Palliative Long-term Abdominal Drains versus Repeated Drainage in Untreatable Cirrhosis: A Randomised Controlled Trial
Chief Investigator: Professor Sumita Verma, BSMS University of Sussex
Sponsor: University of Sussex
Funder: National Institue of Health Research (NIHR), Health Technology Assessment (HTA) Programme
We are working with Brighton and Sussex Medical School on the REDUCe2 study, researching optimal palliative care for patients with refractory ascites, resulting in better health-related quality of life (HRQoL).
Ascites is the most frequent cirrhosis complication, often requiring hospitalisation, and leads to the debilitating condition called refractory ascites, associated with intense pain and breathlessness. Without a liver transplant, refractory ascites has an average life expectancy of between 6-12 months. The most common intervention for refractory ascites is hospitalisation every 10-14 days for palliative large volume paracentesis (LVP). This involves an abdominal drain insertion for up to six hours, removal of 5-15 litres of fluid and administration of intravenous human albumin solution.
The study will compare an alternative intervention, insertion of a palliative tunnelled long-term abdominal drain (LTAD) (Group 1 intervention), to standard of care (Group 2 intervention) large volume paracentesis (LVP) in the management of refractory ascites.
The primary objective is to assess whether palliative LTADs result in better health related quality of life (HRQoL) compared to LVP in patients with refractory ascites due to advanced cirrhosis. We will ask patients to complete the Health-Related Quality of Life in Chronic Liver Disease (SF-LDQOL) and ask the caregivers to complete the Caregiver Roles and Responsibilities Scale (CRRS) four times over a 12-week period.
Secondary outcomes will include assessing the impact of LTAD and LVP on infections, symptoms, informal caregiver workload and health resource utilization. Perceptions of LTADs and LVP by patients, informal caregivers and healthcare professionals will be explored with qualitative interviews. Study-specific communication skills training will be developed by SHORE-C and provided to recruiting centres in four regional workshops during the recruitment phase of the study.
Please see more information on the BSMS site - Click here