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临床试验/NCT06838312
NCT06838312尚未招募不适用

Reuse of Polyp Traps, a Way to Approach Sustainability: A Multicentric Non-inferiority Study

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau0 个研究点目标入组 3,238 人开始时间: 2025年2月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
3,238
主要终点
Number of patients with symptoms suggesting infection

研究概览

简要总结

The environmental impact of healthcare practice in the context of climate change is in the spotlight. Digestive endoscopy units are the third hospital unit that generates the most waste and environmental impact. For this reason, scientific societies advice studying and adopting more sustainable clinical practices, reconsidering current protocols for reprocessing and disinfection of single-use material. One of the devices, widely used and which generates a large amount of waste, is the polyp trap. It allows an easy recovery of the polyps removed during endoscopy. This device is discarded after a single use in some centers, and reused after washing and disinfection in others. Manufacturers recommend the single-use of the device, even there is no scientific evidence to support this action. In the investigators endoscopy unit, 3800 polyp traps are used yearly. The investigators hypothesis is that reusing the polyp catcher has similar safety to disposal after a single use, with better environmental and economic results. Objectives: To evaluate the safety of the reused and discarded after a single-use polyp trap. The investigators will assess 1) the post-colonoscopy infection rate and 2) the reliability of the anatomopathological study, 3) CO2 emissions and 4) costs of each practice. Methodology: A non-inferiority study will be carried out by observing the usual clinical practice of different centers and collecting data that suggest infection, cross-sampling and general complications. The results will be easily applicable in endoscopy units and will serve as a basis for future studies with other more controversial devices.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 18 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who undergo an elective colonoscopy will be recruited for the study.
  • Written informed consent to participate in the study and willingness to be contacted by telephone for follow-up.

排除标准

  • Patients who complete the colonoscopy without a polypectomy.
  • Patients who complete the colonoscopy without the use of a polyp trap.

结局指标

主要结局

Number of patients with symptoms suggesting infection

时间窗: Follow up at day 15

Did the patient present any of the following symptoms or diagnosis after the endoscopy? * Fever * Bacteraemia * Bronchoaspiration / Pneumonia * Other: Comments: * None

Number of infectious events related to endoscopy

时间窗: Follow up at day 15

Was the event related to the endoscopy procedure? Yes / Probably / Doubtfully / No

Number of infectious events related to polyp trap

时间窗: Follow up at day 15

Was the event related to the polyptrap? Yes / Probably / Doubtfully / No

次要结局

  • Number of inconsistent anatomopathological results(Follow up at day 15)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

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