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

Not Applicable

Completed

• Conditions: Colonic Polyp; Colorectal Cancer
• Interventions: Other: educational video

• Registration Number: NCT05854277
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2021-02-15
• Study Completion: 2021-02-28
• Study First Submitted: 2023-03-15
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-02
• Last Update Submitted: 2023-05-02
• Study First Posted: 2023-05-11
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Endoscopists >18 years old

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopists	educational video	-

Primary Outcome Measures

Name	Time	Method
VALIDATE A NOVEL SCORE FOR THE COMPLETENESS OF CAECAL INTUBATION	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

Trial Locations

Locations (1)

UZ Gent; 🇧🇪 Ghent, Belgium