Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000018617
Ethics application status
Approved
Date submitted
29/12/2013
Date registered
7/01/2014
Date last updated
7/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled study evaluating the use of water during a colonoscopy in patients to facilitate the performance of the colonoscopic procedure
Scientific title
A randomised controlled study evaluating the use of water during a colonoscopy in patients to facilitate the performance of the colonoscopic procedure
Secondary ID [1] 283814 0
nil known
Universal Trial Number (UTN)
U1111-1151-5922
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Screening intervention for colorectal cancer prevention.
 290793 0
Investigation for patients with lower gastrointestinal symptoms such as rectal bleeding, altered bowel habit and abdominal pain 290794 0
Condition category
Condition code
Oral and Gastrointestinal 291161 291161 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 291203 291203 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The use of room temperature water as an adjunctive method for distension of colon lumen during colonoscopy. Approximately 300ml of sterile water will be instilled into the colon during the colonoscopy procedure. The addition of water will take approximately 2-3 minutes to the overall time of the procedure. Additional gas insufflation (the normal standard of care) will also be used in addition to the water to achieve adequate colon distension to facilitate the procedure.

Patients will be randomised to either the water assisted group or the standard of care. patients will be blinded to which arm they have been allocated to, but the operator will be unblinded. Standard parameters will be monitored and recorded during the procedure in both arms to assess the effect/difference between the two groups
Intervention code [1] 288505 0
Treatment: Surgery
Comparator / control treatment
Standard method of air/gas insufflation during the colonoscopy procedure
Control group
Active

Outcomes
Primary outcome [1] 291150 0
Time to caecal intubation
Timepoint [1] 291150 0
When the caecal pole is reached
Primary outcome [2] 291151 0
Patient analgesic scores. Pain will be assessed by using a visual analog scale of 1-10 (Wong-Baker Faces Pain rating scale)
Timepoint [2] 291151 0
At conclusion of procedure and if further analgesia is requested by the patient during the procedure.
Primary outcome [3] 291193 0
Sedation requirements. The required quantity of midazolam and fentanyl will be collated and recorded at the conclusion of the procedure. Any extra analgesia during the course of the procedure will be noted in addition to the induction analgesia.
Timepoint [3] 291193 0
At conclusion of the procedure
Secondary outcome [1] 306147 0
Patient satisfaction scores. A 7 point Likert scale is used ( 1- very unsatisfied, 7 - very satisfied) to assess this outcome.
Timepoint [1] 306147 0
At conclusion of procedure/ in recovery
Secondary outcome [2] 306212 0
Polyp detection. This outcome will be assessed by the documentation and removal of the polyp during the procedure. If retrieved, the polyp will be sent to pathology for histological analysis - this will also be noted and amended to the database once received (usually at day 5-7)
Timepoint [2] 306212 0
At conclusion of procedure

Eligibility
Key inclusion criteria
Age over 18 years of age.
Appropriate clinical indication for a colonoscopy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous colonic surgery
Haemodynamic instability

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Noninferiority study design.
Anticipate that water assisted colonoscopy will allow a 25% improvement in caecal intubation time (6 minutes compared to the standard accepted 8 minutes).
Allowing for an 80% power and a significance of 5%, this will require 251 patients in each arm.

Intention to treat analysis. It is assumed that both groups will follow a normal distribution. Categorical outcomes will be assessed with chi-square tests and continuous data will be analysed through t-tests.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
9/07/2012
Actual
8/08/2012
Date of last participant enrolment
Anticipated
28/03/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
410
Accrual to date
Final
Recruitment outside Australia
Country [1] 5704 0
Canada
State/province [1] 5704 0
Ontario

Funding & Sponsors
Funding source category [1] 288481 0
Hospital
Name [1] 288481 0
Division of Gastroenterology, St Michael's Hospital
Country [1] 288481 0
Canada
Primary sponsor type
Hospital
Name
Division of Gastroenterology, St Michael's Hospital
Address
Level 16
Cardinal Carter Wing
St. Michael's Hospital
30 Bond Street
Toronto, Ontario
M5B 1W8, Canada
Country
Canada
Secondary sponsor category [1] 287180 0
None
Name [1] 287180 0
Address [1] 287180 0
Country [1] 287180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290344 0
Research Ethics Board St Michael's Hospital
Ethics committee address [1] 290344 0
Ethics committee country [1] 290344 0
Canada
Date submitted for ethics approval [1] 290344 0
Approval date [1] 290344 0
08/11/2010
Ethics approval number [1] 290344 0

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

Contacts
Principal investigator
Name 45158 0
Dr Michael Swan
Address 45158 0
Department of Gastroenterology
Monash Health
246 Clayton Road
Clayton 3168
Victoria
Australia
Country 45158 0
Australia
Phone 45158 0
+61 3 95435311
Fax 45158 0
+61 3 95433805
Email 45158 0
[email protected]
Contact person for public queries
Name 45159 0
Maria Cirocco
Address 45159 0
St. Michael's Hospital
30 Bond Street
Toronto, Ontario
M5B 1W8, Canada
Country 45159 0
Canada
Phone 45159 0
+1 4163604000
Fax 45159 0
Email 45159 0
[email protected]
Contact person for scientific queries
Name 45160 0
Michael Swan
Address 45160 0
Department of Gastroenterology
Monash Health
246 Clayton Road
Clayton 3168
Victoria
Australia
Country 45160 0
Australia
Phone 45160 0
+61 3 95435311
Fax 45160 0
Email 45160 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.