ACTRN12621000530820招募中3 期
PyRICo-RCT – The effect of Pyridostigmine to Reduce the duration of post-operative Ileus after Colorectal Surgery in adults – a double-blinded Randomised Controlled Trial.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 130
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
- Prevention
- 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
- •Patients over 18 years of age
- •Undergoing treatment from Central Adelaide Local Health Network
- •Able to consent
- •Undergoing elective large or small bowel resection for any indication or undergoing reversal of Hartmann’s or loop ileostomies or formation of stoma procedure will be invited to participate in this study.
排除标准
- •Under 18 years of age.
- •Pregnancy
- •ASA >=4 due to the higher likelihood or morbidity and mortality, which may confound resulting data.
- •Residual active inflammatory bowel disease expected after surgery
- •Prolonged QT syndrome (>0.43sec for males, >0.45 for females)
- •Known adverse reaction to pyridostigmine
- •Prescribing anticholinergic medications (e.g. Glycopyrrolate for drooling; amitriptyline for loose bowel actions);
- •Asthma requiring regular medications (e.g. due to risk of exacerbation)
- •Ischaemic heart disease or cardiac arrhythmias within the previous 12 months
- •History of Epilepsy
- •History of Parkinson’s disease
- •History of Myasthenia gravis
- •Uncontrolled Hyperthyroidism
- •Active peptic ulcer disease
- •Moderate to severe renal impairment Creatinine clearance of < 30 ml/min
- •History of active disease affecting bowel transit (e.g. uncontrolled hypothyroidism, hypercalcaemia)
- •Unable to give consent or participate due to dementia, cognitive impairment or language barrier.
研究者
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