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

    The content on this page is not current guidance and is only for the purposes of the consultation process.

    The evidence assessed

    Rapid review of literature

    The medical literature was searched to identify studies and reviews relevant to biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer. The following databases were searched, covering the period from their start to 04.05.2022: MEDLINE, PREMEDLINE, EMBASE, Cochrane Library and other databases. Trial registries and the Internet were also searched. No language restriction was applied to the searches (see the literature search strategy). Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion.

    The inclusion criteria were applied to the abstracts identified by the literature search. Where selection criteria could not be determined from the abstracts the full paper was retrieved.

    Inclusion criteria for identification of relevant studies

    Characteristic

    Criteria

    Publication type

    Clinical studies were included. Emphasis was placed on identifying good quality studies.

    Abstracts were excluded where no clinical outcomes were reported, or where the paper was a review, editorial, or a laboratory or animal study.

    Conference abstracts were also excluded because of the difficulty of appraising study methodology, unless they reported specific adverse events that were not available in the published literature.

    Patient

    Patients with prostate cancer.

    Intervention/test

    Insertion of biodegradable spacer for prostate rectum separation during radiotherapy.

    Outcome

    Articles were retrieved if the abstract contained information relevant to the safety and/or efficacy.

    Language

    Non-English-language articles were excluded unless they were thought to add substantively to the English-language evidence base.

    List of studies included in the interventional procedures (IP) overview

    This IP overview is based on 7,920 patients from 1 RCT, 2 meta-analysis, 1 HTA, 4 systematic reviews,1 review, 1 commentary and 1 case series. There is likely to be an overlap of primary studies between systematic reviews 2 to 7 and data between studies 9 and 10.

    Other studies that were considered to be relevant to the procedure but were not included in the main summary of the key evidence are listed in the appendix.