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Completed

NCT Number: NCT03763266

Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy

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.

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Key information

Conditions

Colonoscopy Colon Adenoma Colon Disease Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants in the colorectal cancer screening program that give consent

Exclusion criteria

  • Contraindication for colonoscopy

Treatment and study plan

1 day low residue diet

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.

Other names: low fiber diet

3 day low residue diet

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.

Other names: low fiber diet

Primary outcomes

  1. Bowel preparation

    Time frame: During the colonoscopy

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

Secondary outcomes

  1. Diet tolerance

    Time frame: 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.

    Using Likert scale. From 1 to 5, lower is better tolerance.

  2. Preparation tolerance

    Time frame: 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.

    Using Likert scale. From 1 to 5, lower is better tolerance.

  3. Adenoma detection rate

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

    Proportion of colonoscopies with detection of colorectal cancer or adenoma excluding distal hyperplastic

  4. Endoscopic diagnosis

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

    Final endoscopic diagnosis. For example; normal, diverticulosis, polyps, colorectal cancer, etc.

  5. Cecum intubation rate

    Time frame: It will be calculated through study completion, approximately 1 year, for all the study period using all participants having the colonoscopy done

    Cecum intubation will be assessed during each colonoscopy if the endoscope reaches the cecum.

  6. Intubation time

    Time frame: it is assessed from the start of the colonoscopy until cecum is reached (1 day)

    time lapse from the start of the exploration until cecum is reached.

  7. Withdrawal time

    Time frame: it is assessed from at the beginning of the withdrawal of the colonoscope until the colonoscopy is finished. (procedure)

    Time lapse between cecum withdrawal the end of the exploration.

Sponsors and collaborators

Lead sponsor

Parc Taulí Hospital Universitari

Other

Registry information

Official study title

Low Residue Diet 3 Days Versus 1 Day as Preparation for Colonoscopy: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 4, 2018
Registry last updated
Feb 12, 2020

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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