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

• Published in: Colorectal disease Vol. 13; no. 1; pp. 94 - 104
• Main Authors: Hammond, T. M., Porrett, T. R., Scott, S. M., Williams, N. S., Lunniss, P. J.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-01-2011
• Subjects: Adult; Anal fistula; Collagen - therapeutic use; cross-linked collagen; Female; Fibrin Tissue Adhesive - therapeutic use; Humans; Male; management; Middle Aged; Prospective Studies; Rectal Fistula - surgery; Surveys and Questionnaires; Treatment Outcome; Wound Healing
• ISSN: 1462-8910; 1463-1318
• DOI: 10.1111/j.1463-1318.2009.02087.x

Aim  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.
Method  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.
Results  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.
Conclusion  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.