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临床试验/EUCTR2019-003850-10-DK
EUCTR2019-003850-10-DK进行中(未招募)1 期

Oral laxatives after hip fracture surgery: A randomised controlled trial.

Hospital Pharmacy Funen, Research Department, Odense University Hospital0 个研究点目标入组 375 人开始时间: 2019年12月12日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
375

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Hip fracture patients, age= 65 year will be included from three orthopedic departments from hospitals in the Southern Region of Denmark. The patients should be able to speak and understand Danish.
  • Pregnant women can not be included but the women are expected to be postmenopausale why pregnancy test are not performed.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 375

排除标准

  • with known cronic constipation (defined from Wexner constipation score)
  • with known use of laxatives at admission
  • who participate in other similar clinical studies
  • who is terminally ill
  • who is restraint
  • who is in isolation
  • with severe heart disease defined as NYHA III og IV
  • with severe cronically inflamatory bowel disease
  • with acute abdomial surgical conditions, eg. ileus, obstruction or perforation
  • with dysphagia where the patient can not swallow tablets/oral liquids
  • with toxic megacolon
  • with gastric emtying disorder
  • with severe electrolyte disorder (P-kalium: < 2.5 mmol/l og P-natrium: <125 mmol/l)
  • Allergies to the ingredients

研究者

发起方
Hospital Pharmacy Funen, Research Department, Odense University Hospital

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