Effect of Intervention for Colonoscopy Quality is Associated With the Personal Characteristics

September 7, 2020 updated by: Bo-In Lee, Seoul St. Mary's Hospital

Effect of Intervention for Improving Colonoscopy Quality is Associated With the Personal Characteristics of the Endoscopist

This study aims to investigate whether the personal characteristics of the endoscopist is associated with effect of interventions for colonoscopy quality improvement.

This is a prospective, 9-month, multicenter, single-blind study. Baseline quality indicators including adenoma detection rate, polyp detection rate, withdrawal time and adenomas per colonoscopy of each endoscopist were measured in the health promotion centers of academic hospitals for 3 months. Follow-up measurements of quality indicators were repeated every 3 months after each interventions (personal notification of quality indicators, open notification of quality indicators, and colonoscopy quality education by a GI faculty. At the end of the study, personal characteristics of each endoscopist was evaluated using fear of negative evaluation scale, cognitive flexibility inventory, and almost perfect scale.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Suboptimal colonoscopy quality is associated with development of interval colorectal cancer and colorectal cancer-related death. It is uncertain how to improve colonoscopy quality effectively. The quality of screening colonoscopy for colorectal cancer depends on the endoscopist who performed the examination. The aim of this study was to investigate the impact of endoscopists' personal characteristics on the quality of colonoscopy and effectiveness of intervention.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 137-701
        • Division of Gastroenterology; Seoul St. Mary's hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Highly experienced board-certified gastroenterologists performed colonoscopies in health screening endoscopy centers.
  • Endoscopists who sign the consent

  • Patients for quality indicators of endoscopists

    • routinely perform outpatient screening, surveillance and diagnostic colonoscopy (first-time screening colonoscopies performed and had no previous colonoscopy within 3 years).

Exclusion Criteria:

  • endoscopists who refuse to sign the consent

  • Patients for quality indicators of endoscopists

    • Known hereditary polyposis syndrome, Inflammatory bowel disease, those with surgically altered anatomy, undergone previous colonoscopy within 3 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopist
Intervention for personal notification, open notification and colonoscopy quality education by a GI faculty
Behavioral: Personal notification
Baseline quality indicators of each endoscopist were measured and those were notified individually.
Behavioral: Open notification
Quality indicators were measured for 3 months after 1st interventions and those were notified openly
Behavioral: Education
Quality indicators were measured for 3 months after 2nd interventions and educated the importance of colonoscopy quality by a GI faculty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of overall adenoma detection rate
Time Frame: 9 months
Primary outcome measures include overall adenoma detection rate.
9 months
Measurement of adenoma detection rate after personal notification
Time Frame: 3 months after personal notification
Primary outcome measures include adenoma detection rate after personal notification
3 months after personal notification
Measurement of adenoma detection rate after open notification
Time Frame: 3 months after open notification
Primary outcome measures include adenoma detection rate after open notification
3 months after open notification
Measurement of adenoma detection rate after education
Time Frame: 3 months after education
Primary outcome measures include adenoma detection rate after education
3 months after education

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of overall polyp detection rate
Time Frame: 9 months
Secondary outcome measures include overall polyp detection rate.
9 months
Measurement of overall withdrawal time
Time Frame: 9 months
Secondary outcome measures include overall withdrawal time.
9 months
Measurement of overall adenomas per colonoscopy
Time Frame: 9 months
Secondary outcome measures include overall adenomas per colonoscopy.
9 months
Measurement of polyp detection rate after personal notification
Time Frame: 3 months after personal notification
Primary outcome measures include polyp detection rate after personal notification
3 months after personal notification
Measurement of polyp detection rate after open notification
Time Frame: 3 months after open notification
Primary outcome measures include polyp detection rate after open notification
3 months after open notification
Measurement of polyp detection rate after education
Time Frame: 3 months after education
Primary outcome measures include polyp detection rate after education
3 months after education
Measurement of withdrawal time after personal notification
Time Frame: 3 months after personal notification
Primary outcome measures include withdrawal time after personal notification
3 months after personal notification
Measurement of withdrawal time after open notification
Time Frame: 3 months after open notification
Primary outcome measures include withdrawal time after open notification
3 months after open notification
Measurement of withdrawal time after education
Time Frame: 3 months after education
Primary outcome measures include withdrawal time after education
3 months after education
Measurement of adenomas per colonoscopy after personal notification
Time Frame: 3 months after personal notification
Primary outcome measures include adenomas per colonoscopy after personal notification.
3 months after personal notification
Measurement of adenomas per colonoscopy after open notification
Time Frame: 3 months after open notification
Primary outcome measures include adenomas per colonoscopy after open notification
3 months after open notification
Measurement of adenomas per colonoscopy after education
Time Frame: 3 months after education
Primary outcome measures include adenoma detection rate after education
3 months after education

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Collaborators

Saint Vincent's Hospital, Korea
Uijeongbu St. Mary Hospital

Investigators

  • Principal Investigator: Bo-In Lee, MD, PhD, Division of Gastroenterology; Seoul St. Mary's hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2018

Primary Completion (Actual)

December 12, 2019

Study Completion (Actual)

February 12, 2020

Study Registration Dates

First Submitted

December 16, 2018

First Submitted That Met QC Criteria

January 4, 2019

First Posted (Actual)

January 8, 2019

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 7, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • XC15FIMI0020K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colonoscopy

Clinical Trials on Personal notification

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe