Clinical trial NCT04862793: Computerized Feedback in Colonoscopy
Official title: Impact of Computerized Feedback During Colonoscopy on Adenoma Detection Rate of Colorectal Cancer and Patient Related Satisfaction: A Cluster-randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Healthy
Keywords: Colonoscopy
Adenoma Detection Rate
Computerized Feedback
Lead sponsor: Copenhagen Academy for Medical Education and Simulation
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: Ambu A/S
name: Region Capital Denmark
name: Herlev Hospital
name: Bispebjerg Hospital
name: Hillerod Hospital, Denmark
First posted: 2021-04-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled cluster trial following a stepped-wedge randomization.
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feedback from CoRS results in change in Adenoma Detection Rate for individual operators and for the department as a whole.
timeFrame: 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.
measure: Feedback from CoPS results in change in patient discomfort.
timeFrame: 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.
Secondary outcomes:
measure: Make an immediate measure to assess the quality of individual colonoscopy performance.
timeFrame: On data collection completion, estimated December 2023
Other outcomes:
Locations:
Study officials:
affiliation: PhD-alumni
name: Kristoffer Mazanti Cold, MD
role: PRINCIPAL_INVESTIGATOR
References: