Biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer
Closed for comments This consultation ended on at Request commenting lead permission
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 10 sources, which was discussed by the committee. The evidence included 1 randomised controlled trail, 1 meta-analysis, 1 health technology assessment, 4 systematic reviews and 1 review, 1 case series and 1 commentary. 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: reduction in rectal toxicity, improvement in patient-reported outcome measures and quality of life.
3.3 The professional experts and the committee considered the key safety outcomes to be: pain, bleeding, infection, need for spacer removal, rectal perforation and spreading malignant disease.
3.4 Twenty-two commentaries from patients who have had this procedure were discussed by the committee. One patient organisation representing patients who have had this procedure provided submissions and these were also discussed by the committee.
Committee comments
3.5 The committee was informed that there may be groups of patients who derive particular benefit from this procedure because they are at increased risk of developing severe symptoms of rectal toxicity after radiotherapy, including those with inflammatory bowel disease or those on anticoagulation treatment. However there was no published evidence to indicate which groups of patients benefited from this procedure.
3.6 The committee noted that the incidence of rectal toxicity after radiotherapy has decreased over time with improvements in radiotherapy techniques.
Tom Clutton-Brock
Chair, interventional procedures advisory committee
February 2022
ISBN:
How are you taking part in this consultation?
You will not be able to change how you comment later.
You must be signed in to answer questions