Bowel Cleansing, Colonoscopy, Bowel Cancer
Conditions
Keywords
bowel cleansing, Diet, Low residue diet
Brief summary
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.
Interventions
OTHERUnrestricted diet before colonoscopy
Free diet, without restrictions
OTHER1-day low residue diet
To follow a diet low in residues / fiber. the day before the colonoscopy.
DRUGBisacodyl 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.
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 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate bowel cleansing | During colonoscopy (At the withdrawal phase) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preparation tolerability as assessed by a likert scale and Hatoum et al. survey | The day of the colonoscopy just before beginning | 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 |
| Rate of colonoscopies with adenoma | With histology report, an average of 4 weeks after colonoscopy | An adenoma was detected, resected and confirmed by the histology report in the colonoscopy. |
| Rate of colonoscopies with polyps | During colonoscopy | Polyp detection in the colonoscopy as reported by the endoscopist. |
| Cecal intubation time | During colonoscopy | Time expended in reaching the cecum |
| Diet tolerability as assessed by a likert scale | The day of the colonoscopy just before beginning | Tolerance to the diet assigned to the participant measured with a likert scale from 0 to 5, 0 the worst ad 5 the best. |
| Information perceived quality assessed by a likert scale | The day of the colonoscopy just before beginning | Perceived quality of the instructions and education received for the colonoscopy preparation by the participant. Assessed using a likert scale |
| Entry bowel cleansing as assessed by the modified Boston Bowel Preparation Scale | During colonoscopy (At the entry phase) | Bowel cleansing during cecum intubation phase assessed using a modified Boston Bowel Preparation Scale which is without considering any additional cleansing during the endoscopy. |
| Rate of colonoscopies with flat polyps | During colonoscopy | Flat polyp detection defined by Paris criteria: no polypoid nor ulcerated (Paris 0-IIa/b/c) in the colonoscopy as reported by the endoscopist. |
| Withdrawal time | During colonoscopy | Time expended in the withdrawal from cecum till the anus. |
Countries
Spain
Outcome results
None listed