Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Harry Aslanian, Yale University
ClinicalTrials.gov Identifier:
NCT00859625
First received: March 10, 2009
Last updated: January 20, 2015
Last verified: January 2015
  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:


Further study details as provided by Yale University:

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

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

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
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: 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
Study First Received: March 10, 2009
Last Updated: January 20, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
colonoscopy
adenoma detection rate

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

ClinicalTrials.gov processed this record on March 03, 2015