机器人辅助腹腔镜前列腺切除术与开放性耻骨后根治性前列腺切除术的围手术期、肿瘤学及功能结局：一项随机临床试验
Perioperative, Oncological, and Functional Outcomes Between Robot-Assisted Laparoscopic Prostatectomy and Open Radical Retropubic Prostatectomy: A Randomized Clinical Trial.
作者信息
Nahas William Carlos, Rodrigues Gilberto José, Rodrigues Gonçalves Fabio Augusto, Sawczyn Guilherme Vinícius, Barros Guilherme Garcia, Cardili Leonardo, Guglielmetti Giuliano Betoni, Fazoli Arnaldo José De Carvalho, Cordeiro Maurício Dener, Cassão Valter Dell Acqua, Chade Daher Cesar, Neves De Oliveira Luiz Carlos, Murta Cláudio Bovolenta, Pontes Júnior José, Trindade Evelinda Marramon, Bastos Diogo Assed, Sarkis Alvaro Sadek, Mitre Anuar Ibrahim, Trinh Quoc-Dien, Coelho Rafael Ferreira
机构信息
Urologia, Instituto do Cancer do Estado de São Paulo Octavio Frias de Oliveira, Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Laboratorio de Investigacao Medica, Hospital da Clinicas, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
出版信息
J Urol. 2024 Jul;212(1):32-40. doi: 10.1097/JU.0000000000003967. Epub 2024 May 9.
PURPOSE
Limited high-quality studies have compared robot-assisted laparoscopic prostatectomy (RALP) vs open retropubic radical prostatectomy. We sought to compare their postoperative outcomes in a randomized setting.
MATERIALS AND METHODS
In a single center, 354 men with newly diagnosed prostate cancer were assessed for eligibility; 342 were randomized (1:1). The primary outcome was 90-day complication rates. Functional outcomes and quality of life were assessed over 18 months, and oncological outcomes, biochemical recurrence-free survival, and additional treatment over 36 months.
RESULTS
From 2014 to 18, 327 patients underwent surgery (retropubic radical prostatectomy = 156, RALP = 171). Complications occurred in 27 (17.3%) vs 19 (11.1%; = .107). Patients undergoing RALP experienced lower median bleeding (250.0 vs 719.5 mL; < .001) and shorter hospitalization time. Urinary EPIC (Expanded Prostate Cancer Index Composite) median scores were better for RALP over 18 months, with higher continence rate at 3 months (80.5% vs 64.7%; = .002), 6 months (90.1% vs 81.6%; = .036) and 18 months (95.4% vs 78.8%; < .001). Sexual EPIC and Sexual Health Inventory for Men median scores were higher with RALP up to 12 months, while the potency rate was superior at 3 months (23.9% vs 5.3%; = .001) and 6 months (30.6% vs 6.9%; < .001). Quality of life over the 18 months and oncological outcomes over 36 months were not significantly different between arms.
CONCLUSIONS
Complications at 90 days were similar. RALP showed superior sexual outcomes at 1 year, improved urinary outcomes at 18 months, and comparable oncological outcomes at 36 months.
TRIAL REGISTRATION
Prospective Analysis of Robot-Assisted Surgery; NCT02292914. https://clinicaltrials.gov/ct2/show/NCT02292914?cond=NCT02292914&draw=2&rank=1.
目的
比较机器人辅助腹腔镜前列腺切除术（RALP）与开放性耻骨后根治性前列腺切除术的高质量研究有限。我们试图在随机对照的情况下比较它们的术后结果。
材料与方法
在一个中心，对354例新诊断为前列腺癌的男性进行资格评估；342例被随机分组（1:1）。主要结局是90天并发症发生率。在18个月内评估功能结局和生活质量，在36个月内评估肿瘤学结局、无生化复发生存率和额外治疗情况。
结果
2014年至2018年，327例患者接受了手术（耻骨后根治性前列腺切除术=156例，RALP=171例）。并发症发生率分别为27例（17.3%）和19例（11.1%；P=0.107）。接受RALP的患者术中出血中位数较低（250.0 vs 719.5 mL；P<0.001），住院时间较短。在18个月内，RALP组的尿扩展前列腺癌指数综合评分（EPIC）中位数更高，在3个月（80.5% vs 64.7%；P=0.002）、6个月（90.1% vs 81.6%；P=0.036）和18个月（95.4% vs 78.8%；P<0.001）时的控尿率更高。在长达12个月的时间里，RALP组的性EPIC评分和男性性健康量表评分中位数更高，在3个月（23.9% vs 5.3%；P= .001）和6个月（30.6% vs 6.9%；P<0.001）时的勃起功能恢复率更高。两组在18个月内的生活质量和36个月内的肿瘤学结局无显著差异。
结论
90天的并发症发生率相似。RALP在1年时显示出更好的性功能结局，在18个月时改善了排尿结局，在36个月时肿瘤学结局相当。
试验注册
机器人辅助手术前瞻性分析；NCT02292914。https://clinicaltrials.gov/ct2/show/NCT02292914?cond=NCT02292914&draw=2&rank=1 。
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