Purpose: Complex high and recurrent fistulas remain a surgical challenge. Simple division, i.e., fistulotomy, will likely result in fecal incontinence. Various surgical treatment options for these fistulas have shown disappointing results. Recently, a biologic anal fistula plug was developed to treat these high transsphincteric fistulas. To assess the results of the anal fistula plug in patients with complex high perianal fistulas, a prospective, two-center, clinical study was undertaken. Methods: Between April 2006 and October 2006, a consecutive series of patients with difficult therapy-resistant high fistulas were enrolled. During surgery, the internal fistula tract opening was identified. A conical shaped collagen plug was pulled through the fistula tract. Any remaining portion of the plug that was not implanted in the tract was removed. The plug was fixed at the internal opening with a deep 3/0 polydioxanone suture. Results: Seventeen patients with a median age of 45 (range, 27-75) years were included. Of these patients, 71% (12/17) were male. At a median length of follow-up of 7 (range, 3-9) months, 7 of 17 fistulas had healed (41%). In ten patients, the fistula recurred. Conclusion: In these small series of 17 patients with difficult high perianal fistulas, a success rate of 41% is noted. Larger series, preferably in trial setting, must be performed to establish the efficacy of the anal fistula plug in perianal fistula. © 2008 Urban & Vogel.
