Summary

Summary

  • The technology described in this briefing is The Insides System. It is used for managing acute severe intestinal failure (type 2) after bowel surgery.

  • The innovative aspects are that it is a chyme reinfusion system, which is designed to help people with high-output fistulas or stomas by returning their intestinal fluid lost from the fistula or stoma back into the distal gut.

  • The intended place in therapy would be used in addition to parenteral nutrition, or as an alternative to distal enteral tube feeding.

  • The main points from the evidence summarised in this briefing are from 3 studies (2 feasibility studies and 1 case study) including a total of 30 adults in hospitals. They show that The Insides System could be used as an alternative or an addition to parenteral nutrition in managing some patients with acute severe (type 2) intestinal failure. People had reduced stoma losses and reduced the use of anti-diarrhoeal medications.

  • Key uncertainties around the evidence or technology are that all 3 studies had very small sample sizes, and there was no comparative evidence to show that the system would result in fewer complications, improve quality of life or reduce costs compared with standard care (such as parenteral nutrition).

  • There are no safety alerts for this technology. One study found that of 10 people, 1 person had a serious adverse event (severe cholecystitis) during the study.

  • Experts advised that The Insides System should be used in a specialised centre for treating acute severe (type 2) intestinal failure because safe treatment needs a specialist to monitor effectiveness.

  • The cost of using The Insides System is between £1,900 and £2,400 per month per person with type 2 intestinal failure with an enterostomy, or per person with type 2 intestinal failure with an enteroatmospheric fistula. All costs exclude VAT. One expert estimated that the current cost of home parenteral nutrition is about £75,000 per year (on average £6,250 per month).