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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00859625
First Posted: March 11, 2009
Last Update Posted: January 22, 2015
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.
Information provided by (Responsible Party):
Harry Aslanian, Yale University
  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: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Impact of Active Nurse Participation on Adenoma Detection During Routine Colonoscopy

Resource links provided by NLM:


Further study details as provided by Harry Aslanian, Yale University:

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

Enrollment: 500
Study Start Date: November 2008
Study Completion Date: January 2015
Primary Completion Date: January 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • performance of screening colonoscopy

Exclusion Criteria:

  • history of inflammatory bowel disease, gastrointestinal bleeding
  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): NCT00859625


Locations
United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Harry Aslanian, MD Yale University
  More Information

Publications:
Responsible Party: Harry Aslanian, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00859625     History of Changes
Other Study ID Numbers: HIC0809004192
First Submitted: March 10, 2009
First Posted: March 11, 2009
Last Update Posted: January 22, 2015
Last Verified: January 2015

Keywords provided by Harry Aslanian, Yale University:
colonoscopy
adenoma detection rate

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