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神经血管结构相邻冰冻切片检查与标准机器人辅助根治性前列腺切除术:关于功能和肿瘤学结局的双臂比较研究的系统评价和荟萃分析

Neurovascular structure-adjacent frozen-section examination vs. standard robot-assisted radical prostatectomy: a systematic review and meta-analysis of two-arm comparative studies on functional and oncological outcomes.

作者信息

Lv Tingxuan, Chen Xiaowan, Zhang Xiaoyan, Yuan Bolin, Zhang Baolin, Wang Long, Han Xiurui

机构信息

Department of Urology, Affiliated Hospital of Shandong Second Medical University, School of Clinical Medicine, Shandong Second Medical University, Weifang, China.

Department of Anesthesiology and Surgery, Shengli Oilfield Central Hospital, Dongying, China.

出版信息

J Robot Surg. 2025 Jun 24;19(1):321. doi: 10.1007/s11701-025-02486-z.

Abstract

The precise balance between nerve preservation and tumor control during robot-assisted prostatectomy remains a clinical challenge. The NeuroSAFE technique can guide secondary resection through intraoperative real-time frozen pathology, but its overall value for perioperative safety and oncological and functional prognosis is still a matter of debate. The objective of this study was to carry out a systematic evaluation of the impact of NeuroSAFE technology on perioperative safety and functional and oncological outcomes. In accordance with the PRISMA guidelines, a comprehensive search of the PubMed, Web of Science, and Cochrane Library databases was conducted, with a cutoff date of April 2025. NeuroSAFE technology was comprehensively evaluated from the perspectives of oncology, functionality, and perioperative safety. This meta-analysis included 14 studies (2 randomized controlled trials, 12 non-randomized studies; sample size = 26,442), in which a total of 14,458 patients underwent NeuroSAFE robot-assisted radical prostatectomy (RARP) and 11,984 patients underwent standard RARP. NeuroSAFE significantly reduced the rate of positive surgical margins (OR: 0.59, 95% CI: 0.59-0.87, p < 0.001) and the PSA persistence rate (OR: 0.52, 95% CI: 0.05-5.64, p < 0.05) while also reducing the 2-year biochemical recurrence rate (OR: 0.81, 95% CI: 0.45-1.45). The functional outcomes revealed that NeuroSAFE demonstrated superiority in preserving the neurovascular bundle (OR: 3.86, 95% CI: 1.56-9.58, p < 0.001) and improving postoperative erectile function (OR: 2.40, 95% CI: 1.65-3.50, p < 0.05) but no significant advantage in urinary control (OR: 1.49, 95% CI: 1.07-2.09, p > 0.05). During the perioperative period, NeuroSAFE prolonged the surgical time (mean difference: + 22.84 min, p < 0.001) but did not increase the incidence of serious adverse events (3% vs. 3% SAEs). Rare complications included, among other events, one death due to cecal rupture. Our meta-analysis confirmed that the NeuroSAFE technique offers advantages over standard RARP in terms of tumor control, functional preservation, and nerve preservation rates without increasing the incidence of severe postoperative adverse events. Although this technique prolongs the surgical time, its overall advantages are evident. Its long-term efficacy and safety require validation through multicenter, large-sample randomized controlled trials.

摘要

在机器人辅助前列腺切除术中,神经保留与肿瘤控制之间的精确平衡仍是一项临床挑战。NeuroSAFE技术可通过术中实时冷冻病理指导二次切除,但其对围手术期安全性、肿瘤学及功能预后的整体价值仍存在争议。本研究的目的是对NeuroSAFE技术对围手术期安全性、功能及肿瘤学结局的影响进行系统评价。按照PRISMA指南,对PubMed、Web of Science和Cochrane图书馆数据库进行了全面检索,截止日期为2025年4月。从肿瘤学、功能和围手术期安全性的角度对NeuroSAFE技术进行了全面评估。这项荟萃分析纳入了14项研究(2项随机对照试验,12项非随机研究;样本量=26,442),其中共有14,458例患者接受了NeuroSAFE机器人辅助根治性前列腺切除术(RARP),11,984例患者接受了标准RARP。NeuroSAFE显著降低了手术切缘阳性率(OR:0.59,95%CI:0.59 - 0.87,p<0.001)和PSA持续率(OR:0.52,95%CI:0.05 - 5.64,p<0.05),同时也降低了2年生化复发率(OR:0.81,95%CI:0.45 - 1.45)。功能结局显示,NeuroSAFE在保留神经血管束(OR:3.86,95%CI:1.56 - 9.58,p<0.001)和改善术后勃起功能(OR:2.40, 95%CI:1.65 - 3.50,p<0.05)方面表现出优势,但在控尿方面无显著优势(OR:1.49,95%CI:1.07 - 2.09,p>0.05)。在围手术期,NeuroSAFE延长了手术时间(平均差值:+22.84分钟,p<0.001),但未增加严重不良事件的发生率(严重不良事件发生率为3%对3%)。罕见并发症包括,除其他事件外,1例因盲肠破裂死亡。我们的荟萃分析证实,NeuroSAFE技术在肿瘤控制、功能保留和神经保留率方面优于标准RARP,且不增加术后严重不良事件的发生率。虽然该技术延长了手术时间,但其总体优势明显。其长期疗效和安全性需要通过多中心、大样本随机对照试验进行验证。

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