Message from Lead Surgeon Richard Welbourn
Nearly 10 years ago – January 2009 – I was co-chair of a scientific session at the Society of Academic & Research Surgery annual conference in Bristol. My co-chair was Prof Jane Blazeby and over coffee we got talking about bariatric surgery. After a few more meetings and time putting together a research team of surgeons, trials methodologists, statisticians, health economists and qualitative researchers we decided that we should conduct a randomised controlled trial (RCT) – but what operations to evaluate was the big question? Fast forward two years and we were awarded a major NIHR grant for and RCT to compare gastric banding and gastric bypass operations.
We knew from data in the National Bariatric Surgery Registry that these two procedures comprised 80% of operations for severe and complex obesity in the UK and we thought it was important that we asked the most relevant question so the results would influence practice. The operations and aftercare are very different and at the time no one thought it was possible to randomise patients – and this is where Prof Jenny Donovan and her team of qualitative researchers in Bristol came in. She is a world-leading expert in teaching researchers how to randomise into clinical trials – putting patients into equipoise, a skill completely new to me – and for the first year of the study we had to demonstrate that we could indeed recruit. The process involved all our clinic appointments being recorded and analysed so that the phrases we use encourage patient understanding of the equipoise and informed consent. After much one-to-one tuition, the first two centres (Taunton and Southampton) were able to recruit sufficient patients to allow the study to progress from two centres to twelve.
Fast forward another five years from when the first patient was enrolled in 2012 and we have recruited altogether over 900 patients. It is an extraordinary achievement for the UK, which has taken up bariatric surgery much later than many countries and still has one of the lowest per capita rates of surgery. By comparison, the next largest RCT is around 220 patients. “Collaboration is the new competition” is a phrase I have learnt from Jane Blazeby and Natalie Blencowe and this really represents a sea change from consultants doing individual pieces of research for the SpRs to publish in minor journals, to working together on a major project.
One of the challenges is that over time practice has changed and sleeve gastrectomy has largely taken the place of gastric banding in the NHS. With primary endpoints of weight loss and quality of life at 3 years, there was always a risk that ‘technology creep’ would mean that the relevance of the original research question might change over time. Therefore, the NIHR agreed to us adapting the study to add a third group, sleeve gastrectomy, and it became ‘By-Band-Sleeve’. As a consequence, the sample size increased from 724 to over 1,300 patients – another hugely ambitious but get-able target. It is a privilege to be involved in a research effort that could, when published, be regarded as a landmark demonstration of a well-conducted RCT.