UK's top surgeon calls for new procedures to undergo clinical trials

Britain’s most eminent surgeon has called for new surgical procedures and implants to be tested in clinical trials before being made routinely available on the NHS.

Prof Derek Alderson, the president of the Royal College of Surgeons, said the benefits of surgical innovations must “absolutely, unequivocally” be backed by evidence, either through randomised controlled trials or official registries designed to track patient outcomes. The move would bring surgical innovation more closely in line with the way new drugs are introduced.

New surgical techniques and devices are frequently rolled out with no clinical trial and no long-term follow-up, making it difficult to objectively assess benefits to patients or whether complication rates are acceptable. Alderson said this traditional model was not fit for modern surgery.

“If there is to be a new treatment, we need to prove that it’s been tested in a reasonable way before it is widely applied,” he said.

The failure to carry out clinical trials or collect long-term postoperative data may have contributed to the metal-on-metal hip and vaginal mesh scandals, in which thousands of patients have suffered serious complications. “You can’t say that’s the sole driver, but it is one of the things that’s raised awareness, there’s no doubt about that,” said Alderson.

The first ever randomised controlled trials were led by the British Medical Research Council innovation, in 1948, to assess a tuberculosis drug, and such trials are legally required for the licensing of new medicines. Until recently many had argued that requiring the same standards of evidence for surgery was impractical – the range of expertise across doctors and the learning curve associated with the introduction of a new operation complicate things.

However, Alderson said the profession was prepared to rise to the challenge, noting that three years ago there were just 80 surgical trials under way in NHS hospitals, while this year there are about 300.

“We have to accept that society evolves, people’s attitudes evolve and we must find better ways of finding evidence,” he said. If there are ethical issues that make it difficult to conduct a full trial, he said, then the aim should be to seek patient consent for their data to be kept in a secure, anonymised registry.

In particular, Alderson said, the increasing number of people undergoing surgeries aimed at improving quality of life rather than as life-saving treatment, means risks associated with surgery have to be considered more critically.

“In the past, older people had a more fatalistic approach about surgery because it was more risky,” he said. “Now we know how to make surgery safe for the very elderly.”

Surgeons taking part in an operation

Risks associated with surgery have to be considered more critically, said Prof Alderson. Photograph: sturti/Getty Images

Prof Andy Carr, the director of the Nuffield Orthopaedic Centre, Oxford University Hospitals NHS trust, has led a series of UK-wide trials of surgery, including a recent Lancet study showing that a common shoulder surgery is no more effective than a sham version of the same operation, where incisions are made, but the procedure is not carried out.

Previous sham surgery trials by other teams have revealed no meaningful benefits beyond placebo for arthritic knee surgery, spinal cement injections for vertebral fractures, some gastric balloon procedures for obesity and certain forms of endometriosis surgery. This does not mean that patients’ condition does not improve – the placebo effect can be powerful, particularly when treating subjective conditions such as pain, stiffness or impulse control. But surgery is expensive and the risks can be considerable, raising questions about how many elective operations might be unjustifiable if scrutinised more closely.

“Is the evaluation of surgery fit for purpose? I personally don’t think it is in a number of areas and we could and should be doing better,” said Carr.

He welcomed the increase in the number of trials, but said evidence-based surgery remained the exception, not the norm.

“If you go into a cancer clinic you’d expect a significant number of patients to be in some sort of study,” he said. “In a surgical clinic it’s less than 1%. There’s a whole structural healthcare environment that’s not really fit for purpose.”

According to Carr, surgery has retained a “battlefield” culture of “giving it a go”, that is no longer appropriate for the modern NHS where a majority of patients are having operations to improve their life, not to save it.

“The regulatory environment for new technologies is based in a previous era when it was just accepted that you gave it a go and saw what happened – procedures like heart transplants,” Carr said. “We don’t think that’s appropriate for the modern age.”

However, Alderson disputed this stereotype, saying that most surgeons, including consultants, were now accountable to multidisciplinary teams.

“We really shouldn’t perpetuate a myth that this is still the norm in surgery,” he said. “It certainly is not the way most surgeons view their careers nowadays.”


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