Interval Appendectomy in Children, is it Really Necessary? A Randomized, Noninferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Recurrent appendicitis for the conservative group
研究概览
简要总结
Appendicitis is one of the most common surgical problems in children, with 20-35% of patients having perforated by the time they present to a doctor. In these cases, the patient is often treated non-surgically with antibiotics. Once a patient has improved, it is not known whether it is better to perform an interval appendectomy (IA) or to continue a watchful waiting approach. The purpose of this trial is to determine if expectant nonoperative management (watchful waiting) is not inferior compared to IA management after successful conservative treatment of appendiceal mass at admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under 18 years of age
- •Perforated appendicitis where the treating physician chooses to follow the conservative approach rather than performing an immediate appendectomy
排除标准
- •Uncertainty about the diagnosis
- •The need for laparotomy/laparoscopy for another reason
- •Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis
- •Another medical condition that may affect the decision to operate e.g., inflammatory bowel disease
- •A comorbidity or chronic illness that contraindicates the watchful waiting approach, e.g, diabetes or cardiac problems
研究组 & 干预措施
Conservative Management
Children randomized to conservative management will be seen in the clinic 6-10 weeks after discharge and phoned to follow up every 3 month for a total follow-up of a year. Family will be instructed to come back to the hospital or call the treating physician if the child develops any abdominal pain or fever.
干预措施: Conservative Management (Procedure)
Operative Management
Children randomized to IA will be scheduled for an interval appendectomy 6-10 weeks after discharge, and will be seen in the clinic 6-8 weeks following the interval appendectomy and phoned for follow-up every 3 month for a total of one year.
干预措施: Operative Management (Procedure)
结局指标
主要结局
Recurrent appendicitis for the conservative group
时间窗: During a year of follow-up
Operative complications for the operative group
时间窗: During a year of follow-up
次要结局
- Duration of hospital stay(This is the patients' original hospital stay, and re-admission for interval appendectomy when applicable, an expected average of 5 days)
研究者
Ahmed Nasr
Principal Investigator
Children's Hospital of Eastern Ontario