Colorectal Adenocarcinoma, Colorectal Cancer (Diagnosis), Colorectal Cancer Prevention
Conditions
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.
Interventions
PROCEDUREColonoscopy
Colonoscopy performed and Boston score evaluated
OTHERQuestionnaires
LRD satisfaction questionnaire LRD compliance questionnaire
OTHERPre-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
OTHERPre-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.
Sponsors
Clinique Paris-Bercy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boston Score | 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. |
Countries
France
Contacts
CONTACTCoralie DE CLERCK
Outcome results
None listed