CClinicalTrials.gg
CompletedNCT01923155Updated Aug 15, 2013

Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision

An interventional study of Colonoscopy in Colorectal Cancer, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-15.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
731
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 731 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Subjects receiving screening colonoscopy
    1. Age ≥ 18
    1. Informed consent

Exclusion criteria

Exclusion Criteria:

    1. Subjects have undergone colonoscopy in the past 5 years
    1. Patients with prior colorectal surgery
    1. 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
    1. Pregnant or lactating women
    1. Lack of consent
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
731 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureColonoscopy
06

What researchers measure

Primary outcomes

  1. Adenoma detection rate

    Time frame: Up to 3 months

Secondary outcomes

  1. Cecal intubation RATE

    Time frame: Up to 3 months

  2. Withdrawal time

    Time frame: Up to 3 months

  3. Complication rate

    Time frame: Up to 3 months

  4. Patients pain score

    Time frame: Up to 3 months

  5. Patients overall satisfactory score

    Time frame: Up to 3 months

  6. Cecal intubation TIME

    Time frame: up to 3 months

07

Study locations

1 site
  • Combined Endoscopy Unit, Alice Ho Miu Ling Nethersole Hospital
    Tai Po, Hong Kong
08

References and documents

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. PubMed 25524261 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01923155
Lead sponsor
Chinese University of Hong Kong
Responsible party
Aric Josun Hui (Dr, Chinese University of Hong Kong) — Principal investigator
First posted
Aug 15, 2013
Start date
Mar 2012
Primary completion
Jun 2013
Completion
Jun 2013
Last update
Aug 15, 2013
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion