Early clinical evaluation of the Hugo robotic-assisted surgery (RAS) for performing radical prostatectomy: an IDEAL stage 2 study.

IF 2.1 Q2 SURGERY
BMJ Surgery Interventions Health Technologies Pub Date : 2025-04-05 eCollection Date: 2025-01-01 DOI:10.1136/bmjsit-2024-000360
Andrew Shepherd, Ata Jaffer, Angus Bruce, Daniel Chia, Prokar Dasgupta, Ben Challacombe
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Abstract

Objectives: To assess the feasibility and safety of the new Hugo robotic-assisted surgery (RAS) system for robotic-assisted radical prostatectomy (RARP), describing iterative changes in our operative technique-IDEAL stage 2.

Design: Prospective, single-centre series.

Setting: Tertiary urological unit in London, UK.

Participants: Male patients diagnosed with clinically localised prostate cancer and suitable for RARP from February 2023 to May 2024.

Main outcome measures: The primary outcome was to assess the safety of using the device without converting to the existing robotic platform (da Vinci), laparoscopy or open. Secondary outcomes assessed surgical (operative time, blood loss, time to catheter removal, complications), oncologic (surgical pathology and margin status) and early functional (continence) outcomes.

Results: 50 patients were included in the study. No cases required conversion to an existing robotic platform, laparoscopy or open, and there were no intraoperative surgical complications. Mean age was 60 years and mean prostate-specific antigen was 12.2 ng/mL. The mean operative time was 148 min and estimated blood loss was 168 mL. Mean length of stay was 1.5 days and mean length of catheter duration was 13 days. On final pathology, 18 patients (36%) had T3 disease and four had positive surgical margins (8%). The mean International Consultation on Incontinence Questionnaire-Urinary Incontinence score for urinary continence at 3 months was 7. There were six Clavien-Dindo grade 2 complications and two Clavien-Dindo 3a complications. There were four instances of recoverable, temporary device failure. Iterative improvements were made to docking setup, use of robotic instruments and reduction in robotic arm collisions.

Conclusions: We demonstrated feasibility and the safe introduction of the Hugo RAS for RARP into an experienced robotic urological programme. Perioperative, early oncological and functional outcomes were similar to other early series. Further studies will aim to describe the learning curve with this robot and optimisation of surgical quality.

Hugo机器人辅助手术(RAS)进行根治性前列腺切除术的早期临床评估:一项IDEAL 2期研究。
目的:评估新型Hugo机器人辅助手术(RAS)系统用于机器人辅助根治性前列腺切除术(RARP)的可行性和安全性,描述我们的手术技术- ideal 2期的迭代变化。设计:前瞻性单中心研究。地点:英国伦敦第三泌尿科。受试者:2023年2月至2024年5月诊断为临床局限性前列腺癌且适合RARP的男性患者。主要结局指标:主要结局是评估在不转换到现有机器人平台(达芬奇)、腹腔镜或开放式的情况下使用该装置的安全性。次要结果评估了手术(手术时间、出血量、拔管时间、并发症)、肿瘤(手术病理和切缘状态)和早期功能(失禁)结果。结果:50例患者纳入研究。没有病例需要转换到现有的机器人平台,腹腔镜或开放,并且没有术中手术并发症。平均年龄60岁,平均前列腺特异性抗原为12.2 ng/mL。平均手术时间为148 min,估计失血量为168 mL。平均住院时间为1.5天,平均置管时间为13天。在最终病理中,18例患者(36%)有T3疾病,4例手术切缘阳性(8%)。国际尿失禁咨询问卷-尿失禁3个月时尿失禁的平均得分为7分。Clavien-Dindo 2级并发症6例,3a级并发症2例。有四个可恢复的临时设备故障实例。对对接设置、机器人仪器的使用和减少机械臂碰撞进行了迭代改进。结论:我们证明了在经验丰富的机器人泌尿外科项目中引入Hugo RAS治疗RARP的可行性和安全性。围手术期、早期肿瘤和功能结果与其他早期系列相似。进一步的研究将旨在描述该机器人的学习曲线和优化手术质量。
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来源期刊
CiteScore
2.80
自引率
0.00%
发文量
22
审稿时长
17 weeks
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