Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy

NCT ID: NCT01124266

Last Updated: 2011-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

844 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Polyp Adenomatous Polyp Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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endoscopist only

Group Type EXPERIMENTAL

standard of care colonoscopy

Intervention Type PROCEDURE

Single inspection by endoscopist during colonoscopy

nurse participation

Group Type EXPERIMENTAL

standard of care colonoscopy

Intervention Type PROCEDURE

Dual inspection by both endoscopist and nurse during colonoscopy

Interventions

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standard of care colonoscopy

Single inspection by endoscopist during colonoscopy

Intervention Type PROCEDURE

standard of care colonoscopy

Dual inspection by both endoscopist and nurse during colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kangbuk Samsung Hospital

OTHER

Sponsor Role collaborator

Hanyang University

OTHER

Sponsor Role collaborator

Dankook University

OTHER

Sponsor Role collaborator

Incheon St.Mary's Hospital

OTHER

Sponsor Role collaborator

Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role collaborator

Soon Chun Hyang University

OTHER

Sponsor Role lead

Responsible Party

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Soon Chung Hyang Universtiy, Cheonan Hospital

Principal Investigators

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Chang Kyun Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Soon Chun Hyang University

Locations

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Dankook University Hospital

Cheonan, , South Korea

Site Status

Soon Chun Hyang University Cheonan Hospital

Cheonan, , South Korea

Site Status

Hanyang university Guri Hospital

Guri-si, , South Korea

Site Status

The Catholic University Incheon St. Mary's Hospital

Incheon, , South Korea

Site Status

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Kyung Hee University Gangdong Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 18759826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20117245 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21889137 (View on PubMed)

Other Identifiers

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2010-15

Identifier Type: -

Identifier Source: org_study_id

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