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 1 randomised controlled trial, 6 case series and 1 retrospective matched case control study, and 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 specialist advisers and the committee considered the key efficacy outcomes to be: quality of life, functional outcomes (using scales such as the low anterior resection syndrome score), tumour regression or recurrence, and the need for further surgery.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: bleeding, rectal ulceration, rectal perforation, radiation proctitis and faecal incontinence.
3.4 Sixty-one commentaries from patients who had experience of this procedure were received, which were discussed by the committee.