Urology Unit, Department of Surgery, Dentistry, Pediatrics and Gynecology, University of Verona, A.O.U.I. Verona, Verona, Italy -
Urology Unit, Department of Surgery, Dentistry, Pediatrics and Gynecology, University of Verona, A.O.U.I. Verona, Verona, Italy.
Minerva Urol Nephrol. 2024 Oct;76(5):596-605. doi: 10.23736/S2724-6051.24.05928-7.
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.
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.
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.
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.
本研究旨在前瞻性比较使用 Hugo RAS 和 da Vinci Xi 系统进行机器人辅助根治性前列腺切除术(RARP)的结果,重点关注术后过程、病理发现和与健康相关的生活质量。
COMPAR-P 试验是一项前瞻性的上市后研究(clinical-trials.org NCT05766163),于 2023 年 3 月开始,在没有选择标准的情况下,为每个系统招募多达 50 例连续病例的患者进行 RARP。两名经验丰富的控制台外科医生根据标准化技术进行手术。该研究使用 SF-36 和加利福尼亚大学洛杉矶前列腺癌指数问卷评估了达芬奇与 Hugo RAS 之间在术后过程、病理发现、30 天 PSA 值、功能指标和与健康相关的生活质量方面的差异。
50 例患者分别接受了达芬奇和 Hugo RARP。两组之间术后并发症、病理数据和生活质量指标无显著差异。值得注意的局限性包括对前 50 例 Hugo RARP 和后 50 例达芬奇 RARP 病例的比较,以及外科医生专业知识对研究结果普遍性的潜在影响。
这项对 100 例接受达芬奇或 Hugo RAS 系统 RARP 的未选择患者进行的前瞻性研究显示,术后过程、病理学、功能指标和与健康相关的生活质量结果相似。然而,需要进一步进行更大样本量、更长随访期和更多样化的外科专业知识的研究,以验证这些发现,并更好地理解其对临床实践的影响。