Prospective, Multicenter Evaluation of Highly Concentrated Fibrin Glue in the Treatment of Complex Cryptogenic Perianal Fistulas

PURPOSE The surgical management of complex perianal fistulas is challenging and may be associated with the risk of sphincter injury. Instillation of fibrin glue to the fistula tract is a simple procedure that does not involve any muscle division, and potentially results in healing of the fistula. This study was designed to assess the use of highly concentrated fibrin glue with intra-adhesive antibiotics in the treatment of complex cryptogenic perianal fistulas. METHODS Patients with complex perianal fistulas of cryptogenic origin were prospectively included in this multicenter study. Injection of the fibrin glue mixed with antibiotics was performed in a uniform fashion. After the procedure, patients were actively examined at fixed time intervals; in cases of recurrent fistula, reinjection of fibrin glue was offered. RESULTS Sixty patients were enrolled; complete healing of the fistula was achieved in 32 patients (53 percent). Eight of 28 patients (29 percent) who were not completely healed had significant symptomatic improvement. All patients resumed normal daily activity the day after surgery and none had any deterioration in continence related to the procedure. The majority of the 26 (43 percent) adverse events were considered mild and spontaneously resolved; 2 patients (3 percent) with perianal septic complications were successfully treated by drainage. CONCLUSIONS Injection of fibrin glue for the treatment of perianal fistulas is safe, simple, and associated with early return to normal activity. Although moderately successful, it may preclude extensive surgery in more than one-half of these patients. The fibrin glue for this study was supplied by Omrix, Israel. The podium presentation was supported by Omrix, Israel. Reprints are not available. Podium presentation at the meeting of the International Society of University Colon and Rectal Surgeons, Budapest, Hungary, June 6 to 10, 2004.