Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000600347
Ethics application status
Approved
Date submitted
16/09/2008
Date registered
1/12/2008
Date last updated
9/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled blinded trial to investigate the effect of hyoscine butylbromide during colonoscopy on rates of polyp detection.
Scientific title
In patients undergoing standard fibreoptic colonoscopy at a single centre, randomly allocated to receive hyoscine butylbromide or saline; a comparison of polyp detection rates between the two groups is to be undertaken to improve detection of colonic polyps.
Secondary ID [1] 262600 0
A BLINDED RANDOMISED PLACEBO CONTROLLED TRIAL OF HYOSCINE BUTYLBROMIDE GIVEN DURING COLONOSCOPY TO INCREASE POLYP DETECTION
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic polyposis 3702 0
Condition category
Condition code
Oral and Gastrointestinal 3866 3866 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 3867 3867 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During the isolated procedure of a single colonoscopy using the standard equipment, monitoring and sedation; the intervention (a single dose of hyoscine butylbromide 20 mg intravenously over approximately 10 seconds, also commercially known as buscopan) will be administered upon intubation of the caecum.
Intervention code [1] 3414 0
Treatment: Drugs
Comparator / control treatment
Standard treatment for colonoscopy (no treatment in additinoal to standard equipment, monitoring and sedation). Upon intubation of the caecum the control group will receive a single intravenous dose of normal saline solution administered as a placebo. The control group will receive their colonoscopy as an isolated single procedure.
Control group
Placebo

Outcomes
Primary outcome [1] 4768 0
Number of colonic polyps detected by inspection of the bowel via a fibreoptic colonoscope in patients with polyps detected at the isolated single procedure of colonoscopy.
Timepoint [1] 4768 0
At the time of colonoscopy.
Secondary outcome [1] 8055 0
Number of patients with polyps detected by inspection of the bowel with a fibreoptic colonoscope during the isolated single procedure of colonoscopy.
Timepoint [1] 8055 0
At the time of colonoscopy
Secondary outcome [2] 8056 0
Average number of polyps detected by inspection of the bowel with a fibreoptic colonoscope during the isolated single procedure of colonoscopy.
Timepoint [2] 8056 0
At the time of colonoscopy.

Eligibility
Key inclusion criteria
Booking for colonoscopy.
Intact colon (no previous colonic resection).
Minimum age
16 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergency colonoscopic procedure
Previous colon resection
Already included in this study
Glaucoma
Achalasia
Previous urinary retention
Known bowel obstructions
Myasthenia gravis
Porphyria
Fructose intolerance
Megacolon

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)
Allocation concealment via numbered sheets of paper checked against a central computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation via computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1158 0
2050

Funding & Sponsors
Funding source category [1] 3880 0
Self funded/Unfunded
Name [1] 3880 0
Country [1] 3880 0
Primary sponsor type
Individual
Name
Dr A Kaffes
Address
Gastroenterology and Liver Centre
Building 77 Level 9
Royal Prince Alfred Hospital
Missenden Rd
Newtown
NSW 2050
Country
Australia
Secondary sponsor category [1] 3484 0
Other Collaborative groups
Name [1] 3484 0
AW Morrow Gastroenterology and Liver Centre
Address [1] 3484 0
AW Morrow Gastroenterology and Liver Centre
Building 77 Level 9
RPAH
Missenden Rd
Newtown
NSW 2050
Country [1] 3484 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5932 0
Ethics committee address [1] 5932 0
Ethics committee country [1] 5932 0
Date submitted for ethics approval [1] 5932 0
18/09/2008
Approval date [1] 5932 0
Ethics approval number [1] 5932 0

Summary
Brief summary
Some colonic polyps are not seen during colonoscopy, and new therapies are frequently tested to decrease the 'miss-rate' of around 15-20 %. The aim of this study is to test the hypothesis that using an antispasmodic drug (hyoscine butylbromide - also known as buscopan), given as a single intravenous dose during colonoscopy, that polyp detection rates may be improved. The study population will be all patients (who agree to participate)booked in for routine colonoscopy for any indication at a university hospital centre.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28940 0
Address 28940 0
Country 28940 0
Phone 28940 0
Fax 28940 0
Email 28940 0
Contact person for public queries
Name 12097 0
Dr Crispin Corte
Address 12097 0
AW Morrow Gastroenterology and Liver Centre
Building 77 Level 9
RPAH
Missenden Rd
Newtown
NSW 2050
Country 12097 0
Australia
Phone 12097 0
(02) 95156111
Fax 12097 0
Email 12097 0
[email protected]
Contact person for scientific queries
Name 3025 0
Dr Crispin Corte
Address 3025 0
AW Morrow Gastroenterology and Liver Centre
Building 77 Level 9
RPAH
Missenden Rd
Newtown
NSW 2050
Country 3025 0
Australia
Phone 3025 0
(02) 95156111
Fax 3025 0
Email 3025 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

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