Permacol Collagen Paste Injection for Treatment of Complex Cryptoglandular Anal Fistulas: An Observational Cohort Study With a 2-Year Follow-up.

BACKGROUND: Permacol paste injection is a novel treatment approach for complex cryptoglandular anal fistulas. This study was performed to evaluate the long-term clinical outcomes of treatment with Permacol paste for complex cryptoglandular fistulas.

METHODS: Patients with primary or recurrent complex cryptoglandular anal fistulas treated with Permacol paste from 2014 to 2016 were retrospectively analyzed.

RESULTS: A total of 46 patients (median age, 41.3 years; 21 female) underwent Permacol paste injection; 20 patients (43%) had previously undergone failed fistula surgery. The patients had experienced anal fistula-related symptoms for a median of 10 weeks (range, 3-50 weeks). All patients had a draining seton in situ for a median of 10 weeks (range, 4-46 weeks). The median follow-up time was 24 months (range, 1-25 months). At the 1-month follow-up, 2 patients had paste extrusion and 2 had anal abscesses. The mean preoperative Continence Grading Scale score was 1.10 ± 1.40, and that at 3 months postoperatively was 1.13 ± 1.39 ( P = .322). There was a significant difference in the preoperative and the 1- and 3-month postoperative pain scores ( P < .001). At the 24-month follow-up, the healing rate was 50% (n = 23). A total of 19 patients (41%) with a recurrent fistula after failed Permacol paste injection required additional operative procedures. The satisfaction rate at the 2-year follow-up was 65%.

CONCLUSION: Permacol paste injection is minimally invasive and technically easy to perform. It can be considered as a viable and reasonable option for the treatment of complex cryptoglandular anal fistulas in patients with fecal continence disorders.