None listed
Conditions
Brief summary
Title: - Trial of a device to enable recycling of stoma and fistula effluent. Description: - To test and refine a device that can safely and effectively recycle stoma and enterocutaneous fistula effluent, is well-tolerated amongst patients and minimises the stoma-associated harms and costs. Hypothesis: - The device can safely and effectively recycle stoma and enterocutaneous fistula effluent in a manner that is well tolerated by patients.
Interventions
Intervention: - Initiation of device for recycling stoma and fistula effluent. - A tube will be inserted into the stoma orifice to enable stoma output recycling. Who will deliver the intervention: - The intervention will be delivered by a member of the trial team initially, and may subsequently be self-delivered by a patient. Number of times to be delivered: - The intervention will be delivered over increasing periods of time during the trial, initially for single short periods (5-10 minutes), then progressively increasing usage to trials over 3 days and eventually over 6 week periods. Setting: - hospital and/or home environment Strategies to monitor adherence: - research team monitoring / observations initially and later patient self-reporting.
Sponsors
Study design
Eligibility
Inclusion criteria
Temporary stoma of the small intestine or enterocutaneous fistula with two orifices
Exclusion criteria
Distal leak / Distal obstruction / Current pregnancy / Unable to consent / Unable to independently manage stoma cares / Previous or current Clostridium difficile colitis