A prospective multicentre observational study of Permacol collagen paste for anorectal fistula:preliminary results

AIM: Permacol(™) collagen paste (Permacol(™) paste) is a new option for the treatment of anorectal fistula. It functions by filling the fistula tract with an acellular crosslinked porcine dermal collagen matrix suspension. The MASERATI 100 study group was set to evaluate the clinical outcome of Permacol(™) paste in the treatment of anorectal fistula. This paper reports the results from the initial 30 patients enrolled in the MASERATI 100 prospective, observational clinical trial.METHOD: Patients (N=30) with anal fistula presenting to ten European academic surgical units were treated with a sphincter-preserving technique using Permacol(™) paste. Fistula healing was assessed at 1, 3, 6, and 12 months after treatment, with the primary endpoint of fistula healing at 6-months post-surgery. Faecal continence and patient satisfaction were recorded at each follow-up visit and adverse events were monitored throughout the follow-up.RESULTS: Of the 28 patients with data at six months post-surgery, 15 (54%) were healed, and the healing rate was maintained at 12 months. Healing after treatment with Permacol(™) paste was similar for intersphincteric to transsphincteric fistulas and primary or recurrent fistulas. Only one patient exhibited an adverse event (perianal abscess) that was possibly related to the treatment. At the last outpatient visit, over 60% of patients were satisfied or very satisfied with the operation.CONCLUSION: Permacol(™) paste is was shown to be effective in treating primary and recurrent cryptoglandular anorectal fistula with minimal unwanted side effects. This article is protected by copyright. All rights reserved.