Reuse of Polyp Traps, a Way to Approach Sustainability

Официальное название

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

Обзор

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.

Вмешательства

• Другое Reuse or dispose a polyp trap
  Participant hospitals will be separated into two groups, according to their standard clinical practice: A) reuse or B) dispose polyp traps after a colonoscopy with polypectomy. Centres will participate with their current method of using polyp traps. Work dynamics will not change as patients will be recruited from centers that routinely reuse or dispose polyp traps.

Первичные конечные точки

• Number of patients with symptoms suggesting infection [Срок оценки: Follow up at day 15]
• Number of infectious events related to endoscopy [Срок оценки: Follow up at day 15]
• Number of infectious events related to polyp trap [Срок оценки: Follow up at day 15]

Вторичные конечные точки (1)

• Number of inconsistent anatomopathological results [Срок оценки: Follow up at day 15]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06838312 · IIBSP-RPT-2024-69

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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