ACTRN12621000406808撤回未知
Is the time to complete bowel care quicker using transanal irrigation compared to standard bowel care in adults with Spinal Cord Disorders? A randomised controlled trial.
适应症
试验速览
- 阶段
- 未知
- 状态
- 撤回
- 入组人数
- 24
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
- •People will be eligible for inclusion if they:
- •* sustained a spinal cord injury more than 6 months prior or have Spina Bifida
- •* have a Neurogenic Bowel Dysfunction Score greater than or equal to 3
- •* are aged 18 years or over at the time of consent
- •* are willing to participate in the trial
- •* have been recommended to trial transanal irrigation by a clinician because they spend more than 30 mins on toileting AND ANY OF THE FOLLOWING:
- •had more than 1 episode of faecal incontinence per month
- •had a Bristol stool chart result of less than 3 or greater than 6 for more than 3 cycles of bowel care
- •experienced abdominal symptoms such as bloating/cramping
- •experienced inconsistency with defaecation
- •experienced rectal symptoms (bleeding haemorrhoids, rectal prolapse, fissures etc)
- •experienced autonomic dysreflexia in response to bowel care
排除标准
- •People will be excluded if:
- •* they are unable to co-operate (e.g. a serious medical condition, cognitive impairment, drug dependency, psychiatric illness, and behavioural problem)
- •* they are unable to speak sufficient English to provide informed consent
- •* they are currently using bisacodyl suppositories or enemas as the primary method for managing bowel care routine.
- •* transanal irrigation is contraindicated for use for any of the following reasons:
- •anal / rectal stenosis
- •active inflammatory bowel disease
- •acute diverticulitis
- •colorectal cancer
- •within 3 months of rectal surgery
- •within 4 weeks of endoscopic polypectomy
- •ischaemic colitis
- •* current or planned pregnancy
- •* long term steroid therapy
- •* radiotherapy to the pelvis
- •* dense sigmoid disease
- •* on anticoagulants (warfarin, apixaban, rivaroxaban, dabigatran)
研究者
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