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Trial registered on ANZCTR


Registration number
ACTRN12620000094976
Ethics application status
Approved
Date submitted
2/01/2020
Date registered
4/02/2020
Date last updated
4/02/2020
Date data sharing statement initially provided
4/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Botulinum toxin for the treatment of anal fistulae - a double blinded randomized trial
Scientific title
Botulinum toxin for the treatment of anal fistulae - a double blinded randomized trial
Secondary ID [1] 300155 0
Nil
Universal Trial Number (UTN)
U1111-1245-8291
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anal fistula 315693 0
Condition category
Condition code
Oral and Gastrointestinal 313979 313979 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
This is a blinded randomized trial of Botox injection with removal of the Seton drain and de- epithelialisation of the tract compared with Seton removal and de- epithelialisation alone for the treatment of complex anal fistulae.
Dose of Botox: 2 X 40iU injections to the anal sphincters as a single administratio. This will be performed by the patient's treating surgeon. This procedure takes approximately thee minutes.
Follow up will be done by a speicalist surgeon. The fistula will be judged to have healed (primary endpoint of the study) if the following criteria are met:
• The external opening has healed.
• The internal opening cannot be palpated on digital rectal examination.
• The patient does not complain of any ongoing drainage from the fistula site.
Intervention code [1] 316429 0
Treatment: Drugs
Comparator / control treatment
Seton removal and de- epithelialisation plus injection of saline placebo
Control group
Placebo

Outcomes
Primary outcome [1] 322401 0
Healing of fistula
The fistula will be judged to have healed if the following criteria are met:
• The external opening has healed.
• The internal opening cannot be palpated on digital rectal examination.
• The patient does not complain of any ongoing drainage from the fistula site.
This will be assessed by a specialist surgeon investigator who will be blindd to the treatment arm.
Timepoint [1] 322401 0
3 weeks post- procedure
Secondary outcome [1] 378368 0
Faecal incontinence
The presence and severity of faecal incontinence will be documented using the St. Mark’s Incontinence Score. This is a self- reported assessment of the patient’s experience of their continence. It includes both objective statements of the frequency of incontinence episodes (to solid or liquid stool or flatus) as well as a more general perception of how frequently incontinence affects their lifestyle. This is a widely used and well validated questionnaire, the results of which have been shown to correlate well with other measures of quality of life.
Timepoint [1] 378368 0
24 weeks post procedure

Eligibility
Key inclusion criteria
Complex anal fistula with Seton drain in situ
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with known Crohn’s disease of anorectal malignancy.
• Patients with rectovaginal or anovaginal fistulae.
• Patients with known generalised musculoskeletal disease.
• Patients with known sensitivity to Botox.
• Pregnant or breast- feeding women.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 304594 0
University
Name [1] 304594 0
Dept Surgery, Deakin University
Address [1] 304594 0
University Hospital Geelong
Bellarine Street
Geelong
Victoria
3220
Country [1] 304594 0
Australia
Primary sponsor type
University
Name
Dept Surgery, Deakin University
Address
University Hospital Geelong
Bellarine Street
Geelong
Victoria
3220
Country
Australia
Secondary sponsor category [1] 304895 0
None
Name [1] 304895 0
Address [1] 304895 0
Country [1] 304895 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305016 0
Research Ethics, Governance & Integrity (REGI) Unit, Barwon Health
Ethics committee address [1] 305016 0
Research Ethics, Governance & Integrity (REGI) Unit, Barwon Health
Post. PO Box 281 Geelong 3220 Victoria
Email: REGI@barwonhealth.org.au
Ethics committee country [1] 305016 0
Australia
Date submitted for ethics approval [1] 305016 0
Approval date [1] 305016 0
06/12/2019
Ethics approval number [1] 305016 0

Summary
Brief summary
This is a double blinded randomized trial of Botox injection for the treatment of complex anal fistulae.

All patients will have a Seton drain placed at their initial surgery.

After six weeks they will be randomized to either Botox injection to the anal sphincter or placebo as well as (in both groups) removal of the Seton drain.

Patients will be followed up at 3,12 and 24 weeks to assess healing of the fistula.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98978 0
A/Prof Douglas Stupart
Address 98978 0
Dept. Surgery
University Hospital Geelong
Bellarine street
Geelong
Victoria
3220
Country 98978 0
Australia
Phone 98978 0
+61 3 42152001
Fax 98978 0
Email 98978 0
douglas.stupart@deakin.edu.au
Contact person for public queries
Name 98979 0
A/Prof Douglas Stupart
Address 98979 0
Dept. Surgery
University Hospital Geelong
Bellarine street
Geelong
Victoria
3220
Country 98979 0
Australia
Phone 98979 0
+61 3 42152001
Fax 98979 0
Email 98979 0
douglas.stupart@deakin.edu.au
Contact person for scientific queries
Name 98980 0
A/Prof Douglas Stupart
Address 98980 0
Dept. Surgery
University Hospital Geelong
Bellarine street
Geelong
Victoria
3220
Country 98980 0
Australia
Phone 98980 0
+61 3 42152001
Fax 98980 0
Email 98980 0
douglas.stupart@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Allocation (treatment or placebo)
Follow up time
Fistula healing
Complications
When will data be available (start and end dates)?
Immediately following publication.
No end date
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
e-mail access via P.I.
Douglas.Stupart@Deakin.edu.au
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6281 0
Study protocol
Citation [1] 6281 0
Link [1] 6281 0
Email [1] 6281 0
Other [1] 6281 0
Type [2] 6282 0
Ethical approval
Citation [2] 6282 0
Link [2] 6282 0
Email [2] 6282 0
Other [2] 6282 0
Summary results
No Results