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临床试验/NCT00469430
NCT00469430
已完成
2 期

Randomized Study of Conservative Versus Surgical Treatment of Appendicitis; Analyses of Result and Economics

Göteborg University1 个研究点 分布在 1 个国家目标入组 360 人2006年5月

概览

阶段
2 期
干预措施
cefotaxim and metronidazol
疾病 / 适应症
Appendicitis
发起方
Göteborg University
入组人数
360
试验地点
1
主要终点
treatment efficacy
状态
已完成
最后更新
17年前

概览

简要总结

The purpose of this study is to determine if antibiotic treatment of appendicitis is an option compared to surgery. The investigators' hypothesis is that a majority of patients with appendicitis can heal without surgery and that there are several advantages with antibiotic treatment related to time to recover, complications and economical aspects.

详细描述

Appendicitis is a common disease; 1/1000 gets it every year. 7% will get appendicitis during their lifetime. Surgery, open or laparoscopic, is the traditional treatment. A number of these patients don´t have appendicitis when operated on and the operation is therefore unnecessarily performed. It is also a risk for complications after surgery; for instance wound infection, postoperative small bowel obstruction. In our study we will compare antibiotic as the only treatment with traditional surgical treatment. Patients with "suspected appendicitis" are randomized to either surgery or antibiotics according to their birth date. Patients in "the surgery group" are treated according to standard routines. Patients in "the antibiotic group" are treated with intravenous antibiotics for at least 24h - this regime can be prolonged if clinical recovery doesn´t occur - and submitted from hospital with oral antibiotics. If patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation) they will be operated. Parameters that will be analyzed are: * primary healing in the antibiotic group * frequency of relapse in appendicitis in the antibiotic group * complications in both groups * economical analysis (hospital stay, sick leave time, time off work) in both groups

注册库
clinicaltrials.gov
开始日期
2006年5月
结束日期
2008年10月
最后更新
17年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Göteborg University

入排标准

入选标准

  • Suspected appendicitis in patients over 18 years

排除标准

  • Under 18 years

研究组 & 干预措施

Ab

antibiotic treatment

干预措施: cefotaxim and metronidazol

结局指标

主要结局

treatment efficacy

时间窗: one year

次要结局

  • complications(one year)

研究点 (1)

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