Back to resultsInception, Validation and Clinical Utility of a Score to Assess the Completeness of Caecal Visualisation
Primary Purpose
Colonic Polyp, Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
educational video
Sponsored by
About this trial
This is an interventional screening trial for Colonic Polyp
Eligibility Criteria
Inclusion Criteria: Endoscopists >18 years old Exclusion Criteria: Endoscopist not signing informed consent Any other medical doctor not connected with endoscopic practice
Sites / Locations
- UZ Gent
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Endoscopists
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05854277
Brief Title
Inception, Validation and Clinical Utility of a Score to Assess the Completeness of Caecal Visualisation
Official Title
Inception, Validation and Clinical Utility of a Score to Assess the Completeness of Caecal Visualisation.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp, Colorectal Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endoscopists
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
educational video
Intervention Description
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.
Primary Outcome Measure Information:
Title
VALIDATE A NOVEL SCORE FOR THE COMPLETENESS OF CAECAL INTUBATION
Description
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
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Endoscopists >18 years old
Exclusion Criteria:
Endoscopist not signing informed consent
Any other medical doctor not connected with endoscopic practice
Facility Information:
Facility Name
UZ Gent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Inception, Validation and Clinical Utility of a Score to Assess the Completeness of Caecal Visualisation
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