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

NCT06688955 | Recruiting

• 1 other identifier: CHUBX 2023/38
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Colonoscopy

Keywords

COLONOSCOPY; WATER; microbiological safety; organization; ecological impacT; plastic waste

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Workload

  Inclusion visit

• Satisfaction and acceptability healthcare professionals

  Inclusion visit

• Acceptability patient

  Inclusion visit

• Infectious episode

  DAY 1 VISIT AND DAY 7 VISIT

Study Arms (1)

Patient with Bacteriologically Controlled Water procedure

EXPERIMENTAL

patient with colonoscopy with Bacteriologically Controlled Water procedure

Procedure: Colonoscopy with Bacteriological Controlled Water

Interventions

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

Patient with Bacteriologically Controlled Water procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux - Hôpital haut Lévêque

Pessac, France

RECRUITING

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Arthur BERGER

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur BERGER

CONTACT

+335 57 67 49 31; arthur.berger@chu-bordeaux.fr

Caroline ESCLAIR

CONTACT

caroline.esclair@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: September 29, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

FR (1)