Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision
1 other identifier
interventional
731
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Mar 2012
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 12, 2013
CompletedFirst Posted
Study publicly available on registry
August 15, 2013
CompletedAugust 15, 2013
August 1, 2013
1.3 years
August 12, 2013
August 14, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Adenoma detection rate
Up to 3 months
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Nurse endoscopists
ACTIVE COMPARATORColonoscopy performed by nurse endoscopists supervised by senior medical endoscopists
Medical endoscopists
ACTIVE COMPARATORColonoscopy performed by senior medical endoscopists
Interventions
Eligibility Criteria
You may qualify if:
- \. Subjects receiving screening colonoscopy
- \. Age ≥ 18
- \. Informed consent
You may not qualify if:
- \. Subjects have undergone colonoscopy in the past 5 years
- \. Patients with prior colorectal surgery
- \. 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
- \. Pregnant or lactating women
- \. Lack of consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Combined Endoscopy Unit, Alice Ho Miu Ling Nethersole Hospital
Tai Po, Hong Kong
Related Publications (1)
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.
PMID: 25524261DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
August 12, 2013
First Posted
August 15, 2013
Study Start
March 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
August 15, 2013
Record last verified: 2013-08