Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy

Study Overview
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Brief Summary
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Colonoscopy is the gold-standard for the evaluation of the colorectal mucosa. Colonoscopy quality indicators are the adenoma detection rate, the rate of cecal intubation and the bowel preparation. The role of diet in preparing for colonoscopy is not fully established. Currently there is not enough evidence available to choice between 3 days of low residue diet versus 1 day. The research hypothesis is that the low residue diet offers a non-inferior bowel preparation and an improved tolerance.

Official Title
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Low Residue Diet 3 Days Versus 1 Day as Preparation for Colonoscopy: a Randomized Controlled Trial

Conditions
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Colonoscopy, Colon Adenoma, Colorectal Neoplasms, Inflammatory Bowel Diseases, Colon Disease

Intervention / Treatment
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* Other: 1 day low residue diet
* Other: 3 day low residue diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants in the colorectal cancer screening program that give consent Exclusion Criteria: Contraindication for colonoscopy

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: 1 day low residue diet<br>Patients are instructed to complete a low residue diet exclusively one day prior the colonoscopy. | Other: 1 day low residue diet<br>* Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy.<br>* Other names: low fiber diet;|
| Active Comparator: 3 days low residue diet<br>Patients are instructed to complete a low residue diet three days prior the colonoscopy. | Other: 3 day low residue diet<br>* Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy.<br>* Other names: low fiber diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel preparation | Measured with the Boston Bowel Preparation Scale from 0 until 9. 9 represents an excellent preparation. | During the colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet tolerance | Using Likert scale. From 1 to 5, lower is better tolerance. | It is reported before entering the endoscopy room. Regarding the 3 or 1 days on low fiber diet depending on which study group is the participant. | 
| Preparation tolerance | Using Likert scale. From 1 to 5, lower is better tolerance. | It is reported before entering the endoscopy room. Regarding the 3 or 1 day on bowel preparation depending on which study group is the participant. | 
| Adenoma detection rate | Proportion of colonoscopies with detection of colorectal cancer or adenoma excluding distal hyperplastic | up to 2 weeks after colonoscopy depending on pathology department workload. | 
| Endoscopic diagnosis | Final endoscopic diagnosis. For example; normal, diverticulosis, polyps, colorectal cancer, etc. | It is assessed during the colonoscopy and will be reported the same day. | 
| Cecum intubation rate | Cecum intubation will be assessed during each colonoscopy if the endoscope reaches the cecum. | It will be calculated through study completion, approximately 1 year, for all the study period using all participants having the colonoscopy done | 
| Intubation time | time lapse from the start of the exploration until cecum is reached. | it is assessed from the start of the colonoscopy until cecum is reached (1 day) | 
| Withdrawal time | Time lapse between cecum withdrawal the end of the exploration. | it is assessed from at the beginning of the withdrawal of the colonoscope until the colonoscopy is finished. (procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bowel preparation, low residue diet, colonoscopy