A Single-blind, Randomized Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- Boston Score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
- •Free, informed, and signed consent;
- •Patient affiliated with or a beneficiary of a social security scheme, according to Article L.1124-1 of the French Public Health Code;
Exclusion Criteria
- •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;
- •Chronic inflammatory bowel disease;
- •Known colonic stenosis;
- •Diverticulitis of less than 6 weeks duration;
- •Pregnant, parturient, or breastfeeding woman;
- •Patient deprived of liberty by administrative or judicial order, or under guardianship or limited legal protection;
- •Patient unable to understand the objectives and constraints of the study.
Arms & Interventions
Patient with LRD prepared 24 hours before colonoscopy
The LRD prepared is Colobox
Intervention: Colonoscopy (Procedure)
Patient with LRD prepared 24 hours before colonoscopy
The LRD prepared is Colobox
Intervention: Questionnaires (Other)
Patient with LRD prepared 24 hours before colonoscopy
The LRD prepared is Colobox
Intervention: Pre-colonoscopy diet by following a special preparation, Colobox. (Other)
Patients with not prepared LRD, 24 hours before colonoscopy
The LRD is only explained orally and in writing to the patient
Intervention: Colonoscopy (Procedure)
Patients with not prepared LRD, 24 hours before colonoscopy
The LRD is only explained orally and in writing to the patient
Intervention: Questionnaires (Other)
Patients with not prepared LRD, 24 hours before colonoscopy
The LRD is only explained orally and in writing to the patient
Intervention: Pre-colonoscopy diet according to the investigator's oral instructions (Other)
Outcomes
Primary Outcomes
Boston Score
Time Frame: 1 day
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.
Secondary Outcomes
No secondary outcomes reported