Long term abdominal drains in end stage cirrhosis
Research type
Research Study
Full title
Palliative long-term abdominal drains versus repeated drainage in individuals with untreatable ascites due to advanced cirrhosis : a feasibility randomised controlled trial
IRAS ID
173423
Contact name
Sumita Verma
Contact email
Sponsor organisation
Brighton and Sussex Univerisity Hospitals
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
In cirrhosis the liver becomes damaged and scarred. One of the worst aspects is the stomach swelling with fluid (ascites) causing pain and breathlessness. Once the liver is so badly damaged and a liver transplant is not possible, patients are unlikely to survive longer than six months. The patients come to hospital every one-two weeks and the doctors put a drain into their stomach to remove about two gallons of fluid. This fluid immediately starts to build up again: we have no means of stopping that. Draining fluid in this way can cause pain, infection, and is expensive. Our discussions with patients with cirrhosis and their family/carers suggest that most dislike frequent hospitalisation in their last few months of life.
In some advanced cancers this fluid is managed with a more permanent drain into the stomach so smaller amounts of fluid can be removed at home 2-3 times a week. This alternative way of draining fluid improves comfort and allows people to remain out of hospital.
However before we start using this newer technique in patients with cirrhosis we need to collect evidence that it is better than current care. To do this we propose a small study (about 50 patients) in which a computer will randomise patients to the current standard of care (group 1) or to home drainage (group 2). Community (district) nurses (and, if identified as required, specialist community palliative care teams) will support the patients. We will monitor patients over three months to assess symptoms and quality of life and the impact on family/carers. We will calculate the likely costs of the new technique to the NHS. In addition we want to talk to the patients,their cares and medical teams. If their experience with the home drainage is positive then we will run a larger study.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
15/SC/0257
Date of REC Opinion
17 Jun 2015
REC opinion
Further Information Favourable Opinion