None listed
Conditions
Brief summary
The intervention group of this randomised controlled trial will utilize a novel stoma-output recycling device to reinfuse the bowel fluid from the patient’s loop ileostomy into the distal limb. The aim is to determine if stoma-output recycling will reduce post-operative length of stay as well as improve pre-operative quality of life, chemotherapy-related outcomes and post-operative recovery of bowel function for patients undergoing elective reversal of their loop ileostomy. We hypothesize that stoma-output recycling will reduce the length of post-operative stay and provide better pre-operative quality of life, chemotherapy-related outcomes and faster recovery of bowel function.
Interventions
This randomized controlled trial will investigate the efficacy and safety a novel stoma output recycling pump for patients undergoing elective reversal of their loop ileostomy.
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 patient's daily output volume) to achieve bolus refeeding, using a battery-powered driver with 5 spe
This randomized controlled trial will investigate the efficacy and safety a novel stoma output recycling pump for patients undergoing elective reversal of their loop ileostomy. 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 patient's 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 device will be used in patients who are at least 2 weeks post-loop ileostomy formation, have confirmation of adequate downstream anastomosis healing via radiological investigation, and are at least 2 weeks away from having their ileostomy reversed. Patients are fitted with this device in the outpatient clinic by a study investigator (who will be either a surgical registrar/consultant or stoma nurse) after enrolment, are carefully educated on how to use it, undergo a trial run with plain water in the stoma bag, and then are sent home with an information sheet and contact details of the study team if any issues arise. The device will be used during the waiting period for ileostomy reversal (weeks to months) with the frequency of use determined by the individual patient's stoma output per day. The per-protocol population will include all those allocated to using the device and have used it continuously daily for a minimum period of 2 weeks directly prior to the surgery date. The intention to treat population will include all those allocated to using the device and have used it at least once. Strategies to encourage adherence: The research team will be in regular contact with the patient to assess and encourage device usage. Patients will also self-report device use in standardised logbook diaries.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Defunctioning loop ileostomy created during colorectal/gynaecological resection surgery at least 2 weeks prior to enrolment into the study in the Auckland District Health Board catchment area • Age > or = 18 years • Anastomotic leak excluded (via gastrograffin study/ CT with rectal contrast/ endoscopy) • Distal limb of ileostomy can be intubated by a minimum 24Fr feeding tube (dilatation of stoma orifice strictures is allowable) • Able to demonstrate they are able to independently manage their stoma or have a consistent daily caregiver available who can support regular stoma management • Able to understand risks and benefits of participating in the study • Able to provide informed consent
Exclusion criteria
• Pregnancy • Non-English-speaking patients • Insufficient distal access channel (distal limb/fistula) for device insertion • Distal obstruction or anastomotic leak or perforation • Scheduled for stoma reversal within 2 weeks of enrolment date (insufficient time to allow for minimum intervention period of 2 weeks) • Patient and/or clinical team do not wish to have the loop ileostomy reversed • Previous or current Clostridium difficile colitis • Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, faecal incontinence and gastroparesis • Inflammatory bowel disease • Metabolic, neurogenic or endocrine disorders known to cause colonic dysmotility, e.g. multiple sclerosis, Parkinson’s disease, hypothyroidism • Planned laparotomy for ileostomy reversal • Formation of ileal pouches (colonic pouches acceptable) • Known peritoneal metastatic disease prior to ileostomy closure (acceptable if only discovered at time of ileostomy closure) • Liver cirrhosis • Hereditary coagulopathy, e.g. von Willebrand disease • Severe chronic renal impairment prior to ileostomy formation (eGFR<30mL/min/1.73m2)
Outcome results
None listed