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临床试验/ACTRN12621000406808
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.

niversity of Sydney0 个研究点目标入组 24 人开始时间: 2021年4月14日最近更新:
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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