NIHR Nottingham Digestive Diseases BRU, Enteric and Mediplus Ltd

Context

In the chief medical officer's annual report 2012, Professor Dame Sally Davies highlighted that liver disease is a growing clinical burden and public health priority in the United Kingdom. Rising incidence of liver disease means that East Midlands, a region with comparatively lower death rate due to liver disease in early 90's has now moved to mid-table nationally now as shown in the heat map [Figure 1]. Consistent with the regional trend, monthly in-patient activity at Nottingham University Hospitals NHS Trust has increased by 68% in relation to cirrhosis (severely scarred liver) and 81% for procedures related to cirrhosis between 2008 and 2013 [Figure 2].

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Figure 1

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Figure 2

Clinical need

Ascites is the accumulation of fluid inside the abdomen as a consequence of liver failure due to sever scarring of the liver as in cirrhosis. When there is a large amount of fluid collection it stretches and increases pressure within the abdomen. This causes pain, breathlessness and weight gain leading to a marked impairment in the activities and quality of daily life. Majority of patients with ascites will require the fluid inside the abdomen to be drained at some point; as cirrhosis progresses patients will require drainage of ascites repeatedly on a regular basis. Every year, about 500 such procedures are carried out in Nottingham University Hospitals and over 50,000 procedures are performed in the UK.

Opportunity

Current device (needle and catheter system) that is used for draining the accumulated fluid from the abdomen is not specifically designed for this purpose; hence, two thirds of the procedures in the NHS are performed using a system designed for performing urological procedures. Performance of current devices is suboptimal; fluid drainage is slow and incomplete, hence, requiring frequent procedures performed to keep patient's symptoms under control. Both hospital visits and procedures add to the cost of care as well as inconvenience to patients and their carers.

Innovation

Prof Guruprasad Aithal, co-director of NIHR Nottingham Digestive Diseases Biomedical Research Unit at the Nottingham University Hospitals NHS Trust and University of Nottingham with the support of NIHR Enteric Healthcare Technology Cooperative, collaborated with Mediplus, Ltd to develop a new 'Melody device' specifically for the purpose of draining ascites fluid. We expect 'Melody device' to drain fluid faster and more completely. Performing ascites drainage using this device would be easier, and therefore the procedure should cause less discomfort and pain. The use of this device should also reduce the time spent by patient in hospital and increase time between further ascites drainage procedures.

The 'Melody ascites drainage catheter' including 'sterile ascetic drainage sets' is CE marked (EC certificate full quality assurance system GB97/9736 valid from 21 June 2013]. This is supplied by Mediplus Ltd with a detailed and approved user manual. Mediplus Ltd has demonstrated year on year growth for 27 years and have been awarded 'The Queen's Award' for enterprise- International Trade in 2013.

Implementation

Following the pilot carried out in the Queen's Day Case Unit, Nottingham, Enteric held a 'Paracentesis Focus Groups' at the QDCU on the 5th Sept 2013 involving patients who have undergone drainage of ascites. The report from the patients' focus group has informed a clinical trial which is due to start as soon as ethical approval is received.