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Inception, Validation and Clinical Utility of a Score to Assess the Completeness of Caecal Visualisation

Inception, Validation and Clinical Utility of a Score to Assess the Completeness of Caecal Visualisation.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05854277
Enrollment
79
Registered
2023-05-11
Start date
2021-02-01
Completion date
2021-02-28
Last updated
2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Polyp, Colorectal Cancer

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.

Interventions

OTHEReducational video

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.

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Endoscopists \>18 years old

Exclusion criteria

* Endoscopist not signing informed consent * Any other medical doctor not connected with endoscopic practice

Design outcomes

Primary

MeasureTime frameDescription
VALIDATE A NOVEL SCORE FOR THE COMPLETENESS OF CAECAL INTUBATION4 weeksTo 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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026