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
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