Introduction Historically, the treatment of anal fistulas has required a compromise between successful fistula healing and preservation of continence. The aim of this study (NCT01624350) is to evaluate clinical outcomes of anal fistulas treated with Permacol™ collagen paste.
Method Patients (N = 98) with magnetic resonance imaging-confirmed intersphincteric or transsphincteric anal fistulas, cryptoglandular primary or recurrent, from ten European sites were treated with Permacol™ collagen paste. Fistula healing, adverse events, and patient satisfaction were assessed up to 12 months post-surgery, with fistula healing at 6 months confirmed by clinical assessment as the primary endpoint. Cox regression analyses were performed to determine if patient or fistula characteristics correlate with better healing.
Results The median follow-up was 26.8 weeks (range 0.1–62.4 weeks), with 87 and 46 patients having healing data at 6 months and 12 months, respectively. At 6 months follow-up, 51 (58.6%) patients exhibited a clinically-healed anal fistula, including 20/35 (57.1%) that were recurrent at the time of treatment. At 12 months, 19 (41.3%) patients were healed. Younger patients and those with evidence of expulsion or leakage of Permacol™ collagen paste were the only variables associated with a significantly increased risk of failure (p = 0.0017 and p = 0.0068, respectively). A total of six serious adverse events were reported, four of which (perianal abscess, n = 2; non-healing fistula tract, n = 1; complex regional pain syndrome, n = 1) were possibly related to the device and/or the procedure. Continence was preserved throughout the follow-up. At their last visit, over 70% of patients reported being satisfied or very satisfied with their operation, indicating that some patients were satisfied even though their fistula did not heal.
Conclusion These preliminary results demonstrate that Permacol™ collagen paste is a well-tolerated, sphincter-sparing technique for the treatment of anal fistulas with low morbidity.
Disclosure of interest P. Giordano Grant/Research Support from: Covidien, Consultant for: Covidien, Speaker Bureau of: Covidien, P. Sileri Grant/Research Support from: Covidien, S. Buntzen Grant/Research Support from: Covidien, Speaker Bureau of: Medtronic, A. Stuto Grant/Research Support from: Covidien, J. Nunoo-Mensah Grant/Research Support from: Covidien, L. Lenisa Grant/Research Support from: Covidien, B. Singh Grant/Research Support from: Covidien, Speaker Bureau of: Covidien, O. Thorlacius-Ussing Grant/Research Support from: Covidien, B. Griffiths Grant/Research Support from: Covidien, D. Ziyaie Grant/Research Support from: Covidien, Speaker Bureau of: Covidien.
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