ong term abdominal drains in end stage cirrhosis

Not Applicable

Completed

• Conditions: Topic: Gastroenterology; Subtopic: Gastroenterology; Disease: All Gastroenterology; Digestive System; Cirrhosis

• Registration Number: ISRCTN30697116
• Lead Sponsor: Brighton and Sussex University Hospitals NHS Trust

Brief Summary

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30053891 2020 embedded qualitative study results in https://pubmed.ncbi.nlm.nih.gov/33348031/ (added 04/03/2021) 2020 results in https://pubmed.ncbi.nlm.nih.gov/32478917/ (added 04/03/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-07
• Study Completion: 2018-11-16
• Last Update Posted: 15 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

1. Aged 18 years or over
2. Presence of untreatable (refractory) ascites, defined as:
2.1. Ascites that are unresponsive to fluid and sodium restriction and high dose diuretic treatment (spironolactone 400 mg and or furosemide 160 mg) and/or intolerance of diuretics
2.2. Recurs rapidly after LVP (need for one or more LVP per month).
3. Child Pugh Score of greater than 9. unless specifically decided by the medical team that they are to receive only palliative treatment. If less than 9, the participant is considered palliative by medical team.
4. 4.Registered with a GP in Brighton and Hove or West Sussex with community Integrated Primary Care Team provision from Sussex Community NHS Trust
5. Ability to speak read and understand English
6. Capacity to give informed consent as defined using the Capacity to Consent Checklist
7. Signed, informed consent prior to any study specific procedures

Exclusion Criteria

1. Either loculated or chylous ascites
2. Presence of > grade 1 hepatic encephalopathy (specified by West Haven Criteria – appendix 13)
3. Evidence of active infection that in the investigator’s opinion would preclude insertion of LTAD (for example, bacterial peritonitis) – such patients would need to receive appropriate treatment and could then be reconsidered
4. A candidate for liver transplantation
5. Psychosocial issues which in the opinion of the medical team will preclude study participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acceptability of LTAD to patients/carers and staff to be measured at end of study (3 months) or at the time of patient death, which ever occurs first.

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures.