jRCTs042240139招募中不适用
Prospective randomized control trial analyzing the efficacy of LithoVue Elite on postoperative infection of endoscopic combined intrarenal surgery (ECIRS) (Elite ECIRS-2023)
未提供0 个研究点目标入组 150 人开始时间: 2025年2月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 主要终点
- Incidence of postoperative fever
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Single Blind
入排标准
- 年龄范围
- 20age old over 至 85age old under（—）
- 性别
- All
入选标准
- •Patients who will be performed ECIRS for upper tract urinary calculi at the Nagoya City University Hospital or Ngaoya City University East Medical Center
- •Age at the time of informed consent is between 25 and 85 years old
- •Written informed consent from patient to participate in the study, including compliance with study procedures
排除标准
- •Patients with coagulation abnormality or unable to discontinue anticoagulants
- •Pregnant or possibly pregnant or breastfeeding women
- •Patients who are not be able to do general anesthesia
- •Patients unable to maintain the surgical position (prone split-leg position)
- •Patients with active febrile urinary tract infection
- •Patients after urinary diversion
- •Patients with preoperative nephrostomy insertion
- •Patients who cannot be inserted ureteroscopy due to severe ureteral stricture
- •Other patients for whom the investigator or sub-investigator judges the subject to be inappropriate
结局指标
主要结局
Incidence of postoperative fever
时间窗: during hospitalization
a temperature >38.5 for at least 1 day or >38.0 for more than 2 days
次要结局
- Number of SIRS criteria
- quick SOFA (qSOFA)
- Intraoperative inflammatory markers(Intraoperative)
- Postoperative Inflammatory marker(Postoperative)
- Postoperative complications(Postoperative)
研究者
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