Comparison of the Post-operative Infection by Using Different Type Prophylactic Antibiotics in Low Risk Patients Who Underwent Retrograde Intrarenal Surgery
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Post-operative sepsis
研究概览
简要总结
In the treatment of kidney stones and upper ureteral stones, flexible ureteroscopic lithotripsy has become the mainstream choice due to its minimally invasive nature and high safety. However, there is still no universal consensus on the use of prophylactic antibiotics before surgery. Taiwan, located in the subtropical region, is one of the areas in the world with a high incidence of urinary tract stones. Currently, there are no established guidelines for the use of prophylactic antibiotics before flexible ureteroscopic lithotripsy in Taiwan. This study aims to evaluate the differences between single-dose, different types of prophylactic antibiotics in generally healthy adult patients undergoing flexible ureteroscopic lithotripsy.
详细描述
This study focuses on flexible ureteroscopic lithotripsy, a procedure commonly used to treat kidney stones and stones in the upper part of the ureter. This surgery is popular because it is minimally invasive and considered very safe. However, there is no clear agreement on whether or which antibiotics should be given to patients before the surgery to prevent infections.
Taiwan is one of the regions in the world with a high rate of urinary tract stones, and because of this, it is especially important to ensure that the best practices are followed to prevent infections during and after the surgery. Currently, there are no official guidelines in Taiwan on which antibiotics should be used before flexible ureteroscopic lithotripsy.
This study aims to compare different types of single-dose antibiotics given before the surgery to see if one is more effective than others in preventing infections. By looking at how different antibiotics perform, the study hopes to provide clearer guidance for doctors in choosing the best antibiotic treatment for patients, ultimately improving patient care and reducing the risk of infections after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stone diameter < 3 cm or stone area < 900 mm2
- •Preoperative(2 weeks) negative urine culture
- •No active symptoms , including fever, dysuria, urinary frequency, urgency)
- •Urinalysis WBC < 10/HPF
排除标准
- •Immunocompromised
- •Poor control Diabetes mellitus
- •Allergy to antibiotics
- •Ureteric stents or Foley catheter present
- •Ureteric stricture
- •Renal or urethral deformity
- •Antibiotic treatment for urinary tract infection in the preceding 4 weeks
研究组 & 干预措施
Oral Levofloxacin
干预措施: Levofloxacin (Drug)
Intravenous cefmetzole
干预措施: Cefmetazole (drug) (Drug)
结局指标
主要结局
Post-operative sepsis
时间窗: Postoperative two weeks
Postoperative systemic inflammatory response syndrome within two weeks
次要结局
未报告次要终点