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Идёт набор NCT06688955

Microbiological and Organizational Impact of the Use of Bacteriologically Controlled Water in COLOscopy

Без фазы С лечением Colonoscopy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Colonoscopy with Bacteriological Controlled Water.
Кому может быть актуально
Состояния в реестре: Colonoscopy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of the Microbiological and Organizational Impact of the Use of Bacteriologically Controlled Water in COLOscopy for an Evolution of Our Practices Towards a More Ecoresponsible Endoscopic Activity COLO SOUS L'EAU

Обзор

A joint opinion of the SFED and the SF2H recommends to orient our colonoscopy practices towards the use of bacteriologically controlled water in reusable bottles for colonic irrigation. To date, no study exists to validate the proposed set-up. Our main objective is therefore to evaluate the microbiological safety of the use of bacteriologically controlled water, in particular the absence of retro contamination of the water in the wash bottle by the faecal flora of the patient undergoing colonoscopy, in order to be able to generalise this practice

Подробное описание

Colonoscopy is the reference examination for colon exploration. Since 2021, international recommendations recommend the practice of "water-exchange" which consists in performing colonoscopies by irrigating the colon with water, continuously and without insufflation. This technique facilitates the progression of the colonoscope, reduces pain and the risk of perforation for the patient, and improves the detection and resection of polyps. However, it requires a large volume of water, about 1L per patient. We currently use sterile water in single-use bottles. In order to propose a way to limit the production of waste in endoscopy, the SFED and the SF2H have published an opinion proposing to orient our practice towards the use of EBM packaged in reusable bottles. To date, no study has validated the set-up proposed in this advice. We therefore propose to ensure the microbiological safety of the use of EBM during water-assisted colonoscopies before generalizing this practice. A microbiological sample of 200 ml of EBM contained in the wash bottle at the end of each colonoscopy will be collected for bacteriological analysis. In addition, the use of reusable bottles requires the implementation of a maintenance and reconditioning circuit, and therefore a reorganization within the technical platform, the feasibility and acceptability of which must be evaluated by the professionals. Finally, we will also evaluate the carbon footprint of the sterilization circuit and compare the weight of waste related to the current practice, sterile water versus the use of EBM. This study would be the pilot phase for a larger study on the ecological and medico-economic impact of the use of bacteriologically controlled water in endoscopy

Вмешательства

  • Процедура Colonoscopy with Bacteriological Controlled Water
    Patient with coloscopy which used Bacteriological Controlled Water : Collection of 250 ml of bacteriologically controlled water from the wash bottle at the end of each water-assisted colonoscopy to test for enterobacteria and fecal streptococci

Первичные конечные точки

  • Rate of back contamination [Срок оценки: inclusion visit]
Вторичные конечные точки (4)
  • Workload [Срок оценки: Inclusion visit]
  • Satisfaction and acceptability healthcare professionals [Срок оценки: Inclusion visit]
  • Acceptability patient [Срок оценки: Inclusion visit]
  • Infectious episode [Срок оценки: DAY 1 VISIT AND DAY 7 VISIT]

Критерии участия

Критерии включения

  • All patients with a colonoscopy indication whose examination is scheduled in room 4, on a Monday and Tuesday shift (8:30 a.m. - 1:30 p.m.)
  • Male or female of legal age at the time the colonoscopy is ordered
  • Patient willing to participate in the study
  • Person affiliated with or benefiting from a social security plan

Критерии исключения

  • Pregnant woman
  • Patient of legal age under guardianship or protected person
  • Patient requiring indigo-carmine chromoendoscopy
  • Patient requiring an emergency colonoscopy
  • Patient not affiliated to the social security system

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • CHU de Bordeaux - Hôpital haut Lévêque — Pessac

Идентификаторы

NCT: NCT06688955 · CHUBX 2023/38

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗