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
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