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Clinical Trial NCT06688955 (COLOSOUS L'EAU) for Colonoscopy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Microbiological and Organizational Impact of the Use of Bacteriologically Controlled Water in COLOscopy (COLOSOUS L'EAU) 40

Recruiting
Clinical Trial NCT06688955 (COLOSOUS L'EAU) is an interventional study for Colonoscopy that is recruiting. It started on September 29, 2025 with plans to enroll 40 participants. Led by University Hospital, Bordeaux, it is expected to complete by December 1, 2025. The latest data from ClinicalTrials.gov was last updated on October 3, 2025.
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...Show More
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 r...Show More
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

Conditions
Colonoscopy
Other Study IDs
  • COLOSOUS L'EAU
  • CHUBX 2023/38
NCT ID Number
NCT06688955
Start Date (Actual)
2025-09-29
Last Update Posted
2025-10-03
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
COLONOSCOPY
WATER
microbiological safety
organization
ecological impacT
plastic waste
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPatient with Bacteriologically Controlled Water procedure
patient with colonoscopy with Bacteriologically Controlled Water procedure
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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
inclusion visit
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Workload
Estimation of the workload in minutes, per person involved and for each phase of the reusable vial circuit
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).
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
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.
DAY 1 VISIT AND DAY 7 VISIT
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
University Hospital, Bordeaux logoUniversity Hospital, Bordeaux
Study Central Contact
Contact: Arthur BERGER, +335 57 67 49 31, [email protected]
Contact: Caroline ESCLAIR, [email protected]
1 Study Locations in 1 Countries
CHU de Bordeaux - Hôpital haut Lévêque, Pessac, France
Arthur BERGER, MD, Contact, [email protected]
Caroline ESCLAIR, Contact
Recruiting