A Novel Device for Refeeding output in Stoma and Fistula Patients

A specially designed pump device is coupled to the distal limb of the stoma or fistula via a feeding tube. The device will be inserted by an experienced clinician in the hospital setting. Insertion of the device involves intubation of the distal limb of the stoma or fistula using a MIC feeding tube. This procedure takes approximately 10 to 30 minutes, depending on the ease of distal access. Participants would not need to stay in hospital overnight unless they are already inpatients. Patients will be instructed on how to use the pump by a study investigator. They will then be advised to use the pump on an 'as needed basis' to empty their stoma bags, over the three week trial period. A specific frequency of use is not prescribed as we wish to understand how the participants want to use the device, i.e whether they use the device to empty their appliance or whether they empty their appliance as normal into the toilet. Participants must also complete a daily ‘device diary’ which is provided to them. The device diary includes brief questions evaluating the convenience and ease of use of the device, feedback for improvement, symptoms as well as health related and stoma related quality of life questionnaires. The diary is also designed to qualitatively asses the acceptability of the device, including how patients incorporate its use into their daily life . In addition to this a study investigator will contact participants regularly to offer advice and support on using the device as well as to track the individual participant’s experience of using the device. Telephone follow up will be carried out by study investigators familiar with the device’s use and the frequency of these calls is negotiated between the participant and investigator however would be conducted at least once weekly over the test and trial period. From the feedback investigators gather from telephone interviews the design and use of the device will be improved and evaluated continuously such that overall the trial is an iterative process. Participants will be asked to use the device, at home or as an inpatient, to reinfuse as much of their stoma or fistula output as possible. How the pump is used however is an individual decision. The actual use of the pump and reasons for not using it will inform design and workflow improvements. Initially participants will undergo a ‘testing phase’ during which they will become familiar with using the device and any initial difficulties, such as device blockage, are addressed. This 'testing phase' is not specified and depends on the needs and circumstances of individual patients and can require up to one month. Once participants are comfortable with using the device a three week study period is initiated. During this time participants will complete their daily ‘device diary’ and any blood test results will be recorded from patient records.