Back to resultsThe Impact of Active Nurse Participation on Adenoma Detection During Routine Colonoscopy
Primary Purpose
Adenoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nurse observation during colonoscope withdrawal
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenoma focused on measuring colonoscopy, adenoma detection rate
Eligibility Criteria
Inclusion Criteria:
- performance of screening colonoscopy
Exclusion Criteria:
- history of inflammatory bowel disease, gastrointestinal bleeding
Sites / Locations
- Yale-New Haven Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Nurse participation during colonoscope withdrawal
usual colonoscopy practice
Outcomes
Primary Outcome Measures
Adenoma detection rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00859625
Brief Title
The Impact of Active Nurse Participation on Adenoma Detection During Routine Colonoscopy
Official Title
The Impact of Active Nurse Participation on Adenoma Detection During Routine Colonoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma
Keywords
colonoscopy, adenoma detection rate
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Nurse participation during colonoscope withdrawal
Arm Title
2
Arm Type
No Intervention
Arm Description
usual colonoscopy practice
Intervention Type
Procedure
Intervention Name(s)
nurse observation during colonoscope withdrawal
Intervention Description
nurse observation during colonoscope withdrawal
Primary Outcome Measure Information:
Title
Adenoma detection rate
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
performance of screening colonoscopy
Exclusion Criteria:
history of inflammatory bowel disease, gastrointestinal bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Aslanian, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18759826
Citation
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.
Results Reference
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Learn more about this trial
The Impact of Active Nurse Participation on Adenoma Detection During Routine Colonoscopy
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