Guidance
3 Committee considerations
The evidence
3.1 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 8 sources, which was discussed by the committee. The evidence included 3 systematic reviews, 2 registry analyses, 1 propensity score weighted study, 1 retrospective case series and 1 retrospective cohort study. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: recurrence-free survival, metastasis-free survival, improvement in quality of life, need for subsequent intervention and overall survival.
3.3 The professional experts and the committee considered the key safety outcomes to be: pain, bleeding, rectal damage, incontinence and loss of sexual function.
3.4 Three hundred and eight commentaries from people who have had this procedure were discussed by the committee. The committee also discussed 2 submissions from patient organisations.
Committee comments
3.5 There is more than 1 device available for this procedure and the technology is evolving.
3.6 The committee noted that there was limited comparative evidence in the literature, especially for studies comparing this procedure against active surveillance or radical treatments.
ISBN: 978-1-4731-5106-2