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在瑞典 LAPPRO 试验中,24 个月随访时开放与机器人辅助根治性前列腺切除术的功能与肿瘤学结果。

Functional and Oncologic Outcomes Between Open and Robotic Radical Prostatectomy at 24-month Follow-up in the Swedish LAPPRO Trial.

机构信息

Department of Urology, Skåne University Hospital, Malmö, Sweden; Department of Translational Medicine, Division of Urological Cancers, Faculty of Medicine, Lund University, Sweden.

Institute of Clinical Sciences, Department of Urology, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden; Department of Urology, Sahlgrenska University Hospital, Gothenburg, Sweden.

出版信息

Eur Urol Oncol. 2018 Oct;1(5):353-360. doi: 10.1016/j.euo.2018.04.012. Epub 2018 Jun 11.

Abstract

BACKGROUND

The adoption of robot-assisted laparoscopic radical prostatectomy (RALP) has increased rapidly, despite lack of conclusive evidence of its superiority regarding long-term outcomes over open retropubic RP (RRP). In 2015, we reported on 12-mo follow-up from the LAPPRO trial showing a moderate advantage of RALP regarding erectile dysfunction. No significant differences were seen for urinary incontinence or surgical margin status.

OBJECTIVE

To present patient-reported functional outcomes and recurrent and residual disease at 24-mo follow-up from the prospective multicenter LAPPRO trial.

DESIGN, SETTING, AND PARTICIPANTS: A total of 4003 patients with clinically localized prostate cancer were recruited from 14 Swedish centers, seven performing RALP and seven RRP.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Data were only analyzed for patients operated on by surgeons with >100 prior RPs. Adjusted odds ratios (AORs) were calculated using logistic regression, with adjustment for differences in patient mix.

RESULTS AND LIMITATIONS

At 24 mo, there was a significant difference in erectile dysfunction in favor of RALP (68% vs 74%; AOR 0.72, 95% confidence interval [CI] 0.57-0.91; p=0.006). No significant difference was observed for incontinence (19% vs 16%; AOR 1.29, 95% CI 1.00-1.67; p=0.053) or recurrent or residual disease (13% vs 13%; AOR 0.79, 95% CI 0.59-1.07; p=0.13). We did not adjust for individual surgeon volume and experience, which is a potential limitation.

CONCLUSIONS

Extended follow-up corroborated our previous report at 12 mo of a persistent RALP benefit regarding potency.

PATIENT SUMMARY

LAPPRO is a Swedish trial comparing two different prostate cancer surgical techniques (robotic compared to open). At 24-mo follow-up after surgery there was a moderate advantage for the robotic technique regarding erectile dysfunction (potency), while there was a small but not significant difference in urinary leakage in favor of open surgery. We did not find any difference regarding cancer relapse.

摘要

背景

尽管机器人辅助腹腔镜根治性前列腺切除术(RALP)在长期结果方面是否优于开放式经耻骨后前列腺切除术(RRP)缺乏确凿证据,但它的采用迅速增加。2015 年,我们报告了 LAPPRO 试验的 12 个月随访结果,显示 RALP 在勃起功能障碍方面具有适度优势。尿失禁或手术切缘状态方面未见显著差异。

目的

介绍前瞻性多中心 LAPPRO 试验中,4003 例局限性前列腺癌患者的 24 个月随访时的患者报告性功能结果以及复发和残留疾病情况。

设计、地点和参与者:4003 例局限性前列腺癌患者来自瑞典 14 个中心,其中 7 个中心行 RALP,7 个中心行 RRP。

观察指标和统计分析

仅对手术医生具有>100 例 RRP 经验的患者进行数据分析。使用逻辑回归计算调整后的优势比(AOR),并根据患者人群的差异进行调整。

结果和局限性

24 个月时,RALP 在勃起功能障碍方面具有显著优势(68% vs 74%;AOR 0.72,95%置信区间 [CI] 0.57-0.91;p=0.006)。尿失禁方面未见显著差异(19% vs 16%;AOR 1.29,95% CI 1.00-1.67;p=0.053)或复发或残留疾病(13% vs 13%;AOR 0.79,95% CI 0.59-1.07;p=0.13)。我们没有调整个别外科医生的手术量和经验,这是一个潜在的局限性。

结论

扩展随访证实了我们之前在 12 个月时报告的结果,RALP 在勃起功能方面具有持久优势。

患者总结

LAPPRO 是一项瑞典试验,比较了两种不同的前列腺癌手术技术(机器人与开放式)。手术后 24 个月随访时,机器人技术在勃起功能(勃起功能)方面具有适度优势,而开放式手术在尿漏方面具有微小但无统计学意义的优势。我们没有发现任何与癌症复发相关的差异。

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