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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy; Colorectal Cancer
• Intervention / Treatment: Device: Colonoscopy Progression Score (CoPS); Device: Colonoscopy Retraction Score (CoRS)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristoffer Mazanti Cold, MD; Phone Number: +4541442103; Email: kristoffer.mazanti.cold@regionh.dk
• Study Contact Backup: Name: Lars Konge, MD, PhD; Phone Number: +4530230210; Email: lars.konge@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feedback; Feedback system through CoPS and CoRS	Device: Colonoscopy 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.; Device: Colonoscopy Retraction Score (CoRS); The Colonoscopy Retraction Score consists of three different aspects: Tip Retraction, Retraction Efficiency, and Retraction Distance.
No Intervention: Standard procedure; Performing the standard procedure in accordance with the departments usual conduct.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feedback from CoRS results in change in Adenoma Detection Rate for individual operators and for the department as a whole.	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.	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.
Feedback from CoPS results in change in patient discomfort.	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Make an immediate measure to assess the quality of individual colonoscopy performance.	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.	On data collection completion, estimated December 2023

Collaborators and Investigators

• Sponsor: Copenhagen Academy for Medical Education and Simulation
• Collaborators: Bispebjerg Hospital; Danish Cancer Society; Herlev Hospital; Region Capital Denmark; Hillerod Hospital, Denmark; Ambu A/S
• Investigators: Principal Investigator: Kristoffer Mazanti Cold, MD, PhD-alumni

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Colonoscopy; Adenoma Detection Rate; Computerized Feedback
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: P-2021-256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: At end of data collection (December 2023) and for the following 5 years.
• IPD Sharing Access Criteria: On request to the primary investigator with a useful scientific purpose.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No