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Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01124266
First Posted: May 17, 2010
Last Update Posted: February 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Kangbuk Samsung Hospital
Hanyang University
Dankook University
Incheon St.Mary's Hospital
Kyung Hee University Hospital at Gangdong
Information provided by:
Soon Chun Hyang University
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Soon Chun Hyang University:

Primary Outcome Measures:
  • adenoma detection rate [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • subjects with at least one polyp [ Time Frame: 1 year ]
  • Subjects with at least one adenoma [ Time Frame: 1 year ]
  • total number of polyp [ Time Frame: 1 year ]
  • total number of adenoma [ Time Frame: 1 year ]
  • Subjects with at least one advanced adenoma or cancer [ Time Frame: 1 year ]
  • total number of advanced adenoma or cancer [ Time Frame: 1 year ]
  • polyp and adenoma detection rate according to the endoscopists or nurse experience [ Time Frame: 1 year ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Hospital at Gangdong
Investigators
Principal Investigator: Chang Kyun Lee, MD, PhD Soon Chun Hyang University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: May 14, 2010
First Posted: May 17, 2010
Last Update Posted: February 17, 2011
Last Verified: May 2010

Keywords provided by Soon Chun Hyang University:
polyp
adenoma
screening
colonoscopy
diagnosis

Additional relevant MeSH terms:
Polyps
Adenoma
Adenomatous Polyps
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms