative, oncologic, and functional outcomes from two consecutive series of patients with localised prostate cancer treated by retropubic radical prostatectomy (RRP) or recently established RALP in our hospital, which has a limited caseload.

DESIGN, SETTING, AND PARTICIPANTS: One hundred fifty consecutive patients were enrolled. Their data and outcomes were collected and extensively evaluated.

INTERVENTION

Seventy-five consecutive patients underwent RRP, and 75 consecutive patients underwent RALP, including all patients of the learning curve.

MEASUREMENTS

Patient baseline characteristics, perioperative and postoperative outcomes, and complications were evaluated. End points were oncologic data (positive margins, prostate-specific antigen [PSA]), perioperative complications, urinary continence, and erectile function at 3- and 12-mo follow-up.

RESULTS AND LIMITATIONS

The preoperative parameters from the two groups were comparable. The positive surgical margin (PSM) rates were 32% for RRP and 16% for RALP (p=0.002). For RRP and RALP, the PSA value was <0.2 ng/ml in 91% and 88% of patients 3 mo postoperatively (p=0.708) and in 87% and 89% of patients 12 mo postoperatively (p=0.36), respectively. Continence rates for RRP and RALP were 83% and 95% at 3-mo follow-up (p=0.003) and 80% and 89% after 12-mo follow-up (p=0.092), respectively. Among patients who were potent without phosphodiesterase type 5 inhibitors (PDE5-I) before RRP and RALP, recovery of erectile function with and without PDE5-Is was achieved in 25% (12 of 49 patients) and 68% (25 of 37 patients) 3 mo postoperatively (p=0.009) and in 26% (12 of 47 patients) and 55% (12 of 22 patients) 12 mo postoperatively (p=0.009), respectively. Minimal follow-up for RRP was 12 mo; median follow-up for the RALP group was 12 mo (range: 3-12). According to the modified Clavien system, major complication rates for RRP and RALP were 28% and 7% (p=0.025), respectively; minor complication rates were 24% and 35% (p=0.744), respectively.

CONCLUSIONS

Despite a limited caseload and including the learning curve, RALP offers slightly better results than RRP in terms of PSM, major complications, urinary continence, and erectile function.

摘要

背景

机器人辅助根治性前列腺切除术(RALP)在全球范围内开展,即使在病例量有限的机构也是如此。然而,尽管有大量的 RALP 系列结果,但低病例量中心的肿瘤学和功能结果以及并发症仍缺乏相关数据。

目的

比较本医院连续两批接受经耻骨后根治性前列腺切除术(RRP)或最近建立的 RALP 治疗的局限性前列腺癌患者的围手术期、肿瘤学和功能结果,本医院的病例量有限。

设计、设置和参与者:共纳入 150 例连续患者。收集并广泛评估了他们的数据和结果。

干预措施

75 例连续患者接受 RRP,75 例连续患者接受 RALP,包括学习曲线中的所有患者。

测量

评估患者的基线特征、围手术期和术后结果以及并发症。终点是肿瘤学数据(阳性切缘、前列腺特异性抗原[PSA])、围手术期并发症、尿控和勃起功能在 3 个月和 12 个月随访时的情况。

结果和局限性

两组的术前参数具有可比性。RRP 的阳性切缘(PSM)率为 32%,RALP 为 16%(p=0.002)。对于 RRP 和 RALP,术后 3 个月时 PSA 值<0.2ng/ml 的患者分别为 91%和 88%(p=0.708),术后 12 个月时分别为 87%和 89%(p=0.36)。RRP 和 RALP 的控尿率在 3 个月随访时分别为 83%和 95%(p=0.003),在 12 个月随访时分别为 80%和 89%(p=0.092)。在接受 RRP 和 RALP 治疗前未使用磷酸二酯酶 5 抑制剂(PDE5-I)的有勃起功能的患者中,术后 3 个月时分别有 25%(49 例患者中的 12 例)和 68%(37 例患者中的 25 例)恢复勃起功能(p=0.009),术后 12 个月时分别有 26%(47 例患者中的 12 例)和 55%(22 例患者中的 12 例)恢复勃起功能(p=0.009)。RRP 的最短随访时间为 12 个月;RALP 组的中位随访时间为 12 个月(范围:3-12 个月)。根据改良 Clavien 系统,RRP 和 RALP 的主要并发症发生率分别为 28%和 7%(p=0.025),次要并发症发生率分别为 24%和 35%(p=0.744)。

结论

尽管病例量有限,包括学习曲线在内,RALP 在 PSM、主要并发症、尿控和勃起功能方面的结果略优于 RRP。

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