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Completed

NCT Number: NCT02401802

Low-fiber Diet for Colorectal Cancer Screening Colonoscopy

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar

Barcelona, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-residue diet

Dietary Supplement

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

Usual care

Dietary Supplement

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

Primary outcomes

  1. Inadequate bowel preparation.

    Time frame: 1 hour after the colonoscopy

    The 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 outcomes

  1. Cecal intubation rate

    Time frame: 1 hour after the colonoscopy

    Ratio of successful cecal intubations in each study arm

  2. Adenoma detection rate

    Time frame: 1 hour after the colonoscopy

    Ratio of polyps and adenomas detected in each study arm

  3. Polyp detection rate

    Time frame: 1 hour after the colonoscopy

    Ratio of polyps and adenomas detected in each study arm

  4. Abdominal pain

    Time frame: 6 hours after finishing bowel preparation

    Each participant will rate his/her experience in an analogue visual scale

  5. Nausea

    Time frame: 6 hours after finishing bowel preparation

    Each participant will rate his/her experience in an analogue visual scale

  6. Hunger

    Time frame: 6 hours after finishing bowel preparation

    Each participant will rate his/her experience in an analogue visual scale

  7. Bloating

    Time frame: 6 hours after finishing bowel preparation

    Each participant will rate his/her experience in an analogue visual scale

  8. Adverse events

    Time frame: 30 days after the colonoscopy

    Description of all spontaneously reported adverse events.

  9. Adherence to the planned bowel cleansing method (questionnaire)

    Time frame: 6 hours after finishing bowel preparation

    Each participant will rate his/her experience in a questionnaire.

  10. Acceptability of the preparation (interference with work, leisure activities or sleep

    Time frame: 6 hours after finishing bowel preparation

    Each participant will rate his/her experience in a questionnaire.

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

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

Acronym: DIETCOL

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 30, 2015
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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