Unrestricted Diet for Screening Colonoscopy

Study Overview
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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.

Official Title
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Unrestricted Diet vs 1-day Low Residue Diet for Screening Colonoscopy

Conditions
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Bowel Cleansing, Colonoscopy, Bowel Cancer

Intervention / Treatment
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* Other: Unrestricted diet before colonoscopy
* Other: 1-day low residue diet
* Drug: Bisacodyl 5 MG


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unrestricted diet<br>The participant is not instructed to follow any dietary recommendation before colonoscopy. But only the restriction and fasting required for sedation. | Other: Unrestricted diet before colonoscopy<br>* Free diet, without restrictions<br>Drug: Bisacodyl 5 MG<br>* 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.<br>|
| Active Comparator: One day low residue diet<br>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. | Other: 1-day low residue diet<br>* To follow a diet low in residues / fiber. the day before the colonoscopy.<br>Drug: Bisacodyl 5 MG<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate bowel cleansing | Bowel cleansing as a rating using the Boston Bowel Preparation Scale above 1 in each segment . This score ranges fron 0 to 3 in each one of the three segments. Zero is the worst outcome and 3 is the best cleansing | During colonoscopy (At the withdrawal phase) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet tolerability as assessed by a likert scale | Tolerance to the diet assigned to the participant measured with a likert scale from 0 to 5, 0 the worst ad 5 the best. | The day of the colonoscopy just before beginning | 
| Preparation tolerability as assessed by a likert scale and Hatoum et al. survey | Tolerance to the cleansing solution used for bowel cleansing measured with a likert scale from 0 to 5, 0 the worst ad 5 the best. Hatoum et al is a validated survey designed for assessing bowel preparation tolerability DOI 10.1007/s40271-015-0154-8 | The day of the colonoscopy just before beginning | 
| Rate of colonoscopies with adenoma | An adenoma was detected, resected and confirmed by the histology report in the colonoscopy. | With histology report, an average of 4 weeks after colonoscopy | 
| Rate of colonoscopies with polyps | Polyp detection in the colonoscopy as reported by the endoscopist. | During colonoscopy | 
| Cecal intubation time | Time expended in reaching the cecum | During colonoscopy | 
| Withdrawal time | Time expended in the withdrawal from cecum till the anus. | During colonoscopy | 
| Information perceived quality assessed by a likert scale | Perceived quality of the instructions and education received for the colonoscopy preparation by the participant. Assessed using a likert scale | The day of the colonoscopy just before beginning | 
| Entry bowel cleansing as assessed by the modified Boston Bowel Preparation Scale | Bowel cleansing during cecum intubation phase assessed using a modified Boston Bowel Preparation Scale which is without considering any additional cleansing during the endoscopy. | During colonoscopy (At the entry phase) | 
| Rate of colonoscopies with flat polyps | Flat polyp detection defined by Paris criteria: no polypoid nor ulcerated (Paris 0-IIa/b/c) in the colonoscopy as reported by the endoscopist. | During colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bowel cleansing, Diet, Low residue diet