Conservative Treatment of Acute Appendicitis in Children Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Resolution of symptoms without significant complications
研究概览
简要总结
This is a feasibility study that will be performed at the Astrid Lindgren Children´s Hospital, Karolinska University Hospital, Stockholm, Sweden. It will involve 50 patients, randomized to either conservative, non-operative, treatment with antibiotics OR surgery. The study will test an computerized randomization system, the availability of patients willing to participate in the trial and the trial protocol. The investigators will assess the characteristics of the patients who agree to participate in the study and those who do not. The investigators will explore short term outcome and design suitable long term outcome measures.
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
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 5-15 years old with a clinical diagnosis of appendicitis that prior to the trial would have been subjected to a surgical intervention
排除标准
- •Suspicion of perforated appendicitis on the basis of generalized peritonitis
- •An appendiceal mass, diagnosed either by palpation or with radiology
研究组 & 干预措施
Appendectomy
Standard surgical treatment, appendectomy
干预措施: Appendectomy (Procedure)
Conservative, non-surgical treatment
Non-operative treatment with intravenous and oral antibiotics
干预措施: Conservative, non-surgical treatment (Drug)
结局指标
主要结局
Resolution of symptoms without significant complications
时间窗: 30 days
This outcome measure is designed to be similar between the two groups. It is measured in number of participants that fails its designated treatment. Failure of treatment include abscess formation requiring treatment (prolonged antibiotic course or drainage), wound infection requiring intravenous antibiotics, wound dehiscence requiring treatment, prolonged ileus \>5 days, length of stay \>7 days, recurrent appendicitis, persistance of symptoms leading to surgery and negative appendectomy.
次要结局
- Early complications(7 days)
- Time in hospital(7 days)
- Pain(48 hours)
- Time to resolution of symptoms(7 days)
- Abscess formation(7 days)
研究者
Jan Svensson
Principal investigator
Karolinska University Hospital