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Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy

Primary Purpose

Polyp, Adenomatous Polyp, Colonoscopy

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
standard of care colonoscopy
standard of care colonoscopy
Sponsored by
Soon Chun Hyang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Polyp focused on measuring polyp, adenoma, screening, colonoscopy, diagnosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dankook University Hospital
  • Soon Chun Hyang University Cheonan Hospital
  • Hanyang university Guri Hospital
  • The Catholic University Incheon St. Mary's Hospital
  • Kangbuk Samsung Hospital
  • Kyung Hee University Gangdong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

endoscopist only

nurse participation

Arm Description

Outcomes

Primary Outcome Measures

adenoma detection rate

Secondary Outcome Measures

subjects with at least one polyp
Subjects with at least one adenoma
total number of polyp
total number of adenoma
Subjects with at least one advanced adenoma or cancer
total number of advanced adenoma or cancer
polyp and adenoma detection rate according to the endoscopists or nurse experience

Full Information

First Posted
May 14, 2010
Last Updated
February 16, 2011
Sponsor
Soon Chun Hyang University
Collaborators
Kangbuk Samsung Hospital, Hanyang University, Dankook University, Incheon St.Mary's Hospital, Kyung Hee University Hospital at Gangdong
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1. Study Identification

Unique Protocol Identification Number
NCT01124266
Brief Title
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

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Soon Chun Hyang University
Collaborators
Kangbuk Samsung Hospital, Hanyang University, Dankook University, Incheon St.Mary's Hospital, Kyung Hee University Hospital at Gangdong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyp, Adenomatous Polyp, Colonoscopy
Keywords
polyp, adenoma, screening, colonoscopy, diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
844 (Actual)

8. Arms, Groups, and Interventions

Arm Title
endoscopist only
Arm Type
Experimental
Arm Title
nurse participation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
standard of care colonoscopy
Intervention Description
Single inspection by endoscopist during colonoscopy
Intervention Type
Procedure
Intervention Name(s)
standard of care colonoscopy
Intervention Description
Dual inspection by both endoscopist and nurse during colonoscopy
Primary Outcome Measure Information:
Title
adenoma detection rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
subjects with at least one polyp
Time Frame
1 year
Title
Subjects with at least one adenoma
Time Frame
1 year
Title
total number of polyp
Time Frame
1 year
Title
total number of adenoma
Time Frame
1 year
Title
Subjects with at least one advanced adenoma or cancer
Time Frame
1 year
Title
total number of advanced adenoma or cancer
Time Frame
1 year
Title
polyp and adenoma detection rate according to the endoscopists or nurse experience
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Kyun Lee, MD, PhD
Organizational Affiliation
Soon Chun Hyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dankook University Hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Cheonan Hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
Hanyang university Guri Hospital
City
Guri
Country
Korea, Republic of
Facility Name
The Catholic University Incheon St. Mary's Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University Gangdong Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
18759826
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.
Results Reference
background
PubMed Identifier
20117245
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.
Results Reference
background
PubMed Identifier
21889137
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.
Results Reference
derived

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Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy

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