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The Impact of Active Nurse Participation on Adenoma Detection During Routine Colonoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00859625
First received: March 10, 2009
Last updated: June 25, 2010
Last verified: June 2010
History of Changes
  Purpose

Hypothesis-- Nurse observation in addition to the colonoscopist while withdrawing the colonoscope from the cecum leads to a greater adenoma detection rate.

Methods- Patients presenting for screening colonoscopy are randomized to nurse observation or usual practice. Risk factors for adenoma development and the adenoma detection rate in each group will be evaluated.


Condition Intervention
Adenoma
 Procedure: nurse observation during colonoscope withdrawal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Impact of Active Nurse Participation on Adenoma Detection During Routine Colonoscopy

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Adenoma detection rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: November 2008
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nurse participation during colonoscope withdrawal
 Procedure: nurse observation during colonoscope withdrawal
nurse observation during colonoscope withdrawal
No Intervention: 2
usual colonoscopy practice

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • performance of screening colonoscopy

Exclusion Criteria:

  • history of inflammatory bowel disease, gastrointestinal bleeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00859625

Locations
United States, Connecticut
Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Contact: Harry Aslanian, MD     203-785-6228     harry.aslanian@yale.edu    
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Harry Aslanian, MD Yale University
  More Information

Publications:

Responsible Party: Harry Aslanian MD, Yale University
ClinicalTrials.gov Identifier: NCT00859625     History of Changes
Other Study ID Numbers: HIC0809004192
Study First Received: March 10, 2009
Last Updated: June 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
colonoscopy
adenoma detection rate

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013