Anal Fistula, Fistula in Ano, Sphincter Ani Incontinence
Conditions
Keywords
sphincter injury, anal abscess, incontinence
Brief summary
Laser closure of the perianal fistula is the minimally invasive and low complication rate procedure which is a life-saving way for complex fistulas, preserving anal sphincter injury. Unfortunately, wide range success rate reported before (30-80%), the investigators are searching to reach better rates. Internal closure of the fistula orifice offered by some authors. The investigators are aimed to identify the efficiency of this.
Detailed description
Despite the developments in the surgical field, the treatment of anal fistula is still a challenging problem, especially in complex, transsphincteric cases. The surgical treatment aims to avoid recurrences and also to preserve normal sphincter functions. The FiLaC procedure was recently reported non-invasive technique in perianal fistulas for treatment and preserving anal sphincter function with a good success rate. In 2018, one of our colleagues published a 40% complete healing rate by using only FiLaC technique in 103 consecutive perianal fistula patients (Prof. Cem Terzi). Some authors advocated that the closure of the internal orifice increasing the success rate. Therefore, the investigators decided to modify the surgical technique focusing closure of the internal opening associated with the FiLaC procedure.
Interventions
PROCEDURELaser closure of the anal fistula tract (FiLaC)
The FiLaC procedure was performed using a ceramic diode laser platform (12 watts, 1470-nm wavelength). The laser fiber was introduced into the fistula tract via the external orifice using the seldinger maneuver until the internal orifice was found. The fiber delivered laser energy homogenously at 3600, causing shrinkage of the fistula tract around the fiber while it was withdrawn at the speed of 1 mm/s
PROCEDUREInternal orifice closure
Closure of internal orifice with a purse-string suture using 2-0 polyglactin suture material.
Sponsors
Surp Pırgiç Armenian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The FiLaC procedure was performed using a ceramic diode laser platform (12 watts, 1470-nm wavelength). The laser fiber was introduced into the fistula tract via the external orifice using the seldinger maneuver until the internal orifice was found. The fiber delivered laser energy homogenously at 3600, causing shrinkage of the fistula tract around the fiber while it was withdrawn at the speed of 1 mm/s (2). We planned to randomized patients in two groups. Group 1) FiLaC closure of the tract, group 2) FiLaC closure of the tract with an additional surgical technique as the closure of the internal orifice with a purse-string suture using 2-0 polyglactin (VicrylR).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* complex anal fistula * high anal fistulas * recurrent anal fistulas
Exclusion criteria
* superficial anal fistulas * multibranching anal fistulas
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from perianal fistula disease severity score at 6 months | 6th month after the surgery | 0: no active disease or complete healing, 1. slight drainage with minimal symptoms, 2. persistent symptomatic drainage, 3. painful symptomatic drainage, 4. severe perianal disease potentially requiring diversion |
Countries
Turkey (Türkiye)
Contacts
Primary ContactKursat Serin, Ass. Prof.
Backup ContactCem Terzi, Prof.
Outcome results
None listed