Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy

This study has been completed.

Sponsor:

Collaborators:

Kangbuk Samsung Hospital

Hanyang University

Dankook University

Incheon St.Mary's Hospital

Kyung Hee University Gangdong Hospital

Information provided by:

Soon Chun Hyang University

ClinicalTrials.gov Identifier:

NCT01124266

First received: May 14, 2010

Last updated: February 16, 2011

Last verified: May 2010

History of Changes

Purpose

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).

Condition	Intervention	Phase
Polyp Adenomatous Polyp Colonoscopy	Procedure: standard of care colonoscopy	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Can Involvement of Endoscopy Nurse Participation Increase Adenoma Detection Rate During Screening Colonoscopy?:A Prospective Multicenter Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Benign Tumors Cancer Colonoscopy Endoscopy

U.S. FDA Resources

Further study details as provided by Soon Chun Hyang University:

Primary Outcome Measures:

adenoma detection rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

subjects with at least one polyp [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Subjects with at least one adenoma [ Time Frame: 1 year ] [ Designated as safety issue: No ]
total number of polyp [ Time Frame: 1 year ] [ Designated as safety issue: No ]
total number of adenoma [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Subjects with at least one advanced adenoma or cancer [ Time Frame: 1 year ] [ Designated as safety issue: No ]
total number of advanced adenoma or cancer [ Time Frame: 1 year ] [ Designated as safety issue: No ]
polyp and adenoma detection rate according to the endoscopists or nurse experience [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	844
Study Start Date:	May 2010
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: endoscopist only	Procedure: standard of care colonoscopy Single inspection by endoscopist during colonoscopy
Experimental: nurse participation	Procedure: standard of care colonoscopy Dual inspection by both endoscopist and nurse during colonoscopy

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124266

Locations

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, Korea, Republic of

Sponsors and Collaborators

Soon Chun Hyang University

Kangbuk Samsung Hospital

Hanyang University

Dankook University

Incheon St.Mary's Hospital

Kyung Hee University Gangdong Hospital

Investigators

Principal Investigator:

Chang Kyun Lee, MD, PhD

Soon Chun Hyang University Cheonan Hospital

More Information

Publications:

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. Epub 2008 Aug 27.

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. Epub 2010 Feb 1.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Sep 1.

Responsible Party:	Chang Kyun Lee, MD, PhD, Soon Chung Hyang Universtiy, Cheonan Hospital
ClinicalTrials.gov Identifier:	NCT01124266 History of Changes
Other Study ID Numbers:	2010-15
Study First Received:	May 14, 2010
Last Updated:	February 16, 2011
Health Authority:	Korea: Institutional Review Board

Keywords provided by Soon Chun Hyang University:

polyp
adenoma
screening
colonoscopy
diagnosis

Additional relevant MeSH terms:

Adenoma
Polyps
Adenomatous Polyps
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
Neoplasms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013

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