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临床试验/NCT03719755
NCT03719755已完成不适用

Comparison of Urinary Tract Infections Rates Using 50% Dextrose Plus Washout Versus Normal Saline as Cystoscopy Fluid: a Prospective Study

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
152
试验地点
2
主要终点
rates of urinary tract infections at 6-9 days post-operative

研究概览

简要总结

Our study will compare the rates of postoperative urinary tract infections (UTI) between patients who undergo cystoscopy using 50% dextrose injection plus bladder washout versus normal saline after hysterectomy for benign indications. Primary outcome will be rates of urinary tract infections at 6-9 days post-operatively. This will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter.

详细描述

This will be a prospective cohort study of the rate of UTIs after cystoscopic distention media of normal saline with maximum injection of 40 cc of 50% dextrose plus 300 cc of normal saline washout versus normal saline after hysterectomy for benign indications.

A pre-operative urine culture will be obtained via mid-stream clean catch prior to administration of routine pre-operative prophylactic antibiotics.

At 6-9 days post-operatively, a repeat urine culture will be obtained via mid-stream clean catch. Appropriate treatment will be administered if the urine culture is positive.Primary outcome will be rates of urinary tract infections at 6-9 days post-operatively. This will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

盲法说明

Participant masked to distention media

入排标准

性别
Female
接受健康志愿者

入选标准

  • Preoperative scheduling CPT codes for hysterectomy

排除标准

  • Discharged home with indwelling foley catheter
  • Indwelling foley catheter > 24 hours
  • Ureteral injury
  • Chronic immunosuppression
  • History of diabetes
  • Recurrent UTIs (≥2 infections in six months or ≥3 infections in one year)
  • Reported Chronic Kidney Disease
  • Renal anomalies

结局指标

主要结局

rates of urinary tract infections at 6-9 days post-operative

时间窗: 6-9 days post-operative

be rates of urinary tract infections at 6-9 days post-operatively. This will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Johnny Yi

Principal Investigator

Mayo Clinic

研究点 (2)

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