跳至主要内容
临床试验/CTRI/2025/07/092092
CTRI/2025/07/092092尚未招募不适用

Evaluation of prophylactic antibiotic usage in prevention of postoperative infection in patients undergoing percutaneous nephrolithotomy

vVASAVI KESANA1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2025年8月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
126
试验地点
1
主要终点
The study is aimed to analyze the effectiveness of prophylactic antibiotics usage in prevention of postoperative infection rate in patients undergoing percutaneous nephrolithotomy

研究概览

简要总结

Postoperative infections are a common complication following Percutaneous Nephrolithotomy (PCNL), even in patients with negative preoperative urine cultures. While prophylactic antibiotics are routinely used to prevent such infections, there is ongoing debate over the optimal regimen, particularly between single-dose and multi-dose protocols. This randomized controlled trial aims to compare the effectiveness of single-dose versus multi-dose prophylactic Amikacin in preventing postoperative infections in PCNL patients with sterile urine cultures. By focusing on this specific patient subgroup and incorporating robust randomization and blinding methods, the study seeks to generate evidence-based recommendations that enhance patient outcomes while supporting antibiotic stewardship. The results may contribute to standardizing prophylactic antibiotic protocols for PCNL procedures.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age more than 18 years 2) Patients of male and female sex 3) Upper urinary tract stones of any size for which PCNL was recommended 4) Preoperative urine culture negative patients.

排除标准

  • ) Antibiotic use within 2 weeks before randomization 2) contraindiaction to Injection amikacin 3)patients who are unable to tolerate surgery and anesthesia 4) patients who are having spinal deformity 5) pregnant or lactating female patients.

结局指标

主要结局

The study is aimed to analyze the effectiveness of prophylactic antibiotics usage in prevention of postoperative infection rate in patients undergoing percutaneous nephrolithotomy

时间窗: 18 months

次要结局

未报告次要终点

研究者

发起方
vVASAVI KESANA
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Vasavi kesana

sri manakula vinayagar medical college and hospital

研究点 (1)

Loading locations...

相似试验