This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 In a case series of 6 patients, 100% (6/6) of fistulas had closed at 2 weeks but the fistula recurred in 33% (2/6) of patients. In both patients, the fistulas recurred at 9 months. The first patient died from postoperative complications after additional surgical repairs (no further details provided). For the second patient, after a short period of drainage, the procedure was repeated without any further recurrence at 6‑month follow‑up. In a case series of 5 patients, 40% (2/5) of fistulas closed after a few days. Of those that did not close, 67% (2/3) were closed by further treatment (timing not reported) without any further recurrence at 18‑month median follow‑up (range 8 to 29 months). In a second case series of 5 patients, 80% (4/5) of fistulas had closed by 80‑day mean follow‑up (range 30 to 120 days). In the remaining patient 2 separate procedures were done, 1 week apart, but the fistula did not close.
4.2 The specialist advisers stated that the key efficacy outcomes are permanent fistula closure and avoiding the need for surgical repair.