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.

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colonic Polyp
• Intervention / Treatment: Other: educational video

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • UZ Gent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Endoscopists >18 years old

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Endoscopists	Other: educational 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Estimate): May 11, 2023

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Colonic Polyps
• Other Study ID Numbers: BC-09013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No