Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy

NCT ID: NCT03763266

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

858 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-06

Study Completion Date

2020-01-20

Brief Summary

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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

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Conditions

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Colonoscopy Colon Adenoma Colorectal Neoplasms Inflammatory Bowel Diseases Colon Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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1 day low residue diet

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

Group Type EXPERIMENTAL

1 day low residue diet

Intervention Type OTHER

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 days low residue diet

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

Group Type ACTIVE_COMPARATOR

3 day low residue diet

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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low fiber diet low fiber diet

Eligibility Criteria

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Inclusion Criteria

* Participants in the colorectal cancer screening program that give consent

Exclusion Criteria

* Contraindication for colonoscopy
Minimum Eligible Age

50 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Parc Taulí Hospital Universitari

OTHER

Sponsor Role lead

Responsible Party

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Salvador Machlab

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva Martínez, PhD

Role: STUDY_DIRECTOR

Corporació Sanitaria Parc Taulí

Salvador Machlab, MD

Role: PRINCIPAL_INVESTIGATOR

Corporació Sanitaria Parc Taulí

Rafel Campo, PhD

Role: STUDY_DIRECTOR

Corporació Sanitaria Parc Taulí

Locations

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Hospital Parc Taulí

Sabadell, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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2017308

Identifier Type: -

Identifier Source: org_study_id

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