None listed
Conditions
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.
Interventions
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 linin
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.
Sponsors
Dr Toufic El-Khoury
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
- Age greater than or equal to 18 years old - Known perianal fistula disease
Exclusion criteria
- Pregnancy - Unable to consent or unwilling to consent to procedure - Crohn’s disease
Outcome results
None listed