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

NCT05854277 | Completed

• 1 other identifier: BC-09013
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyp; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Endoscopists

OTHER

Other: educational video

Interventions

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.

Endoscopists

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Endoscopists \>18 years old

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

UZ Gent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Colonic Polyps; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: May 11, 2023
• Study Start: February 1, 2021
• Primary Completion: February 15, 2021
• Study Completion: February 28, 2021
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

BE (1)