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

This study is currently recruiting participants.

Verified June 2010 by Yale University

First Received on March 10, 2009. Last Updated on June 25, 2010 History of Changes

Sponsor:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00859625

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:

Rogart JN, Siddiqui UD, Jamidar PA, Aslanian HR. Fellow involvement may increase adenoma detection rates during colonoscopy. Am J Gastroenterol. 2008 Nov;103(11):2841-6. Epub 2008 Aug 27.

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 February 09, 2012