Currently the Biodesign® Surgisis® anal fistula plug is being used on an ad hoc basis to treat a variety of fistulae based on limited scientific evidence for its efficacy. It costs more then standard treatments and there are legitimate concerns regarding reported healing and recurrence.
Recently NICE has reviewed the evidence for the fistula plug and concluded:
"Current evidence suggests that there are no major safety concerns associated with the closure of anal fistula using a suturable bioprosthetic plug. However, evidence on the efficacy and cost effectiveness of the procedure is not adequate for it to be used without special arrangements for consent and audit or research."
There is therefore an urgent need for a randomised controlled trial to evaluate the role of the anal fistula plug in the treatment of these high anal fistulae and to determine whether its higher initial cost as compared to other current techniques is justified in terms of better patient outcomes.
The Fistula-In-Ano Trial (FIAT) aims to address this knowledge gap by evaluating whether the fistula plug can produce relief of symptoms whilst maintaining anal sphincter function and preserving symptom-specific (incontinence) quality of life.
The information obtained by randomising 500 patients into FIAT will help guide the treatment of many thousands of future patients.