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Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Colonoscopy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Combined Endoscopy Unit, Alice Ho Miu Ling Nethersole Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nurse endoscopists

Medical endoscopists

Arm Description

Colonoscopy performed by nurse endoscopists supervised by senior medical endoscopists

Colonoscopy performed by senior medical endoscopists

Outcomes

Primary Outcome Measures

Adenoma detection rate

Secondary Outcome Measures

Cecal intubation RATE
Withdrawal time
Complication rate
Patients pain score
Patients overall satisfactory score
Cecal intubation TIME

Full Information

First Posted
August 12, 2013
Last Updated
August 14, 2013
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01923155
Brief Title
Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision
Official Title
Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision: A Randomized Controlled Study in Asia (NE Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
731 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nurse endoscopists
Arm Type
Active Comparator
Arm Description
Colonoscopy performed by nurse endoscopists supervised by senior medical endoscopists
Arm Title
Medical endoscopists
Arm Type
Active Comparator
Arm Description
Colonoscopy performed by senior medical endoscopists
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy
Primary Outcome Measure Information:
Title
Adenoma detection rate
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Cecal intubation RATE
Time Frame
Up to 3 months
Title
Withdrawal time
Time Frame
Up to 3 months
Title
Complication rate
Time Frame
Up to 3 months
Title
Patients pain score
Time Frame
Up to 3 months
Title
Patients overall satisfactory score
Time Frame
Up to 3 months
Title
Cecal intubation TIME
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Combined Endoscopy Unit, Alice Ho Miu Ling Nethersole Hospital
City
Tai Po
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
25524261
Citation
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.
Results Reference
derived

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Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision

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