Unrestricted Diet for Screening Colonoscopy (CriLiP)

Parc Taulí Hospital Universitari

Status: Completed

Conditions: Bowel Cleansing; Bowel Cancer; Colonoscopy

Treatments: Other: Unrestricted diet before colonoscopy; Drug: Bisacodyl 5 MG; Other: 1-day low residue diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05032794

2021/3009

Details and patient eligibility

About

Colonoscopy is the technique of choice for the evaluation of the mucosa of the colon. To be able to do the procedure in optimal conditions, it needs to be clean. Therefore, it is necessary to carry out a preparation as safe and tolerable as possible. This preparation generally consists in a low residue diet the days before the colonoscopy and in the intake of a laxative solution. In previous studies, it has been shown that the low residue diet does not play a relevant role as it was considered before. Recent studies demonstrated that reducing the days of low residue diet does not worsen the cleansing and improves the patient experience. The results of this study are required for determining the role of diet restrictive diet in colon cleansing.

Enrollment: 553 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals on the early colorectal cancer detection program who agreed to undergo colonoscopy after positive results on the fecal immunochemical test (FIT)

Exclusion criteria

• Individuals in which colonoscopy, cleansing solution or bisacodyl are contraindicated
• Subjects that are considered to have a linguistic barrier or to be unable to understand the instructions and / or give informed consent.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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553 participants in 2 patient groups

Unrestricted diet

Experimental group

Description:

The participant is not instructed to follow any dietary recommendation before colonoscopy. But only the restriction and fasting required for sedation.

Treatment:

Drug: Bisacodyl 5 MG

Other: Unrestricted diet before colonoscopy

One day low residue diet

Active Comparator group

Description:

The participant is instructed to follow a low residue diet the day before the colonoscopy. It will be given a informative document and educated by a nurse.

Treatment:

Drug: Bisacodyl 5 MG

Other: 1-day low residue diet