Abstract
PURPOSE: The Surgisis (R) AFP (TM) anal fistula plug is a bioabsorbable xenograft designed to assist in the closure of anorectal fistulas. Its efficacy was studied in a series of patients at King Khalid University Hospital, in Riyadh, Saudi Arabia.
METHODS: Patients with chronic and/or complicated anorectal fistulas were prospectively studied. Diagnoses were made by clinical, radiographic, or endoscopic criteria. The number of fistula tracts (based on the number of primary openings) and the duration of draining setons was recorded. Under general anesthesia, patients underwent identification and irrigation of the fistula tracts using hydrogen peroxide. The anal fistula plug was used to occlude the primary opening for each high anal/anorectal fistula not amenable to fistulotomy. The plug was securely sutured into place at the primary opening using absorbable suture.
RESULTS: Twenty-two consecutive patients were prospectively enrolled. In total, 23 fistula tracts were treated. Three anorectal fistulas failed to close early in the study, but two failures were attributed to technical error. Both patients refused to undergo a second procedure. The third failure occurred because of recurrent Crohn's disease. After a mean follow-up of 12 months, 19 of the 23 fistula tracts remained successfully closed, for an overall success rate of 83%. There was no relationship between closure of the fistula and the presence of draining setons.
CONCLUSIONS: In our experience, closure of cryptoglandular anorectal fistula tracts using the Surgisis (R) AFP (TM) anal fistula plug is safe and successful in 83% of fistula tracts at 12 months of follow-up.