1.1 The evidence on endoluminal gastroplication for gastro-oesophageal reflux disease (GORD) raises no major safety concerns. Evidence from a number of randomised controlled trials (RCTs) shows a degree of efficacy in terms of reduced medication requirement in the short term, but changes in other efficacy outcomes are inconsistent and there is no good evidence of sustained improvement in oesophageal pH measurements. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to undertake endoluminal gastroplication for GORD should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients and their carers understand the uncertainty about the procedure's efficacy, particularly in the long term, and provide them with clear written information. In addition, the use of NICE's information for patients ('Understanding NICE guidance') is recommended (available from www.nice.org.uk/guidance/IPG404/publicinfo).
Audit and review clinical outcomes of all patients having endoluminal gastroplication for GORD (see section 3.1).
1.3 Any further studies should include measurements of oesophageal pH and report long-term outcomes.