ColonoscopyNCT03763266
Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy
A study testing 1 day low residue diet and 3 day low residue diet in people with Colonoscopy and Colon Adenoma, run by Parc Taulí Hospital Universitari at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Colon Adenoma, Colorectal Neoplasms
- What is being tested?
- 1 day low residue diet and 3 day low residue diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 858 participants
- Where
- 1 siteSpain
- Study dates
- 6 Dec 2018to 20 Jan 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants in the colorectal cancer screening program that give consent
Who cannot join
- Contraindication for colonoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Residue Diet 3 Days Versus 1 Day as Preparation for Colonoscopy: a Randomized Controlled Trial
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.
- Conditions
- Colonoscopy, Colon Adenoma, Colorectal Neoplasms, Inflammatory Bowel Diseases, Colon Disease
- Being tested
- 1 day low residue diet, 3 day low residue diet
- Keywords
- bowel preparation, low residue diet, colonoscopy
- Medical subject headings
- Colorectal Neoplasms, Inflammatory Bowel Diseases, Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 day low residue dietOther
Also called low fiber diet
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.
3 day low residue dietOther
Also called low fiber diet
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 day low residue diet | Experimental | Patients are instructed to complete a low residue diet exclusively one day prior the colonoscopy. Receives: Other: 1 day low residue diet |
| 3 days low residue diet | Active comparator | Patients are instructed to complete a low residue diet three days prior the colonoscopy. Receives: Other: 3 day low residue diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel preparation
Measured with the Boston Bowel Preparation Scale from 0 until 9. 9 represents an excellent preparation.
Measured: During the colonoscopy
Secondary outcomes (7)
Diet tolerance
Using Likert scale. From 1 to 5, lower is better tolerance.
Measured: 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.
Preparation tolerance
Using Likert scale. From 1 to 5, lower is better tolerance.
Measured: 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.
Adenoma detection rate
Proportion of colonoscopies with detection of colorectal cancer or adenoma excluding distal hyperplastic
Measured: up to 2 weeks after colonoscopy depending on pathology department workload.
Endoscopic diagnosis
Final endoscopic diagnosis. For example; normal, diverticulosis, polyps, colorectal cancer, etc.
Measured: It is assessed during the colonoscopy and will be reported the same day.
Cecum intubation rate
Cecum intubation will be assessed during each colonoscopy if the endoscope reaches the cecum.
Measured: It will be calculated through study completion, approximately 1 year, for all the study period using all participants having the colonoscopy done
Intubation time
time lapse from the start of the exploration until cecum is reached.
Measured: it is assessed from the start of the colonoscopy until cecum is reached (1 day)
Withdrawal time
Time lapse between cecum withdrawal the end of the exploration.
Measured: it is assessed from at the beginning of the withdrawal of the colonoscope until the colonoscopy is finished. (procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start6 Dec 2018
- Primary completion10 Nov 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- 858 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
- Eva Martínez, PhD, Study director, Corporació Sanitaria Parc TaulíSalvador Machlab, MD, Principal investigator, Corporació Sanitaria Parc TaulíRafel Campo, PhD, Study director, Corporació Sanitaria Parc Taulí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763266
- Sponsor's protocol ID
- 2017308
- Status last verified
- Feb 2020
- First submitted
- 10 Nov 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Residue Diet 3 Days Versus 1 Day as Preparation for Colonoscopy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03763266
- Acronym / sponsor ID
- 2017308
- Conditions
- Colonoscopy, Colon Adenoma, Colorectal Neoplasms, Inflammatory Bowel Diseases, Colon Disease
- Keywords
- bowel preparation, low residue diet, colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 858 participants (actual)
- Lead sponsor
- Parc Taulí Hospital UniversitariUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 4 Dec 2018 (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 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.
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 |
|---|---|---|
| 1 day low residue diet | Experimental | Other: 1 day low residue dietPatients are instructed to complete a low residue diet exclusively one day prior the colonoscopy. |
| 3 days low residue diet | Active comparator | Other: 3 day low residue dietPatients are instructed to complete a low residue diet three days prior the colonoscopy. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants in the colorectal cancer screening program that give consent
Key exclusion criteria (1 listed)
- Contraindication for colonoscopy
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 |
|---|---|---|
| 1 day low residue dietAlso: low fiber dietPatients 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 | 1 day low residue diet |
| 3 day low residue dietAlso: low fiber dietPatients 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 | 3 days low residue diet |
Primary outcome
Bowel preparation
Time frame: During the colonoscopy
Measured with the Boston Bowel Preparation Scale from 0 until 9. 9 represents an excellent preparation.
7 secondary outcomes
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.
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.
Adenoma detection rate
Time frame: up to 2 weeks after colonoscopy depending on pathology department workload.
Endoscopic diagnosis
Time frame: It is assessed during the colonoscopy and will be reported the same day.
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
Intubation time
Time frame: it is assessed from the start of the colonoscopy until cecum is reached (1 day)
Withdrawal time
Time frame: it is assessed from at the beginning of the withdrawal of the colonoscope until the colonoscopy is finished. (procedure)
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 12 Feb 2020.
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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
Corporació Sanitaria Parc Taulí
Salvador Machlab, MD principal investigator
Corporació Sanitaria Parc Taulí
Rafel Campo, PhD study director
Corporació Sanitaria 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 1 day low residue diet and 3 day low residue diet in people with Colonoscopy and Colon Adenoma, 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 1 inclusion and 1 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 12 Feb 2020. 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 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?
Bowel preparation (time frame: During the colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2020.