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Nice guidance document

UK guidance: plication only for governance or research

The guidance documents will be used by local bodies for commissioning decisions.
More evidence needed for procedure's long-term efficacy
Long-term safety and reversibility concerns raised

The National Institute for Health and Clinical Excellence (Nice) have released a guidance document for laparoscopic gastric plication, saying that it should currently only be used for the treatment of severe obesity with special arrangements for clinical governance, consent and audit or research.

Nice say that while there are no major concerns over its short-term safety, there is inadequate data on its long-term safety. They add that while there is limited evidence of efficacy in the short and medium term, more evidence is needed about the long-term efficacy of the procedure.

They also raised concerns about its long-term reversibility, and the possibility that it may interfere with future gastric surgeries.

The guidance recommends that clinicians who wish to use the procedure should 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 might need, with clear written information. Nice have provided a document intended to provide information to the public for this purpose.

Nice define “severe obesity” as a BMI of 40 or more, or between 35 and 40 with significant comorbidities including hypertension and diabetes. They recommend bariatric surgery in the event that other methods of weight loss have been attempted and have failed.

The report also calls for further research on the procedure, including information about its long-term efficacy and safety, information about how it could affect future operations, and comparative data about alternative procedures like sleeve gastrectomy.

The report considered five case series to form their conclusions, totalling approximately 412 patients.

The review period was completed in February 2012, meaning that later studies like Mohammad Talebpour’s 12-year results were not included in their assessment.

Nice also sought opinions from seven specialists: Mr Ashish Desai, Mr James C Halstead, Mr Haris Khwaja, Mr Abeezar Sarela, Mr Muhammed Shafiq, Mr Richard Welbourn of the Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland, and Mr Michael Rhodes of the British Obesity & Metabolic Surgery Society.

Six of the seven said that the procedure was “novel” and of “uncertain safety”, while one described it as a variation on an existing procedure. Five advisors said they believed the procedure is likely to be performed by less than 10% of specialists.

Two advisors said that the procedure could have a major impact on the National Health Service in terms of patient numbers and resources, one noting that the cost was likely to be lower than other operations because it did not require staplers, bands, or other specialist equipment.

While Nice guidance has no statutory power, as local commissioning bodies have the final decision on whether to fund specific operations on the NHS, the bodies normally use Nice guidance as a large part of the decision-making process.

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