Ensuring surgical treatments and procedures are introduced responsibly

We have produced more than 480 pieces of guidance on treatments, surgery and diagnostics tests.

NICE interventional procedures guidance provides recommendations on a wide range of treatments, and some diagnostic tests, to ensure that they are introduced into the NHS in a responsible way.  These include all kinds of surgical operations, procedures done through the arteries and veins and procedures done using ultrasound or X-rays.

Interventional procedures guidance aims to support healthcare professionals who are in the process of introducing new procedures, and protect patient safety. Many of the procedures we examine are new, but we also investigate more established procedures if there is any uncertainty about how safe they are or how well they work.

So far, we have produced more than 480 pieces of guidance on treatments, surgery and diagnostics tests, that involve a cut or puncture of the skin, endoscopy, or energy sources such X-rays heat or ultrasound.

In 2013/14 we produced 34 pieces of guidance on procedures such as:

Negative pressure wound therapy for open abdomen

In November 2013, we produced updated recommendations for a surgical technique to heal people left with their abdomen open, to treat severe infection or after emergency surgery.

Surgeons may choose to leave a patient with an open abdomen for certain reasons, such as swelling of the bowel, or severe infection, because it is not safe or practical to close it. However, once left open the surgeon faces the dilemma as to how to avoid the risks of infection or fluid loss. For example, it may be considered after emergency surgery if there is too much swelling to close the abdomen or when there is very serious infection inside the abdomen and closure would be unwise.

Negative wound therapy involves a ‘vacuum system’ being applied to the open abdominal wound and surrounding area. The equipment generates a gentle vacuum, which helps to remove any excess blood or fluid and keeps the wound clean. This aims to reduce the risk of infection.

NICE originally produced in on this procedure 2009, which said that there was not enough good evidence on its safety and efficacy. Following concerns raised over its safety by a specialist unit, NICE organised a national clinical audit into the management of open abdomen.

Professor Bruce Campbell, Chair of the Interventional Procedures Advisory Committee, said: “As a direct result of this audit, we have now been able to conclude that the procedure does not cause the problems which were suspected and that its routine use in the NHS is entirely reasonable.”

You can read more about this technique, how the guidance was developed, and more on why it was updated on the NICE website.

Faecal microbiota transplant for Clostridium difficile

Clostridium difficile (C. difficile) is a bacterial infection that affects the digestive system, and is commonly caught in hospitals. The infection is caused by an imbalance of bacteria in the colon, and is common in people who have received antibiotics. Symptoms can range from mild to potentially life-threatening.

In March 2014, we produced guidance that recommended faecal microbiota transplant as a safe and effective procedure for people who experience persistent C. difficile infections and in whom antibiotics have failed. The procedure involves putting healthy donor faeces into the gut of the affected person. This restores the balance of bacteria and prevents further relapses.

Professor Bruce Campbell, Chair of the Interventional Procedures Advisory Committee at NICE, said: “Treatment with antibiotics is usually effective but in about 1 in 4 people, symptoms return and some people experience repeated C. diff infections, which can be very serious.”

 “Our guidance recommends that faecal microbiota transplant is safe and effective enough for doctors to use as part of their normal practice. It recommends that it should only be considered for people who have had at least 2 previous courses of antibiotic treatment for their C. diff infection.”

Professor Campbell continued: “The procedure involves taking a stool sample from a donor (often a family member). The stool is screened to ensure there are no potentially harmful bacteria in it and then it is diluted it with fluid and put into the patient's gut. That can be done through a fine tube inserted into the gut through the patient's nose, or via a telescope inserted through the anus. The healthy donor stool helps to stimulate the growth of ‘good' bacteria, restoring the body's natural balance.”

“It doesn't sound pleasant, but the evidence shows that it is a safe and effective for 4 in 5 people with recurrent C. diff infections.”

Interview with Professor Bruce Campbell

1. What were the initial aims of the Interventional procedures programme?

The Department of Health asked NICE to set up the Interventional Procedures programme at the end of 2001. This followed the concerns raised by the report into the Bristol children’s heart surgery affair, publicity about complications from the introduction of laparoscopic (keyhole) surgery during the 1990s, and a variety of high profile cases of harm which patients had suffered as a result of procedures.  Unlike medicines and medical devices, there was no system for regulating or evaluating procedures.  There had been a register in the UK for new procedures since 1996 but that had not worked very well and NICE was asked to take over its role and to develop it.

The fundamental aims of the programme were to help patients to get acces to new and effective procedures as soon as possible, but to protect them from harm.  The guidance aims to balance the evidence that procedures work well enough and are safe enough.  It specifies whether special training, expertise, teams or facilities are necessary for procedures to be done safely.  It flags up what additional information is needed from research or collection of data, to know enough about the procedure to judge it fully.

2. Which pieces of IP guidance stand out as being particularly memorable?

Transcatheter aortic valve replacement (TAVI) was memorable as a procedure for which guidance was updated as a result of increasing evidence – and further updates are likely as still more evidence becomes available. This procedure aims to avoid major cardiac surgery for people with diseased aortic valves, many of whom are very unfit and at high risk for surgery.

In 2008 a recommendation was made for use only with “special arrangements” (interventional procedure guidance 266). By 2012 more evidence was available, which enabled guidance targeted at groups of patients whose levels of risk for open cardiac surgery were different.  “Normal arrangements” for use of TAVI were recommended for patients judged to be unsuitable for open surgery.  Entry into the UK TAVI trial was encouraged for patients at high risk for open cardiac surgery, and was recommended as the only justification for offering TAVI to patients whose risk for open surgery was not high.   This is a good example of the gradual introduction of a procedure as a result of increasing research and collection of registry data.

Two recent pieces of guidance on the same procedure, when used for different, indications also come to mind. The procedure was endoscopic thoracic sympathectomy and we produced guidance on its use for facial blushing (IPG480) and hyperhidrosis (IPG 487). These were unusual because in each case, the procedure was notified by patients who were concerned about side effects which they had suffered. The procedure itself was not novel. There were a lot of published reports on which to base the discussion about the balance of safety and efficacy. The evidence showed that the procedure produced substantial benefits for many patients, but that it could cause lasting harm for a minority. In balancing these complex considerations of benefits and risks, the guidance included very strong recommendations on thorough information for patients and on good training for surgeons doing these procedures,

3. How valuable has been the role of healthcare professionals in the production of the guidance?

Not just valuable – it is vital. The published evidence on procedures is often limited and sometimes very poor, so it is essential to know what specialists think – both those who have used the procedure and those who have not. They tell us whether they consider any procedure to be established or novel, what the uncertainties are about its benefits and risks, and what the main issues are affecting its use. They help to interpret the limited data which are available, they advise on what additional evidence might be useful and they tell us about research that is in progress.  The Specialist Advisers are nominated by their UK specialist organisations and we are continuously grateful to them all.