Colonoscopy Clinical Trial
Official title:
Can Involvement of Endoscopy Nurse Participation Increase Adenoma Detection Rate During Screening Colonoscopy?:A Prospective Multicenter Randomized Trial
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 |
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).
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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 |
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 |
Korea, Republic of,
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
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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