Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Successful treatment of appendicitis
研究概览
简要总结
This study aims to compare antibiotic treatment versus surgery for patients with uncomplicated appendicitis.
详细描述
The study will include patients aged 16 and over, with a first admission with right iliac fossa pain and a raised white cell count or C-reactive protein. Patients will be randomised electronically in a 1:1 ratio either to undergo emergency appendectomy or to receive intravenous antibiotics as an inpatient, until clinical and biochemical improvement is observed, followed by outpatient oral antibiotics. Those who have surgery will have 3 post-operative doses of intravenous antibiotics, unless perforation was identified at the time of surgery, in which case, microbiology will be contacted to advise regarding antibiotic choice and duration. Follow-up by telephone interview will be at 1 week, 1, 3 and 12-month intervals.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Right iliac fossa pain
- •1st episode in the past 1 year
- •Raised WCC or CRP
- •Fluent in English
排除标准
- •History of inflammatory bowel disease or appendectomy
- •B-HCG positive
- •Significant co-morbidities
- •Complicated appendicitis as proven by ultrasound, CT or MRI
- •Anaphylaxis to penicillin
研究组 & 干预措施
Operative Intervention
Laparoscopic +/- open appendicectomy, with antibiotics at induction and 3 further doses of intravenous antibiotics. Co-amoxiclav, or cefuroxime and metronidazole if previous rash-allergy to penicillin.
干预措施: Laparoscopic +/- Open Appendicectomy (Procedure)
Antibiotic Treatment
Intravenous antibiotics until clinical improvement and then 5 further days of oral antibiotics. Co-amoxiclav, or if rash-allergy to penicillin, cefuroxime and metronidazole.
干预措施: Antibiotic treatment (Drug)
结局指标
主要结局
Successful treatment of appendicitis
时间窗: 1 year post enrollment
Successful treatment is defined as the resolution of appendicitis resulting in discharge from the hospital and no recurrent appendicitis during the one-year follow-up. The number of patients requiring surgery for appendicitis in the non-operative group will be measured.
次要结局
- Clostridium difficile infection(1 year post enrollment)
- Need for re-admission or repeat imaging(1 year post enrollment)
- Quality of life Questionnaire taken over the year after recruitment(1 year post enrollment)
- Complication of treatment(1 year post enrollment)
- Cost evaluation(1 year post enrollment)
- Recurrence of appendicitis(1 year post enrollment)
研究者
Arnold Hill
Professor of Surgery
Beaumont Hospital