NCT01124266

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
844

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 17, 2011

Status Verified

May 1, 2010

Enrollment Period

8 months

First QC Date

May 14, 2010

Last Update Submit

February 16, 2011

Conditions

PolypAdenomatous PolypColonoscopy

Keywords

polypadenomascreeningcolonoscopydiagnosis

Outcome Measures

Primary Outcomes (1)

  • adenoma detection rate

    1 year

Secondary Outcomes (7)

  • subjects with at least one polyp

    1 year

  • Subjects with at least one adenoma

    1 year

  • total number of polyp

    1 year

  • total number of adenoma

    1 year

  • Subjects with at least one advanced adenoma or cancer

    1 year

  • +2 more secondary outcomes

Study Arms (2)

endoscopist only

EXPERIMENTAL
Procedure: standard of care colonoscopy

nurse participation

EXPERIMENTAL
Procedure: standard of care colonoscopy

Interventions

standard of care colonoscopyPROCEDURE

Single inspection by endoscopist during colonoscopy

endoscopist only

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age over 50
  • screening colonoscopy

You may not qualify if:

  • History of colorectal surgery
  • History of hereditary colorectal cancers or polyposis syndrome
  • Gastrointestinal bleeding
  • Inflammatory bowel diseases
  • Inability to provide informed consent
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Dankook University Hospital

Cheonan, South Korea

Location

Soon Chun Hyang University Cheonan Hospital

Cheonan, South Korea

Location

Hanyang university Guri Hospital

Guri-si, South Korea

Location

The Catholic University Incheon St. Mary's Hospital

Incheon, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Kyung Hee University Gangdong Hospital

Seoul, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 18759826BACKGROUND

  • 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.

    PMID: 20117245BACKGROUND

  • 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.

    PMID: 21889137DERIVED

MeSH Terms

Conditions

PolypsAdenomatous PolypsAdenomaDisease

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPathologic Processes

Study Officials

  • Chang Kyun Lee, MD, PhD

    Soon Chun Hyang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 14, 2010

First Posted

May 17, 2010

Study Start

May 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 17, 2011

Record last verified: 2010-05

Locations

KR(6)