Department of Urology and Pediatric Urology, University Medical Center Mainz, Langenbeckstr. 1, 55131, Mainz, Germany.
Urolithiasis. 2018 Nov;46(6):587-593. doi: 10.1007/s00240-018-1042-1. Epub 2018 Jan 22.
The purpose of this study is to analyze clinical outcomes and costs of single-use flexible ureterorenoscopes in comparison with reusable flexible ureterorenoscopes in a tertiary referral center. Prospectively, 68 flexible ureterorenoscopies utilizing reusable (Flex-X2S, Flex-X, Karl Storz) and 68 applying single-use flexible ureterorenoscopes (LithoVue, Boston Scientific) were collected. Clinical outcome parameters such as overall success rate, complication rates according to Clavien-Dindo, operation time and radiation exposure time were measured. Cost analysis was based on purchase costs and recurrent costs for repair and reprocessing divided by number of procedures. In each group 68 procedures were available for evaluation. In 91% of reusable and 88% of single-use ureterorenoscopies stone disease was treated with a mean stone burden of 101 ± 226 and 90 ± 244 mm and lower pole involvement in 47 and 41%, respectively (p > 0.05). Comparing clinical outcomes of reusable vs. single-use instruments revealed no significant difference for overall success rates (81 vs. 87%), stone-free rates (82 vs. 85%), operation time (76.2 ± 46.8 vs. 76.8 ± 40.2 min), radiation exposure time (3.83 ± 3.15 vs. 3.93 ± 4.43 min) and complication rates (7 vs. 17%) (p > 0.05). A wide range of repair and purchase costs resulted in total to $1212-$1743 per procedure for reusable ureterorenoscopy whereas price of single-use ureterorenoscopy was $1300-$3180 per procedure. The current work provided evidence for equal clinical effectiveness of reusable and single-use flexible ureterorenoscopes. Partially overlapping ranges of costs for single-use and reusable scopes stress the importance to precisely know the expenses and caseload when negotiating purchase prices, repair prices and warranty conditions.
本研究旨在分析在三级转诊中心,单次使用的软性输尿管镜与可重复使用的软性输尿管镜在临床结果和成本方面的差异。前瞻性地收集了 68 例使用可重复使用的软性输尿管镜(Flex-X2S、Flex-X、Karl Storz)和 68 例使用单次使用软性输尿管镜(LithoVue、Boston Scientific)的软性输尿管镜检查。测量了总体成功率、Clavien-Dindo 分级的并发症发生率、手术时间和辐射暴露时间等临床结果参数。成本分析基于购买成本和维修及再处理的重复成本,除以手术次数。在每组中,均有 68 例手术可供评估。在可重复使用的输尿管镜和单次使用的输尿管镜中,分别有 91%和 88%的患者因结石疾病接受治疗,结石负荷分别为 101±226 和 90±244mm,下极受累分别为 47%和 41%(p>0.05)。比较可重复使用和单次使用器械的临床结果发现,总体成功率(81%对 87%)、无结石率(82%对 85%)、手术时间(76.2±46.8 对 76.8±40.2min)、辐射暴露时间(3.83±3.15 对 3.93±4.43min)和并发症发生率(7%对 17%)无显著差异(p>0.05)。广泛的维修和购买成本导致可重复使用的输尿管镜检查的每次手术费用为 1212-1743 美元,而单次使用的输尿管镜检查的每次手术费用为 1300-3180 美元。本研究结果为可重复使用和单次使用软性输尿管镜的临床效果相当提供了证据。单次使用和可重复使用输尿管镜的成本范围部分重叠,这强调了在谈判购买价格、维修价格和保修条件时,准确了解费用和病例量的重要性。