Clinical trial NCT06688955: Microbiological and Organizational Impact of the Use of Bacteriologically Controlled Water in COLOscopy
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colonoscopy
Keywords: COLONOSCOPY
WATER
microbiological safety
organization
ecological impacT
plastic waste
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of back contamination
timeFrame: inclusion visit
Secondary outcomes:
measure: Workload
timeFrame: Inclusion visit
measure: Satisfaction and acceptability healthcare professionals
timeFrame: Inclusion visit
measure: Acceptability patient
timeFrame: Inclusion visit
measure: Infectious episode
timeFrame: DAY 1 VISIT AND DAY 7 VISIT
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Arthur BERGER
role: PRINCIPAL_INVESTIGATOR
References: