Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting email@example.com.
Three studies including 1 abstract are summarised in this briefing. Two feasibility studies included a total of 29 people with a defunctioning ileostomy or with high-output proximal enterostomies and fistulas. One case study reported using The Insides System in a person with high-output enterocutaneous fistulas.
The evidence base is limited and mainly comes from single-centre observational studies that involve a relatively small number of people (30 people in all included studies). Two studies assessed the feasibility of using The Insides System for reinfusing chyme in people who had an intestinal failure. All 3 studies had no comparators. None of the studies were done in the UK.
Overall, the evidence base suggests that The Insides System has potential benefits in remediating high-output losses, improving fluid and electrolyte balance, weaning off parenteral nutrition and improving surgical recovery. The device was reported to be easy to use and well tolerated.
The evidence suggested that the system could be used as an alternative intervention to manage intestinal failure. The evidence base would benefit from further evidence including a larger cohort of patients, ideally in the UK. Also, future comparative studies evaluating the impact of using the technology on patient outcomes and changes in clinical management would be useful.
Chyme reinfusion (CR) provided adequate nutritional support, with successful stopping of parenteral nutrition. The device was easy to use with minimal need for nursing assistance. Side effects of CR including diarrhoea and abdominal cramping improved because the patient learned to manually adjust the reinfusion rate. No complications were encountered with CR and the use of this novel device.
A total of 549 patient days of device use were recorded. Clinical benefits included a reduction in net stoma losses per day, testing of bowel function and reduction or stopping of anti-diarrhoeal medications. There were 14 people who had stoma reversal, with 3 experiencing postoperative ileus. There were 7 minor and 2 serious device-related adverse events recorded including:
one patient who was unable to exchange the custom feeding tube because of bowel mucosa ingrowth around the flanges of the Malecot tube tip that needed removing under general anaesthetic.
The study covered over 740 patient days of device installation and testing (median 39.5, range 1 to 234 days). There were 6 out of 10 people who transitioned to outpatient device use once trained. One person withdrew from the study because of bowel obstruction. Another person with multiple enteroatmospheric fistulas had 2 pumps installed.
Reinfusion was well tolerated with the use of regular boluses of about 200 ml. The common patient concerns were pump inlet blockages and reduced CR efficiency because of pump congestion. Clinical benefits included resumption of oral diet, stopping parenteral nutrition (4 of 5 people), correction of electrolytes and liver enzymes, and hospital discharge (6 of 10 people). Of 7 people with restored intestinal continuity, 1 had postoperative ileus. The most common side effects were abdominal discomfort (7 of 10 people), bloating (4 people) and nausea (4 people). One person had a serious adverse event (severe cholecystitis) that needed invasive intervention during the study.
This is the first study of humans using the device. It is a single-centre study with a small number of people included. Some people did not always use the pump every day it was installed, depending on their medical needs. Six of the 10 study authors were employees of the company.
The company noted that a randomised controlled study is currently recruiting in 6 sites in New Zealand. This trial aims to evaluate using the device in people with regular diverting ileostomies with outputs more than 800 ml. Recruitment is expected to be finished in mid‑2022. There is also a trial planned that will recruit people with type 2 intestinal failure from 5 sites in the UK and the US, respectively. Recruitment is expected to start in the first quarter of 2022.