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    1 Draft recommendations

    1.1

    More research is needed on laparoscopic insertion of an inactive implant for gastro-oesophageal reflux disease before it can be used in the NHS.

    1.2

    This procedure should only be done as part of a formal research study and a research ethics committee needs to have approved its use.

    What research is needed

    1.3

    More research, in the form of randomised controlled trials, registry studies or other suitably designed studies, is needed on:

    • patient selection

    • patient-reported outcomes, including validated health-related quality-of-life measures

    • long-term outcomes.

    Why the committee made these recommendations

    There is evidence that this procedure works, but this is from small studies with limited follow-up. It is also unclear who would benefit most from this procedure. The short-term safety evidence suggests this procedure is as safe as other common laparoscopic procedures for gastro-oesophageal reflux disease. But, more research is needed on long-term safety. So, this procedure should only be used in research.