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Completed

NCT Number: NCT03796169

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

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.

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Key information

Conditions

Colonoscopy Human Characteristics

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Gastroenterology; Seoul St. Mary's hospital

Seoul, 137-701, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personal notification

Behavioral

Baseline quality indicators of each endoscopist were measured and those were notified individually.

Open notification

Behavioral

Quality indicators were measured for 3 months after 1st interventions and those were notified openly

Education

Behavioral

Quality indicators were measured for 3 months after 2nd interventions and educated the importance of colonoscopy quality by a GI faculty

Primary outcomes

  1. Measurement of overall adenoma detection rate

    Time frame: 9 months

    Primary outcome measures include overall adenoma detection rate.

  2. 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. 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

  4. Measurement of adenoma detection rate after education

    Time frame: 3 months after education

    Primary outcome measures include adenoma detection rate after education

Secondary outcomes

  1. Measurement of overall polyp detection rate

    Time frame: 9 months

    Secondary outcome measures include overall polyp detection rate.

  2. Measurement of overall withdrawal time

    Time frame: 9 months

    Secondary outcome measures include overall withdrawal time.

  3. Measurement of overall adenomas per colonoscopy

    Time frame: 9 months

    Secondary outcome measures include overall adenomas per colonoscopy.

  4. 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

  5. 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

  6. Measurement of polyp detection rate after education

    Time frame: 3 months after education

    Primary outcome measures include polyp detection rate after education

  7. Measurement of withdrawal time after personal notification

    Time frame: 3 months after personal notification

    Primary outcome measures include withdrawal time after personal notification

  8. Measurement of withdrawal time after open notification

    Time frame: 3 months after open notification

    Primary outcome measures include withdrawal time after open notification

  9. Measurement of withdrawal time after education

    Time frame: 3 months after education

    Primary outcome measures include withdrawal time after education

  10. 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.

  11. 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

  12. Measurement of adenomas per colonoscopy after education

    Time frame: 3 months after education

    Primary outcome measures include adenoma detection rate after education

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 8, 2019
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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