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Jena, 12th December 2019 – The minimally invasive sphincter-protecting FiLaC® laser method from the laser device manufacturer biolitec® has already proven its effectiveness in several studies in recent years. Now in Belgium, 10 patients have been examined in two hospitals* to see how the FiLaC® treatment affects one or more complex fistulas.

The study**, published in September 2019, was conducted between November 2016 and December 2018 on 10 patients with a total of 15 fistulas who had been under treatment for more than one year. At least three had had unsuccessful interventions and were subsequently treated with FiLaC®. After the first treatment with FiLaC®, 10 fistulas healed completely (primary healing rate 67%). After a median follow-up after 9 months (range 4-26 months), 80% (12 out of 15 fistulas) were completely closed (secondary healing rate). 5 fistulas required several sessions (range 2-4). In the two patients with Crohn’s disease only one FiLaC® session per fistula was needed (follow-up 4-9 months). In only three patients no complete healing was observed after one or more sessions after completion of the study on December 31, 2018. However, these patients reported a temporary improvement in symptoms after each FiLaC® treatment.

With the FiLaC® method, a flexible, radially radiating quartz glass fiber is inserted into the outer fistula orifice, through the fistula tract into the fistula cavity. The fistula cavity and the fistula tract are then irradiated from the inside using the LEONARDO® DUAL 45 laser device with a combination of two wavelengths and 45 watts, while the FiLaC® fiber is slowly drawn out again. The inner fistula orifice is also closed. By combining the wavelengths 980 nm and 1470 nm, the optimal absorption of the laser light in water and hemoglobin is achieved, which allows maximum protection of surrounding tissue and organs.

FiLaC® laser therapy is easy to carry out due to its simple handling. The short duration of treatment, the possibility of avoiding open wounds and the minimal follow-up measures represent advantages over other techniques that protect the sphincter muscle. The FiLaC® method can also be repeated as often as required. In none of the cases investigated here or in earlier studies did flatal or fecal incontinence occur.

After comparing the good primary healing rates of the results of this study with the primary healing rates of previous studies in single fistulas (65-80%), the current study comes to the conclusion that the FiLaC® method of biolitec® represents an attractive alternative to repeatedly difficult and invasive treatment methods in patients with complex fistulas. The current results compared to previously determined secondary healing rates of 88% for single fistulas can also be regarded as good under the given circumstances of the patients.

Further information on the unique FiLaC® treatment method and other continent-preserving therapies for proctology (pilonidal cysts, hemorrhoids) as well as the versatile and universally applicable LEONARDO® DUAL laser family can be found at www.biolitec.com.
(https://www.biolitec.de/en/applications/coloproctology.html)

* Department of Abdominal Surgery, H.-Hartziekenhuis, Lier, sowie Department of Abdominal Surgery, University Hospital of Antwerp, Edegem

** De Hous, N., de Gheldere, C., Van den Broeck, S. et al. Tech Coloproctol (2019) 23: 937-938. https://link.springer.com/article/10.1007%2Fs10151-015-1282-9