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 3 systematic reviews and 4 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 the fistula, prevention of recurrence and the need for repeated 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 Seven commentaries from patients who had experience of this procedure were received, which were discussed by the committee.
3.5 The committee noted that the procedure needs specialised instrumentation and appropriate training.
3.6 The committee was informed that this procedure allows the direct visualisation of the fistula tract to allow treatment planning, and that this is important for the procedure's success.
3.7 The committee was informed that for patients with inflammatory bowel disease, the aim of the procedure is often visualisation of the tract and reducing the inflammatory burden within a complex fistula tract system, rather than definitive treatment.