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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05854277
• Other study ID #: BC-09013
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 28, 2021

Study information

• Verified date: May 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: February 28, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Endoscopists >18 years old

Exclusion Criteria:

• Endoscopist not signing informed consent

• Any other medical doctor not connected with endoscopic practice

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Colorectal Cancer

Intervention

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.

Locations

Country	Name	City	State
Belgium	UZ Gent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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