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临床试验/ACTRN12618000221257
ACTRN12618000221257已完成未知

Is the time to complete bowel care as quick if not quicker using a low micro enema compared to a high micro enema in people with a recent spinal cord injury?: A non-inferiority, double blinded, cross over randomised control trial

orthern Sydney Local Health District0 个研究点目标入组 20 人开始时间: 2018年2月12日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
20

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
16 Years 至 o limit(—)
性别
All

入选标准

  • * have a complete or incomplete SCI sustained within the past six months (as defined by the International Standards for Neurological classification of SCI)
  • * have return of gastrointestinal tract function (ie., adequate oral intake, bowel sounds, passing flatus / stool) and are in a stable bowel care routine
  • * have intact anorectal reflexes as confirmed by per rectal (pr) examination
  • * are an inpatient at one of the participating SCI units and likely to remain there for the duration of his/her involvement in the trial (i.e., approximately 8 weeks)
  • * aged 16 years or over at the time of consent
  • * willing to participate in the trial

排除标准

  • * unable to co-operate (e.g. a serious medical condition, cognitive impairment, drug dependency, psychiatric illness, or behavioural problem)
  • * unable to speak sufficient English to fully understand and perform required activities and complete assessments
  • * unable to tolerate an enema for medical reasons (i.e, contraindicated)
  • * have any other type of neurological condition or injury other than spinal cord injury affecting bowel function
  • * have an allergy to any of the ingredients used in Microlax ®
  • * have complications related to bowel care (eg. Autonomic Dysreflexia, haemodynamic instability)

研究者

发起方
orthern Sydney Local Health District

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