Computerized Feedback in Colonoscopy

NCT04862793 — Not applicable, Unknown, 3000 participants, Copenhagen Academy for Medical Education and Simulation

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

RegistryNCT04862793
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, diagnostic
Enrollment3000 (Estimated)
SponsorCopenhagen Academy for Medical Education and Simulation (Other); collaborators: Danish Cancer Society, Ambu A/S, Region Capital Denmark, Herlev Hospital, Bispebjerg Hospital, Hillerod Hospital, Denmark
ConditionsColorectal Cancer, Healthy
InterventionsColonoscopy Progression Score (CoPS), Colonoscopy Retraction Score (CoRS) (Device)
Datesstart 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)

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
FeedbackExperimentalDevice: Colonoscopy Progression Score (CoPS); Device: Colonoscopy Retraction Score (CoRS)Feedback system through CoPS and CoRS
Standard procedureNo interventionPerforming the standard procedure in accordance with the departments usual conduct.
  • Colonoscopy Progression Score (CoPS) (Device): The Colonoscopy Progression Score consists of five different aspects: Travel length, Tip progression, chase efficiency, shaft movement without tip progression and looping.
  • Colonoscopy Retraction Score (CoRS) (Device): The Colonoscopy Retraction Score consists of three different aspects: Tip Retraction, Retraction Efficiency, and Retraction Distance.

+Outcome measures

Primary outcomes

  • Feedback from CoRS results in change in Adenoma Detection Rate for individual operators and for the department as a whole. [Baseline (pre-intervention) and with the end of each time cluster (month 8, 12, 16, 18). The intervention will be at different time clusters for the three participating hospitals, and therefore the baseline sampling period will be different.]: The Adenoma Detection Rate of an operator is correlated to patient survival of colorectal cancer. A low Adenoma Detection Rate is correlated with a higher occurrence of interval cancer. Increasing the Adenoma Detection Rate will result in a more beneficial screening program with more cancers being caught in an earlier state and thereby increase patient survival.
  • Feedback from CoPS results in change in patient discomfort. [Baseline (pre-intervention) and with the end of each time cluster (month 8, 12, 16, 18). The intervention will be at different time clusters for the three participating hospitals, and therefore the baseline sampling period will be different.]: Patient discomfort will be assessed by a post-procedure questionnaire. We will examine the correlation between the intervention and patient discomfort, and assess if more procedures can be completed due to less patient discomfort using the intervention.

Secondary outcomes

  • Make an immediate measure to assess the quality of individual colonoscopy performance. [On data collection completion, estimated December 2023]: To measure a reliable Adenoma detection rate, 500 procedures are needed. We will aim to make an immediate measure based on CoRS to assess the quality of each colonoscopy and investigate this measures correlation to the ADR in the intervention period.

+Eligibility

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

+Publications

  • Results publication: Cold KM, Vamadevan A, Heen A, Vilamann AS, Rasmussen M, Svendsen MBS, Konge L. Effect of a computer-aided quality feedback system on colonoscopists' adenoma detection rate in Denmark: a multicentre, stepped-wedge, cluster-randomised, controlled trial. Lancet Digit Health. 2026 Sep 2:101046. doi: 10.1016/j.landig.2026.101046. Online ahead of print. PMID 42686507

+Investigators