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Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01923155
Enrollment
731
Registered
2013-08-15
Start date
2012-03-31
Completion date
2013-06-30
Last updated
2013-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

PROCEDUREColonoscopy

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Adenoma detection rateUp to 3 months

Secondary

MeasureTime frame
Withdrawal timeUp to 3 months
Complication rateUp to 3 months
Cecal intubation RATEUp to 3 months
Patients overall satisfactory scoreUp to 3 months
Cecal intubation TIMEup to 3 months
Patients pain scoreUp to 3 months

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026