Collagen fistula plug for the treatment of anal fistulas

PURPOSE: This study was designed to evaluate the efficacy of the Surgisis (R) (Anal Fistula Plug(TM)) in multiple patients at our institution and present early clinical results along with notable clinical observations from our experience. METHODS: This was a prospective analysis of all patients who received the Anal Fistula Plug(TM) for treatment of anorectal fistulas between April 2006 and February 2007. All tracts were irrigated with peroxide, the plug was inserted in the tract, and buried at the internal opening with 2-0 vicryl and mucosal advancement flap. Statistical analysis was performed with Fisher's exact test. RESULTS: Forty-five patients were treated with the Anal Fistula Plug(TM) and one patient was lost to follow-up. There were 27 males and 17 females with average age of 44.1 years treated for simple (n=24) or complex (n=20) fistulas. Preliminary results indicated an 84 percent healing rate by 3 to 8 weeks postoperatively, which progressively declined from 72.7 percent at 8 weeks to 62.4 percent at 12 weeks and 54.6 percent at a median follow-up of 6.5 (range, 3-13) months. Long-term Anal Fistula Plug(TM) closure rate was significantly higher in patients with simple than complex fistulas (70.8 vs. 35 percent; P < 0.02) and with non-Crohn's disease vs. Crohn's disease (66.7 vs. 26.6 percent; P < 0.02). Patients with two successive plug placements had significantly lower closure rates than patients who underwent placement of the plug once (12.5 vs. 63.9 percent; P < 0.02). No significant difference in closure rates were found between patients with one vs. multiple fistula tracts. Postoperative complications included perianal abscess in five patients (3 Crohn's disease, 2 non-Crohn's disease). CONCLUSIONS: Anal Fistula Plug(TM) is most successful in the treatment of simple anorectal fistulas but is associated with a high failure rate in complex fistula and particularly in patients with Crohn's disease. Repeat plug placement is associated with increased failure. Given the relatively low morbidity associated with the procedure, Anal Fistula Plug(TM) should be considered as a first-line treatment for patients with simple fistulas and as an alternative in selected patients with complex fistulas.