Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: Colonoscopy

• Registration Number: NCT01923155
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-08
• Study First Submitted: 2013-08-12
• Study First Submitted QC: 2013-08-14
• Last Update Submitted: 2013-08-14
• Study First Posted: 2013-08-15
• Last Update Posted: 2013-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 731

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse endoscopists	Colonoscopy	Colonoscopy performed by nurse endoscopists supervised by senior medical endoscopists
Medical endoscopists	Colonoscopy	Colonoscopy performed by senior medical endoscopists

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	Up to 3 months

Secondary Outcome Measures

Name	Time	Method
Cecal intubation RATE	Up to 3 months
Withdrawal time	Up to 3 months
Complication rate	Up to 3 months
Patients pain score	Up to 3 months
Patients overall satisfactory score	Up to 3 months
Cecal intubation TIME	up to 3 months

Trial Locations

Locations (1)

Combined Endoscopy Unit, Alice Ho Miu Ling Nethersole Hospital; 🇭🇰 Tai Po, Hong Kong