Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).

Clinique Paris-Bercy

Status: Not yet enrolling

Conditions: Colorectal Adenocarcinoma; Colorectal Cancer (Diagnosis); Colorectal Cancer Prevention

Treatments: Other: Pre-colonoscopy diet; Procedure: Colonoscopy; Other: Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT07361575

POG

Details and patient eligibility

About

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.

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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230 participants in 2 patient groups

Patient with LRD prepared 24 hours before colonoscopy

Experimental group

Description:

The LRD prepared is Colobox

Treatment:

Other: Questionnaires

Procedure: Colonoscopy

Other: Pre-colonoscopy diet

Patients with not prepared LRD, 24 hours before colonoscopy

Active Comparator group

Description:

The LRD is only explained orally and in writing to the patient

Treatment:

Other: Questionnaires

Procedure: Colonoscopy

Other: Pre-colonoscopy diet