Computerized Feedback in Colonoscopy

NCT04862793 | Unknown DMC

• 1 other identifier: P-2021-256
• Study Type: interventional
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer; Healthy

Keywords

Colonoscopy; Adenoma Detection Rate; Computerized Feedback

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Make an immediate measure to assess the quality of individual colonoscopy performance.

  On data collection completion, estimated December 2023

Study Arms (2)

Feedback

EXPERIMENTAL

Feedback system through CoPS and CoRS

Device: Colonoscopy Progression Score (CoPS); Device: Colonoscopy Retraction Score (CoRS)

Standard procedure

NO INTERVENTION

Performing the standard procedure in accordance with the departments usual conduct.

Interventions

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.

Feedback

Colonoscopy Retraction Score (CoRS) DEVICE

The Colonoscopy Retraction Score consists of three different aspects: Tip Retraction, Retraction Efficiency, and Retraction Distance.

Feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted for a screening colonoscopy through the Danish National Screening Program for Colorectal Cancer.

You may not qualify if:

• In cases were the cecum is not reached.
• Unsatisfactory bowel preparation which results in admission for a new procedure

Sponsors & Collaborators

• Copenhagen Academy for Medical Education and Simulation: lead
• Danish Cancer Society: collaborator
• Ambu A/S: collaborator
• Region Capital Denmark: collaborator
• Herlev Hospital: collaborator
• Bispebjerg Hospital: collaborator
• Hillerod Hospital, Denmark: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Kristoffer Mazanti Cold, MD

  PhD-alumni

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristoffer Mazanti Cold, MD

CONTACT

+4541442103; kristoffer.mazanti.cold@regionh.dk

Lars Konge, MD, PhD

CONTACT

+4530230210; lars.konge@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized controlled cluster trial following a stepped-wedge randomization.

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 28, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At end of data collection (December 2023) and for the following 5 years.
• Access Criteria: On request to the primary investigator with a useful scientific purpose.