NCT03763266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
858

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

December 6, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

11 months

First QC Date

November 10, 2018

Last Update Submit

February 10, 2020

Conditions

ColonoscopyColon AdenomaColorectal NeoplasmsInflammatory Bowel DiseasesColon Disease

Keywords

bowel preparationlow residue dietcolonoscopy

Outcome Measures

Primary Outcomes (1)

  • Bowel preparation

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

    During the colonoscopy

Secondary Outcomes (7)

  • 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.

  • 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.

  • Adenoma detection rate

    up to 2 weeks after colonoscopy depending on pathology department workload.

  • Endoscopic diagnosis

    It is assessed during the colonoscopy and will be reported the same day.

  • 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

  • +2 more secondary outcomes

Study Arms (2)

1 day low residue diet

EXPERIMENTAL

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

Other: 1 day low residue diet

3 days low residue diet

ACTIVE COMPARATOR

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

Other: 3 day low residue diet

Interventions

1 day low residue dietOTHER

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.

Also known as: low fiber diet
1 day low residue diet
3 day low residue dietOTHER

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.

Also known as: low fiber diet
3 days low residue diet

Eligibility Criteria

Age50 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants in the colorectal cancer screening program that give consent

You may not qualify if:

  • Contraindication for colonoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Colorectal NeoplasmsInflammatory Bowel DiseasesColonic Diseases

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesGastroenteritis

Study Officials

  • Eva Martínez, PhD

    Corporació Sanitaria Parc Taulí

    STUDY DIRECTOR

  • Salvador Machlab, MD

    Corporació Sanitaria Parc Taulí

    PRINCIPAL INVESTIGATOR

  • Rafel Campo, PhD

    Corporació Sanitaria Parc Taulí

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 10, 2018

First Posted

December 4, 2018

Study Start

December 6, 2018

Primary Completion

November 10, 2019

Study Completion

January 20, 2020

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

ES(1)