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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05032794
Other study ID # 2021/3009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 13, 2021
Est. completion date September 1, 2022

Study information

Verified date December 2022
Source Hospital Parc Taulí, Sabadell
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Unrestricted diet before colonoscopy
Free diet, without restrictions
1-day low residue diet
To follow a diet low in residues / fiber. the day before the colonoscopy.
Drug:
Bisacodyl 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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Hospital Parc Taulí, Sabadell

Country where clinical trial is conducted

Spain, 

Outcome

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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