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临床试验/NCT06379841
NCT06379841已完成不适用

Comparing Operative Times in Hysteroscopies With Full Draping vs Green Draping

Emory University6 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
6
主要终点
Difference in operative times

研究概览

简要总结

The purpose of this study is to determine whether green draping in the operating room prior to a hysteroscopy results in a decreased operating room time.

Secondary aims are to determine whether there are any differences in infection rate, complication rate, fluid deficit, operating room turnover time

详细描述

Climate change will affect global health, with a disproportionate effect on women. To continue advocating for the patient population, it is necessary to decrease the carbon footprint of the medical field. The healthcare industry is responsible for many carbon emissions and waste generation. In a hospital, the operating room contributes 20-30% and uses 3-6 times more energy per square foot. There are growing attempts at "green" strategies to minimize the carbon footprint of surgery. Parts of this strategy include decreasing the amount of single-use supplies. From its production, transport, use, and disposal life cycle, single-use supplies contribute to a large amount to waste.

Hysteroscopies are a very common procedure with over 200,00 performed per year. hysteroscopy involves placing a camera into the uterus via the vagina and cervix. This can be performed for both diagnostic and therapeutic indications. Hysteroscopies have been classically performed in the operating room. In the operating room, there is an emphasis on maintaining the sterile field. The patient is prepped and draped, resulting in a large amount of excess drape usage. However, in-office hysteroscopies are gaining in popularity. In the office, draping is limited to the under buttock to capture the efflux. Institutions such as Newton Wellesley Hospital and Medstar Hospital systems all utilize minimal draping in the in-office setting.

There is no further sterile draping. There is not an increased risk of infections from in-office hysteroscopies. Overall, the rate of infections from hysteroscopy is very low ranging from 0.06- 0.18%. A study has shown that the usage of preoperative iodine in hysteroscopic in-office procedures does not decrease the postoperative infection rate. New studies focused on a minimal drape cystoscopy have also not shown any increase in infection rate.

The investigator and the team hypothesize that green draping for a hysteroscopy can decrease the operative time of a procedure without causing increased complications. This will also add to the procedure's decreased cost and carbon footprint.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • All women undergoing a hysteroscopic procedure at Emory St Joseph's, Emory Dunwoody ASC, Emory University Hospital, Emory University Hospital ASC.

排除标准

  • Women undergoing a concomitant procedure along with the hysteroscopic procedure
  • Pregnant women,
  • Prisoners
  • Cognitively impaired or Individuals with impaired decision-making capacity

结局指标

主要结局

Difference in operative times

时间窗: Baseline

The principal investigator will begin timing the case on a stopwatch when the surgeon has finished scrubbing and reentered the operating room. The investigator will note the end time of the procedure as when the procedure has concluded, and the patient's legs are brought out of lithotomy back onto the bed.

次要结局

  • Operative room turnover time in Full Draping(Baseline)
  • Post Operative complication Rate(Baseline, 2 weeks)
  • Number of cases of Fluid deficits(Baseline, 2 weeks)
  • Infection Rate(Baseline, 2 weeks)
  • Peri operative Complication Rate(Baseline, 2 weeks)

研究者

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

Michael Heit

Professor

Emory University

研究点 (6)

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