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临床试验/ACTRN12620001262998
ACTRN12620001262998招募中2 期

PyRICo-P – Pyridostigmine to Reduce the duration of postoperative Ileus after Colorectal Surgery – a Phase II study.

The Royal Adelaide Hospital0 个研究点目标入组 15 人开始时间: 2020年11月24日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
15

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
Non-randomised trial
主要目的
Prevention
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Adult patients (aged 18 or older) from Central Adelaide Local Health Network catchment area
  • - Undergoing elective colorectal surgery (including large or small bowel resections for any indication or undergoing reversal of Hartmann's or loop-ileostomy closure or formation of a stoma
  • - Able to give informed consent

排除标准

  • Under 18 years of age.
  • Previous adverse reaction to pyridostigmine
  • ASA >=4 due to the higher likelihood or morbidity and mortality, which may confound resulting data.
  • Active inflammatory bowel disease
  • Prolonged QT syndrome (greater than 0.43sec for males, 0.45 for females)
  • Medications that are prescribed directly for their anti-cholinergic effects (e.g. Glycopyrrolate for drooling; amitriptyline for loose bowel actions);
  • Asthma requiring regular medications
  • Ischaemic heart disease or cardiac arrhythmias within the previous 12 months
  • History of epilepsy
  • History of Parkinson’s disease
  • Hyperthyroidism
  • Peptic ulcer disease
  • Diagnosed pelvic disorders that may be a cause of constipation
  • Moderate to severe renal impairment Creatinine clearance of < 30 ml/min
  • CrCl ml/min = [140-age(years)] x bodyweight (kg) / R x serum creatinine (micromol/L)
  • R = 0.815 for males, 0.85 for females
  • History of bowel obstructions, strictures or history of any diseases affecting bowel transit (e.g. uncontrolled hypothyroidism, hypercalcaemia), irritable bowel syndrome (IBS), history of faecal incontinence)
  • Inability to give consent or participate in post-operative assessments due to dementia, cognitive impairment and/or language barrier.

研究者

发起方
The Royal Adelaide Hospital

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