Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy

Not Applicable

Completed

• Conditions: Colonoscopy; Colon Adenoma; Inflammatory Bowel Diseases; Colorectal Neoplasms; Colon Disease
• Interventions: Other: 1 day low residue diet; Other: 3 day low residue diet

• Registration Number: NCT03763266
• Lead Sponsor: Parc Taulí Hospital Universitari

Brief Summary

Colonoscopy is the gold-standard for the evaluation of the colorectal mucosa. Colonoscopy quality indicators are the adenoma detection rate, the rate of cecal intubation and the bowel preparation.

The role of diet in preparing for colonoscopy is not fully established. Currently there is not enough evidence available to choice between 3 days of low residue diet versus 1 day.

The research hypothesis is that the low residue diet offers a non-inferior bowel preparation and an improved tolerance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-10
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Study Start: 2018-12-06
• Primary Completion: 2019-11-10
• Study Completion: 2020-01-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 858

Inclusion Criteria

• Participants in the colorectal cancer screening program that give consent

Exclusion Criteria

• Contraindication for colonoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 day low residue diet	1 day low residue diet	Patients are instructed to complete a low residue diet exclusively one day prior the colonoscopy.
3 days low residue diet	3 day low residue diet	Patients are instructed to complete a low residue diet three days prior the colonoscopy.

Primary Outcome Measures

Name	Time	Method
Bowel preparation	During the colonoscopy	Measured with the Boston Bowel Preparation Scale from 0 until 9. 9 represents an excellent preparation.

Secondary Outcome Measures

Name	Time	Method
Endoscopic diagnosis	It is assessed during the colonoscopy and will be reported the same day.	Final endoscopic diagnosis. For example; normal, diverticulosis, polyps, colorectal cancer, etc.
Diet tolerance	It is reported before entering the endoscopy room. Regarding the 3 or 1 days on low fiber diet depending on which study group is the participant.	Using Likert scale. From 1 to 5, lower is better tolerance.
Withdrawal time	it is assessed from at the beginning of the withdrawal of the colonoscope until the colonoscopy is finished. (procedure)	Time lapse between cecum withdrawal the end of the exploration.
Adenoma detection rate	up to 2 weeks after colonoscopy depending on pathology department workload.	Proportion of colonoscopies with detection of colorectal cancer or adenoma excluding distal hyperplastic
Intubation time	it is assessed from the start of the colonoscopy until cecum is reached (1 day)	time lapse from the start of the exploration until cecum is reached.
Cecum intubation rate	It will be calculated through study completion, approximately 1 year, for all the study period using all participants having the colonoscopy done	Cecum intubation will be assessed during each colonoscopy if the endoscope reaches the cecum.
Preparation tolerance	It is reported before entering the endoscopy room. Regarding the 3 or 1 day on bowel preparation depending on which study group is the participant.	Using Likert scale. From 1 to 5, lower is better tolerance.

Trial Locations

Locations (1)

Hospital Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain