Colon Adenoma, Colon Disease, Colonoscopy, Colorectal Neoplasms, Inflammatory Bowel Diseases
Conditions
Keywords
bowel preparation, low residue diet, colonoscopy
Brief summary
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.
Interventions
OTHER1 day low residue diet
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.
OTHER3 day low residue diet
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.
Sponsors
Parc Taulí Hospital Universitari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants in the colorectal cancer screening program that give consent
Exclusion criteria
* Contraindication for colonoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel preparation | During the colonoscopy | Measured with the Boston Bowel Preparation Scale from 0 until 9. 9 represents an excellent preparation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preparation 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. | Using Likert scale. From 1 to 5, lower is better tolerance. |
| Adenoma detection rate | up to 2 weeks after colonoscopy depending on pathology department workload. | Proportion of colonoscopies with detection of colorectal cancer or adenoma excluding distal hyperplastic |
| Endoscopic diagnosis | It is assessed during the colonoscopy and will be reported the same day. | Final endoscopic diagnosis. For example; normal, diverticulosis, polyps, colorectal cancer, etc. |
| Diet 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. | Using Likert scale. From 1 to 5, lower is better tolerance. |
| Intubation time | it is assessed from the start of the colonoscopy until cecum is reached (1 day) | time lapse from the start of the exploration until cecum is reached. |
| Withdrawal time | it is assessed from at the beginning of the withdrawal of the colonoscope until the colonoscopy is finished. (procedure) | Time lapse between cecum withdrawal the end of the exploration. |
| Cecum intubation rate | It will be calculated through study completion, approximately 1 year, for all the study period using all participants having the colonoscopy done | Cecum intubation will be assessed during each colonoscopy if the endoscope reaches the cecum. |
Countries
Spain
Outcome results
None listed