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Completed

NCT Number: NCT05032794

Unrestricted Diet for Screening Colonoscopy

Colonoscopy is the technique of choice for the evaluation of the mucosa of the colon. To be able to do the procedure in optimal conditions, it needs to be clean. Therefore, it is necessary to carry out a preparation as safe and tolerable as possible. This preparation generally consists in a low residue diet the days before the colonoscopy and in the intake of a laxative solution. In previous studies, it has been shown that the low residue diet does not play a relevant role as it was considered before. Recent studies demonstrated that reducing the days of low residue diet does not worsen the cleansing and improves the patient experience. The results of this study are required for determining the role of diet restrictive diet in colon cleansing.

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Key information

Conditions

Bowel Cleansing Bowel Cancer Colonoscopy Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Mataró. Consorci Sanitari del Maresme., Mataró, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individuals on the early colorectal cancer detection program who agreed to undergo colonoscopy after positive results on the fecal immunochemical test (FIT)

Exclusion criteria

  • Individuals in which colonoscopy, cleansing solution or bisacodyl are contraindicated
  • Subjects that are considered to have a linguistic barrier or to be unable to understand the instructions and / or give informed consent.

Treatment and study plan

Unrestricted diet before colonoscopy

Other

Free diet, without restrictions

1-day low residue diet

Other

To follow a diet low in residues / fiber. the day before the colonoscopy.

Bisacodyl 5 mg

Drug

If the participant is at risk of inadequate bowel cleansing, defined by a score of Dik et al ≥ 2 it will be given Bisacodyl 5 milgrams bid for 3 days.

Primary outcomes

  1. Adequate bowel cleansing

    Time frame: During colonoscopy (At the withdrawal phase)

    Bowel cleansing as a rating using the Boston Bowel Preparation Scale above 1 in each segment . This score ranges fron 0 to 3 in each one of the three segments. Zero is the worst outcome and 3 is the best cleansing

Secondary outcomes

  1. Diet tolerability as assessed by a likert scale

    Time frame: The day of the colonoscopy just before beginning

    Tolerance to the diet assigned to the participant measured with a likert scale from 0 to 5, 0 the worst ad 5 the best.

  2. Preparation tolerability as assessed by a likert scale and Hatoum et al. survey

    Time frame: The day of the colonoscopy just before beginning

    Tolerance to the cleansing solution used for bowel cleansing measured with a likert scale from 0 to 5, 0 the worst ad 5 the best.

    Hatoum et al is a validated survey designed for assessing bowel preparation tolerability DOI 10.1007/s40271-015-0154-8

  3. Rate of colonoscopies with adenoma

    Time frame: With histology report, an average of 4 weeks after colonoscopy

    An adenoma was detected, resected and confirmed by the histology report in the colonoscopy.

  4. Rate of colonoscopies with polyps

    Time frame: During colonoscopy

    Polyp detection in the colonoscopy as reported by the endoscopist.

  5. Cecal intubation time

    Time frame: During colonoscopy

    Time expended in reaching the cecum

  6. Withdrawal time

    Time frame: During colonoscopy

    Time expended in the withdrawal from cecum till the anus.

  7. Information perceived quality assessed by a likert scale

    Time frame: The day of the colonoscopy just before beginning

    Perceived quality of the instructions and education received for the colonoscopy preparation by the participant. Assessed using a likert scale

  8. Entry bowel cleansing as assessed by the modified Boston Bowel Preparation Scale

    Time frame: During colonoscopy (At the entry phase)

    Bowel cleansing during cecum intubation phase assessed using a modified Boston Bowel Preparation Scale which is without considering any additional cleansing during the endoscopy.

  9. Rate of colonoscopies with flat polyps

    Time frame: During colonoscopy

    Flat polyp detection defined by Paris criteria: no polypoid nor ulcerated (Paris 0-IIa/b/c) in the colonoscopy as reported by the endoscopist.

Sponsors and collaborators

Lead sponsor

Parc Taulí Hospital Universitari

Other

Registry information

Official study title

Unrestricted Diet vs 1-day Low Residue Diet for Screening Colonoscopy

Acronym: CriLiP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 2, 2021
Registry last updated
Dec 7, 2022

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

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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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