An interventional study of Colonoscopy with Bacteriological Controlled Water in Colonoscopy, sponsored by University Hospital, Bordeaux. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Other
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
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
University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patient with colonoscopy with Bacteriologically Controlled Water procedure
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
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
Time frame: inclusion visit
Workload
Estimation of the workload in minutes, per person involved and for each phase of the reusable vial circuit
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: DAY 1 VISIT AND DAY 7 VISIT
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University Hospital, Bordeaux