Antibiotic Treatment Alone for Acute Simple Appendicitis in Children; a Prospective Cohort Study Part of the Antibiotic Versus Primary Appendectomy in Children (APAC) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Safety of initial antibiotic treatment strategy
研究概览
简要总结
Appendectomy for acute appendicitis has recently been questioned as being the only correct treatment for appendicitis. Appendectomy has been reported to have significant early and late morbidity. This can be avoided with antibiotic treatment alone. Moreover, better quality of life and lower costs have been associated with antibiotic treatment alone. Five clinical trials in selected patients (males, older than 18 years) comparing appendectomy and antibiotic treatment alone as primary mode of treatment found that antibiotic treatment alone is safe and effective in 48-95% of the patients Conclusive evidence with regard to the efficacy of antibiotic treatment alone in children with proven acute appendicitis however is lacking. We propose a prospective cohort study to answer the following questions:
详细描述
Primary Objective:
What is the complication rate of the initial antibiotic treatment strategy (IATS) for acute simple appendicitis (radiological proven) in children aged 7-17 years old?
Secondary Objective:
What is the complication rate of the direct appendectomy treatment strategy (DATS) for acute simple appendicitis (radiological proven) in children aged 7-17 years old?
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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. Without fecalith iv. Infiltration of surrounding fat v. No signs of perforation vi. No signs of intra abdominal abscess/phlegmon
- •Exclusion criteria:
- •Patients with severe general illness at time of presentation:
- •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
- •Severe sepsis or septic shock, as defined by the international paediatric sepsis consensus conference [39]. See attachment
- •Signs of complex appendicitis
- •Children with a fecalith on ultrasonography.
- •Patients with serious associated conditions or malformations such as:
- •Congenital or acquired cardiac or pulmonary disease with significant hemodynamic consequences
- •Immunodeficiency
- •Homozygous sickle cell disease
- •Metabolic disorders
- •Patient with documented type 1 allergy to the antibiotics used
排除标准
- 未提供
研究组 & 干预措施
Antibiotic treatment alone
Intravenous administration:
Amoxicillin/clavulanic acid 100/10 mg/kg 6-hourly Gentamicin 7mg/kg once daily
Oral administration of:
Amoxicillin/clavulanic acid 50/12.5 mg/kg/day (in three doses)
干预措施: Antibiotic treatment alone (Drug)
Appendectomy
Routine appendectomy either laparoscopic or open depending on the surgeon's preference
干预措施: Appendectomy (Procedure)
结局指标
主要结局
Safety of initial antibiotic treatment strategy
时间窗: 0-12 months
Occurrence of major complications, such as: A. Anaphylactic shock and other allergic reaction to antibiotics administered b. Recurrent appendicitis within 8 weeks c. Recurrent appendicitis within one year after discharge d. Development of perforated appendicitis e. Occurrence of major complaints after delayed appendectomy such as intra-abdominal abscess (IAA), stumpleakage, superficial site infection (SSI), anaesthesia related complications, secondary bowel obstruction (SBO), re-admission, need for re-intervention f. Re-admission g. Re-intervention other than delayed appendectomy
次要结局
- Safety of the direct appendectomy treatment strategy(0-12 months)
研究者
Ramon R. Gorter
MD, PhD candidate
VU University of Amsterdam