Unrestricted Diet for Screening Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

553 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-13

Study Completion Date

2022-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Bowel Cleansing Colonoscopy Bowel Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Unrestricted diet

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

Group Type EXPERIMENTAL

Unrestricted diet before colonoscopy

Intervention Type OTHER

Free diet, without restrictions

Bisacodyl 5 MG

Intervention Type DRUG

If the participant is at risk of inadequate bowel cleansing, defined by a score of Dik et al ≥ 2 it will be given Bisacodyl 5 milgrams bid for 3 days.

One day low residue diet

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.

Group Type ACTIVE_COMPARATOR

1-day low residue diet

Intervention Type OTHER

To follow a diet low in residues / fiber. the day before the colonoscopy.

Bisacodyl 5 MG

Intervention Type DRUG

If the participant is at risk of inadequate bowel cleansing, defined by a score of Dik et al ≥ 2 it will be given Bisacodyl 5 milgrams bid for 3 days.

Interventions

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Unrestricted diet before colonoscopy

Free diet, without restrictions

Intervention Type OTHER

1-day low residue diet

To follow a diet low in residues / fiber. the day before the colonoscopy.

Intervention Type OTHER

Bisacodyl 5 MG

If the participant is at risk of inadequate bowel cleansing, defined by a score of Dik et al ≥ 2 it will be given Bisacodyl 5 milgrams bid for 3 days.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No