Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Colonoscopy, Questionnaires, Pre-colonoscopy diet according to the investigator's oral instructions, Pre-colonoscopy diet by following a special preparation, Colobox..
- Who it may be relevant to
- Registry conditions: Colorectal Cancer Prevention, Colorectal Cancer (Diagnosis), Colorectal Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Single-blind, Randomized Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).
Overview
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.
Interventions
- Procedure Colonoscopy
Colonoscopy performed and Boston score evaluated - Other Questionnaires
LRD satisfaction questionnaire LRD compliance questionnaire - Other Pre-colonoscopy diet according to the investigator's oral instructions
24 hours before the colonoscopy, The patients follow a special diet, either by themselves according to the investigator's oral instructions - Other Pre-colonoscopy diet by following a special preparation, Colobox.
24 hours before the colonoscopy, The patients follow a special diet, by following a special preparation, Colobox.
Primary outcome measures
- Boston Score [Time frame: 1 day]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
France · 1 center
- Clinique Paris Bercy — Charenton-le-Pont
Identifiers
NCT: NCT07361575 · POG