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NCT Number: NCT06688955

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux - Hôpital haut Lévêque

Pessac, France

Location status: Recruiting

Location contact

Arthur BERGER, MD

CONTACT

[email protected]

Caroline ESCLAIR

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colonoscopy with Bacteriological Controlled Water

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

Primary outcomes

  1. Rate of back contamination

    Time frame: inclusion visit

    Rate of back contamination after colonoscopy using the EBM procedure. The absence of retro-contamination is defined as the absence of fecal flora (enterobacteria and fecal streptococci) in the wash bottle during the bacteriological analysis of the EBM microbiological samples taken after each colonoscopy

Secondary outcomes

  1. Workload

    Time frame: Inclusion visit

    Estimation of the workload in minutes, per person involved and for each phase of the reusable vial circuit

  2. Satisfaction and acceptability healthcare professionals

    Time frame: Inclusion visit

    Evaluation of satisfaction and acceptability among healthcare professionals using the French version of the System Usability Scale (FSUS).

  3. Acceptability patient

    Time frame: Inclusion visit

    Assessment of patient acceptability of Bacteriologically Controlled Water use by counting the total number of patients offered the study to obtain 40 consents

  4. Infectious episode

    Time frame: DAY 1 VISIT AND DAY 7 VISIT

    Monitoring the occurrence of an infectious episode (D+1 and D+7) characterized by the occurrence of a fever episode higher than 38.5°C.

Study contacts

Contact information is provided by the study sponsor or research team.

Arthur BERGER

CONTACT

[email protected]

+335 57 67 49 31

Caroline ESCLAIR

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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

Acronym: COLOSOUS L'EAU

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2024
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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