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临床试验/NCT01926756
NCT01926756Unknown不适用

Intraoperative One-Time Catheterization in Short Gynecologic Procedures and Its Potential Effect on Symptomatic and Asymptomatic Bacteriuria

Abington Memorial Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
Postoperative Bacteriuria

研究概览

简要总结

This is a prospective randomized controlled trial to look into the reduction of catheter associated urinary tract infections in the postoperative period. It will specifically look at short gynecologic procedures such as D&C (dilation and curettage), hysteroscopies and LEEP procedures and the need to perform intraoperative catheterization. If a patient urinates immediately before a short operation then there is no need to drain the bladder with a catheter during the procedure. The investigators hypothesize that eliminating catheterization during these short procedures may decrease postoperative urinary tract infections. The hope is that this study would provide evidence to support a change in practice.

详细描述

The majority of research currently concentrates on indwelling catheters rather than one-time catheterization. Current practice at our institution in the gynecologic operating room is to perform a one time catheterization on patient's undergoing short procedures, yet it is unclear if this is a necessary intervention. If patients are asked to void immediately before their procedure it would eliminate the need for intra-operative catheterization and eliminate a potential source of infection.

The study is designed to determine whether routine catheterization prior to a minor OB/GYN procedure causes symptomatic or asymptomatic bacteria in the urine. Current practice is one-time catheterization of patients undergoing minor OB/GYN procedures prior to the beginning of the procedure. The investigators hypothesize that this causes asymptomatic or symptomatic bacteriuria.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • The patient must be 18 years of age or older.
  • The patient must be female.
  • The patient must be undergoing a same-day gynecologic procedure where catheterization is usually performed.
  • The patient must have general anesthesia or monitored anesthesia care (MAC). This includes IV sedation.

排除标准

  • The patient cannot be undergoing intermittent one-time catheterization.
  • The patient can not have had an indwelling catheter placed in the past 6 months.
  • The patients cannot have a concomitant pelvic infection.
  • The procedure cannot require spinal anesthesia.
  • The patient cannot be taking immunosuppressive medications.
  • The patient cannot be taking antibiotics and/or suppressive therapy for chronic urinary tract infections.
  • The patient cannot receive pre-operative or intra-operative antibiotics.

结局指标

主要结局

Postoperative Bacteriuria

时间窗: 2 -4 weeks

Urine cultures are obtained preoperatively (baseline), immediately postoperatively and 2 to 4 weeks postoperatively.

次要结局

  • Subjective urinary tract discomfort(2-4 weeks postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily G. Parent, D.O.

OB/GYN Resident Physician PGY-IV

Abington Memorial Hospital

研究点 (2)

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