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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

May 14, 2010
February 16, 2011
May 2010
January 2011   (final data collection date for primary outcome measure)
adenoma detection rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01124266 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy
Can Involvement of Endoscopy Nurse Participation Increase Adenoma Detection Rate During Screening Colonoscopy?:A Prospective Multicenter Randomized Trial

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Polyp
  • Adenomatous Polyp
  • Colonoscopy
  • Procedure: standard of care colonoscopy
    Single inspection by endoscopist during colonoscopy
  • Procedure: standard of care colonoscopy
    Dual inspection by both endoscopist and nurse during colonoscopy
  • Experimental: endoscopist only
    Intervention: Procedure: standard of care colonoscopy
  • Experimental: nurse participation
    Intervention: Procedure: standard of care colonoscopy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
844
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01124266
2010-15
Yes
Chang Kyun Lee, MD, PhD, Soon Chung Hyang Universtiy, Cheonan Hospital
Soon Chun Hyang University
  • Kangbuk Samsung Hospital
  • Hanyang University
  • Dankook University
  • Incheon St.Mary's Hospital
  • Kyung Hee University Gangdong Hospital
Principal Investigator: Chang Kyun Lee, MD, PhD Soon Chun Hyang University
Soon Chun Hyang University
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP