Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Colonoscopy

• Study Type: Interventional
• Enrollment (Actual): 731
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Tai Po, Hong Kong
    • Combined Endoscopy Unit, ALice Ho Miu Ling Nethersole Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Nurse endoscopists; Colonoscopy performed by nurse endoscopists supervised by senior medical endoscopists	Procedure: Colonoscopy
ACTIVE_COMPARATOR: Medical endoscopists; Colonoscopy performed by senior medical endoscopists	Procedure: Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adenoma detection rate	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: August 12, 2013
• First Submitted That Met QC Criteria: August 14, 2013
• First Posted (ESTIMATE): August 15, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 15, 2013
• Last Update Submitted That Met QC Criteria: August 14, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NE