Bowel CleansingCriLiPNCT05032794
Unrestricted Diet for Screening Colonoscopy
A study testing Unrestricted diet before colonoscopy, 1-day low residue diet and Bisacodyl 5 MG in people with Bowel Cleansing and Colonoscopy, run by Parc Taulí Hospital Universitari at 5 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Bowel Cleansing, Colonoscopy, Bowel Cancer
- What is being tested?
- Unrestricted diet before colonoscopy, 1-day low residue diet and Bisacodyl 5 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 553 participants
- Where
- 5 sitesSpain
- Study dates
- 13 Oct 2021to 1 Sep 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals on the early colorectal cancer detection program who agreed to undergo colonoscopy after positive results on the fecal immunochemical test (FIT)
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital de Mataró. Consorci Sanitari del Maresme.
Mataró, Barcelona
Hospital Universitari Parc Taulí
Sabadell, Barcelona, 08208
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Consorci Sanitari de Terrassa
Terrassa
Hospital Universitary Mutua de Terrassa
Terrassa
About this study
Official title: Unrestricted Diet vs 1-day Low Residue 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.
- Conditions
- Bowel Cleansing, Colonoscopy, Bowel Cancer
- Being tested
- Unrestricted diet before colonoscopy, 1-day low residue diet, Bisacodyl 5 MG
- Keywords
- bowel cleansing, Diet, Low residue diet
- Medical subject headings
- Intestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unrestricted diet before colonoscopyOther
Free diet, without restrictions
1-day low residue dietOther
To follow a diet low in residues / fiber. the day before the colonoscopy.
Bisacodyl 5 MGDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Unrestricted diet | Experimental | The participant is not instructed to follow any dietary recommendation before colonoscopy. But only the restriction and fasting required for sedation. Receives: Other: Unrestricted diet before colonoscopy; Drug: Bisacodyl 5 MG |
| One day low residue diet | Active comparator | The participant is instructed to follow a low residue diet the day before the colonoscopy.
It will be given a informative document and educated by a nurse. Receives: Other: 1-day low residue diet; Drug: Bisacodyl 5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate bowel cleansing
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
Measured: During colonoscopy (At the withdrawal phase)
Secondary outcomes (9)
Diet tolerability as assessed by a likert scale
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 as assessed by a likert scale and Hatoum et al. survey
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
Measured: The day of the colonoscopy just before beginning
Rate of colonoscopies with adenoma
An adenoma was detected, resected and confirmed by the histology report in the colonoscopy.
Measured: With histology report, an average of 4 weeks after colonoscopy
Rate of colonoscopies with polyps
Polyp detection in the colonoscopy as reported by the endoscopist.
Measured: During colonoscopy
Cecal 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
Information perceived quality assessed by a likert scale
Perceived quality of the instructions and education received for the colonoscopy preparation by the participant. Assessed using a likert scale
Measured: The day of the colonoscopy just before beginning
Entry bowel cleansing as assessed by the modified Boston Bowel Preparation Scale
Bowel cleansing during cecum intubation phase assessed using a modified Boston Bowel Preparation Scale which is without considering any additional cleansing during the endoscopy.
Measured: During colonoscopy (At the entry phase)
Rate of colonoscopies with flat polyps
Flat polyp detection defined by Paris criteria: no polypoid nor ulcerated (Paris 0-IIa/b/c) in the colonoscopy as reported by the endoscopist.
Measured: During colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start13 Oct 2021
- Primary completion19 Aug 2022
- Study completion1 Sep 2022
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 Bowel CleansingStudies 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
- 553 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc Taulí Hospital Universitari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvador Machlab, Parc Taulí Hospital Universitari
- Investigators
- Salvador Machlab, Principal investigator, Corporació Sanitaria Parc Taulí. Universidad Autónoma de Barcelona.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032794
- Sponsor's protocol ID
- 2021/3009
- Acronym
- CriLiP
- Status last verified
- Dec 2022
- First submitted
- 15 Jul 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Machlab S, Martinez-Bauer E, Lopez P, Ruiz-Ramirez P, Gomez B, Gimeno-Garcia AZ, Pujals MDM, Tanco S, Sargatal L, Perez B, Justicia R, Enguita M, Pique N, Valero O, Calvet X, Campo R. Restrictive diets are unnecessary for colonoscopy: Non-inferiority randomized trial. Endosc Int Open. 2024 Mar 7;12(3):E352-E360. doi: 10.1055/a-2256-5356. eCollection 2024 Mar.
PubMed 38464979
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unrestricted Diet vs 1-day Low Residue Diet for Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT05032794
- Acronym / sponsor ID
- CriLiP / 2021/3009
- Conditions
- Bowel Cleansing, Colonoscopy, Bowel Cancer
- Keywords
- bowel cleansing, Diet, Low residue diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 553 participants (actual)
- Lead sponsor
- Parc Taulí Hospital UniversitariUniversity, hospital or other
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 2 Sep 2021 (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.
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.
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 |
|---|---|---|
| Unrestricted diet | Experimental | Other: Unrestricted diet before colonoscopy, Drug: Bisacodyl 5 MGThe participant is not instructed to follow any dietary recommendation before colonoscopy. But only the restriction and fasting required for sedation. |
| One day low residue diet | Active comparator | Other: 1-day low residue diet, Drug: Bisacodyl 5 MGThe participant is instructed to follow a low residue diet the day before the colonoscopy. It will be given a informative document and educated by a nurse. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals on the early colorectal cancer detection program who agreed to undergo colonoscopy after positive results on the fecal immunochemical test (FIT)
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Unrestricted diet before colonoscopyFree diet, without restrictions | Other | Unrestricted diet |
| 1-day low residue dietTo follow a diet low in residues / fiber. the day before the colonoscopy. | Other | One day low residue diet |
| Bisacodyl 5 MGIf 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. | Drug | One day low residue diet, Unrestricted diet |
Primary outcome
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
9 secondary outcomes
Diet tolerability as assessed by a likert scale
Time frame: The day of the colonoscopy just before beginning
Preparation tolerability as assessed by a likert scale and Hatoum et al. survey
Time frame: The day of the colonoscopy just before beginning
Rate of colonoscopies with adenoma
Time frame: With histology report, an average of 4 weeks after colonoscopy
Rate of colonoscopies with polyps
Time frame: During colonoscopy
Cecal intubation time
Time frame: During colonoscopy
Withdrawal time
Time frame: During colonoscopy
Information perceived quality assessed by a likert scale
Time frame: The day of the colonoscopy just before beginning
Entry bowel cleansing as assessed by the modified Boston Bowel Preparation Scale
Time frame: During colonoscopy (At the entry phase)
Rate of colonoscopies with flat polyps
Time frame: During colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Derived from this study: PubMed 38464979Machlab S, Martinez-Bauer E, Lopez P, Ruiz-Ramirez P, Gomez B, Gimeno-Garcia AZ, Pujals MDM, Tanco S, Sargatal L, Perez B, Justicia R, Enguita M, Pique N, Valero O, Calvet X, Campo R. Restrictive diets are unnecessary for colonoscopy: Non-inferiority randomized trial. Endosc Int Open. 2024 Mar 7;12(3):E352-E360. doi: 10.1055/a-2256-5356. eCollection 2024 Mar.
- Individual participant dataSharing planned: No
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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.
Salvador Machlab principal investigator
Corporació Sanitaria Parc Taulí. Universidad Autónoma de Barcelona.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unrestricted diet before colonoscopy, 1-day low residue diet and Bisacodyl 5 MG in people with Bowel Cleansing and Colonoscopy, run by Parc Taulí Hospital Universitari at 5 sites 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT05032794, 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 7 Dec 2022.