Evaluation of the use of BioGlue® in the treatment of high anal fistulas:: Preliminary results of a pilot study

PURPOSE: Treatment of anal fistulas by use of adhesives is an attractive method because of its simplicity and it can be performed on an ambulatory basis. Furthermore, if the treatment is unsuccessful, adhesive use does not subsequently prevent the surgeon from utilizing alternative surgical techniques and/or products. BioGlue(R) Surgical Adhesive is a two-component surgical adhesive composed of bovine serum albumin and glutaraldehyde. We evaluated the usefulness of BioGlue(R) for the treatment of high transsphincter anal fistulas. METHODS: Patients diagnosed with high transsphincter anal fistulas of cryptoglandular origin, whether relapsed or not, were included in this study. A seton was placed before the injection of BioGlue(R) into the fistula track of high transsphincter anal fistulas in patients with secondary tracts and/or purulent collections. Clinical charts, operative reports, and endoanal echography results obtained for each patient were reviewed. RESULTS: Fourteen patients (13 males; mean age, 39.9 (range, 24-66) years) with high transsphincter anal fistulas of cryptoglandular origin were recruited into the study. The average time of symptom evolution was 35.6 (range, 2-96) months. Ten of 14 cases were for relapsed fistulas. Six patients required the placement of a scion 37 (range, 32-42) days before the BioGlue(R) injection. Patients were followed for a mean length of 13.92 (range, 3-21) months, and the fistula healed completely in only seven patients (50 percent). CONCLUSIONS: These preliminary results demonstrate that BioGlue(R) may be useful for treating patients with high transsphincter anal fistulas. Further prospective long-term studies are needed.