Impact of Computerized Feedback During Colonoscopy on Adenoma Detection Rate of Colorectal Cancer and Patient Related Satisfaction: A Cluster-randomized Controlled Trial.
| Registry | NCT04862793 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, diagnostic |
| Enrollment | 3000 (Estimated) |
| Sponsor | Copenhagen Academy for Medical Education and Simulation (Other); collaborators: Danish Cancer Society, Ambu A/S, Region Capital Denmark, Herlev Hospital, Bispebjerg Hospital, Hillerod Hospital, Denmark |
| Conditions | Colorectal Cancer, Healthy |
| Interventions | Colonoscopy Progression Score (CoPS), Colonoscopy Retraction Score (CoRS) (Device) |
| Dates | start 2021-06-01 (estimated), primary completion 2023-12-01 (estimated), completion 2023-12-01 (estimated), first posted 2021-04-28, last updated 2021-04-28 |
Related Papers Related Patents Related Grants Related Experts
All trials for Colorectal Cancer All trials for Healthy All trials of Colonoscopy Progression Score (CoPS) All trials of Colonoscopy Retraction Score (CoRS)
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Feedback | Experimental | Device: Colonoscopy Progression Score (CoPS); Device: Colonoscopy Retraction Score (CoRS) | Feedback system through CoPS and CoRS |
| Standard procedure | No intervention | Performing the standard procedure in accordance with the departments usual conduct. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * Admitted for a screening colonoscopy through the Danish National Screening Program for Colorectal Cancer. Exclusion Criteria: Incomplete procedure due to: * In cases were the cecum is not reached. * Unsatisfactory bowel preparation which results in admission for a new procedure