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Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision

NCT ID: NCT01923155

Last Updated: 2013-08-15

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

731 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-06-30

Brief Summary

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There is no theoretical or practical reason why non-medical personnel such as nurses could not be trained to perform diagnostic colonoscopy with comparable proficiency as medical endoscopists. Nurse endoscopists have been widely accepted in the United Kingdom for the past 15 years as a valuable resource to cope with the increasing demand for endoscopic service, in particular diagnostic colonoscopy for colorectal screening. A pilot study performed in Hong Kong in 2008 has shown that endoscopy nurses can be trained to perform diagnostic endoscopy safely and reliably. This study aims to demonstrate that properly trained nurse endoscopists have a comparable proficiency in performing colonoscopy procedures as their medical counterparts.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Nurse endoscopists

Colonoscopy performed by nurse endoscopists supervised by senior medical endoscopists

Group Type ACTIVE_COMPARATOR

Colonoscopy

Intervention Type PROCEDURE

Medical endoscopists

Colonoscopy performed by senior medical endoscopists

Group Type ACTIVE_COMPARATOR

Colonoscopy

Intervention Type PROCEDURE

Interventions

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Colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1\. Subjects receiving screening colonoscopy
* 2\. Age ≥ 18
* 3\. Informed consent

Exclusion Criteria

* 1\. Subjects have undergone colonoscopy in the past 5 years
* 2\. Patients with prior colorectal surgery
* 3\. Subjects with a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of Familial Adenomatous Polyposis or Familial non-polyposis syndrome
* 4\. Pregnant or lactating women
* 5\. Lack of consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Aric Josun Hui

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Combined Endoscopy Unit, Alice Ho Miu Ling Nethersole Hospital

Tai Po, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Hui AJ, Lau JY, Lam PP, Chui AO, Fan AS, Lam TY, Tse YK, Tang RS, Ng SC, Wu JC, Ching JY, Wong MC, Chan FK, Sung J. Comparison of colonoscopic performance between medical and nurse endoscopists: a non-inferiority randomised controlled study in Asia. Gut. 2015 Jul;64(7):1058-62. doi: 10.1136/gutjnl-2013-306293. Epub 2014 Dec 18.

Reference Type DERIVED
PMID: 25524261 (View on PubMed)

Other Identifiers

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NE

Identifier Type: -

Identifier Source: org_study_id