Clinical Trials Directory

Trials / Completed

CompletedNCT02401802

Low-fiber Diet for Colorectal Cancer Screening Colonoscopy

Low-fiber Diet for Colorectal Cancer Screening Colonoscopy. Randomized Clinical Trial. Dietcol Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
276 (actual)
Sponsor
Parc de Salut Mar · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This trial will compare the efficacy of 2 different sets of dietary recommendations to be followed before colon cleansing for colorectal cancer screening colonoscopy.

Detailed description

There is no enough evidence in the literature to recommend a low-fiber diet for screening colonoscopy. Although evidence of benefit of a liquid diet is minimal and there is a growing body of evidence about the benefits of a liberalized diet, a high degree of heterogeneity in the clinical trials comparing the diet modifications before colonoscopy prevents a formal recommendation in current guidelines. A low-fiber diet the day before colonoscopy may result in same efficacy of bowel cleanliness, with an improved tolerability and acceptability. All consecutive patients of a population-based colorectal screening cancer program referred for a colonoscopy will be invited to participate in the study. After obtaining informed consent, they will be randomized to one of the groups: liquid diet or low-fiber diet. The will be interviewed by a registered research nurse, and they will be provided with written instructions for bowel preparation and questionnaires for registering the data of the study. The day of the colonoscopy, questionnaires will be collected and endoscopists blinded for the study bowel preparation will perform the colonoscopy. Patients will be contacted for adverse events and a general satisfaction questionnaire, 3 days after colonoscopy.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTLow-residue dietSubjects will be instructed by members of the research team to follow a standardized low residue diet for 4 days
DIETARY_SUPPLEMENTUsual careSubjects will be instructed by members of the research team to follow a low-residue diet for 3 days followed by 24 hours of liquid diet

Timeline

Start date
2015-01-01
Primary completion
2015-06-01
Completion
2015-12-01
First posted
2015-03-30
Last updated
2017-02-15

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT02401802. Inclusion in this directory is not an endorsement.