PURPOSE: Bioprosthetic plugs are appealing, allow simple, repeatable applications, preserve sphincter integrity, minimize patient discomfort, and allow subsequent surgical options when needed. However, success rates vary widely. This study assessed the healing rate in our department when both the Cook-Surgisis and the Gore fistula plugs were used and the long-term effectiveness of using anal plugs for managing anal fistulae. METHODS: A chart review was performed for patients who had undergone plug insertion between January 2008 and December 2015 at Copenhagen University Hospital, Hvidovre. Data were collected through a prospectively collected database. Plugs were inserted according to guidance provided by 2 experienced surgeons. Long-term results were determined by clinical visits 3, 6, and 12 months after surgery and once yearly thereafter. RESULTS: From 2008 to 2015, 36 fistula plugs were inserted. During the follow-up period with a median duration of 18 months (range, 7–60 months), the fistulae of 52.8% of the patients healed. The plug failure rate was 44.4%, and the fistula recurrence rate was 26.3%. The median time to recurrence was 12 months. The overall success rate for plug treatment in our department was 39% when adjusted for recurrence. CONCLUSION: The use of bioprosthetic plugs to treat patients with complex anal fistulae seems to be a safe, viable option for complex fistula repair when other surgical attempts have failed. However, it should not be the treatment of choice. Further prospective randomized studies with a sufficient sample-size and standardized measurements are necessary to evaluate the efficacy of fistula plugs fully.
Fistula ; Follow-Up Studies ; Humans ; Prospective Studies ; Rectal Fistula ; Recurrence ; Surgeons