Clinical Trial
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Efficacy of anal fistula plug in closure of cryptoglandular fistulas: long-term follow-up.

PURPOSE: The long-term efficacy of Surgisis anal fistula plug in closure of cryptoglandular anorectal fistulas was studied.

METHODS: Patients with high cryptoglandular anorectal fistulas were prospectively studied. Additional variables recorded were: number of fistula tracts, and presence of setons. Under general anesthesia and in prone jackknife position, patients underwent irrigation of the fistula tract by using hydrogen peroxide. Each primary opening was occluded by using a Surgisis anal fistula plug, which was securely sutured in place at the primary opening and tacked to the periphery of the secondary opening.

RESULTS: Forty-six patients were prospectively enrolled during a two-year period. Follow-up was six months to two years (median, 12 months). At final follow-up, all fistula tracts had been successfully closed in 38 patients, for an overall success rate of 83 percent. Seven patients had multiple tracts, for a total of 55 fistula tracts in the series. Of the 55 individual tracts, 47 (85 percent) were closed at final follow-up. Patients with one primary opening were most likely to have successful closure by using the anal fistula plug, although this was not significant. Successful closure was not correlated with the presence of setons.

CONCLUSIONS: Long-term closure of cryptoglandular anorectal fistula tracts using Surgisis anal fistula plug is safe and successful in 83 percent of patients and 85 percent of tracts.

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