For people with ineffective oesophageal motility (IOM), laparoscopic insertion of an inactive implant can be used to treat gastro-oesophageal reflux disease in the NHS while more evidence is generated. It can only be used with special arrangements for clinical governance, consent, and audit or research.
Clinicians wanting to do this procedure should:
Inform the clinical governance leads in their healthcare organisation.
Ensure that people (and their families and carers as appropriate) understand the procedure's safety and efficacy, and any uncertainties about these.
Take account of NICE's advice on shared decision making, including NICE's information for the public.
Audit and review clinical outcomes of everyone having the procedure. The main efficacy and safety outcomes identified in this guidance can be entered into NICE's interventional procedure outcomes audit tool (for use at local discretion).
Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.
Healthcare organisations should:
Ensure systems are in place that support clinicians to collect and report data on outcomes and safety for everyone having this procedure.
Regularly review data on outcomes and safety for this procedure.
For people without IOM, more research is needed on laparoscopic insertion of an inactive implant for gastro-oesophageal reflux disease before it can be used in the NHS.
This procedure should only be done as part of a formal research study and a research ethics committee needs to have approved its use.
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
The evidence suggests this procedure is as safe as other common laparoscopic procedures for gastro-oesophageal reflux disease. But the efficacy evidence is from small studies, so further research is needed on short- and long-term efficacy.
People with IOM could benefit from this procedure, because other laparoscopic treatment options are limited. So it can be used with special arrangements for these people.
Because the efficacy evidence for this procedure is limited, and other common laparoscopic procedures are available for people without IOM, this procedure should only be used in research for these people.