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临床试验/EUCTR2015-005736-17-NL
EUCTR2015-005736-17-NL进行中(未招募)1 期

Prevention of severe infectious complications after colorectal surgery using antimicrobial decontamination of the digestive tract (PreCaution trial) - PreCaution

niversity Medical Center Utrecht0 个研究点目标入组 966 人开始时间: 2016年6月27日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
966

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

入选标准

  • - Adult patients (18 years of age or older) undergoing elective colorectal surgery. Elective surgery is defined as surgery for which there is no need to be performed immediately, with the possibility to be scheduled at the patient’s and surgeon’s convenience
  • - Abovementioned patients may not meet any of the exclusion criteria
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 483
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 483

排除标准

  • Patients who meet one or more of the following criteria will not be eligible to participate in this study:
  • - Patients aged <18 years
  • - Legally incapacitated patients or patients who refuse to sign informed consent.
  • - Patients with an inability to take oral medication
  • - Patients who have undergone abdominal surgery within 30 days before randomisation
  • - Patients who have a known and documented allergy to any of the medications or agents used (i.e. colistin, tobramycin or other aminoglycoside antibiotics)
  • - Patients diagnosed with myasthenia gravis
  • - Pregnant women and nursing mothers
  • - Patients undergoing colorectal surgery in an emergency setting (i.e. not elective)
  • - Patients with an ileostomy
  • - Patients who already participated in the PreCaution trial

研究者

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