Bowel Preparation for ColonoscopyCALICOLNCT02839824
Evaluation of the Quality of Bowel Cleansing in a Real Clinical Practice Setting
An observational study of Bowel Preparation for Colonoscopy, run by Casen Recordati S.L. at 1 site in Spain.
Trial summary
Publications of the use of bowel cleansers in usual clinical practice are lacking. Patient adherence to investigational products increases in the context of clinical trials. By the same token, efficacy of interventions may be overestimated in clinical trials. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bowel Preparation for Colonoscopy
- What is being tested?
- Bowel preparation
- Type of treatment
- Surgery or procedure
- How many people
- 412 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2016to 6 Mar 2017
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who have been performed a colonoscopy and who have received a bowel cleansing agent according to the investigator criteria
Who may be able to join
- Age 18-80 years
- Subjects who have been performed a colonoscopy
Who cannot join
- Subjects being previously performed colon surgery.
- Subjects suffering from active inflammatory bowel disease at the time of performing colonoscopy.
- Subjects with extreme limitations due to disease.
- Subjects in who Boston Bowel Preparation Scale (BBPS) is not available
- Subjects who have undergone a colonoscopy during their participation in another clinical study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clínica de Medicina Integral Diagonal
Esplugues de Llobregat, Barcelona, 08950
About this study
Official title: Evaluation of the Quality of Bowel Cleansing in a Real Clinical Practice Setting (CALICOL Study)
Publications of the use of bowel cleansers in usual clinical practice are lacking. Patient adherence to investigational products increases in the context of clinical trials. By the same token, efficacy of interventions may be overestimated in clinical trials.
For this reason, an observational study to collect data on the effectiveness of several colonic preparations when these are used under usual clinical practice is proposed.
- Conditions
- Bowel Preparation for Colonoscopy
- Being tested
- Bowel preparation
- Keywords
- bowel cleansing, bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel preparationProcedure or surgery
Bowel preparation for bowel cleansing in a real clinical practice
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with adequate colon cleansing
Percentage of patients with punctuation in Boston bowel preparation scale (BBPS) ≥ 5
Measured: Through study completion, an average of 6 months
Secondary outcomes (6)
Percentage of patients with adequate colon cleansing of different administration schedules
Percentage of patients with punctuation in BBPS ≥ 5 in each administration schedule
Measured: Through study completion, an average of 6 months
Identify factors influencing bowel cleansing quality
Relationship between BBPS ≥ 5 and age, gender, ethnicity, weight, height, tobacco consumption, concomitant diseases, medications and indication for colonoscopy in a multivariate analysis.
Measured: Through study completion, an average of 6 months
Influence of total volume of liquid ingestion in the effectiveness of bowel cleansing agents
Relationship between BBPS ≥ 5and the volume of liquid ingestion
Measured: Through study completion, an average of 6 months
Patients' tolerance
Percentage of each adverse event reported per patient in each administration schedule
Measured: Through study completion, an average of 6 months
Quality of bowel cleansing comparison among different bowel cleansing agents
Comparison of percentage of patients with BBPS ≥ 5 between different bowel cleansing agents
Measured: Through study completion, an average of 6 months
Subjects' satisfaction
Comparison of subjects' satisfaction between different bowel cleansing agents with a five point likert scale
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start15 Sep 2016
- Primary completion6 Mar 2017
- Study completion6 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Preparation 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Casen Recordati S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ana Bargalló, MD, Study director, Clínica de Medicina Integral Diagonal, Gastroenterology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839824
- Sponsor's protocol ID
- CAS-EVA-2016-01
- Acronym
- CALICOL
- Status last verified
- Jan 2018
- First submitted
- 14 Jul 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quality of Bowel Cleansing in a Real Clinical Practice Setting (CALICOL Study)
- ClinicalTrials.gov ID
- NCT02839824
- Acronym / sponsor ID
- CALICOL / CAS-EVA-2016-01
- Conditions
- Bowel Preparation for Colonoscopy
- Keywords
- bowel cleansing, bowel preparation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Casen Recordati S.L.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 6 Mar 2017 (actual)
- Study completion
- 6 Mar 2017 (actual)
- First posted
- 21 Jul 2016 (estimated)
- 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.
Publications of the use of bowel cleansers in usual clinical practice are lacking. Patient adherence to investigational products increases in the context of clinical trials. By the same token, efficacy of interventions may be overestimated in clinical trials.
For this reason, an observational study to collect data on the effectiveness of several colonic preparations when these are used under usual clinical practice is proposed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who have been performed a colonoscopy and who have received a bowel cleansing agent according to the investigator criteria
Key inclusion criteria (2 listed)
- Age 18-80 years
- Subjects who have been performed a colonoscopy
Key exclusion criteria (5 listed)
- Subjects being previously performed colon surgery.
- Subjects suffering from active inflammatory bowel disease at the time of performing colonoscopy.
- Subjects with extreme limitations due to disease.
- Subjects in who Boston Bowel Preparation Scale (BBPS) is not available
- Subjects who have undergone a colonoscopy during their participation in another clinical study.
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 |
|---|---|---|
| Bowel preparationBowel preparation for bowel cleansing in a real clinical practice | Procedure or surgery | – |
Primary outcome
Percentage of patients with adequate colon cleansing
Time frame: Through study completion, an average of 6 months
Percentage of patients with punctuation in Boston bowel preparation scale (BBPS) ≥ 5
6 secondary outcomes
Percentage of patients with adequate colon cleansing of different administration schedules
Time frame: Through study completion, an average of 6 months
Identify factors influencing bowel cleansing quality
Time frame: Through study completion, an average of 6 months
Influence of total volume of liquid ingestion in the effectiveness of bowel cleansing agents
Time frame: Through study completion, an average of 6 months
Patients' tolerance
Time frame: Through study completion, an average of 6 months
Quality of bowel cleansing comparison among different bowel cleansing agents
Time frame: Through study completion, an average of 6 months
Subjects' satisfaction
Time frame: Through study completion, an average of 6 months
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 26 Jan 2018.
- 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.
Ana Bargalló, MD study director
Clínica de Medicina Integral Diagonal, Gastroenterology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Preparation for Colonoscopy, run by Casen Recordati S.L. 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 2 inclusion and 5 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 26 Jan 2018. 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?
Percentage of patients with adequate colon cleansing (time frame: Through study completion, an average of 6 months). 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 26 Jan 2018.