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

NCT ID: NCT00859625

Last Updated: 2015-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Nurse participation during colonoscope withdrawal

Group Type EXPERIMENTAL

nurse observation during colonoscope withdrawal

Intervention Type PROCEDURE

nurse observation during colonoscope withdrawal

2

usual colonoscopy practice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nurse observation during colonoscope withdrawal

nurse observation during colonoscope withdrawal

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* performance of screening colonoscopy

Exclusion Criteria

* history of inflammatory bowel disease, gastrointestinal bleeding
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Harry Aslanian

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harry Aslanian, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18759826 (View on PubMed)

Other Identifiers

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HIC0809004192

Identifier Type: -

Identifier Source: org_study_id

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