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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796169
• Other study ID #: XC15FIMI0020K
• Status: Completed
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: February 12, 2020

Study information

• Verified date: September 2020
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 12, 2020
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy
• Human Characteristics

Intervention

Behavioral:
• Personal notification
Baseline quality indicators of each endoscopist were measured and those were notified individually.
• Open notification
Quality indicators were measured for 3 months after 1st interventions and those were notified openly
• Education
Quality indicators were measured for 3 months after 2nd interventions and educated the importance of colonoscopy quality by a GI faculty

Locations

Country	Name	City	State
Korea, Republic of	Division of Gastroenterology; Seoul St. Mary's hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital	Saint Vincent's Hospital, Korea, Uijeongbu St. Mary Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

Jover R, Zapater P, Bujanda L, Hernández V, Cubiella J, Pellisé M, Ponce M, Ono A, Lanas A, Seoane A, Marín-Gabriel JC, Chaparro M, Cacho G, Herreros-de-Tejada A, Fernández-Díez S, Peris A, Nicolás-Pérez 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. — View Citation

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. — View Citation

Outcome

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