达芬奇®前列腺癌根治术与雨果RAS®前列腺癌根治术的疗效:100例连续病例的术后过程、病理结果以及患者与健康相关的生活质量(COMPAR-P前瞻性试验)。

IF 4.9 2区 医学 Q1 UROLOGY & NEPHROLOGY Minerva Urology and Nephrology Pub Date : 2024-10-01 DOI:10.23736/S2724-6051.24.05928-7
Alessandro Antonelli, Alessandro Veccia, Sarah Malandra, Riccardo Rizzetto, Francesco Artoni, Piero Fracasso, Francesca Fumanelli, Iolanda Palumbo, Antonio Raiti, Luca Roggero, Lorenzo P Treccani, Vincenzo Vetro, Vincenzo DE Marco, Antonio B Porcaro, Maria A Cerruto, Matteo Brunelli, Riccardo Bertolo
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引用次数: 0

摘要

研究背景本研究旨在前瞻性比较使用Hugo RAS和达芬奇Xi系统进行机器人辅助前列腺癌根治术(RARP)的疗效,重点关注术后过程、病理结果以及与健康相关的生活质量:COMPAR-P试验是一项上市后前瞻性研究(clinical-trials.org NCT05766163),于2023年3月开始,招募使用达芬奇或Hugo RAS进行RARP手术的患者,不设选择标准,每个系统最多可连续进行50例手术。两名经验丰富的控制台外科医生按照标准化技术进行手术。研究使用 SF-36 和加州大学洛杉矶分校前列腺癌指数问卷评估了达芬奇和雨果 RAS 在术后过程、病理结果、30 天 PSA 值、功能指标和健康相关生活质量方面的差异:结果:50名患者分别接受了DV-RARP和H-RARP手术。两组患者的术后并发症、病理数据和生活质量指标无明显差异。值得注意的局限性包括前50例H-RARP和后50例DV-RARP之间的比较,以及外科医生的专业知识对研究结果普遍性的潜在影响:这项前瞻性研究选取了100名未经筛选的患者,通过达芬奇或雨果RAS系统进行了RARP手术,结果显示,他们在术后病程、病理、功能指标和健康相关生活质量方面都具有可比性。不过,要验证这些发现并更好地理解其对临床实践的影响,还必须进行样本量更大、随访时间更长、手术专家更多样化的进一步研究。
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Outcomes of da Vinci® versus Hugo RAS® radical prostatectomy: focus on postoperative course, pathological findings, and patients' health-related quality of life after 100 consecutive cases (the COMPAR-P prospective trial).

Background: This study aims to prospectively compare the outcomes of robot-assisted radical prostatectomy (RARP) performed using the Hugo RAS and da Vinci Xi systems, focusing on the postoperative course, pathological findings, and health-related quality of life.

Methods: The COMPAR-P trial, a prospective post-market study (clinical-trials.org NCT05766163), commenced in March 2023, enrolling patients for RARP performed with either da Vinci or Hugo RAS without selection criteria for up to 50 consecutive cases per system. Two experienced console surgeons performed the procedures according to a standardized technique. The study evaluated differences between da Vinci and Hugo RAS regarding the postoperative course, pathology findings, 30-day PSA value, functional metrics, and health-related quality of life using SF-36 and University of California Los Angeles Prostate Cancer Index questionnaires.

Results: Fifty patients underwent DV-RARP and H-RARP each. Postoperative complications, pathological data, and quality of life metrics did not significantly differ between the groups. Noteworthy limitations include the comparison between the first 50 H-RARP and last 50 DV-RARP cases, as well as the potential influence of surgeons' specialized expertise on the generalizability of findings.

Conclusions: This prospective study of 100 unselected patients undergoing RARP with either da Vinci or Hugo RAS systems reveals comparable outcomes in postoperative course, pathology, functional metrics, and health-related quality of life. However, further research with larger sample sizes, longer follow-up periods, and diverse surgical expertise is essential to validate these findings and better understand the implications for clinical practice.

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来源期刊
Minerva Urology and Nephrology
Minerva Urology and Nephrology UROLOGY & NEPHROLOGY-
CiteScore
8.50
自引率
32.70%
发文量
237
期刊最新文献
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