Gram Stain of the First Urine After Intraoperative Renal Puncture in Predicting the Systemic Inflammatory Response After Percutaneous Nephrolithotomy: A Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Efficacy of Gram stain in predicting systemic inflammatory response after percutaneous nephrolithotomy.
研究概览
简要总结
In this study, investigators compared the systemic inflammatory responses after percutaneous nephrolithotomy (PCNL) patients who were given an expanded empirical antibiotic regimen based on the prediction of the possibility of bacteria identified by Gram staining the first urine after renal puncture and patients whose antibiotic regimen was not performed and whose antibiotic regimen was adjusted according to patient symptoms and culture results. Investigators aimed to test its diagnostic value in predicting and preventing complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with an indication for percutaneous nephrolithotomy due to kidney stone disease.
排除标准
- •under 18 years old,
- •having an active urinary tract infection before surgery and positive urine cultures,
- •Patients with bilateral kidney stones,
- •DJ stent or nephrostomy placement,
- •Solitary kidney stones,
- •Bleeding disorders,
- •impaired kidney function,
- •a history of antibiotic use for any reason within 2 weeks before randomization were excluded from the study.
研究组 & 干预措施
Gram staining
Gram staining of post-puncture urine in percutaneous nephrolithotomy
干预措施: Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy. (Diagnostic Test)
control
non-intervention percutaneous nephrolithotomy
结局指标
主要结局
Efficacy of Gram stain in predicting systemic inflammatory response after percutaneous nephrolithotomy.
时间窗: immediately after the surgery
Gram staining of urine after puncture to detect the presence of bacteria that are a possible source of infection according to the rate of gram-stained and non-gram-stained patients by microscopic examination.
次要结局
- Change of antibiotic regimen after bacterial estimation of Gram stain(immediately after the surgery)
研究者
Bedreddin Kalyenci
Assistant professor doctor
Adiyaman University