Gore BioA Fistula Plug in the treatment of high anal fistulas--initial results from a German multicenter-study.

BACKGROUND

Treatment of high anal fistulas may be associated with a high risk of continence disorders. Beside traditional procedure of flap-reconstruction the occlusion of the fistula tract using fistula-plugs offers a new sphincter-saving treatment option. In this study for the first time results from Germany are described.

PATIENTS AND METHOD: 40 patients (30 male, 10 female, age 51 ± 12 years) underwent closure of a high trans-sphincteric (n = 28) or supra-sphincteric (n = 12) fistula with Gore BioA Fistula Plug(®) in three surgical departments. The surgical procedures had been performed by five colorectal surgeons. Four patients had Crohn's disease. Preoperatively 33 patients were completely continent; seven patients complained of minor continence disorders. Treatment of the patients was performed on a intent-to-treat basis and evaluation of the results was retrospective using pooled data from each center.

RESULTS

Postoperatively one patient developed an abscess, which had to be managed surgically. In two patients the plug had fallen out within the first two weeks postoperatively. Six months after surgery the fistula has been healed in 20 patients (50.0%). Three additional fistulas healed after 7, 9 rsp. 12 months. The overall healing-rate was 57.5% (23/40). The healing rate differs considerably between the surgeons from 0 to 75% and depends on the number of previous interventions. In patients having only drainage of the abscess success occurred in 63.6% (14/22) whereas in patients after one or more flap fistula reconstruction the healing rate decreased slightly to 50% (9/18). No patient complained about any impairment of his preoperative continence status.

CONCLUSION

By occlusion of high anal fistulas with a plug technique definitive healing could be achieved in nearly every second patients. Previous surgery seems to have a negative impact on success rate. We have not observed any negative impact on anal continence. From that point of view anal fistula plugs might be discussed as a treatment option for high anal fistulas, but further studies are needed to gain conclusive evidence.