Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 530
- 试验地点
- 6
- 主要终点
- The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis
研究概览
简要总结
Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a "routine" operation. At the same time other similar intra-abdominal infections, such as diverticulitis, are treated with antibiotics. There have been some encouraging reports on successful treatment of appendicitis with antibiotics and it has been estimated that operative treatment might be necessary for only 15 - 20 % of patients with acute appendicitis.
The aim of this randomized prospective study is to compare operative treatment (open appendicectomy) with conservative treatment with antibiotics (ertapenem, Invanz). Before randomization acute uncomplicated appendicitis is diagnosed with a CT scan.The hypothesis of the study is that the majority of patients with uncomplicated acute appendicitis can be treated successfully with antibiotics and unnecessary appendicectomies can be avoided.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range from 18 to 60 years
- •CT scan diagnosed uncomplicated acute appendicitis
排除标准
- •Age under 18 years or age over 60 years
- •Pregnancy or breast-feeding
- •Allergy to contrast media or iodine
- •Renal insufficiency
- •metformin medication (DM)
- •Peritonitis (a perforated appendix)
- •Lack of co-operation (unable to give consent)
- •A severe other medical condition
- •CT-scan: other diagnosis, fecal lithiasis in appendix, perforation, abscess, suspicion of a tumour
研究组 & 干预措施
Operative treatment
Regular open appendicectomy
干预措施: Appendicectomy (Procedure)
Antibiotic treatment
Ertapenem 1 g i.v. x 1 three days
干预措施: Ertapenem (Drug)
结局指标
主要结局
The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis
时间窗: Up to 10 years
A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.
次要结局
- The Direct and Indirect Costs of Both Treatment Arms(1 year)
- The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment(1 year)
- The Recurrence of Conservatively Treated Appendicitis(up to 10 years)
研究者
Paulina Salminen
MD, PhD
Turku University Hospital