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 6 sources, which was discussed by the committee. The evidence included 1 non-randomised comparative study and 5 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: ablation of fistula, 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: bleeding and infection.
3.4 Four commentaries from patients who had experience of this procedure were received, which were discussed by the committee.