Colonic PolypNCT05854277
Inception, Validation and Clinical Utility of a Score to Assess the Completeness of Caecal Visualisation
A study testing educational video in people with Colonic Polyp and Colorectal Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
CCIS is a novel score, created specifically to evaluate the completeness of caecal visualized. It can be applied to a single or multiple images. To create the CCIS, the caecum was divided into eight parts: the appendiceal orifice (AO), the tri-radiate fold part 1 (TF-1), 2 (TF-2), 3 (TF-3) and four outer quadrants (OQ… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp, Colorectal Cancer
- What is being tested?
- educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2021to 28 Feb 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Endoscopists >18 years old
Who cannot join
- Endoscopist not signing informed consent
- Any other medical doctor not connected with endoscopic practice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inception, Validation and Clinical Utility of a Score to Assess the Completeness of Caecal Visualisation.
CCIS is a novel score, created specifically to evaluate the completeness of caecal visualized. It can be applied to a single or multiple images. To create the CCIS, the caecum was divided into eight parts: the appendiceal orifice (AO), the tri-radiate fold part 1 (TF-1), 2 (TF-2), 3 (TF-3) and four outer quadrants (OQ 1-4). The ileo-caecal valve (ICV) is a reference point but is not part of the score. The quadrant adjacent to the ICV is labelled OQ1. The three other quadrants are labelled clockwise from this quadrant. The tri-radiate folds are also labelled clockwise with TF1 representing the triangle side that is majority-contained within OQ1. TF2 and TF3 are then labelled clockwise from TF1.
- Conditions
- Colonic Polyp, Colorectal Cancer
- Being tested
- educational video
- Medical subject headings
- Colonic Polyps, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational videoOther
To explain the novel score, a six-minute instructional video was compiled and available to watch, as well as an online tool on the GIEQs website that could be used to grade the image-sets using the score.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopists | Other | Not described Receives: Other: educational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
VALIDATE A NOVEL SCORE FOR THE COMPLETENESS OF CAECAL INTUBATION
To create the CCIS, the caecum is divided into eight parts: the appendiceal orifice (AO), the tri-radiate fold part 1 (TF-1), 2 (TF-2), 3 (TF-3) and four outer quadrants (OQ 1-4). The ileo-cacecal valve (ICV) is a reference point but is not part of the score. The quadrant adjacent to the valve is labelled OQ1. The three other quadrants are labelled clockwise from this quadrant. For every component of the CCIS that is completely visualized on the image, one point is gained with a maximum possible CCIS of 8 and a minimum of 0. Participants were asked to answer the same six questions for each image-set.
- Is this an image of the caecum?
- What is the Boston Bowel Preparation score for this segment of the colon?
- What is your subjective first impression (yes/no) regarding completeness of caecal intubation?
- What subjective percentage do you believe was assessed?
- What is the CCIS score for this image-set?
- Using the online tool, which components of the CCIS were seen
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Feb 2021
- Primary completion15 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854277
- Sponsor's protocol ID
- BC-09013
- Status last verified
- May 2023
- First submitted
- 15 Mar 2023
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inception, Validation and Clinical Utility of a Score to Assess the Completeness of Caecal Visualisation.
- ClinicalTrials.gov ID
- NCT05854277
- Acronym / sponsor ID
- BC-09013
- Conditions
- Colonic Polyp, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 11 May 2023 (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.
CCIS is a novel score, created specifically to evaluate the completeness of caecal visualized. It can be applied to a single or multiple images. To create the CCIS, the caecum was divided into eight parts: the appendiceal orifice (AO), the tri-radiate fold part 1 (TF-1), 2 (TF-2), 3 (TF-3) and four outer quadrants (OQ 1-4). The ileo-caecal valve (ICV) is a reference point but is not part of the score. The quadrant adjacent to the ICV is labelled OQ1. The three other quadrants are labelled clockwise from this quadrant. The tri-radiate folds are also labelled clockwise with TF1 representing the triangle side that is majority-contained within OQ1. TF2 and TF3 are then labelled clockwise from TF1.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopists | Other | Other: educational video |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Endoscopists >18 years old
Key exclusion criteria (2 listed)
- Endoscopist not signing informed consent
- Any other medical doctor not connected with endoscopic practice
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 |
|---|---|---|
| educational videoTo explain the novel score, a six-minute instructional video was compiled and available to watch, as well as an online tool on the GIEQs website that could be used to grade the image-sets using the score. | Other | Endoscopists |
Primary outcome
VALIDATE A NOVEL SCORE FOR THE COMPLETENESS OF CAECAL INTUBATION
Time frame: 4 weeks
To create the CCIS, the caecum is divided into eight parts: the appendiceal orifice (AO), the tri-radiate fold part 1 (TF-1), 2 (TF-2), 3 (TF-3) and four outer quadrants (OQ 1-4). The ileo-cacecal valve (ICV) is a reference point but is not part of the score. The quadrant adjacent to the valve is labelled OQ1. The three other quadrants are labelled clockwise from this quadrant. For every component of the CCIS that is completely visualized on the image, one point is gained with a maximum possible CCIS of 8 and a minimum of 0. Participants were asked to answer the same six questions for each image-set. * Is this an image of the caecum? * What is the Boston Bowel Preparation score for this segment of the colon? * What is your subjective first impression (yes/no) regarding completeness of caecal intubation? * What subjective percentage do you believe was assessed? * What is the CCIS score for this image-set? * Using the online tool, which components of the CCIS were seen
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 11 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational video in people with Colonic Polyp and Colorectal Cancer, run by University Hospital, Ghent at 1 site in Belgium.
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 11 May 2023. 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 Belgium. 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?
VALIDATE A NOVEL SCORE FOR THE COMPLETENESS OF CAECAL INTUBATION (time frame: 4 weeks). 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 11 May 2023.