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NCT01124266 Clinical Trial

Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy

Colonoscopy Clinical Trial

Official title:
Can Involvement of Endoscopy Nurse Participation Increase Adenoma Detection Rate During Screening Colonoscopy?:A Prospective Multicenter Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01124266
Other study ID # 2010-15
Secondary ID
Status Completed
Phase Phase 4
First received May 14, 2010
Last updated February 16, 2011
Start date May 2010
Est. completion date January 2011

Study information
Verified date May 2010
Source Soon Chun Hyang University
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Colorectal cancer (CRC) is the second most common cancer and the fourth leading cause of cancer death in Korea. Colonoscopy with polypectomy decreases the incidence and mortality from colorectal cancer. However, significant lesions can be missed during colonoscopy. Recent retrospective studies have shown that fellow involvement as a second observer may increase adenoma detection rate in colonoscopy.

The aim of this prospective, multicenter, randomized study is to evaluate the impact when endoscopy nurse participate in adenoma detection during screening colonoscopy. The primary outcome measure is the adenoma detection rate (ADR).

Recruitment information / eligibility
Status Completed
Enrollment 844
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- age over 50

- screening colonoscopy

Exclusion Criteria:

- History of colorectal surgery

- History of hereditary colorectal cancers or polyposis syndrome

- Gastrointestinal bleeding

- Inflammatory bowel diseases

- Inability to provide informed consent

- Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• standard of care colonoscopy
Single inspection by endoscopist during colonoscopy
• standard of care colonoscopy
Dual inspection by both endoscopist and nurse during colonoscopy

Locations
Country Name City State
Korea, Republic of Dankook University Hospital Cheonan
Korea, Republic of Soon Chun Hyang University Cheonan Hospital Cheonan
Korea, Republic of Hanyang university Guri Hospital Guri
Korea, Republic of The Catholic University Incheon St. Mary's Hospital Incheon
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Kyung Hee University Gangdong Hospital Seoul

Sponsors (6)
Lead Sponsor Collaborator
Soon Chun Hyang University Dankook University, Hanyang University, Incheon St.Mary's Hospital, Kangbuk Samsung Hospital, Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Peters SL, Hasan AG, Jacobson NB, Austin GL. Level of fellowship training increases adenoma detection rates. Clin Gastroenterol Hepatol. 2010 May;8(5):439-42. doi: 10.1016/j.cgh.2010.01.013. Epub 2010 Feb 1. — View Citation

Rogart JN, Siddiqui UD, Jamidar PA, Aslanian HR. Fellow involvement may increase adenoma detection rates during colonoscopy. Am J Gastroenterol. 2008 Nov;103(11):2841-6. doi: 10.1111/j.1572-0241.2008.02085.x. Epub 2008 Aug 27. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary adenoma detection rate 1 year No
Secondary subjects with at least one polyp 1 year No
Secondary Subjects with at least one adenoma 1 year No
Secondary total number of polyp 1 year No
Secondary total number of adenoma 1 year No
Secondary Subjects with at least one advanced adenoma or cancer 1 year No
Secondary total number of advanced adenoma or cancer 1 year No
Secondary polyp and adenoma detection rate according to the endoscopists or nurse experience 1 year No
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