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临床试验/ACTRN12620000537954
ACTRN12620000537954招募中3 期

aparoscopic Appendicectomy versus Antibiotics for Imaging Confirmed Acute Uncomplicated Appendicitis: A Multisite Randomised Controlled Trial

niversity of Queensland0 个研究点目标入组 300 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
300

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
Open (masking not used)

入排标准

年龄范围
18 Years 至 50 Years(—)
性别
All

入选标准

  • Uncomplicated acute appendicitis as deemed by reporting radiologist at time of admission
  • - Clinical diagnosis of appendicitis as per treating physician
  • - Age 18 to 50, both males and females
  • - Able to speak English and consent to follow up

排除标准

  • - Age < 18 or > 50
  • - Severe sepsis / septic shock / medically unstable as per treating physician
  • - Severe peritonitis (as per treating physician)
  • - Abdominal surgery within last month
  • - Received antibiotics within last week
  • - Allergy to all study antibiotics
  • Co-morbidities
  • - Pregnancy
  • - Complex diabetes: requiring any medication (e.g. metformin, insulin), ketoacidosis or coma
  • - Immunodeficiency
  • - Ischaemic heart disease, Congestive heart failure, Congenital heart disease
  • - Cardiac surgery or coronary stents
  • - Takin aspirin, antiplatelet, anticoagulant medications
  • - History of bleeding disorders
  • - History of chronic liver disease, cirrhosis, liver failure
  • - Chronic renal insufficiency (eGFR < 40), haemodialysis, peritoneal dialysis, plasmapheresis
  • - Concurrent severe illness requiring hospitalization
  • - Other infection requiring antibiotic treatment
  • - Intravenous drug use (ever)
  • - Cognitive impairment, intellectual disability, severe mental illness
  • - Previous colonic or small bowel surgery
  • - Any active malignancy apart from non-metastatic skin cancer
  • - Inability/unwilling to return for follow up
  • - Inability to provided written informed consent
  • - Non-English speaker
  • Radiological Exclusion Criteria
  • - CT / USS evidence of complicated appendicitis (phlegmon, abscess, perforation)
  • - Presence of faecolith
  • - Any radiological suspicion for alternative diagnosis or malignancy

研究者

发起方
niversity of Queensland

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