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OC-094 Interim results of a european, multi-centre, prospective, observational study of permacol™ collagen paste injection for the treatment of anal fistulas
  1. P Giordano1,
  2. P Sileri2,
  3. S Buntzen3,
  4. A Stuto4,
  5. J Nunoo-Mensah5,
  6. L Lenisa6,
  7. B Singh7,
  8. O Thorlacius-Ussing8,
  9. B Griffiths9,
  10. D Ziyaie10
  1. 1Whipps Cross University Hospital, London, UK
  2. 2University of Rome Tor Vergata, Rome, Italy
  3. 3Aarhus University Hospital, Aarhus, Denmark
  4. 4Ospedale Santa Maria Degli Angeli, Pordenone, Italy
  5. 5King’s College Hospital, London, UK
  6. 6San Pio X Hospital, Milan, Italy
  7. 7Leicester General Hospital, Leicester, UK
  8. 8Aalborg University Hospital, Aalborg, Denmark
  9. 9NUTH Foundation Trust, Newcastle
  10. 10Ninewells Hospital and Medical School, Dundee, UK

Abstract

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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