Closure of fistula-in-ano with laser--FiLaC™: an effective novel sphincter-saving procedure for complex disease.

AIM Fistula laser closure (FiLaC™) is a novel sphincter-saving procedure for the treatment of anal fistula. Primary closure of the track is achieved using laser energy emitted by a radial fibre connected to a diode laser. The energy causes shrinkage of the tissue around the radial fibre with the aim being to close the track. This pilot study was designed to investigate the safety and effectiveness of this new technique in the treatment of anal fistula. METHOD Thirty-five patients with anal fistula underwent the FiLaC™ procedure. They had either a primary or a recurrent trans-sphincteric anal fistula, a previously placed seton or a fistula involving a significant portion of the sphincter with a potential risk of postoperative incontinence on fistulotomy. The surgical procedure consisted of 'sealing' the fistula by laser energy. The primary end-point was cure of the disease and evaluation of morbidity. The secondary end-point was an assessment of the degree of postoperative continence using the Cleveland Clinic Florida (CCF) Fecal Incontinence Score. RESULTS The median operation time was 20 (6-35) min. No intra-operative complications were reported. Median duration of follow up was 20 (3-36) months. Primary healing was observed in 25 (71.4%) patients. There were eight (23%) failures and two recurrences at 3 and 6 months after the operation. No patient reported incontinence postoperatively. CONCLUSION The laser FiLaC™ procedure for fistula-in-ano is a safe, relatively simple, minimally invasive, sphincter-saving procedure with a high chance of success.