Clinical trial NCT01124266: Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy
Official title: Can Involvement of Endoscopy Nurse Participation Increase Adenoma Detection Rate During Screening Colonoscopy?:A Prospective Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polyp
Adenomatous Polyp
Colonoscopy
Keywords: polyp
adenoma
screening
colonoscopy
diagnosis
Lead sponsor: Soon Chun Hyang University
Sponsor class: OTHER
Collaborators: name: Kangbuk Samsung Hospital
name: Hanyang University
name: Dankook University
name: Incheon St.Mary's Hospital
name: Kyung Hee University Hospital at Gangdong
First posted: 2010-05-17
Enrollment: 844
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: adenoma detection rate
timeFrame: 1 year
Secondary outcomes:
measure: subjects with at least one polyp
timeFrame: 1 year
measure: Subjects with at least one adenoma
timeFrame: 1 year
measure: total number of polyp
timeFrame: 1 year
measure: total number of adenoma
timeFrame: 1 year
measure: Subjects with at least one advanced adenoma or cancer
timeFrame: 1 year
measure: total number of advanced adenoma or cancer
timeFrame: 1 year
measure: polyp and adenoma detection rate according to the endoscopists or nurse experience
timeFrame: 1 year
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Cheonan Hospital
city: Guri
country: Korea, Republic of
facility: Hanyang university Guri Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University Incheon St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Gangdong Hospital
Study officials:
affiliation: Soon Chun Hyang University
name: Chang Kyun Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Lee CK, Park DI, Lee SH, Hwangbo Y, Eun CS, Han DS, Cha JM, Lee BI, Shin JE. Participation by experienced endoscopy nurses increases the detection rate of colon polyps during a screening colonoscopy: a multicenter, prospective, randomized study. Gastrointest Endosc. 2011 Nov;74(5):1094-102. doi: 10.1016/j.gie.2011.06.033. Epub 2011 Sep 1.