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临床试验/NCT03614247
NCT03614247已完成不适用

Cost-Effectiveness of Different Treatment Options for Lower Calyceal Stones of 1 to 2 Centimeters: A Prospective, Randomized Study

Ankara Training and Research Hospital0 个研究点目标入组 175 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
175
主要终点
Stone free status

研究概览

简要总结

The aim of the present study to perform a full cost analysis for the complete clearance of calyceal stones by retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL) for the treatment of lower calyceal stones between 1 and 2 centimeters (cm) in size.

详细描述

The lifelong prevalence of urinary system stone disease is approximately 15%. The lower calyx is the most common location where renal calculi occur. Because anatomical factors preclude spontaneous passage in this area, the need for treatment is more likely in lower calyceal stones. The European Association of Urology (EAU) suggests percutaneous nephrolithotomy (PNL) for stones larger than 2 centimeters (cm) and shock wave lithotripsy (SWL) or retrograde intrarenal surgery (RIRS) for stones smaller than 1cm as a first option, but controversy continues regarding the best treatment option for medium-sized lower calyceal stones of between 1cm and 2cm.

Medical costs are divided into two components: direct and indirect. Direct costs encompass all medical expenditures (e.g., drugs, hospital bed, all consumable and non-consumable materials used during the operation), while indirect costs include loss of working days for the patient. The stone-free rates (SFR) are reported as approximately 60% and 90% for one session of RIRS and PNL, respectively; however, no physician can guarantee a 100% SFR for one session. For this reason, a full cost analysis must include the direct and indirect costs of both the first and all auxiliary procedures.

The aim of this study was to perform a full cost analysis for the complete clearance of calyceal stones by RIRS and all PNL types for the treatment of lower calyceal stones between 1cm and 2cm in size.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who had a lower calyceal stone between 1cm and 2 cm in size

排除标准

  • solitary or anomaly (horseshoe or pelvic kidney) kidney,
  • renal insufficiency,
  • pregnancy,
  • patient younger than 18 or older than 75 years,
  • non-interrupted antithrombotic medication before surgery,
  • urinary tract infection,
  • double-j or nephrostomy insertion before surgery

结局指标

主要结局

Stone free status

时间窗: 3 months

Stone-free was defined as no rest stone or ≤ 3mm clinical insignificance rest stone

次要结局

未报告次要终点

研究者

发起方
Ankara Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammet Fatih Kilinc

Principal Investigator

Ankara Training and Research Hospital

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