ColonoscopyCOLOSOUS L'EAUNCT06688955
Microbiological and Organizational Impact of the Use of Bacteriologically Controlled Water in COLOscopy
A study of Colonoscopy, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Caroline ESCLAIR contact
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux - Hôpital haut Lévêque
Pessac
Arthur BERGER, MD, arthur.berger@chu-bordeaux.fr
Caroline ESCLAIR
About this study
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
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
Read the 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
- Being tested
- Colonoscopy with Bacteriological Controlled Water
- Keywords
- COLONOSCOPY, WATER, microbiological safety, organization, ecological impacT, plastic waste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy with Bacteriological Controlled WaterProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Patient with Bacteriologically Controlled Water procedure | Experimental | patient with colonoscopy with Bacteriologically Controlled Water procedure Receives: Procedure: Colonoscopy with Bacteriological Controlled Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of back contamination
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
Measured: inclusion visit
Secondary outcomes (4)
Workload
Estimation of the workload in minutes, per person involved and for each phase of the reusable vial circuit
Measured: Inclusion visit
Satisfaction and acceptability healthcare professionals
Evaluation of satisfaction and acceptability among healthcare professionals using the French version of the System Usability Scale (FSUS).
Measured: Inclusion visit
Acceptability patient
Assessment of patient acceptability of Bacteriologically Controlled Water use by counting the total number of patients offered the study to obtain 40 consents
Measured: Inclusion visit
Infectious episode
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.
Measured: DAY 1 VISIT AND DAY 7 VISIT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start29 Sep 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur BERGER, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688955
- Sponsor's protocol ID
- CHUBX 2023/38
- Acronym
- COLOSOUS L'EAU
- Status last verified
- Sep 2025
- First submitted
- 12 Nov 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06688955
- Acronym / sponsor ID
- COLOSOUS L'EAU / CHUBX 2023/38
- Conditions
- Colonoscopy
- Keywords
- COLONOSCOPY, WATER, microbiological safety, organization, ecological impacT, plastic waste
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Bacteriologically Controlled Water procedure | Experimental | Procedure: Colonoscopy with Bacteriological Controlled Waterpatient with colonoscopy with Bacteriologically Controlled Water procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonoscopy with Bacteriological Controlled WaterPatient 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 | Procedure or surgery | Patient with Bacteriologically Controlled Water procedure |
Primary outcome
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
4 secondary outcomes
Workload
Time frame: Inclusion visit
Satisfaction and acceptability healthcare professionals
Time frame: Inclusion visit
Acceptability patient
Time frame: Inclusion visit
Infectious episode
Time frame: DAY 1 VISIT AND DAY 7 VISIT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline ESCLAIR contact
Arthur BERGER principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Colonoscopy, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arthur BERGER (+335 57 67 49 31, arthur.berger@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of back contamination (time frame: inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.