Guidance
3 Committee considerations
The evidence
3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 5 sources, which was discussed by the committee. The evidence included 1 systematic review, 2 small randomised controlled trials (1 of which was a feasibility randomised controlled trial that was described in 2 reports), 1 case report and 1 conference abstract. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: improvement in health-related quality of life, and reductions in hospital visits, pain and symptoms relating to intra-abdominal pressure.
3.3 The professional experts and the committee considered the key safety outcomes to be: peritonitis, catheter insertion site infection, and fluid and electrolyte imbalances.
3.4 Patient commentary was sought but none was received. However, a submission from a patient organisation was discussed by the committee.
Committee comments
3.5 The primary intention of the procedure is to improve health-related quality of life and reduce the number of hospital visits.
3.6 This guidance does not cover the use of this procedure for malignant ascites, see NICE's medical technologies guidance on PeritX peritoneal catheter drainage system for vacuum-assisted drainage of treatment-resistant, recurrent malignant ascites.
3.7 The committee was informed that:
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the procedure has the potential to increase the pre-existing risk of bacterial peritonitis in people with refractory ascites in cirrhosis
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a National Institute for Health Research health technology assessment (a randomised controlled trial, the REDUCe 2 study) has been funded.
ISBN: 978-1-4731-4801-7