Management of idiopathic anal fistula using cross-linked collagen: a prospective phase 1 study.

Fibrin glue and porcine intestinal submucosa are used in novel sphincter-preserving techniques to heal anal fistulae. However, their success is highly variable and decreases with the length of follow up. The aim of this study was to assess the safety, feasibility and potential efficacy of another novel agent, cross-linked collagen, in two different physical formats, to heal anal fistulae.
Prospectively recruited patients underwent symptom, continence and anal physiology assessments and magnetic resonance imaging. Patients with secondary tracts or acute sepsis were excluded. At operation, participants were randomized to receiving a solid collagen implant or collagen fibres suspended in fibrin glue. Follow up included repeat symptom, continence and physiological assessments at 3 months, and regular clinical review thereafter.
Twenty-nine of 43 entrants were eligible for inclusion. Thirteen patients received the collagen implant, and 16 collagen-fibrin glue. Three months postoperation, no patient experienced acute sepsis or continence disturbance, and sphincter function and integrity were unchanged. At 29 months, 12 of 15 (one lost to follow up) patients treated with collagen-fibrin glue were healed, compared with seven of 13 who received the implant.
In the short-to-medium term, both techniques are safe and equally effective. The results justify continued research into the use of biomaterials to heal anal fistulae.
AuthorsT M Hammond, T R Porrett, S M Scott, N S Williams, P J Lunniss
JournalColorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland (Colorectal Dis) Vol. 13 Issue 1 Pg. 94-104 (Jan 2011) ISSN: 1463-1318 [Electronic] England
PMID19863602 (Publication Type: Clinical Trial, Phase I, Comparative Study, Journal Article, Randomized Controlled Trial)
Copyright© 2010 The Authors. Colorectal Disease © 2010 The Association of Coloproctology of Great Britain and Ireland.
Chemical References
  • Fibrin Tissue Adhesive
  • Permacol
  • Collagen
  • Adult
  • Collagen (therapeutic use)
  • Female
  • Fibrin Tissue Adhesive (therapeutic use)
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Rectal Fistula (surgery)
  • Surveys and Questionnaires
  • Treatment Outcome
  • Wound Healing

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