None listed
Conditions
Brief summary
Aim: To test the efficacy of a novel pump device for recycling high-output stoma and fistula losses. Hypothesis: - the novel device can safely and effectively return stoma and fistula outputs to the distal gut - Output recycling will eliminate the need for parenteral support (IV fluids and/or parenteral nutrition) in patients with high-output stomas and fistulas and an accessible distal gut Patients with high-output stomas/fistulas face substantial morbidities such as; fluid and electrolyte losses, renal impairment, prolonged hospital stays, loss of the microbiome, post-op ileus, impaired quality of life and large cost burdens on the health care industry. A potential remedial solution to the morbidity of high-output losses is to recycle the losses back into the distal gastrointestinal tract. The concept of chyme reinfusion is well known and has been broadly validated as feasible and appropriate. A nutrient recycling pump offering a significantly improved workflow has been designed . This device is currently in the final stages of a first-in-human feasibility study. The device is showing sustained performance in achieving successful nutrient recycling across a broad range of effluent viscosities. The device is now ready for efficacy trials to formally evaluate whether nutrient recycling can be achieved in a sustained fashion during clinical use.
Interventions
This trial will evaluate the efficacy and safety of a novel nutrient recycling pump device for patients with high-output stomas and fistulas. The device is a centrifugal pump (impeller) housed within a stoma appliance and connected to an enteral feeding tube placed inside the distal limb. The pump is activated on-demand (as individually indicated by a specific patients daily output volume) to achieve bolus refeeding, using a battery-powered driver with 5 speed settings. The correct speed settin
This trial will evaluate the efficacy and safety of a novel nutrient recycling pump device for patients with high-output stomas and fistulas. The device is a centrifugal pump (impeller) housed within a stoma appliance and connected to an enteral feeding tube placed inside the distal limb. The pump is activated on-demand (as individually indicated by a specific patients daily output volume) to achieve bolus refeeding, using a battery-powered driver with 5 speed settings. The correct speed setting is determined by the viscosity of the patient's chyme. - The study will be a before and after trial. Baseline data will be recorded for one week. The intervention (pump device) will then be initiated. Patients will have a tube inserted into the distal stoma limb, with a pump attached, and will be trained in the use of the device according to a standardised template and with the help of visual aids. The training will be conducted on an individual basis (face-to-face) by a member of the research team with the assistance of an standardised instruction manual and visual aids. The training session will take approximately 15 minutes. - The intervention will be delivered over a 4 week evaluation period. The primary outcome will be cessation vs continuation of parenteral therapy (parenteral nutrition and/or replacement IV fluids). Judgement of the primary outcome will be made at the end of the 4 week period. Withdrawal of the device will also be subsequently undertaken in selected patients to validate the primary outcome. Once the primary trial is completed, the patient will enter an optional maintenance phase, where the device will be available on request. This could continue for a period of up to 6 months in patients or time of reversal surgery (as per device availability). Strategies to monitor adherence: - research team monitoring / observations and later patient self-reporting.
Sponsors
University of Auckland
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Patient aged 18 or older, with double enterotomy/enterocutaneous fistula - Inability to maintain nutrition and fluid requirement without parenteral therapy (IV fluids and/or parenteral nutrition) - Established or anticipated to develop (by specialist clinician opinion) Type II intestinal failure as defined by requirement of parenteral support for >20 days. - Distal orifice can be intubated by a minimum 24Fr feeding tube (dilitation of stoma orifice strictures is allowable) - If a distal anastomosis present, anastomotic leak and distal obstruction will be excluded e.g. via gastrograffin enema or CT scan with rectal contrast or clinical evaluation such as endoscopy, when clinically indicated. - Able to independently manage their stoma, or consistent daily caregiver available who can support regular stoma management - Able to understand risks and benefits of the study - Able to provide informed consent
Exclusion criteria
- Under 18 years of age - Active anastomotic leak, perforation or distal obstruction - Distal gut out of circuit for >6 months - Inadequate total function gut length - Underlying gastrointestinal motility disorder such as chronic intestinal pseudo-obstruction, gastroparesis or slow-transit constipation - Scheduled for stoma closure or fistula surgery within the next 4 weeks (insufficient time to allow minimum study evaluation periods of 1 week before and 3 weeks after intervention) - Unable to understand the risks/benefits of the study to provide informed consent - Previous or current diagnosis of Clostridium Difficile colitis
Outcome results
None listed