A Clinical Validation Study of Two Computerized Systems Called the 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score

Objectives:

1. Gather validity evidence for the 3D-Colonoscopy Progression score (3D-CoPS) and 3D-Colonoscopy Retraction Score (3D-CoRS) in a clinical setting.
2. Investigate the relationship between 3D-CoPS/3D-CoRS and a retrospective calculated Adenoma Detection Rate (ADR) of endoscopists with various experience.

Background:

Colonoscopy is the gold standard for diagnosing adenomas and colorectal cancer. High Adenoma Detection Rate (ADR) is essential to reduce the risk of subsequent colorectal cancer .To maximize the detection of adenomas during a colonoscopy the endoscopist need to see as much mucosa as possible. To increase the mucosa visualized quality indicators, such as bowel preparatin, cecal intubation rate and an average time of at least 6 minutes spent during withdrawal, should be used as supportive measures to minimize missed lesions and thereby decreasing interval cancer. Bowel preparation, cecal intubation and time spent during withdrawal are prerequisite measures for optimal visualization of the mucosa in the colorectum, but are not a quality measure for actual detected pathology. Time as a quality assurance for detection of adenomas means nothing if the physician isn't careful during withdrawal and look behind folds and change position to get a clear view of the mucosa surface. The ADR has been introduced as a surrogate measure of adequate visualization of the mucosa, but a recommend and a minimum number of 500 colonoscopies are needed to calculate a statistic reliable ADR. Although ADR is one of the most widely used and accepted quality indicators great variance in number of performed procedures and ADR among physicians exits, which makes ADR difficult to use in practice. Currently there is no quality parameter evaluating the individual procedure and to our knowledge no objective tools exits to help increase diagnostic accuracy during a colonoscopy. Objective, easy implementable and automatic measures are needed to ensure a high detection of adenomas and subsequently prevent missed lesions and interval cancers.

In collaboration with the Technical University of Denmark we have developed a score of progression and retraction during a colonoscopy, called 3D-Colonoscopy Progression Score (3D-CoPS) and 3D-Colonoscopy Retraction Score (3D-CoRS). We predict the systems to be automated and objective tool correlated with the endoscopists technical level of expertise in clinical colonoscopy.