Anal fistula plug: a prospective evaluation of success, continence and quality of life in the treatment of complex fistulae

Aim Curing complex anal fistula without compromising continence can be extremely challenging. This study investigated the healing rate, continence and quality of life of patients after treatment of complex anal fistula of cryptoglandular origin with a bioprosthetic plug. Method Consecutive patients were prospectively followed in four referral centres. Following seton conditioning, a bioprosthetic plug was inserted into the fistula and sutured to the anal sphincter. Clinical evaluation was performed at 10days, 6weeks and 6months after surgery, and was completed by telephone interviews. Anal continence and quality of life were evaluated using the Fecal Incontinence Score Index and the Short Form-36 Health Survey, version 2 (SF-36 v2) questionnaire. Results Forty-six patients presenting with a complex anal fistula and a median of three previous fistula surgeries were included. The 6-month recurrence rate was 30.7% (95% CI: 15.9-42.8%), increasing to 48.0% (95% CI: 30.6-61.1%) after 2years. Follow up was continued for a median of 68.1months, and 26 (56.5%) recurrences were identified. Anal continence improved from a median of 19 points to 12 points at 6months of follow up (P=0.008). Quality of life markedly improved in all scales. The physical summary score increased from 47.2 to 56.2 (P<0.001), and the mental summary score increased from 48.5 to 55.3 (P=0.013). Conclusion The bioprosthetic fistula plug demonstrated a healing rate close to 50% in complex cryptoglandular fistula. Also, it markedly improved anal continence and quality of life. These data support the use of a bioprosthetic plug as first-line therapy for complex fistula instead of more aggressive and potentially debilitating surgical options.