Enhancing automated chyme reinfusion therapy with The Insides System

What is the purpose of the study: Surgery to treat bowel cancer or other bowel diseases can involve formation of a ‘temporary stoma’. Small bowel stomas mean that chyme (gut contents) exit the small intestine and flow into a ‘stoma bag’ on the abdomen, instead of passing into the colon. “Temporary stomas” are usually reversed when it is safe to operate. The colon normally reabsorbs a lot of gut fluid. But when a patient has a stoma, this reabsorption cannot occur because it is being diverted out through the stoma, into a stoma bag before it can reach the colon. Some patients become dehydrated. Sometimes patients need to have medications or fluids to prevent dehydration. About 15% of patients have to be re-admitted to hospital for extra fluids. A stoma can cause other difficulties. Some patients find managing a stoma bag bothersome. Stomas may leak or cause skin irritation. Having a stoma can have a negative impact on quality of life. Chyme reinfusion therapy is when the chyme which comes out of the stoma is put back into the distal intestine. This fluid then travels through the rest of the intestine, and colon which absorbs the fluid and nutrients. The leftover waste forms a stool or bowel motion. Chyme reinfusion therapy has been used safely for many decades. It is approved by many of the leading authorities on nutrition for example European Society for Clinical Nutrition and Metabolism (ESPEN) and the American Society for Parenteral and Enteral Nutrition (ASPEN). The Insides System is a commercially available medical device designed to perform chyme reinfusion therapy. It comprises three components: a tube, pump, and driver. The tube is inserted into the distal intestine (downstream end) of the stoma, and the pump attaches to the end of the tube. The tube and pump within the stoma bag, collecting chyme from the stoma. When the bag is filled with chyme, a driver couples to the pump from outside the stoma bag, causing chyme to move from the bag up into the tube, and into the downstream intestine. The Insides System, in its current form, has been used commercially in over 300 intestinal failure patients globally. Although this device has been used successfully around the world, feedback from patients and clinicians have requested improvements to the tube and driver are being considered to make it even easier to use. This study involves testing an improved version of The Insides System in the hope that the investigational version of the device can be used to perform chyme reinfusion and improve care in a wider range of patients. What is being studied: -The Insides Tube (Self Insertable) A straight ended tube has been developed which can be inserted by the participant or their carer. It is secured to the stoma bag and as the stoma bag is applied to the skin the tube is slowly inserted into the distal limb of the stoma. -The Insides Driver Two different versions of The Insides Driver have been developed which participants will be asked to trial: Driver A: Remote monitoring The remote monitoring is a new feature to the existing driver. The driver has remote monitoring built in to capture use of the driver such as length of time it is turned on, what speed is used, and the volume reinfused. This information will be stored against the driver serial number on a secure website online and remotely viewed by a clinician. There is no geographic monitoring, only how the driver is used when it is turned on, will be recorded. The driver has a lithium-ion battery and is charged via a normal wall charger, like a phone charger. It will need to be recharged on average every 2 weeks, for 4 hours. Driver B: Automated Driver A driver similar in shape to the current driver but only weighs 150 grams. It will be secured to the body via a stoma belt and will automatically turn on during the night to reinfuse chyme without requiring the participant to do anything. This driver will provide continuous refeeding and volume recording. Once consented, taking part in this study will involve using the device for multiple 3-day trials consecutively over two weeks. The patient will complete 5x 3-day trials in total. There are allowances for patient schedules but as close to two weeks as possible. • The participant will be given the option to insert the self-insertable tube into the stoma, but they do not have to, to take part in this study. If the participant wants to test the self-insertable tube, they will be supervised by the research nurse during this process. If the participant does not want to install the self-insertable tube, the tube and stoma bag will be fitted by the research nurse at either the participants home or in the clinic room. • The participant will be taught how to use one of the drivers to reinfuse chyme and will be provided with the contact details of the research nurse and study investigator should they need to contact them at any time of day. • The research nurse will contact The participant each day and will visit the day after insertion to watch a reinfusion and check it’s working well for the first two times. • At the end of each trial (3 days), the research nurse will visit to remove the stoma bag and tube and replace it with a new one and ask The participant to fill in a one-page feedback form. The participant can provide verbal feedback at any time throughout the study. After the first 3-day trial, The participant can adjust the timing for subsequent trials so that they fit in with your lifestyle/work requirements. Visiting will be based on clinical need after the initial set-up and your independence grows with the device. • After 2 weeks, you will be invited to continue trials up to stoma reversal. If the participant chooses to continue performing chyme reinfusion with the new version, they will continue to see the research nurse to provide more self-insertable tubes but the contact will be based on clinical need so will likely be less than during the trial period. Conversely, the participant is welcome to stop testing.