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

NCT ID: NCT06688955

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-29
• Study Completion Date: 2025-12-31

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

Conditions

Colonoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient with Bacteriologically Controlled Water procedure

patient with colonoscopy with Bacteriologically Controlled Water procedure

Group Type: EXPERIMENTAL

Colonoscopy with Bacteriological Controlled Water

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur BERGER

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux - Hôpital haut Lévêque

Pessac, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Arthur BERGER

Role: CONTACT

arthur.berger@chu-bordeaux.fr

+335 57 67 49 31

Caroline ESCLAIR

Role: CONTACT

caroline.esclair@chu-bordeaux.fr

Facility Contacts

Arthur BERGER, MD

Role: primary

arthur.berger@chu-bordeaux.fr

Caroline ESCLAIR

Role: backup

Other Identifiers

CHUBX 2023/38

Identifier Type: -

Identifier Source: org_study_id