研究动态
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da Vinci® 与 Hugo RAS® 根治性前列腺切除术的结果:重点关注 100 例连续病例后的术后病程、病理结果以及患者的健康相关生活质量(COMPAR-P 前瞻性试验)。

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).

发表日期:2024 Oct
作者: 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,
来源: Minerva Urology and Nephrology

摘要:

本研究旨在前瞻性比较使用 Hugo RAS 和达芬奇 Xi 系统进行的机器人辅助根治性前列腺切除术 (RARP) 的结果,重点关注术后病程、病理结果和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,招募患者接受使用达芬奇或 Hugo RAS 进行的 RARP,每个系统最多 50 个连续病例的选择标准。两名经验丰富的控制台外科医生根据标准化技术进行了手术。该研究使用 SF-36 和加州大学洛杉矶分校前列腺癌指数调查问卷评估了达芬奇和 Hugo RAS 在术后病程、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。 50患者分别接受了 DV-RARP 和 H-RARP。术后并发症、病理数据和生活质量指标在各组之间没有显着差异。值得注意的局限性包括前 50 个 H-RARP 和最后 50 个 DV-RARP 病例之间的比较,以及外科医生的专业知识对研究结果的普遍性的潜在影响。这项前瞻性研究对 100 名未经选择的患者进行了达芬奇 RARP 治疗或 Hugo RAS 系统揭示了术后病程、病理学、功能指标和健康相关生活质量的可比结果。然而,更大的样本量、更长的随访期和多样化的外科专业知识的进一步研究对于验证这些发现并更好地理解对临床实践的影响至关重要。
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.