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Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy

Primary Purpose

Colonoscopy, Colon Adenoma, Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
1 day low residue diet
3 day low residue diet
Sponsored by
Parc Taulí Hospital Universitari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonoscopy focused on measuring bowel preparation, low residue diet, colonoscopy

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants in the colorectal cancer screening program that give consent

Exclusion Criteria:

  • Contraindication for colonoscopy

Sites / Locations

  • Hospital Parc Taulí

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 day low residue diet

3 days low residue diet

Arm Description

Patients are instructed to complete a low residue diet exclusively one day prior the colonoscopy.

Patients are instructed to complete a low residue diet three days prior the colonoscopy.

Outcomes

Primary Outcome Measures

Bowel preparation
Measured with the Boston Bowel Preparation Scale from 0 until 9. 9 represents an excellent preparation.

Secondary Outcome Measures

Diet tolerance
Using Likert scale. From 1 to 5, lower is better tolerance.
Preparation tolerance
Using Likert scale. From 1 to 5, lower is better tolerance.
Adenoma detection rate
Proportion of colonoscopies with detection of colorectal cancer or adenoma excluding distal hyperplastic
Endoscopic diagnosis
Final endoscopic diagnosis. For example; normal, diverticulosis, polyps, colorectal cancer, etc.
Cecum intubation rate
Cecum intubation will be assessed during each colonoscopy if the endoscope reaches the cecum.
Intubation time
time lapse from the start of the exploration until cecum is reached.
Withdrawal time
Time lapse between cecum withdrawal the end of the exploration.

Full Information

First Posted
November 10, 2018
Last Updated
February 10, 2020
Sponsor
Parc Taulí Hospital Universitari
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1. Study Identification

Unique Protocol Identification Number
NCT03763266
Brief Title
Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy
Official Title
Low Residue Diet 3 Days Versus 1 Day as Preparation for Colonoscopy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 6, 2018 (Actual)
Primary Completion Date
November 10, 2019 (Actual)
Study Completion Date
January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc Taulí Hospital Universitari

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy, Colon Adenoma, Colorectal Neoplasms, Inflammatory Bowel Diseases, Colon Disease
Keywords
bowel preparation, low residue diet, colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
858 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 day low residue diet
Arm Type
Experimental
Arm Description
Patients are instructed to complete a low residue diet exclusively one day prior the colonoscopy.
Arm Title
3 days low residue diet
Arm Type
Active Comparator
Arm Description
Patients are instructed to complete a low residue diet three days prior the colonoscopy.
Intervention Type
Other
Intervention Name(s)
1 day low residue diet
Other Intervention Name(s)
low fiber diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
3 day low residue diet
Other Intervention Name(s)
low fiber diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bowel preparation
Description
Measured with the Boston Bowel Preparation Scale from 0 until 9. 9 represents an excellent preparation.
Time Frame
During the colonoscopy
Secondary Outcome Measure Information:
Title
Diet tolerance
Description
Using Likert scale. From 1 to 5, lower is better tolerance.
Time Frame
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.
Title
Preparation tolerance
Description
Using Likert scale. From 1 to 5, lower is better tolerance.
Time Frame
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.
Title
Adenoma detection rate
Description
Proportion of colonoscopies with detection of colorectal cancer or adenoma excluding distal hyperplastic
Time Frame
up to 2 weeks after colonoscopy depending on pathology department workload.
Title
Endoscopic diagnosis
Description
Final endoscopic diagnosis. For example; normal, diverticulosis, polyps, colorectal cancer, etc.
Time Frame
It is assessed during the colonoscopy and will be reported the same day.
Title
Cecum intubation rate
Description
Cecum intubation will be assessed during each colonoscopy if the endoscope reaches the cecum.
Time Frame
It will be calculated through study completion, approximately 1 year, for all the study period using all participants having the colonoscopy done
Title
Intubation time
Description
time lapse from the start of the exploration until cecum is reached.
Time Frame
it is assessed from the start of the colonoscopy until cecum is reached (1 day)
Title
Withdrawal time
Description
Time lapse between cecum withdrawal the end of the exploration.
Time Frame
it is assessed from at the beginning of the withdrawal of the colonoscope until the colonoscopy is finished. (procedure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants in the colorectal cancer screening program that give consent Exclusion Criteria: Contraindication for colonoscopy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Martínez, PhD
Organizational Affiliation
Corporació Sanitaria Parc Taulí
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Salvador Machlab, MD
Organizational Affiliation
Corporació Sanitaria Parc Taulí
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rafel Campo, PhD
Organizational Affiliation
Corporació Sanitaria Parc Taulí
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain

12. IPD Sharing Statement

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Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy

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