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 7 sources, which was discussed by the committee. The evidence included 7 case series, 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, quality of life and recurrence.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: incontinence, abscess, pain, anismus, bleeding and urinary retention.
3.4 One commentary from a patient who had experience of this procedure was received, which was discussed by the committee.