NCT03796169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

December 16, 2018

Last Update Submit

September 7, 2020

Conditions

ColonoscopyHuman Characteristics

Outcome Measures

Primary Outcomes (4)

  • Measurement of overall adenoma detection rate

    Primary outcome measures include overall adenoma detection rate.

    9 months

  • Measurement of adenoma detection rate 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

    Primary outcome measures include adenoma detection rate after open notification

    3 months after open notification

  • Measurement of adenoma detection rate after education

    Primary outcome measures include adenoma detection rate after education

    3 months after education

Secondary Outcomes (12)

  • Measurement of overall polyp detection rate

    9 months

  • Measurement of overall withdrawal time

    9 months

  • Measurement of overall adenomas per colonoscopy

    9 months

  • Measurement of polyp detection rate after personal notification

    3 months after personal notification

  • Measurement of polyp detection rate after open notification

    3 months after open notification

  • +7 more secondary outcomes

Study Arms (1)

Endoscopist

EXPERIMENTAL

Intervention for personal notification, open notification and colonoscopy quality education by a GI faculty

Behavioral: Personal notificationBehavioral: Open notificationBehavioral: Education

Interventions

Personal notificationBEHAVIORAL

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

Endoscopist
Open notificationBEHAVIORAL

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

Endoscopist
EducationBEHAVIORAL

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

Endoscopist

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Gastroenterology; Seoul St. Mary's hospital

Seoul, 137-701, South Korea

Location

Related Publications (4)

  • Coe SG, Crook JE, Diehl NN, Wallace MB. An endoscopic quality improvement program improves detection of colorectal adenomas. Am J Gastroenterol. 2013 Feb;108(2):219-26; quiz 227. doi: 10.1038/ajg.2012.417. Epub 2013 Jan 8.

    PMID: 23295274BACKGROUND

  • Shaukat A, Oancea C, Bond JH, Church TR, Allen JI. Variation in detection of adenomas and polyps by colonoscopy and change over time with a performance improvement program. Clin Gastroenterol Hepatol. 2009 Dec;7(12):1335-40. doi: 10.1016/j.cgh.2009.07.027. Epub 2009 Aug 7.

    PMID: 19665583BACKGROUND

  • Jover R, Zapater P, Bujanda L, Hernandez V, Cubiella J, Pellise M, Ponce M, Ono A, Lanas A, Seoane A, Marin-Gabriel JC, Chaparro M, Cacho G, Herreros-de-Tejada A, Fernandez-Diez S, Peris A, Nicolas-Perez D, Murcia O, Castells A, Quintero E; COLONPREV Study Investigators. Endoscopist characteristics that influence the quality of colonoscopy. Endoscopy. 2016 Mar;48(3):241-7. doi: 10.1055/s-0042-100185. Epub 2016 Feb 4.

    PMID: 26845473BACKGROUND

  • Choi HH, Sung SY, Lee BI, Cho H, Jung Y, Park JM, Cho YS, Lee KM, Kim SW, Choi H, Chae HS, Choi MG. The Effect of Intervention for Improving Colonoscopy Quality Is Associated with the Personality Traits of Endoscopists. Gut Liver. 2024 Mar 15;18(2):265-274. doi: 10.5009/gnl220280. Epub 2023 May 9.

    PMID: 37158042DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Bo-In Lee, MD, PhD

    Division of Gastroenterology; Seoul St. Mary's hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

December 16, 2018

First Posted

January 8, 2019

Study Start

December 12, 2018

Primary Completion

December 12, 2019

Study Completion

February 12, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)