3 Committee considerations

3 Committee considerations

The evidence

3.1

NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 8 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial, 4 systematic reviews and meta-analyses, 2 cohort studies and 1 propensity score matched study. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

3.2

The professional experts and the committee considered the key efficacy outcomes to be: weight loss (percentage total weight loss and percentage excess weight loss) in the short and long term, quality of life, improvement in comorbidities (diabetic control, blood pressure, obstructive sleep apnoea score and liver health), nutritional status and technical success of the procedure.

3.3

The professional experts and the committee considered the key safety outcomes to be: perioperative complications including pain, rate of gastroesophageal reflux disease, rate of readmissions, damage to adjacent structures, gastric perforation and need for further procedures.

3.4

Five commentaries from people who have had this procedure were discussed by the committee.

Committee comments

3.5

The committee noted that evidence included people with obesity (a body mass index [BMI] over 30 kg/m2) for whom non-surgical weight loss treatments had not worked, and people with class 3 obesity for whom invasive bariatric surgery would be considered high risk.

3.6

The committee considered that this procedure may particularly benefit people:

  • with class 3 obesity for whom invasive bariatric surgery would be considered high risk

  • who decline bariatric surgery because of the associated risks and complications

  • who have class 1 or class 2 obesity, for whom the procedure may prevent progression of obesity and associated comorbidities.

3.7

The committee suggested that a lower BMI threshold of 27.5 kg/m2 or above should be used for people with a South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean ethnicity.

3.8

The committee noted that this procedure is not used in children.

3.9

The committee noted that some people experience self-limiting side effects immediately after the procedure and there is a high incidence of readmission for abdominal pain when the procedure is done as a day case.

3.10

The committee noted that more than one device is available for doing this procedure and the exact suture technique may vary.

3.11

The committee noted that more detailed data collection on the exact type of procedure technique used and nutritional status would be useful for the National Bariatric Surgery Registry.

3.12

The committee noted the importance of multidisciplinary team training for wider introduction into the NHS, particularly around malabsorption post-procedure.

3.13

The committee noted that gastro-oesophageal reflux disease is not a contraindication for this procedure.

ISBN: 978-1-4731-5742-2