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NCT00859625 Clinical Trial

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

Adenoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00859625
Other study ID # HIC0809004192
Secondary ID
Status Completed
Phase N/A
First received March 10, 2009
Last updated January 20, 2015
Start date November 2008
Est. completion date January 2015

Study information
Verified date January 2015
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years and older
Eligibility Inclusion Criteria:

- performance of screening colonoscopy

Exclusion Criteria:

- history of inflammatory bowel disease, gastrointestinal bleeding

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• nurse observation during colonoscope withdrawal
nurse observation during colonoscope withdrawal

Locations
Country Name City State
United States Yale-New Haven Hospital New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1111/j.1572-0241.2008.02085.x. Epub 2008 Aug 27. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Adenoma detection rate 1 year No
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