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

Sponsor
Seoul St. Mary's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03796169
Collaborator
Saint Vincent's Hospital, Korea (Other), Uijeongbu St. Mary Hospital (Other)
15
1
1
14
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Personal notification
  • Behavioral: Open notification
  • Behavioral: Education
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Effect of Intervention for Improving Colonoscopy Quality is Associated With the Personal Characteristics of the Endoscopist
Actual Study Start Date :
Dec 12, 2018
Actual Primary Completion Date :
Dec 12, 2019
Actual Study Completion Date :
Feb 12, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Measurement of overall adenoma detection rate [9 months]

    Primary outcome measures include overall adenoma detection rate.

  2. Measurement of adenoma detection rate after personal notification [3 months after personal notification]

    Primary outcome measures include adenoma detection rate after personal notification

  3. Measurement of adenoma detection rate after open notification [3 months after open notification]

    Primary outcome measures include adenoma detection rate after open notification

  4. Measurement of adenoma detection rate after education [3 months after education]

    Primary outcome measures include adenoma detection rate after education

Secondary Outcome Measures

  1. Measurement of overall polyp detection rate [9 months]

    Secondary outcome measures include overall polyp detection rate.

  2. Measurement of overall withdrawal time [9 months]

    Secondary outcome measures include overall withdrawal time.

  3. Measurement of overall adenomas per colonoscopy [9 months]

    Secondary outcome measures include overall adenomas per colonoscopy.

  4. Measurement of polyp detection rate after personal notification [3 months after personal notification]

    Primary outcome measures include polyp detection rate after personal notification

  5. Measurement of polyp detection rate after open notification [3 months after open notification]

    Primary outcome measures include polyp detection rate after open notification

  6. Measurement of polyp detection rate after education [3 months after education]

    Primary outcome measures include polyp detection rate after education

  7. Measurement of withdrawal time after personal notification [3 months after personal notification]

    Primary outcome measures include withdrawal time after personal notification

  8. Measurement of withdrawal time after open notification [3 months after open notification]

    Primary outcome measures include withdrawal time after open notification

  9. Measurement of withdrawal time after education [3 months after education]

    Primary outcome measures include withdrawal time after education

  10. Measurement of adenomas per colonoscopy after personal notification [3 months after personal notification]

    Primary outcome measures include adenomas per colonoscopy after personal notification.

  11. Measurement of adenomas per colonoscopy after open notification [3 months after open notification]

    Primary outcome measures include adenomas per colonoscopy after open notification

  12. Measurement of adenomas per colonoscopy after education [3 months after education]

    Primary outcome measures include adenoma detection rate after education

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Division of Gastroenterology; Seoul St. Mary's hospital Seoul Korea, Republic of 137-701

Sponsors and Collaborators

  • Seoul St. Mary's Hospital
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bo-In Lee, Professor, MD, PhD, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT03796169
Other Study ID Numbers:
  • XC15FIMI0020K
First Posted:
Jan 8, 2019
Last Update Posted:
Sep 9, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 9, 2020