Colonoscopy Clinical Trial
— CriLiPOfficial title:
Unrestricted Diet vs 1-day Low Residue Diet for Screening Colonoscopy
Verified date | December 2022 |
Source | Hospital Parc Taulí, Sabadell |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 553 |
Est. completion date | September 1, 2022 |
Est. primary completion date | August 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de Mataró. Consorci Sanitari del Maresme. | Mataró | Barcelona |
Spain | Hospital Universitari Parc Taulí | Sabadell | Barcelona |
Spain | Hospital Universitario de Canarias | San Cristóbal de la Laguna | Santa Cruz De Tenerife |
Spain | Consorci Sanitari de Terrassa | Terrassa | |
Spain | Hospital Universitary Mutua de Terrassa | Terrassa |
Lead Sponsor | Collaborator |
---|---|
Hospital Parc Taulí, Sabadell |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Rate of colonoscopies with polyps | Polyp detection in the colonoscopy as reported by the endoscopist. | During colonoscopy | |
Secondary | Cecal intubation time | Time expended in reaching the cecum | During colonoscopy | |
Secondary | Withdrawal time | Time expended in the withdrawal from cecum till the anus. | During colonoscopy | |
Secondary | 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 | |
Secondary | 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) | |
Secondary | 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 |
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