Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.
Four of all 5 experts were familiar with or had used this technology before.
All 5 experts agreed that The Insides System is an innovative approach to deliver chyme mixed with feeding. One expert said that the concept of distal feeding or fistuloclysis is not new, but reinfusion of chyme and intestinal fluid is novel.
The main benefits identified by the experts are the potential to improve the management of intestinal failure and reduce the need for parenteral nutrition. Three experts explained that the device would be likely to get some people off intravenous feeding or distal enteral tube feeding and accelerate recovery to allow surgical reconstruction sooner. One expert suggested that people found the device easy to use, and there was anecdotal evidence that patient experience was positive.
The experts thought that people with intestinal failure or patients with high-output stoma or fistula would be most likely to benefit from the device. One expert said that it would also be beneficial to some people with high-output enterocutaneous fistulae. But the lumen of the fistula may be too small (not mature enough) to place the device. Another expert added that older people may benefit from the device when distal enteral tube feeding or parenteral nutrition is less suitable. Also, people who may be able to manage at home while waiting for reconstruction surgery would benefit from using the device.
The experts said that the device is currently not widely used in the NHS, and it has been used in a few specialist intestinal failure centres. Three experts thought that there may be potential for cost savings over parenteral nutrition because the device was less expensive, less labour intensive and had a shorter hospital stay. Two experts were uncertain about the potential saving when compared with distal enteral tube feeding because distal enteral tube feeding is less expensive. There is no evidence on the cost impact of using The Insides System.
A reduction in hospital visits and hospital stays were also identified as potential benefits to the healthcare system.
All experts agreed that parenteral nutrition, with or without distal enteral feeding or fistuloclysis, was the current standard care for intestinal failure. They thought that The Insides System was likely to be used with parenteral nutrition and it could potentially replace distal enteral tube feeding or fistuloclysis in the care pathway.
Three experts agreed that there would be potential risks of using the device outside recognised specialist intestinal failure centres. For example, people would have inadequate treatment for their intestinal failure and have an increased risk of death or delayed provision of adequate treatment. Other potential risks identified by the experts included pain, intolerability of infusion rate, tube or pump blockage, reflux, misplacement of the device, and gut injury, perforation or bleeding from the tube. Two experts said that the device should only be used when distal gut integrity was established. Distal contrast studies are essential before using the device. All experts agreed that training for both nurses and patients would be needed to ensure that the device was used correctly and safely. Evidence on the number of people who have avoided long-term or home parenteral nutrition is needed to show its efficacy.