Clinical Trials Directory

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UnknownNCT04862793

Computerized Feedback in Colonoscopy

Impact of Computerized Feedback During Colonoscopy on Adenoma Detection Rate of Colorectal Cancer and Patient Related Satisfaction: A Cluster-randomized Controlled Trial.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
3,000 (estimated)
Sponsor
Copenhagen Academy for Medical Education and Simulation · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

In a cluster-randomized study compare if feedback from two computerized feedback systems doing a colonoscopy (CoPS and CoRS) can improve the adenoma detection rate and decrease patient discomfort.

Detailed description

Background: Approximately 4,600 persons get colon cancer annually in Denmark and it is the second most common cause of cancer death. Survival is highly dependent on early detection through a colonoscopy. A thorough colonoscopy is essential to detect early cancers but unfortunately the quality of colonoscopies varies widely between operators. A study of 314,872 colonoscopies performed by 136 gastroenterologists found that the adenoma detection rate (ADR) ranged from 7 - 53% and was inversely associated with the risks of fatal interval cancer. The investigators have developed to tools that can generate automatic, computerized feedback in order to make a more thorough procedure and reduce patient discomfort, the Colonoscopy Progression Score (CoPS) and Colonoscopy Retraction Score (CoRS) Objectives: The investigators predict that live-feedback from CoPS and CoRS doing a colonoscopy can improve the ADR and subsequent prevent colorectal cancer. The aim of this project is to: 1. In a cluster-randomized study compare if feedback from CoPS and CoRS can improve the adenoma detection rate and patient satisfaction for individual operators and the department as a whole. 2. Make an immediate measure to assess the quality of individual colonoscopy performance. Materials and methodology: As a randomized controlled cluster trial following a stepped-wedge program, feedback doing a colonoscopy from these (CoPS and CoRS) will be tested compared to no feedback. Three test departments consisting of three University Hospital in the Capital region of Denmark will be included.

Conditions

Interventions

TypeNameDescription
DEVICEColonoscopy Progression Score (CoPS)The Colonoscopy Progression Score consists of five different aspects: Travel length, Tip progression, chase efficiency, shaft movement without tip progression and looping.
DEVICEColonoscopy Retraction Score (CoRS)The Colonoscopy Retraction Score consists of three different aspects: Tip Retraction, Retraction Efficiency, and Retraction Distance.

Timeline

Start date
2021-06-01
Primary completion
2023-12-01
Completion
2023-12-01
First posted
2021-04-28
Last updated
2021-04-28

Source: ClinicalTrials.gov record NCT04862793. Inclusion in this directory is not an endorsement.