Surgical treatment of complex anal fistulas with the anal fistula plug: a prospective, multicenter study.

PURPOSE: This study was designed to analyze the efficacy of the Surgisis Anal Fistula Plug for the closure of transsphincteric anorectal fistulas.

METHODS

Patients with single transsphincteric anorectal fistulas were prospectively enrolled. Setons were used in all tracts for at least eight weeks before surgery. Continence, surgical variables, complications, and healing rates were recorded. Surgery was performed in a standardized manner. The fistula tract and external opening were debrided, the tract was irrigated, and the plug was placed. The external opening was left open. Success was defined as the absence of drainage and closure of the external opening. Follow-up examinations were performed at 2 days, 2, 4, 6, and 12 weeks, and 6 and 12 months after surgery.

RESULTS

Sixty patients were enrolled. Seventeen patients were smokers, and ten had diabetes mellitus. The mean surgical time was 23 (range, 13-50) minutes; no morbidity occurred. The overall success rate after 12 months was 62%. Nineteen fistulas recurred, and four fistulas never completely healed. The success rate was significantly lower in smokers and diabetics. Two patients had a plug dislodgement, and plugs were successfully replaced. No change in continence was observed.

CONCLUSION

Because there is still no standard for the treatment of high transsphincteric fistulas and because recurrence rates are high for all procedures performed, new techniques are needed for this complex disease. Our success rate of 62% is promising because this technique can be used as a first approach to close the fistula tract without destruction of the sphincter muscle.