Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000254796
Ethics application status
Approved
Date submitted
28/02/2013
Date registered
4/03/2013
Date last updated
4/03/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Botulinum toxin versus botulinum toxin with low dose Glyceryltrinitrite (GTN) cream for healing of chronic anal fissure: prospective, randomised trial
Scientific title
Botulinum toxin versus botulinum toxin with low dose Glyceryltrinitrite (GTN) cream for healing of chronic anal fissure: prospective, randomised trial
Secondary ID [1] 282039 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic anal fissure 288494 0
Condition category
Condition code
Oral and Gastrointestinal 288842 288842 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
Botox-A injection 20 units in total, 10 units intramuscular to each side of internal anal sphincter at 3 and 9 o`clock position and 1cm of 0.2% GTN cream applied topically to anal fissure area for 6 weeks thrice daily.
Intervention code [1] 286629 0
Treatment: Drugs
Comparator / control treatment
Botox-A injection 20 units to Internal anal sphincter
Control group
Active

Outcomes
Primary outcome [1] 288970 0
Healing of anal fissure by direct visualization of fissure area using anal fissure grades.
Timepoint [1] 288970 0
12 weeks
Secondary outcome [1] 301471 0
Head aches with GTN by using numeric pain scale with range from 0-10.
Timepoint [1] 301471 0
6 weeks.

Eligibility
Key inclusion criteria
All patients with chronic anal fissure(CAF) from the Waikato region of New Zealand, with ages ranging from 18-80 years.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous surgical treatment for anal fissure, pregnancy (current or planned) & lactation, inflammatory bowel disease, rectal or anal malignancy, unable to self administer medications, unable to complete necessary trial documentation or unable to attend necessary clinical follow up, any history of unexplained syncope or orthostatic hypotension, history of faecal incontinence, tuberculosis, HIV/AIDS, syphilis, peri-anal sepsis or fistulas, immunosuppressant and use of Viagra or other nitrate preparations for IHD

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 presenting after referral from GP to Anal fissure clinic in Waikato Hospital were assessed for their suitability for trial and then informed consent was obtained. Patients were allocated to group A (control) to receive 20 units of Botox injection only to internal anal sphincter and group B (exposure) to recieve 20 units of Botox injection and were prescribed with 0.2% GTN cream to apply 1cm of cream with glove to fissure area for 6 weeks.
Randomisation codes were generated by computer with study number from 1-50 before study started and patients were recruited to trial as they come in serial manner. There was no concealment in this study by means of third person.
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
Logistic regression for headache or not as the outcome and headache scores at baseline and group as explanatory variables.
Generalised linear mixed model to compare fissure pain score in two groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/03/2010
Actual
26/03/2010
Date of last participant enrolment
Anticipated
16/09/2011
Actual
16/09/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4887 0
New Zealand
State/province [1] 4887 0
Waikato

Funding & Sponsors
Funding source category [1] 286817 0
Self funded/Unfunded
Name [1] 286817 0
Country [1] 286817 0
New Zealand
Primary sponsor type
Hospital
Name
Waikato District Health Board
Address
Waikato Hospital, Pembroke street, Hamilton, Waikato 3204.
New Zealand.
Country
New Zealand
Secondary sponsor category [1] 285605 0
None
Name [1] 285605 0
Address [1] 285605 0
Country [1] 285605 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288883 0
Northern-Y Regional Ethics Committee
Ethics committee address [1] 288883 0
Ethics committee country [1] 288883 0
New Zealand
Date submitted for ethics approval [1] 288883 0
01/09/2009
Approval date [1] 288883 0
27/11/2009
Ethics approval number [1] 288883 0
NTY/09/04/032

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

Contacts
Principal investigator
Name 38214 0
Dr Muhammad Asim
Address 38214 0
Department of colorectal surgery, Waikato Hospital, Pembroke street, Hamilton. 3204
Country 38214 0
New Zealand
Phone 38214 0
+64211448889
Fax 38214 0
Email 38214 0
[email protected]
Contact person for public queries
Name 38215 0
Muhammad Asim
Address 38215 0
Department of colorectal surgery, Waikato Hospital, Pembroke street, Hamilton. 3204
Country 38215 0
New Zealand
Phone 38215 0
+64211448889
Fax 38215 0
Email 38215 0
[email protected]
Contact person for scientific queries
Name 38216 0
Simione Lolohea
Address 38216 0
Colorectal surgeon, Department of Colorectal Surgery, Waikato Hospital, Hamilton. 3204
Country 38216 0
New Zealand
Phone 38216 0
+64274822382
Fax 38216 0
Email 38216 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
SourceTitleYear of PublicationDOI
EmbaseBotulinum toxin versus botulinum toxin with low-dose glyceryltrinitrate for healing of chronic anal fissure: A prospective, randomised trial.2014
N.B. These documents automatically identified may not have been verified by the study sponsor.