Evidence needed for new weight loss operation
NICE encourages more research
28th November 2012 - A new keyhole operation to help weight-loss in people who are severely obese could be considered more routinely by UK doctors. It follows the publication for the NHS of the first evidence based guidance on the safety and efficacy of laparoscopic gastric plication.
Weight-loss (bariatric) operations are considered by doctors and patients if other options such as diet, exercise and medication have failed. Common weight-loss procedures include gastric banding and gastric bypass.
It's hoped the guidance by the National Institute for Health and Clinical Excellence (NICE) could encourage clinicians to consider laparoscopic gastric plication as a further option. However, there are no long term studies on the procedure which is carried out using keyhole surgery.
More evidence needed
Laparoscopic gastric plication involves folding part of the stomach inwards and stitching it together to make a person's stomach up to two-thirds smaller. None of the stomach is removed and the procedure is potentially reversible. There is no published research from the UK on the procedure but international studies, from the US, Greece, Iran, Lebanon and Brazil, show that it could be a further treatment option for people with severe obesity.
In a study of 100 people who had the procedure, half had lost 60% of their excess weight after two years. However, there are some uncertainties in the published studies regarding the safety and efficacy of the procedure, particularly in the long term (i.e. beyond two years) as the available research does not go beyond this period.
If clinicians do consider the new procedure NICE advises them to:
- take special care to explain the uncertainties and risks to their patients before obtaining their consent, such as how it could affect future operations on the stomach, and to
- inform their clinical governance leads (usually the hospital’s medical director) that they would like to perform the procedure
- submit data to the National Bariatric Surgery Register and make special arrangements to monitor what happens to their patients after the procedure
Professor Bruce Campbell, chair of the independent committee that develops NICE’s interventional procedures guidance says in a press release: "Although there is evidence that laparoscopic gastric plication is safe in the short term and could help people with severe obesity to lose weight, there are a number of uncertainties from the published research regarding its long term implications.
"In particular, we would like to find out if there are potential risks associated with plication being reversed, how the procedure could affect future operations on the stomach, and whether it really is an effective weight management option long term.
"Our guidance encourages further research on the procedure for severe obesity by advising doctors to monitor the long term outcomes of their patients and to submit data to a national register.
Comparison with alternative procedures would also be useful, so that patients who do require surgery can be offered the most suitable option."
NICE’s new guidance does not advise on the funding of the procedure or on how widely it should be offered; these are decisions made at local NHS levels.