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.

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Key information

Conditions

Colonic Polyp Colonic Diseases Colonic Polyps Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Gent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Endoscopists >18 years old

Exclusion criteria

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

Treatment and study plan

Educational Video

Other

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 outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: May 11, 2023
Registry last updated: May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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