title: Permacol™ collagen paste injection for the treatment of complex anal fistula: 1-year follow-up.
abstract: BACKGROUND
  Optimal surgical treatment for anal fistula should result in healing of the fistula track and preserve anal continence. The aim of this study was to evaluate Permacol™ collagen paste (Covidien plc, Gosport, Hampshire, UK) injection for the treatment of complex anal fistulas, reporting feasibility, safety, outcome and functional results.
  
  
  METHODS
  Between May 2013 and December 2014, 21 consecutive patients underwent Permacol paste injection for complex anal fistula at our institutions. All patients underwent fistulectomy and seton placement 6-8 weeks before Permacol™ paste injection. Follow-up duration was 12 months.
  
  
  RESULTS
  Eighteen patients (85.7%) had a high transsphincteric anal fistula, and three female patients (14.3%) had an anterior transsphincteric fistula. Fistulas were recurrent in three patients (14.3%). Seven patients (33%) had a fistula with multiple tracts. After a follow-up of 12 months, ten patients were considered healed (overall success rate 47.6%). The mean preoperative FISI score was 0.33 ± 0.57 and 0.61 ± 1.02 after 12 months.
  
  
  CONCLUSIONS
  Permacol™ paste injection was safe and effective in some patients with complex anal fistula without compromising continence.
authors.affiliation: Proctological and Perineal Surgical Unit, Department of Gastroenterology, Cisanello University Hospital, Pisa, Italy.
authors.forename: B
authors.initials: B
authors.lastname: Fabiani
authors.affiliation: Proctological and Perineal Surgical Unit, Department of Gastroenterology, Cisanello University Hospital, Pisa, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Menconi
authors.affiliation: General, Emergency and Minimaly Invasive Surgery, Careggi University Hospital, largo Brambilla 3, 50134, Florence, Italy. jamjac64@hotmail.com.
authors.forename: J
authors.initials: J
authors.lastname: Martellucci
authors.affiliation: Proctological and Perineal Surgical Unit, Department of Gastroenterology, Cisanello University Hospital, Pisa, Italy.
authors.forename: I
authors.initials: I
authors.lastname: Giani
authors.affiliation: Proctological and Perineal Surgical Unit, Department of Gastroenterology, Cisanello University Hospital, Pisa, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Toniolo
authors.affiliation: Proctological and Perineal Surgical Unit, Department of Gastroenterology, Cisanello University Hospital, Pisa, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Naldini
mesh_terms: D000328:Adult; D000368:Aged; D001003:Anal Canal / Q000601:surgery; D001672:Biocompatible Materials / Q000008:administration & dosage*; D003094:Collagen / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D012003:Rectal Fistula / Q000188:drug therapy* / Q000601:surgery; D012008:Recurrence; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001672:Biocompatible Materials; C422414:Permacol; D003094:Collagen
keywords: Anal fistula; Biomaterial; Fistula treatment; Permacol; Porcine dermal collagen matrix; Seton