Initial Clinical Experience With a Novel Robotically Assisted Platform for Combined Mini-Percutaneous Nephrolithotomy and Flexible Ureteroscopic Lithotripsy.

IF 5.9 2区 医学 Q1 UROLOGY & NEPHROLOGY Journal of Urology Pub Date : 2024-09-01 Epub Date: 2024-08-08 DOI:10.1097/JU.0000000000004079
Jaime Landman, Ralph V Clayman, Andrei D Cumpanas, Roshan M Patel, Pengbo Jiang, Zachary E Tano, Sohrab N Ali, Nancy L Sehgel, Jacob W Caldwell, Chiara Gatti, William J Petraiuolo, Paul T Morris, Mihir M Desai
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Abstract

Purpose: We sought to evaluate the technical feasibility of performing a combined robotically assisted mini-percutaneous nephrolithotomy (PCNL) and flexible ureteroscopy (URS) procedure by a single urologist using the MONARCH Platform, Urology (Johnson & Johnson MedTech, Redwood City, California).

Material and methods: In this prospective, first-in-human clinical trial, 13 patients underwent robotically-assisted PCNL for renal calculi at the University of California-Irvine, Department of Urology. Successful completion of the procedure was assessed as the primary endpoint. Postoperative adverse events were monitored for 30 days following the completion of the procedure. Stone ablation efficiency was evaluated on postoperative day 30 with low-dose 2-3 mm slice CT scans. Patients were classified according to the maximum length of their residual stone fragments as either absolute stone-free (Grade A), < 2 mm remnants (Grade B), or 2.1-4.0 mm remnants (Grade C).

Results: The combined robotic mini-PCNL and URS procedure was successfully completed in 12 of 13 procedures. No robotic device-related adverse events occurred. Preoperative stone burden was quantified by both maximum linear measurement (median 32.8 mm) as well as by CT-based volume (median 1645.9 mm3). Using the unique robotically assisted targeting system, percutaneous access was gained directly through the center of the renal papilla in a single pass in all cases. Median operative time was 187 minutes (range: 83-383 minutes). On postoperative day 30, a 98.7% (range: 72.9%-100.0%) volume reduction was achieved, with 5 Grade A (38.5%), 1 Grade B (7.7%), and 2 Grade C (15.4%). Three patients experienced complications (2 grade 1 and one grade 2 Clavien-Dindo).

Conclusions: Our preliminary investigation demonstrates the safety, efficacy, and feasibility of a unique robotic-assisted combined mini-PCNL and URS platform.

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新型机器人辅助平台联合微型经皮肾镜碎石术和柔性输尿管镜碎石术的初步临床经验。
目的:我们试图评估由一名泌尿科医生使用 MONARCH 平台、泌尿外科(强生医疗技术公司,加利福尼亚州红木城)进行机器人辅助迷你经皮肾镜碎石术(PCNL)和柔性输尿管镜检查(URS)联合手术的技术可行性:在这项前瞻性的首次人体临床试验中,13 名患者在加州大学尔湾分校泌尿外科接受了机器人辅助 PCNL 治疗肾结石。成功完成手术是主要评估终点。在手术完成后的 30 天内,对术后不良事件进行监测。术后第30天,通过低剂量2-3毫米切片CT扫描评估结石消融效率。根据患者残留结石碎片的最大长度将其分为绝对无结石(A级)、残留量小于2毫米(B级)或残留量为2.1-4.0毫米(C级):13例手术中有12例成功完成了机器人迷你PCNL和URS联合手术。没有发生与机器人设备相关的不良事件。术前结石负荷通过最大线性测量值(中位数32.8毫米)和CT体积(中位数1645.9立方毫米)进行量化。使用独特的机器人辅助瞄准系统,所有病例都能直接通过肾乳头中心,一次性完成经皮取石。手术时间中位数为 187 分钟(范围:83-383 分钟)。术后第 30 天,体积缩小率为 98.7%(范围:72.9%-100.0%),其中 5 例为 A 级(38.5%),1 例为 B 级(7.7%),2 例为 C 级(15.4%)。3名患者出现并发症(2例1级,1例2级Clavien-Dindo):我们的初步研究证明了独特的机器人辅助微型 PCNL 和 URS 联合平台的安全性、有效性和可行性。
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来源期刊
Journal of Urology
Journal of Urology 医学-泌尿学与肾脏学
CiteScore
11.50
自引率
7.60%
发文量
3746
审稿时长
2-3 weeks
期刊介绍: The Official Journal of the American Urological Association (AUA), and the most widely read and highly cited journal in the field, The Journal of Urology® brings solid coverage of the clinically relevant content needed to stay at the forefront of the dynamic field of urology. This premier journal presents investigative studies on critical areas of research and practice, survey articles providing short condensations of the best and most important urology literature worldwide, and practice-oriented reports on significant clinical observations.
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