Treatment of complex anal fistulas with the collagen fistula plug.

Purpose: Anal fistulas that involve a significant amount of sphincter may be difficult to treat without compromising continence function. In this study, we evaluated our experience with the Surgisis anal fistula plug, which was recently reported to be successful in >80 percent of patients with complex fistulas.
Methods: We retrospectively collected patient and fistula characteristics, procedure details, and follow-up information for all patients treated with the anal fistula plug at our institution from January 2006 through April 2007. The outcome was considered successful if the external opening was closed and if the patient had no drainage at the last follow-up. Using multivariate statistics, we analyzed the relationship between anal fistula plug success and several key variables.
Results: From January 2006 through April 2007, 47 patients with 49 complex anal fistulas underwent 64 anal fistula plug procedures. The median follow-up time for patients who were considered healed was 6.5 (range, 3-11) months. The success rate was 31 percent per procedure and 43 percent per patient. An increased amount of external sphincter involvement was associated with a higher failure rate (P < 0.05).
Conclusions: In our early experience with the anal fistula plug, 43 percent of patients with complex anal fistulas were successfully treated. Patients with less external sphincter involvement were more likely to heal.