Long‐term Outcome of the Surgisis® (biodesign®) Anal Fistula Plug for Complex Cryptoglandular and Crohn’s Fistulas

Aim To evaluate the long-term success rate of treatment with the Surgisis(R) (Biodesign(R)) anal fistula plug for complex anal fistulas, assess fistula plug failure over time and compare success rates for fistula plug between a group of patients with cryptoglandular fistula and another group with Crohn's fistula. Method This is a single-centre study of consecutive patients treated with the Surgisis(R) (Biodesign(R)) anal fistula plug between May 2006 and October 2009. All patients had complex anal fistulas in need of surgical treatment. The patients were assessed preoperatively by physical examination and three-dimensional (3D) endoanal ultrasound, and treated with a loose seton. Postoperative assessment by clinical examination and 3D endoanal ultrasound was performed at 2 weeks, 3 months and 6-12 months. Long-term follow-up was carried out in 2017 using a questionnaire, and clinical examination combined with 3D endoanal ultrasound was performed if the questionnaire indicated any signs of fistula recurrence. Results A total of 95 patients were included; 30 had quiescent Crohn's disease. Overall, 151 plug procedures were performed. Long-term follow-up was undertaken in 90 (95%) patients; the results showed that after a median period of 110 months, the overall healing rate after one to five plug procedures was 38%. No statistically significant difference in success rate was found between the cryptoglandular fistula group and the Crohn's fistula group (P = 0.37). No further healing was observed after the use of three plugs. Conclusion Considering its low morbidity in a complex disease with high recurrence rates over time, the anal fistula plug may still be considered as one of the first-line treatments for patients with complex anal fistulas.