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

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ClinicalTrials.gov Identifier: NCT00859625
Recruitment Status : Completed
First Posted : March 11, 2009
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Adenoma Procedure: nurse observation during colonoscope withdrawal

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
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
Study Start Date : November 2008
Primary Completion Date : January 2015
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Nurse participation during colonoscope withdrawal
Procedure: nurse observation during colonoscope withdrawal
nurse observation during colonoscope withdrawal
No Intervention: 2
usual colonoscopy practice


Outcome Measures

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

Eligibility Criteria

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 Posted: March 11, 2009    Key Record Dates
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