EUCTR2011-004495-12-NL进行中（未招募）1 期
Antibiotic treatment alone for children with acute appendicitis; a prospective cohort study part of the Antibiotic versus Primary Appendectomy for Children with acute appendicitis; the APAC trial.
VU University Medical center0 个研究点目标入组 50 人开始时间: 2013年4月11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
- 50
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
- •Written Informed consent obtained
- •Age 7-17 years
- •Radiologically confirmed simple appendicitis, defined as:
- •a.Clinical findings:
- •i.Unwell, but not generally ill
- •ii.Localized tenderness in the right iliac fossa region
- •iii.Normal/hyperactive bowel sounds
- •iv.No guarding
- •v.No mass palpable
- •b.Ultrasonography:
- •i.Incompressible appendix with an outer diameter of =6 mm
- •ii.Hyperaemia within the appendiceal wall
- •iii.With or without faecolith
- •iv.Infiltration of surrounding fat
- •v.No signs of perforation
- •vi.No signs of intra abdominal abscess/phlegmone
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The following patients will be excluded from participating in this study:
- •1.Patients with severe general illness at time of presentation:
- •a.Generalized peritonitis defined as:
- •Diffuse inflammation of the peritoneum with clinical signs consisting of increasing abdominal pain, generalized tenderness, diffuse abdominal rigidity, sinus tachycardia, signs of paralytic ileus
- •b.Severe sepsis or septic shock, as defined by the international paediatric sepsis consensus conference [36]. See attachment 1.
- •2.Patients with serious associated conditions or malformations such as:
- •a.Congenital or acquired cardiac or pulmonary disease with significant hemodynamic consequences
- •b.Immunodeficiency
- •c.Malignancy
- •d.Homozygous sickle cell disease
- •e.Metabolic disorders
- •3.Patient with documented type 1 allergy to the antibiotics used
- •4. Children with a faecolith on ultrasonography
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