Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000385347
Ethics application status
Approved
Date submitted
14/07/2008
Date registered
1/08/2008
Date last updated
20/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Low air pressure insufflation during insertion phase of colonoscopy
Scientific title
Low air pressure insufflation during insertion phase of colonoscopy on cecal intubation time
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
colorectal adenoma 3407 0
Condition category
Condition code
Oral and Gastrointestinal 3555 3555 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We use low pressure air insufflation instead of high pressure during insertion phase of colonoscopy. Air insufflation is usually needed during colonoscopy. There are 3 air pressure level of air pressures on the control panel: high, median and low. Traditionaly, high pressure (0.05 MPa) is used. In this study, we use low pressure (0.0075-0.015 MPa) during insertion phase of colonoscopy to minimize loop formation. Before the colonoscopy is started, the air pressure was switched to low level on the control panel.
Intervention code [1] 3132 0
Diagnosis / Prognosis
Comparator / control treatment
high pressure air (0.05 MPa) insufflation
Control group
Dose comparison

Outcomes
Primary outcome [1] 4460 0
to reduce cecal intubation time by one minute
Timepoint [1] 4460 0
At the end of colonoscopy
Secondary outcome [1] 7586 0
post-procedure discomfort
Timepoint [1] 7586 0
At the end of colonoscopy
Secondary outcome [2] 7587 0
total dose of propofol
Timepoint [2] 7587 0
At the end of colonoscopy
Secondary outcome [3] 7588 0
satisfaction score
Timepoint [3] 7588 0
At the end of colonoscopy

Eligibility
Key inclusion criteria
age 16 to 80 year old
asymptomatic patients admitted the physical check department of our hospital.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unwilling to sign informed consent, prevoious colectomy, allergic to buscopan, meperidine or propofol, colon obstruction, and poor preparation

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 1040 0
Taiwan, Province Of China
State/province [1] 1040 0

Funding & Sponsors
Funding source category [1] 3593 0
Hospital
Name [1] 3593 0
Buddhist Dalin Tzu Chi General Hospital
Country [1] 3593 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Buddhist Dalin Tzu Chi General Hospital
Address
2 Min-Sheng Road, Dalin, Chia-Yi 622, Taiwan, R.O.C
Country
Taiwan, Province Of China
Secondary sponsor category [1] 3229 0
None
Name [1] 3229 0
Address [1] 3229 0
Country [1] 3229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5638 0
The Research Ethics Committee of Buddhist Dalin Tzu Chi General Hospital
Ethics committee address [1] 5638 0
2 Min-Sheng Road, Dalin, Chia-Yi 622, Taiwan, R.O.C
Ethics committee country [1] 5638 0
Date submitted for ethics approval [1] 5638 0
27/05/2008
Approval date [1] 5638 0
07/06/2008
Ethics approval number [1] 5638 0
B09702017

Summary
Brief summary
Too much air insufllated during colonoscopy results in loop formation and patient discomfort. We conducted this study to see if low air pressure insufflation could reduce loop fromation and thus improve efficiency of colonoscopy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28748 0
Address 28748 0
Country 28748 0
Phone 28748 0
Fax 28748 0
Email 28748 0
Contact person for public queries
Name 11905 0
Yu-Hsi Hsieh
Address 11905 0
2 Min-Sheng Road, Dalin, Chia-Yi 622, Taiwan, R.O.C
Country 11905 0
Taiwan, Province Of China
Phone 11905 0
+886-5-2648000
Fax 11905 0
Email 11905 0
[email protected]
Contact person for scientific queries
Name 2833 0
Yu-hsi Hsieh
Address 2833 0
2 Min-Sheng Road, Dalin, Chia-Yi 622, Taiwan, R.O.C
Country 2833 0
Taiwan, Province Of China
Phone 2833 0
+886-5-2648000
Fax 2833 0
Email 2833 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.