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基于注册登记的使用Versius机器人手术系统进行的泌尿外科手术改良IDEAL 2b期评估。

A registry-based modified IDEAL stage 2b evaluation of urological procedures performed using the versius robotic surgical system.

作者信息

Jaffer Ata, Chia Daniel, Rai Sonpreet, Veer Sachin, Gallagher Kevin, Aldiwani Mohammed, Hussain Muddassar, Nakhuda Sohail, Reeves Farleigh, Rane Abhay, Ourselin Sebastian, McNeill Alan, Challacombe Ben, Dasgupta Prokar

机构信息

Guy's and St Thomas' Hospital, London, UK.

Milton Keynes University Hospital, Milton Keynes, UK.

出版信息

J Robot Surg. 2025 May 26;19(1):240. doi: 10.1007/s11701-025-02324-2.

Abstract

The IDEAL stage 1/2a study demonstrated feasibility of the use of the Versius robotic platform at a single institution. This multi-center collaborative modified stage 2b study adds wider exploration assessing surgical, oncologic and functional outcomes in patients undergoing urological procedures with the Versius. Data were collected from a prospective registry. Surgical outcomes were cross-checked from electronic patient records held at each hospital included in the study. All UK-based centers performing urological procedures using the Versius robot. All patients who underwent a robotic procedure using the Versius robot since inception to Jan 2023. Five UK hospitals have undertaken a total of 70 urological procedures using the Versius (Table 1). Device failure occurred in one of the cases requiring conversion to laparoscopy and a further case required conversion to open due to intra-operative complication (2/70, 2.9%). One positive margin was observed in a robotic prostatectomy patient (12.5%). Immediate continence was achieved in 4 of 8 (50%) after prostatectomy. Eight patients (11.4%) had complications within 30 days, and three were Clavien-Dindo class 3 and one class 4. A range of urological procedures were shown to be feasible and safe using the Versius across multiple sites.

摘要

IDEAL 1/2a期研究证明了在单一机构使用Versius机器人平台的可行性。这项多中心协作的改良2b期研究进行了更广泛的探索,评估了使用Versius进行泌尿外科手术的患者的手术、肿瘤学和功能结果。数据来自前瞻性登记处。手术结果通过研究中纳入的每家医院保存的电子患者记录进行交叉核对。所有英国的中心都使用Versius机器人进行泌尿外科手术。所有自开始使用Versius机器人至2023年1月接受机器人手术的患者。英国五家医院共使用Versius进行了70例泌尿外科手术(表1)。其中1例因设备故障需要转为腹腔镜手术,另有1例因术中并发症需要转为开放手术(2/70,2.9%)。1例机器人前列腺切除术患者切缘阳性(12.5%)。前列腺切除术后8例中有4例(50%)立即实现了控尿。8例患者(11.4%)在30天内出现并发症,其中3例为Clavien-Dindo 3级,1例为4级。多项研究表明,在多个地点使用Versius进行一系列泌尿外科手术是可行且安全的。

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