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.
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.
Show all 14Show fewer
- 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.
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.
- Conditions
- Colorectal Cancer, Colon Polyp, Colon Adenoma
- 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 group | Role | What they receive |
|---|---|---|
| 3 days of low residue diet | Active comparator | Currently 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 diet | Experimental | Participants 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.
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)
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
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
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
Polyp detection
Polyp detection in the colonoscopy as reported by the endoscopist.
Measured: During colonoscopy
Ceacal intubation time
Time expended in reaching the cecum
Measured: During colonoscopy
Withdrawal time
Time expended in the withdrawal from cecum till the anus.
Measured: During colonoscopy
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
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
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.
- First posted11 Dec 2020
- Study start1 Dec 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Why it stopped: Organization and logistic problems due to COVID19 pandemy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Parc Taulí Hospital Universitari
- Sponsor type
- University, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa, Hospital Mutua de Terrassa
- Responsible party
- Principal investigator, Salvador Machlab, Parc Taulí Hospital Universitari
- Investigators
- Eva Martínez, PhD, Study director, Hospital Universitari Parc Taulí
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Free Versus Low Residue Diet as Preparation for Screening Colonoscopy: CriLi Study, a Pilot Trial
- ClinicalTrials.gov ID
- NCT04664543
- Acronym / sponsor ID
- CriLi / 2019307
- Conditions
- Colorectal Cancer, Colon Polyp, Colon Adenoma
- Keywords
- colonoscopy, bowel cleansing, low fiber diet, colonoscopy preparation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Organization and logistic problems due to COVID19 pandemy
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Parc Taulí Hospital UniversitariUniversity, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa, Hospital Mutua de Terrassa
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 days of low residue diet | Active comparator | Other: Three days low residue dietCurrently 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. |
| Free diet | Experimental | Other: Free dietParticipants assigned to this arm are NOT instructed to follow any kind of restriction in the diet before colonoscopy. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free dietAlso: Liberal diet, habitual dietTo follow the regular dietary habits with no restriction nor modification. | Other | Free diet |
| Three days low residue dietAlso: low fiber dietTo follow the three days before colonoscopy a diet with low content in fiber or residues. | Other | 3 days of low residue diet |
Primary outcome
Adequate bowel cleansing
Time frame: During colonoscopy (At the withdrawal phase)
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
9 secondary outcomes
Diet tolerability
Time frame: The day of the colonoscopy just before beginning
Preparation tolerability
Time frame: The day of the colonoscopy just before beginning
Adenoma detection
Time frame: adenoma detection is done during the colonoscopy but assesment will be done at the end of the study with the histology reports
Polyp detection
Time frame: During colonoscopy
Ceacal intubation time
Time frame: During colonoscopy
Withdrawal time
Time frame: During colonoscopy
Excellent cleansing
Time frame: During colonoscopy
Information perceived quality
Time frame: The day of the colonoscopy just before beginning
Preparation quality in each segment
Time frame: During colonoopy
Results and safety
The study was stopped early (reason given: Organization and logistic problems due to COVID19 pandemy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Derived from this study: PubMed 38591600Machlab 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Martínez, PhD study director
Hospital Universitari Parc Taulí
1 site in 1 country: see every site and its status.
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.