Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy

Inflammatory Bowel Diseases Clinical Trial

Official title:

Low Residue Diet 3 Days Versus 1 Day as Preparation for Colonoscopy: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03763266
• Other study ID #: 2017308
• Status: Completed
• Phase: N/A
• Start date: December 6, 2018
• Est. completion date: January 20, 2020

Study information

• Verified date: February 2020
• Source: Hospital Parc Taulí, Sabadell
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 858
• Est. completion date: January 20, 2020
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

Inclusion Criteria:

• Participants in the colorectal cancer screening program that give consent

Exclusion Criteria:

• Contraindication for colonoscopy

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma
• Colon Disease
• Colonic Diseases
• Colonoscopy
• Colorectal Neoplasms
• Inflammatory Bowel Diseases

Intervention

Other:
• 1 day low residue diet
Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy.
• 3 day low residue diet
Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy.

Locations

Country	Name	City	State
Spain	Hospital Parc Taulí	Sabadell	Barcelona

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	Bowel preparation	Measured with the Boston Bowel Preparation Scale from 0 until 9. 9 represents an excellent preparation.	During the colonoscopy
Secondary	Diet tolerance	Using Likert scale. From 1 to 5, lower is better 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.
Secondary	Preparation tolerance	Using Likert scale. From 1 to 5, lower is better 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.
Secondary	Adenoma detection rate	Proportion of colonoscopies with detection of colorectal cancer or adenoma excluding distal hyperplastic	up to 2 weeks after colonoscopy depending on pathology department workload.
Secondary	Endoscopic diagnosis	Final endoscopic diagnosis. For example; normal, diverticulosis, polyps, colorectal cancer, etc.	It is assessed during the colonoscopy and will be reported the same day.
Secondary	Cecum intubation rate	Cecum intubation will be assessed during each colonoscopy if the endoscope reaches the cecum.	It will be calculated through study completion, approximately 1 year, for all the study period using all participants having the colonoscopy done
Secondary	Intubation time	time lapse from the start of the exploration until cecum is reached.	it is assessed from the start of the colonoscopy until cecum is reached (1 day)
Secondary	Withdrawal time	Time lapse between cecum withdrawal the end of the exploration.	it is assessed from at the beginning of the withdrawal of the colonoscope until the colonoscopy is finished. (procedure)