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Low-fiber Diet for Colorectal Cancer Screening Colonoscopy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02401802
Acronym
DIETCOL
Enrollment
276
Registered
2015-03-30
Start date
2015-01-31
Completion date
2015-12-31
Last updated
2017-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Diseases

Keywords

Colonoscopy, Diet, Polyethylene glycols, Efficacy, Personal satisfaction, Colorectal cancer screening

Brief 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.

Interventions

DIETARY_SUPPLEMENTLow-residue diet

Subjects will be instructed by members of the research team to follow a standardized low residue diet for 4 days

DIETARY_SUPPLEMENTUsual care

Subjects 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

Sponsors

Parc de Salut Mar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Consecutive patients referred for a colonoscopy in a population-based colorectal screening program.

Exclusion criteria

* Unwillingness to participate. * Inability to follow instructions * Active inflammatory bowel disease * Incomplete colonoscopies for technical reasons or contraindication as evaluated by the endoscopist

Design outcomes

Primary

MeasureTime frameDescription
Inadequate bowel preparation.1 hour after the colonoscopyThe efficacy of bowel preparation will be rated by blinded endoscopists using the Boston Bowel Preparation Scale (BBPS). Colonoscopies with a BBPS score of less than 5 points, or any segment rated less than 2 points will be considered with an inadequate bowel preparation

Secondary

MeasureTime frameDescription
Adenoma detection rate1 hour after the colonoscopyRatio of polyps and adenomas detected in each study arm
Polyp detection rate1 hour after the colonoscopyRatio of polyps and adenomas detected in each study arm
Abdominal pain6 hours after finishing bowel preparationEach participant will rate his/her experience in an analogue visual scale
Nausea6 hours after finishing bowel preparationEach participant will rate his/her experience in an analogue visual scale
Cecal intubation rate1 hour after the colonoscopyRatio of successful cecal intubations in each study arm
Bloating6 hours after finishing bowel preparationEach participant will rate his/her experience in an analogue visual scale
Adverse events30 days after the colonoscopyDescription of all spontaneously reported adverse events.
Adherence to the planned bowel cleansing method (questionnaire)6 hours after finishing bowel preparationEach participant will rate his/her experience in a questionnaire.
Acceptability of the preparation (interference with work, leisure activities or sleep6 hours after finishing bowel preparationEach participant will rate his/her experience in a questionnaire.
Hunger6 hours after finishing bowel preparationEach participant will rate his/her experience in an analogue visual scale

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026