Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000493145p
Ethics application status
Submitted, not yet approved
Date submitted
11/03/2019
Date registered
26/03/2019
Date last updated
26/03/2019
Date data sharing statement initially provided
26/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Role of Fistula-tract Laser Closure in the Management of Perianal Fistula (FiLaC)
Scientific title
The Efficacy of Fistula-tract Laser Closure in the Management of Perianal Fistula
Secondary ID [1] 297691 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perianal fistula 311975 0
Condition category
Condition code
Surgery 310545 310545 0 0
Surgical techniques
Oral and Gastrointestinal 310711 310711 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
The aim of FiLaC (produced by Bio Litec ®) is to gently remove the fistula tract without damaging the anal sphincter (important for faecal continence). FiLaC is administered by the treating surgeon. The approximate duration of the procedure is 30 minutes. A flexible, radially emitting laser fiber is inserted through the external fistula opening (skin opening) and positioned exactly using a pilot beam. Energy (1470nm) is then emitted radially into the fistula, with the epitheliaized tissue lining the tract being destroyed. It uses the surgical diode laser system (composed of aluminium) which is approved by the Therapeutic Goods Administration (TGA) of the Australian Government for treatment of this condition.
Intervention code [1] 313922 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319409 0
Resolution of perianal fistula disease.
This will be assessed by assessment of the perianal region by the treating surgeon in their consulting rooms at 3 months post-operation. The absence of a perianal fistula on clinical examination will indicate resolution of perianal fistula disease.
Timepoint [1] 319409 0
3 months
Secondary outcome [1] 368042 0
Post-operative faecal incontinence - this will be assessed via patient questionnaire, asking the patient if they experience any faecal incontinence, and if yes, the frequency.
Timepoint [1] 368042 0
3 months
Secondary outcome [2] 368673 0
Post-operative pain.
This will be assessed both Day 1 and at 3 months post-operation via the use a a Visual Analogue Score (VAS) ranging from 0-10.
Timepoint [2] 368673 0
3 months
Secondary outcome [3] 368681 0
Time to return to work/normal daily activities.
This will be assessed at the 3 month follow-up visit, by asking the patient the date they returned to work. If the patient does not work, then the date they resumed their normal daily household chores.
Timepoint [3] 368681 0
3 months

Eligibility
Key inclusion criteria
- Age greater than or equal to 18 years old
- Known perianal fistula disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pregnancy
- Unable to consent or unwilling to consent to procedure
- Crohn’s disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13358 0
Auburn Hospital & Community Health Services - Auburn
Recruitment postcode(s) [1] 25958 0
2144 - Auburn

Funding & Sponsors
Funding source category [1] 302216 0
Commercial sector/Industry
Name [1] 302216 0
Bio-Litec
Country [1] 302216 0
Australia
Primary sponsor type
Individual
Name
Dr Toufic El-Khoury
Address
Auburn Hospital
18/20 Hargrave Rd, Auburn NSW 2144
Country
Australia
Secondary sponsor category [1] 302065 0
None
Name [1] 302065 0
Address [1] 302065 0
Country [1] 302065 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302895 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 302895 0
Westmead Hospital
Corner Darcy Road and Hawkesbury Road
Westmead, NSW, 2145
Ethics committee country [1] 302895 0
Australia
Date submitted for ethics approval [1] 302895 0
11/03/2019
Approval date [1] 302895 0
Ethics approval number [1] 302895 0

Summary
Brief summary
The research project is testing a new treatment for perianal fistula. The new treatment is called Fistula-tract Laser Closure (FiLaC), produced by Bio-litec ®. This treatment is approved by the Therapeutic Goods Administration for treatment of this condition. The aim of this study is to assess the efficacy of FiLaC in treating patients with perianal fistula disease. This includes success rate of the treatment, associated pain, and return to normal daily activities post-operation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91766 0
Dr Toufic El-Khoury
Address 91766 0
Auburn Hospital
18/20 Hargrave Rd, Auburn NSW 2144
Country 91766 0
Australia
Phone 91766 0
+61 287593000
Fax 91766 0
Email 91766 0
[email protected]
Contact person for public queries
Name 91767 0
Dr Toufic El-Khoury
Address 91767 0
Auburn Hospital
18/20 Hargrave Rd, Auburn NSW 2144
Country 91767 0
Australia
Phone 91767 0
+61 287593000
Fax 91767 0
Email 91767 0
[email protected]
Contact person for scientific queries
Name 91768 0
Dr Toufic El-Khoury
Address 91768 0
Auburn Hospital
18/20 Hargrave Rd, Auburn NSW 2144
Country 91768 0
Australia
Phone 91768 0
+61 287593000
Fax 91768 0
Email 91768 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.