ACTRN12619000745145尚未招募未知
A randomized controlled trial of a novel stoma-output recycling device to reduce the length of post-operative stay in patients undergoing reversal of loop ileostomy
niversity of Auckland0 个研究点目标入组 68 人开始时间: 2019年5月20日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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)
研究者
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