title: The type of loose seton for complex anal fistula is essential to improve perianal comfort and quality of life.
abstract: OBJECTIVE
  The use of a loose seton for complex anal fistulae can cause perianal discomfort and reduced quality of life. The aim of this study was to assess the impact of the novel knot-free Comfort Drain on quality of life, perianal comfort and faecal continence compared to conventional loose setons.
  
  
  METHODS
  Forty-four patients treated for complex anal fistula at a single institution between July 2013 and September 2014 were included in the study. A matched-pair analysis was performed to compare patients with a knot-free Comfort Drain and controls who were managed by conventional knotted setons. The 12-item Short Form survey (SF-12) questionnaire was used to assess quality of life. Additionally, patients reported perianal comfort and faecal incontinence using a Visual Analog Scale (VAS) and the St Mark's Incontinence Score.
  
  
  RESULTS
  The Comfort Drain was associated with improved quality of life with significant higher median physical (P = 0.001) and mental (P = 0.04) health scores compared with a conventional loose seton. According to the VAS, patients with a Comfort Drain in situ reported greater perianal comfort with significantly less burning sensation (P < 0.001) and pruritus (P < 0.001). Faecal continence was similar in each group.
  
  
  CONCLUSIONS
  The Comfort Drain offers improved perianal comfort and better quality of life compared with a conventional loose seton and therefore facilitates long-term therapy in patients with complex fistula-in-ano.
authors.affiliation: Department of Surgery, Medical University of Vienna, Vienna, Austria.
authors.forename: I
authors.initials: I
authors.lastname: Kristo
authors.affiliation: Department of Surgery, Medical University of Vienna, Vienna, Austria.
authors.forename: A
authors.initials: A
authors.lastname: Stift
authors.affiliation: Department of Surgery, Medical University of Vienna, Vienna, Austria.
authors.forename: C
authors.initials: C
authors.lastname: Staud
authors.affiliation: Department of Nephrology, Medical University of Vienna, Vienna, Austria.
authors.forename: A
authors.initials: A
authors.lastname: Kainz
authors.affiliation: Department of Surgery, Medical University of Vienna, Vienna, Austria.
authors.forename: T
authors.initials: T
authors.lastname: Bachleitner-Hofmann
authors.affiliation: York Teaching Hospital, NHS Foundation Trust, York, UK.
authors.forename: P
authors.initials: P
authors.lastname: Chitsabesan
authors.affiliation: Department of Surgery, Medical University of Vienna, Vienna, Austria.
authors.forename: S
authors.initials: S
authors.lastname: Riss
mesh_terms: D000328:Adult; D016022:Case-Control Studies; D004322:Drainage / Q000295:instrumentation; D005242:Fecal Incontinence / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology / Q000601:surgery; D011788:Quality of Life; D012003:Rectal Fistula / Q000209:etiology / Q000601:surgery*; D012189:Retrospective Studies; D011795:Surveys and Questionnaires; D013536:Suture Techniques
keywords: Comfort Drain; Fistula-in-ano; anal fistula; complex fistula; loose seton