Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000861853
Ethics application status
Approved
Date submitted
18/07/2012
Date registered
15/08/2012
Date last updated
16/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial Comparing Carbon Dioxide & Air As The Insufflation Agent During Colonoscopy in Sedated Patients
Scientific title
A Randomised Controlled Trial Comparing Carbon Dioxide & Air As The Insufflation Agent During Colonoscopy in Sedated Patients
Secondary ID [1] 280874 0
Nil
Secondary ID [2] 281035 0
Nil
Universal Trial Number (UTN)
U1111-1132-7848
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal disease 286945 0
Condition category
Condition code
Surgery 287281 287281 0 0
Surgical techniques
Oral and Gastrointestinal 287496 287496 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
Randomisation of Carbon Dioxide versus Air as the insufflation agent during colonoscopy & impacts this has on post-procedural pain/discomfort

Patients presenting for colonoscopy with an intact colon (that is not had any previous bowel resections) will be randomised through concealed envelopes to either carbon dioxide or air as their insufflation agent during their procedure. Once the procedure is completed, the patient will be asked to rate their pain using a Visual Analog Scale (VAS) from 0-10 by a blinded trained member of the nursing staff. Scoring of pain will take place at 15, 30 & 60 minutes post procedure.

Air or carbon dioxide will ONLY be used for the duration of the colonoscopic procedure for which the patient has been consented for. The agent will be used to insufflate the colon to enable the procedure to be performed; the duration will be until completion of the colonoscopy as deemed by the proceduralists. The amount insufflated per agent during a procedure is not routinely recorded (as it makes no physiological difference) and the time for the colonoscopy varies accordingly (in fact, it is one of our secondary endpoints - to measure the time to completion and determine if a difference exists between the two agents). There will be otherwise no difference as to what is performed during a 'routine' colonoscopy.
Intervention code [1] 285309 0
Treatment: Surgery
Intervention code [2] 285495 0
Treatment: Other
Comparator / control treatment
Air is the control treatment; at present most colonoscopic procedures are performed using air as the insufflation agent. Although carbon dioxide is available as an alternative in most institutions/endoscopic units, the standard is still air and the choice of agent is presently left up to the individual proceduralist to determine.
Control group
Active

Outcomes
Primary outcome [1] 287558 0
Post-procedural pain using visual analog scale
Timepoint [1] 287558 0
At 15, 30 & 60 minutes post-procedure
Secondary outcome [1] 298388 0
Time to reach caecum
Timepoint [1] 298388 0
Upon commencement of colonoscopy, a stopwatch will be started and the time to reach the caecum will be recorded once the proceduralist has reached the point.
Secondary outcome [2] 298772 0
Time to complete procedure
Timepoint [2] 298772 0
At the end of the procedure - that is withdrawal of the colonoscope and cessation by the proceduralist - the stopwatch will be ceased and the time recorded.
Secondary outcome [3] 298773 0
Successful completion of procedure
Timepoint [3] 298773 0
The proceduralist will be asked to complete a short questionnaire indicating if they had successfully completed the procedure or had abandoned it for whatever reason in free text (difficult sedation, difficult anatomy, etc.). This is to ensure that all patients recruited have a complete colonoscopy for purposes of data analysis; those that have an abandoned procedure will be withdrawn from the trial.
Secondary outcome [4] 298774 0
Proceduralist rating of procedure
Timepoint [4] 298774 0
The proceduralist will also be asked on the short questionnaire if they rated their procedure as easy, moderate or challenging.

Eligibility
Key inclusion criteria
Any patient over the age of 18 undergoing colonoscopy for any indication in absence of previous colorectal bowel resection.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to consent
Previous colorectal bowel resection (non-intact lower GI tract)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are placed on the colonoscopy waiting list for their procedure by a treating specialist at the hospital after being assessed as requiring the procedure. Although specialists consenting these patients for the procedure will be aware that this trial exists, they are not involved in recruiting patients for the trial and will be unaware if the patient is to be included or not.

Patients are then met prior to their colonoscopy and are informed about the trial using a Patient Information & Consent Form by a member of the research team. Once they have consented, they are randomised to a treatment arm by the investigator contacting the Department Secretary. All randomisation are done using the randomisation function of Microsoft Excel and placed in sealed opaque envelopes. Upon contact, the Department Secretary will open a sealed envelope and inform the investigator whether the patient has been randomised to air or CO2.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is done using the equation function of Microsoft Excel where the random generator number function is used; subsequently this list is then sort according to order & allocated to either air or CO2.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5594 0
3011

Funding & Sponsors
Funding source category [1] 285659 0
Hospital
Name [1] 285659 0
Western Health
Country [1] 285659 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
Gordon Street
Footscray, VIC 3011
Country
Australia
Secondary sponsor category [1] 284496 0
None
Name [1] 284496 0
Address [1] 284496 0
Country [1] 284496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287655 0
Western Health Low Risk Human Research Ethics Panel
Ethics committee address [1] 287655 0
Ethics committee country [1] 287655 0
Australia
Date submitted for ethics approval [1] 287655 0
Approval date [1] 287655 0
22/06/2011
Ethics approval number [1] 287655 0
HREC/11/WH/34

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34458 0
Address 34458 0
Country 34458 0
Phone 34458 0
Fax 34458 0
Email 34458 0
Contact person for public queries
Name 17705 0
Manny Cao
Address 17705 0
Western Hospital
Gordon Street
Footscray, VIC 3011
Country 17705 0
Australia
Phone 17705 0
+61 0422 647 760
Fax 17705 0
Email 17705 0
mannycao@bigpond.com
Contact person for scientific queries
Name 8633 0
Manny Cao
Address 8633 0
Western Hospital
Gordon Street
Footscray, VIC 3011
Country 8633 0
Australia
Phone 8633 0
+61 0422 647 760
Fax 8633 0
Email 8633 0
mannycao@bigpond.com

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.