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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

Publications:
Additional 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
Study First Received: May 14, 2010
Last Updated: February 16, 2011
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014