Anal fistula plug: initial experience and outcomes.

PURPOSE: This study was designed to analyze the efficacy of the Cook Surgisis AFP anal fistula plug for the management of complex anal fistulas.

METHODS: This was a retrospective review of all patients prospectively entered into a database at our institution who underwent treatment for complex anal fistulas using Cook Surgisis AFP anal fistula plug between July 2005 and July 2006. Patient's demographics, fistula etiology, and success rates were recorded. The plug was placed in accordance with the inventor's guidelines. Success was defined as closure of all external openings, absence of drainage without further intervention, and absence of abscess formation.

RESULTS: Thirty-five patients underwent 39 plug insertions (22 men; mean age, 46 (range, 15-79) years). Three patients were lost to follow-up, therefore, 36 procedures to be analyzed. The fistula etiology was cryptoglandular in 31 (88.6 percent) patients and Crohn's disease associated in the other 4 (11.4 percent). There were 11 smokers and 3 patients with diabetes. The mean follow-up was 126 days (standard = 69.4). The overall success rate was 5 of 36 (13.9 percent). One of the four Crohn's disease-associated fistulas healed (25 percent) and 4 of 32 (12.5 percent) procedures resulted in healing of cryptoglandular fistulas. In 17 patients, further procedures were necessary as a result of failure of treatment with the plug. The reasons for failure were infection requiring drainage and seton placement in 8 patients (25.8 percent), plug dislodgement in 3 (9.7 percent), persistent drainage/tract and need for other procedures in 20 patients (64.5 percent).

CONCLUSIONS: The success rate for Surgisis AFP anal fistula plug for the treatment of complex anal fistulas was (13.9 percent), which is much lower than previously described. Further analysis is needed to explain significant differences in outcomes.