Unrestricted Diet for Screening Colonoscopy

Not Applicable

Completed

• Conditions: Bowel Cleansing; Bowel Cancer; Colonoscopy
• Interventions: Other: 1-day low residue diet; Other: Unrestricted diet before colonoscopy; Drug: Bisacodyl 5 MG

• Registration Number: NCT05032794
• Lead Sponsor: Parc Taulí Hospital Universitari

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-09-01
• Study First Posted: 2021-09-02
• Study Start: 2021-10-13
• Primary Completion: 2022-08-19
• Study Completion: 2022-09-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-04
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 553

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unrestricted diet	Bisacodyl 5 MG	The participant is not instructed to follow any dietary recommendation before colonoscopy. But only the restriction and fasting required for sedation.
One day low residue diet	1-day low residue diet	The participant is instructed to follow a low residue diet the day before the colonoscopy. It will be given a informative document and educated by a nurse.
Unrestricted diet	Unrestricted diet before colonoscopy	The participant is not instructed to follow any dietary recommendation before colonoscopy. But only the restriction and fasting required for sedation.
One day low residue diet	Bisacodyl 5 MG	The participant is instructed to follow a low residue diet the day before the colonoscopy. It will be given a informative document and educated by a nurse.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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 polyps	During colonoscopy	Polyp detection in the colonoscopy as reported by the endoscopist.
Cecal intubation time	During colonoscopy	Time expended in reaching the cecum
Withdrawal time	During colonoscopy	Time expended in the withdrawal from cecum till the anus.
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.

Trial Locations

Locations (5)

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Spain

Hospital de Mataró. Consorci Sanitari del Maresme.; 🇪🇸 Mataró, Barcelona, Spain

Hospital Universitario de Canarias; 🇪🇸 San Cristóbal de la Laguna, Santa Cruz De Tenerife, Spain

Hospital Universitari Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Universitary Mutua de Terrassa; 🇪🇸 Terrassa, Spain