Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Paris-Bercy
About this trial
Low-residue diet (LRD) in patient improves the quality of the colon cleanliness and thus the adenoma detection rate (ADR). This is a key criterion in colonoscopy screening for colorectal cancer (CRC). The benefit of an LRD lasting more than 24 hours before colonoscopy has not been demonstrated compared to a 24-hour LRD.
Few studies have evaluated the benefit of a prepackaged 24-hour LRD compared to simply receiving oral and written LRD instructions during a consultation.
The aim of the study is to evaluate the usefulness of a prepackaged LRD (Colobox®) compared to simple LRD instructions on colon cleanliness (Boston score) in patients examined by endoscopy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient of one of the investigators for total colonoscopy (no prior colonic surgery);
Patient aged 18 years or older;
Patient classified as ASA 1, ASA 2, or ASA 3;
Not participating in any other current clinical trial;
Disqualifiers
Patient taking major psychotropic medications;
Patient with uncontrolled diabetes;
Patient with coagulation abnormalities preventing polypectomy: PT <50%, Platelets <50,000/mm³, current effective anticoagulation therapy (clopidogrel, prasugrel, or ticagrelor);
Patient referred for removal of a known polyp;
Trial design
Design model
Parallel
Treatments tested in this trial
Colonoscopy
Procedure/SurgeryColonoscopy performed and Boston score evaluated
Questionnaires
Other interventionLRD satisfaction questionnaire LRD compliance questionnaire
Pre-colonoscopy diet according to the investigator's oral instructions
Other intervention24 hours before the colonoscopy, The patients follow a special diet, either by themselves according to the investigator's oral instructions
Pre-colonoscopy diet by following a special preparation, Colobox.
Other intervention24 hours before the colonoscopy, The patients follow a special diet, by following a special preparation, Colobox.
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: Patient with LRD prepared 24 hours before colonoscopyExperimental treatment 3 interventions
Group B: Patients with not prepared LRD, 24 hours before colonoscopyActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Boston Score
A 9-point system, helps them see how clean a patient's large intestine is during a colonoscopy. This scale divides the large intestine into three parts: right, middle, and left. Each part can score from : BBPS = 0 (per segment) : unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared. BPPS=3 (per segment) : entire mucosa of the colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid.
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: