Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Inflammatory Bowel Diseases; Colonoscopy; Colon Adenoma; Colon Disease
• Intervention / Treatment: Other: 1 day low residue diet; Other: 3 day low residue diet

• Study Type: Interventional
• Enrollment (Actual): 858
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Hospital Parc Tauli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants in the colorectal cancer screening program that give consent

Exclusion Criteria:

• Contraindication for colonoscopy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1 day low residue diet; Patients are instructed to complete a low residue diet exclusively one day prior the colonoscopy.	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.; Other Names: low fiber diet
ACTIVE_COMPARATOR: 3 days low residue diet; Patients are instructed to complete a low residue diet three days prior the colonoscopy.	Other: 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.; Other Names: low fiber diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel preparation	Measured with the Boston Bowel Preparation Scale from 0 until 9. 9 represents an excellent preparation.	During the colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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
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)
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)

Collaborators and Investigators

• Sponsor: Hospital Parc Taulí, Sabadell
• Investigators: Study Director: Eva Martínez, PhD, Corporacio Sanitaria Parc Tauli; Principal Investigator: Salvador Machlab, MD, Corporacio Sanitaria Parc Tauli; Study Director: Rafel Campo, PhD, Corporacio Sanitaria Parc Tauli

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 6, 2018
• Primary Completion (ACTUAL): November 10, 2019
• Study Completion (ACTUAL): January 20, 2020

Study Registration Dates

• First Submitted: November 10, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (ACTUAL): December 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: colonoscopy; bowel preparation; low residue diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Inflammatory Bowel Diseases; Adenoma; Colonic Diseases
• Other Study ID Numbers: 2017308

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No