Treatment of Crohn's Fistulae Using an Anal Fistula Plug of Porcine Small Intestinal Submucosa Origin

Abstract

Objective: This study was designed to evaluate the efficacy of the Biodesign ® Anal Fistula Plug (AFP) for the closure of Crohn's anorectal fistula. Patients & Methods: This study was a prospective analysis of patients with Crohn's disease who received the AFP for the treatment of anorectal fistulas of Crohn's origin. Under general anesthesia and in the lithotomy or prone jackknife posi- tion, patients underwent irrigation of the fistula tract by saline or hydrogen peroxide. The AFP was then inserted into the fistula tract until it was snug. The internal end of the plug was securely sutured with 2-0 Vicryl ® and covered with a small mucosal advancement flap, while the external opening was left open to allow for drainage. Results: Twenty-one patients with a combined 28 fistula tracts were prospectively enrolled. Three single tract fistula pa- tients were lost to follow up and were excluded from the analysis. At the final follow-up of 12 months, all fistula tracts were successfully closed in 10 of 18 patients, for an overall success rate of 56%; total fistula tracts were closed in 17 of 25 tracts, for an overall success rate of 68%. None of the tracts that were closed recurred during the study period. Conclusions: Closure of Crohn's anorectal fistulas using the anal fistula plug is safe and successful in 56% of patients and 68% of fistula tracts. Given the relatively low morbidity associated with the procedure, the AFP should be considered as a viable treatment option for patients with Crohn's-associated anorectal fistulas.