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AzTrials

Colorectal CancerCriLiNCT04664543

Efficacy of Free Versus Low Residue Diet as Preparation for Screening Colonoscopy

A study testing Free diet and Three days low residue diet in people with Colorectal Cancer and Colon Polyp, run by Parc Taulí Hospital Universitari at 1 site in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

One tricky aspect of the recommendations for colonoscopy prep is diet. This has a significant impact on the experience of the patient or participant in the screening program and, on the other hand, low adherence has been found in some studies despite a potential Hawthorne effect . Read more about this study

Who is it for?
Ages 50 to 69 years
Conditions the study is for
Colorectal Cancer, Colon Polyp, Colon Adenoma
What is being tested?
Free diet and Three days low residue diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSpain
Study dates
1 Dec 2019to 30 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women between 50 and 69 years old.
  • Participants in the Program for the Early Detection of Colorectal Cancer with a positive result in the test for detecting occult blood in feces
  • That they accept a colonoscopy and that they agree to participate in the study.

Who cannot join

  • Contraindication to performing a colonoscopy.
  • Severe renal insufficiency (<30 ml / min).
  • Known hypersensitivity or allergy to polyethylene glycol, ascorbic acid or sulfate.
  • Known glucose-6-phosphate dehydrogenase deficiency.
  • Known phenylketonuria.
  • Known dyselectrolytemia: hyper / hyponatremia, hyperphosphatemia, hypermagnesemia, hyper / hypokalemia, hypocalcemia.
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  • Gastric emptying disorders: Known gastroparesis.
  • Known hypoalbuminemia less than 3.4 g / dl.
  • Crohn's disease or known ulcerative colitis.
  • Participants with difficult-to-control hypertension (SBP> 170mmHg or TAD> 100mmHg) or NYHA grade III or IV heart failure.
  • Ascites of any etiology
  • People with cognitive impairment or mental illness that makes it difficult to adhere to instructions.
  • People who do not understand Catalan or Spanish.
  • Factors of poor preparation: liver cirrhosis, diabetes mellitus, treatment with tricyclic antidepressants, opioids or neuroleptics, limited mobility, chronic constipation, history of colon or intestinal resection (appendectomy is not an exclusion criterion), poor preparation in previous colonoscopy Parkinson's disease, multiple sclerosis.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Universitari Parc Taulí

    Sabadell, Barcelona, 08208

Other trials in Spain

About this study

Official title: Efficacy of Free Versus Low Residue Diet as Preparation for Screening Colonoscopy: CriLi Study, a Pilot Trial

One tricky aspect of the recommendations for colonoscopy prep is diet. This has a significant impact on the experience of the patient or participant in the screening program and, on the other hand, low adherence has been found in some studies despite a potential Hawthorne effect . It is noteworthy that despite its impact on patient experience, it is an area for which little evidence is available, which is why the guidelines give low-quality recommendations and there is probably considerable variability in clinical practice .

In the early days of colonoscopy, a liquid diet for 48 hours was mainly recommended, although some centers indicated a low-residue diet or even the commercially available NASA astronaut diet. Later, the indication for a liquid diet was consolidated until finally numerous studies were published in favor of a low-residue diet, managing to increase tolerance and the quality of the preparation . A limitation of the preparation studies must be borne in mind that the colon cleansing rating scales were not introduced until 1999 when the Aronchick scale was published.

Read more

Although there is solid evidence in favor of a low-residue diet versus a liquid diet, the investigators do not have evidence on how many days of a low-residue diet should be recommended, and this is reflected in the ESGE (European Society of Gastrointestinal Endoscopy) and ASGE (American Society of Gastrointestinal Endoscopy) guidelines . A randomized clinical trial comparing 3 days versus 1 day of a low residue diet has recently been published . There were no statistically significant differences in the rate of adequate preparations (82.7% vs. 85.6% OR 1.2 95% IC 0.72 to 2.15). However, this study has limited statistical power and a design that allows a non-inferiority analysis has not been followed. In relation to this, our research group is finalizing a non-inferiority clinical trial in whose intermediate analysis, with 421 participants, the non-inferiority of 1 day of diet is fulfilled (rate of poor preparation in 1 day 0.95% vs. 4.74% in 3 days; d + 5%, difference -3.78% IC -6.88% to -1.12%) (38).

It is likely, taking into account the available evidence and its evolution, that diet plays a secondary role in preparation. Although no studies designed to directly assess this have been conducted, the research group has indirect data.

Walter et al, under the hypothesis that the impact of the fractional preparation and the new preparations on the preparation diminished the importance of the diet, conducted a non-inferiority clinical trial between 2012 and 2013 in which they randomized the patients to follow a diet liquid versus low residue for one day and fractional preparation with Moviprep (39). They established a non-inferiority margin of -13.5%. Their results show a rate of good preparation (Boston> 5) in 68/72 (94.4%) in a liquid diet compared to 60/68 (88.2%) in a low-residue diet (p = 0.04) with a difference of -5.08% demonstrating non-inferiority of the low residue diet.

Being tested
Free diet, Three days low residue diet
Keywords
colonoscopy, bowel cleansing, low fiber diet, colonoscopy preparation
Medical subject headings
Colorectal Neoplasms, Colonic Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Free dietOther

    Also called Liberal diet, habitual diet

    To follow the regular dietary habits with no restriction nor modification.

  • Three days low residue dietOther

    Also called low fiber diet

    To follow the three days before colonoscopy a diet with low content in fiber or residues.

Study groups in NCT04664543
Study groupRoleWhat they receive
3 days of low residue dietActive comparatorCurrently participants in the colorectal cancer screening program follow a 3 days low residue diet before colonoscopy. This is the active comparator arm of this study.
Receives: Other: Three days low residue diet
Free dietExperimentalParticipants assigned to this arm are NOT instructed to follow any kind of restriction in the diet before colonoscopy.
Receives: Other: Free diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adequate bowel cleansing

    Bowel cleansing has 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

    Measured: During colonoscopy (At the withdrawal phase)

Secondary outcomes (9)
  1. Diet tolerability

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

    Measured: The day of the colonoscopy just before beginning

  2. Preparation tolerability

    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.

    Measured: The day of the colonoscopy just before beginning

  3. Adenoma detection

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

    Measured: adenoma detection is done during the colonoscopy but assesment will be done at the end of the study with the histology reports

  4. Polyp detection

    Polyp detection in the colonoscopy as reported by the endoscopist.

    Measured: During colonoscopy

  5. Ceacal intubation time

    Time expended in reaching the cecum

    Measured: During colonoscopy

  6. Withdrawal time

    Time expended in the withdrawal from cecum till the anus.

    Measured: During colonoscopy

  7. Excellent cleansing

    Colonoscopy achieving a Boston Bowel Preparation Scale (BBPS) of at least 8 points or above. BBPS global score ranges from 0 to 9, being 9 the best cleansing outcome.

    Measured: During colonoscopy

  8. Information perceived quality

    Perceived quality of the instructions and education received for the colonoscopy. preparation by the participant. Assessed using a likert scale from 0 to 5. Five is the best outcome and 0 the worst.

    Measured: The day of the colonoscopy just before beginning

  9. Preparation quality in each segment

    Boston Bowel Preparation Score in each segment, it ranges from 0 to 3 being 3 the best cleansing outcome and 0 the worst.

    Measured: During colonoopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2020
  2. Study start1 Dec 2019
  3. Primary completion30 Dec 2020
  4. Study completion30 Dec 2020

Why it stopped: Organization and logistic problems due to COVID19 pandemy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04664543
Sponsor's protocol ID
2019307
Acronym
CriLi
Status last verified
Jan 2021
First submitted
6 Dec 2020
Last updated
26 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Machlab Mashlab S, Martinez-Bauer E, Lopez P, Pujals MDM, Fernandez-Banares F, Selva A, Calvet X, Campo R. Unrestricted vs three-day low-residue diet for colonoscopy preparation. Results of a feasibility randomized trial. Rev Esp Enferm Dig. 2025 Jun;117(6):349-350. doi: 10.17235/reed.2024.10417/2024.

    PubMed 38591600

Questions about this trial

What is this clinical trial studying?

A study testing Free diet and Three days low residue diet in people with Colorectal Cancer and Colon Polyp, run by Parc Taulí Hospital Universitari at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Organization and logistic problems due to COVID19 pandemy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adequate bowel cleansing (time frame: During colonoscopy (At the withdrawal phase)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04664543, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.

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