Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision

Colorectal Cancer Clinical Trial

Official title:

Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision: A Randomized Controlled Study in Asia (NE Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923155
• Other study ID #: NE
• Status: Completed
• Phase: N/A
• First received: August 12, 2013
• Last updated: August 14, 2013
• Start date: March 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 731
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Procedure:
• Colonoscopy

Locations

Country	Name	City	State
Hong Kong	Combined Endoscopy Unit, Alice Ho Miu Ling Nethersole Hospital	Tai Po

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate		Up to 3 months	No
Secondary	Cecal intubation RATE		Up to 3 months	No
Secondary	Withdrawal time		Up to 3 months	No
Secondary	Complication rate		Up to 3 months	No
Secondary	Patients pain score		Up to 3 months	No
Secondary	Patients overall satisfactory score		Up to 3 months	No
Secondary	Cecal intubation TIME		up to 3 months	No