1.1 The evidence on laparoscopic gastric plication for severe obesity raises no major safety concerns in the short term. There is inadequate evidence about safety in the long term, specifically with regard to the reversibility of the procedure and how it affects the safety of any further gastric surgery that may be necessary. There is limited evidence of efficacy in the short and medium term but more evidence is needed about the long-term efficacy of the procedure. Therefore, laparoscopic gastric plication for the treatment of severe obesity should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to undertake laparoscopic gastric plication for the treatment of severe obesity should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients understand the uncertainties about the procedure's long-term efficacy and about how the procedure may affect the safety of any further gastric surgery that they may need. Clinicians should provide patients with clear written information. In addition, the use of NICE's information for the public is recommended.
1.3 Laparoscopic gastric plication for severe obesity should only be carried out in units specialising in bariatric surgery that can offer the procedure as one of a range of treatment options. This recommendation is consistent with Obesity: guidance on the prevention, identification, assessment and management of overweight and obesity in adults and children (NICE clinical guideline 43; see section 1.2.6 of the guideline for details on surgical interventions).
1.4 Clinicians should submit data on all patients undergoing laparoscopic gastric plication for severe obesity to the National Bariatric Surgery Registry. Data should be entered into the register under the 'other' procedure category. Clinicians should also collect and review these data as part of local audit.
1.5 NICE encourages further research on laparoscopic gastric plication for severe obesity, which should include information about long-term efficacy and safety, and specifically how the procedure influences further gastric surgery. Comparison with alternative procedures would be useful.