|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01923155 |
|
Date of registration:
|
12/08/2013 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision
|
|
Scientific title:
|
Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision: A Randomized Controlled Study in Asia (NE Study) |
|
Date of first enrolment:
|
March 2012 |
|
Target sample size:
|
731 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01923155 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Hong Kong
| | | | | | | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Colorectal Cancer
|
|
Intervention(s)
|
|
Procedure: Colonoscopy
|
|
Primary Outcome(s)
|
|
Adenoma detection rate
[Time Frame: Up to 3 months]
|
|
Secondary Outcome(s)
|
|
Cecal intubation TIME
[Time Frame: up to 3 months]
|
|
Cecal intubation RATE
[Time Frame: Up to 3 months]
|
|
Complication rate
[Time Frame: Up to 3 months]
|
|
Withdrawal time
[Time Frame: Up to 3 months]
|
|
Patients pain score
[Time Frame: Up to 3 months]
|
|
Patients overall satisfactory score
[Time Frame: Up to 3 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|