Preliminary Results on Efficacy in Closure of Transsphincteric and Rectovaginal Fistulas Associated With Crohn's Disease Using New Biomaterials

Background and aims: it was the aim of this prospective study to analyze the efficacy of the Surgisis (R) AFP (TM) anal fistula plug and the Surgisis (R) mesh for the closure of complex fistulas in Crohn's disease. Methods: All patients with perianal Crohn's disease suffering from transsphincteric and rectovaginal fistulas who underwent surgery using the Surgisis (R) anal fistula plug or the Surgisis (R) mesh were prospectively enrolled in this study. Inclusion criteria included transsphincteric single-tract fistulas and rectovaginal fistulas. Surgery was performed using a standardized technique, including irrigation of the fistula tract, placement and internal fixation of the Surgisis (R) anal fistula plug, and combined transanal/transvaginal excision of rectovaginal fistula with transvaginal placement of the mesh. Success was defined as closure of both internal and external (perianal or vaginal) openings, absence of drainage without further intervention, and absence of abscess formation. Follow-up information was obtained from clinical examination 3, 6, 9, and 12 months post-operatively. Results: Within the observation period, a total of 16 procedures were performed. After a mean follow-up of 9 months and 1 patient lost to follow-up, the overall success rate was 75%. For transsphincteric fistulas, the success rate was 77%, whereas it was 66% in rectovaginal fistulas associated with Crohn's disease. All 4 patients with failure had reoperation. Rate of stoma reversal in those patients who had fecal diversion was 66%. No deterioration of continence was documented. Conclusion: The short-term success rates are promising. Further analysis is needed to explain the definite role of this technique in comparison with traditional surgical techniques.