3.1 To inform the committee, NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 12 sources, which was discussed by the committee. The evidence included 3 systematic reviews, 4 randomised controlled trials, 4 case series and 1 unpublished NIHR Health Technology Assessment report on the fistula-in-ano trial (FIAT), and is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: fistula closure, resolution of symptoms, prevention of recurrence and the need for further surgery, and improved quality of life.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: plug extrusion, incontinence, abscess or infection, bleeding, pain and anismus.
3.4 Patient commentary was sought but none was received.
3.5 The committee was informed that the success rate of the procedure is likely to be higher for single tracts and posterior fistulas.
3.6 The evidence reviewed by the committee shows that bioprosthetic plug insertion for anal fistula has a similar safety and efficacy profile to standard treatments for anal fistulas.
3.7 The committee was informed that bioprosthetic plug insertion for anal fistula may be used in combination with other treatments.