Palliative long-term abdominal drains versus repeated drainage in individuals with untreatable ascites due to advanced cirrhosis: a feasibility randomised controlled trial
Trial acronym: REDUCe (Repeated Drainage Untreatable Cirrhosis)
Description
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 and there are currently no means of stopping this. 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 are carrying out a feasibility randomised controlled trial of the current standard of care versus home drainage. Community (district) nurses (and, if identified as required, specialist community palliative care teams) will support the patients. Participants will be monitored over three months to assess symptoms and quality of life and the impact on family/carers. The costs of the new technique to the NHS will be analysed. The impact on the patients, their cares and medical teams will also be assessed using questionnaires and interview. If their experience with the home drainage is positive then a larger study will be carried out.
Study design: Feasibility randomised controlled multi-centre trial (RCT)
Trial status: Recruiting
Chief Investigator: Dr Sumita Verma >
Start date: November 2015
End date: August 2017
Recruitment target: 48
Summary of study results: n/a
Patient Information Sheet
Download Patient Information Sheet >
For further information contact:
E: reduce@bsuh.nhs.uk