1 Guidance

1 Guidance

This document replaces previous guidance on closure of anal fistula using a suturable bioprosthetic plug (interventional procedure guidance 221). For details see 'About this guidance'.

1.1 Current evidence on closure of anal fistula using a suturable bioprosthetic plug raises no major safety concerns. The evidence on efficacy is inadequate in quantity and quality. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2 Clinicians wishing to undertake closure of anal fistula using a suturable bioprosthetic plug are encouraged to enter patients into the Fistula-In-Ano Trial (FIAT) (www.hta.ac.uk/project/1998.asp or www.controlled-trials.com/ISRCTN78352529). Clinicians wishing to undertake closure of anal fistula using a suturable bioprosthetic plug outside a clinical trial should take the following actions.

  • Inform the clinical governance leads in their Trusts.

  • Ensure that patients understand the uncertainty about the procedure's efficacy and provide them with clear written information. In addition, use of NICE's information for patients (Understanding NICE guidance) is recommended.

  • Audit and review clinical outcomes of all patients having closure of anal fistula using a suturable bioprosthetic plug (see section 3.1).

1.3 Closure of anal fistula using a suturable bioprosthetic plug should only be carried out by surgeons with specific training in the procedure. The methods agreed for the FIAT trial provide a useful source of information on technical aspects of the procedure.

1.4 NICE may review the procedure upon publication of further evidence.

  • National Institute for Health and Care Excellence (NICE)