Efficacy Trial of a Novel Pump Device for Output Recycling in Patients with High-Output Losses

niversity of Auckland0 个研究点目标入组 15 人开始时间: 2019年1月22日最近更新: 2019年1月28日

适应症

试验速览

暂无简介。

•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

•- 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

发起方

niversity of Auckland