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临床试验/CTRI/2017/09/009721
CTRI/2017/09/009721已完成不适用

Prospective, Randomized, Comparative Study on the Efficacy of one day versus 3 days of intravenous Amikacin(15mg/Kg) as prophylaxis in patients undergoing transurethral resection of the Prostate

Fluid research fund CMC Vellore1 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2016年1月4日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
334
试验地点
1
主要终点
To assess the rate of bacteriuria (CFU 104/ml) 4 days after TUR-P

研究概览

简要总结

In urological practice transurethral resection of prostate (TURP) is the most commonly performed operation. The aim of antibiotic prophylaxis is to reduce the bacteriuria rate and thereby reduce the complications associated with it. This is a prospective, randomized comparative study conducted in the department of Urology at Christian Medical College, Vellore. Patients with a sterile preoperative urine culture (CFU< 104/ml) undergoing TURP will be included. Patients will receive either one day or 3 days of intravenous Amikacin(15mg/Kg). Clinical examination and urine culture of the patients will be performed pre operatively and 5-7 days postoperatively. Post-operative bacteriuria rate (CFU> 104/ml) will be considered as significant. A follow up at 4 weeks will be done either through an OPD visit or a telephonic interview. Postoperative bacteriuria, symptomatic UTI and development of sepsis and other complications will be recorded. The efficacy (non inferiority) of single versus 3 doses of intravenous Amikacin will be assessed.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Open Label

入排标准

年龄范围
40.00 Year(s) 至 90.00 Year(s)(—)
性别
Male

入选标准

  • Patients undergoing TURP who have sterile preoperative urine culture (patients without bacteriuria preoperatively.

排除标准

  • 1.Patients on a catheter(SPC/perurethral) 2.Preoperative urine culture positivity.
  • 3.Patients who have received antibiotics in the past 1 week.
  • 4.Any contraindication to aminoglycoside
  • Patients who require prolonged catheterization or who develop AUR(acute urinary retention) and need re-catheterisation/ Bladder wash and Re-operation due to hematuria.

结局指标

主要结局

To assess the rate of bacteriuria (CFU 104/ml) 4 days after TUR-P

时间窗: 4 days after TUR-P

次要结局

  • a.Incidence of postoperative symptomatic UTI and other complications.(b.To assess the risk factors for developing complications)

研究者

发起方
Fluid research fund CMC Vellore
申办方类型
Private medical college

研究点 (1)

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