Unrestricted Diet for Screening Colonoscopy

Colonoscopy Clinical Trial

— CriLiP  

Official title:

Unrestricted Diet vs 1-day Low Residue Diet for Screening Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05032794
• Other study ID #: 2021/3009
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Bowel Cancer
• Bowel Cleansing
• Colonoscopy

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