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新型一次性输尿管镜的初步经验:Axis输尿管镜的前瞻性单臂90天试验

Initial Experience with Novel Single-Use Disposable Ureteroscopy: A Prospective, Single Arm 90-Day Trial of the Axis Ureteroscope.

作者信息

Large Tim, Rivera Marcelino, Nottingham Charles, Agarwal Deepak, Mellon Matthew, Krambeck Amy

机构信息

Department of Urology, Indiana University, Indianapolis, Indiana.

出版信息

Urol Pract. 2021 Mar;8(2):196-202. doi: 10.1097/UPJ.0000000000000194. Epub 2020 Sep 4.

DOI:10.1097/UPJ.0000000000000194
PMID:37145609
Abstract

INTRODUCTION

Novel digital disposable ureteroscopes are becoming more commonplace in endourological practices. We trialed the Axis™ single-use ureteroscope, which is distributed within the United States by Dornier MedTech. Our goal was to demonstrate clinical equivalence to our reusable platform and to evaluate the cost-effectiveness of a single-use digital ureteroscope.

METHODS

We conducted a prospective 90-day trial where all flexible ureteroscopic procedures were completed using the single-use ureteroscope. The cases were monitored for scope failure, scope deficiencies and surgeon satisfaction scores via an immediate postoperative REDCap® survey. We also performed a cost analysis between reusable scopes and the single-use ureteroscope. The cost of the reusable platform included the amortized initial purchase, maintenance and clean processing.

RESULTS

Over a 90-day period, we performed 93 flexible ureteroscopy procedures with a single-use ureteroscope, of which 74 were completed using Axis. After controlling for operating room time and disposable items used, the utilization of Axis was associated with an average reduction of $140.31 per case. Extrapolating the per-case savings over an annual case volume, we estimate a total savings of $56,127.15. There were no disposable scope malfunctions. There were 4 (4.3%) cases converted to reusable scopes due to image quality (1), inadequate secondary deflection (2) and a tight ureter (1). Mean±SD score for image quality, mobility and ergonomics was 9.1±1.1, 8.9±1.1, 9.3±1.1, respectively. The 90-day complication rates were equal to our controls.

CONCLUSIONS

We demonstrated that the Axis single-use digital ureteroscope is equivalent in function to our digital reusable scope and reduced the cost of flexible ureteroscopy.

摘要

引言

新型数字式一次性输尿管镜在腔内泌尿外科手术中越来越常见。我们试用了由多尼尔医疗技术公司在美国销售的Axis™一次性输尿管镜。我们的目标是证明其与我们的可重复使用平台具有临床等效性,并评估一次性数字输尿管镜的成本效益。

方法

我们进行了一项为期90天的前瞻性试验,所有软性输尿管镜检查程序均使用一次性输尿管镜完成。通过术后立即进行的REDCap®调查监测病例的镜体故障、镜体缺陷和外科医生满意度评分。我们还对可重复使用的输尿管镜和一次性输尿管镜进行了成本分析。可重复使用平台的成本包括分摊的初始购买成本、维护成本和清洁处理成本。

结果

在90天的时间里,我们使用一次性输尿管镜进行了93例软性输尿管镜检查手术,其中74例使用Axis完成。在控制手术室时间和使用的一次性物品后,使用Axis的成本平均每例降低140.31美元。将每例节省的费用推算到年度病例数量上,我们估计总共节省56,127.15美元。没有一次性输尿管镜出现故障。有4例(4.3%)因图像质量问题(1例)、二级偏转不足(2例)和输尿管狭窄(1例)而改用可重复使用的输尿管镜。图像质量、灵活性和人体工程学的平均±标准差评分分别为9.1±1.1、8.9±1.1、9.3±1.1。90天的并发症发生率与我们的对照组相同。

结论

我们证明了Axis一次性数字输尿管镜在功能上与我们的数字可重复使用输尿管镜等效,并降低了软性输尿管镜检查的成本。

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