Prospective Randomized Clinical Trial for the Management of Uncomplicated Diverticulitis in Right Colon; Non-antibiotics Versus Antibiotics
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Treatment Failure
研究概览
简要总结
The aim of the present study was to evaluate whether antibiotics is mandatory for the treatment of acute uncomplicated right-sided diverticulitis.
The hypothesis is that patients having acute uncomplicated diverticulitis at right-sided colon will be recovered without antibiotics.
详细描述
All patients in the study were randomly allocated to one of the following two treatment groups; no-antibiotics group or antibiotics group.
Patients of no-antibiotics group were admitted to the ward and administered intravenous fluid and bowel rest at least up to 5 days until clinical symptom and sign were stabilized. And then the patient discharge until oral intake was tolerated.
In antibiotics group, the treatment was initiated with an intravenous combination of a third generation cephalosporin or quinolone and metronidazole until oral intake was tolerated. Oral antibiotics such as cefpodoxime together with metronidazole were initiated subsequently on the ward. The total duration of antibiotic treatment was an expected average 10days.
Patients in both group were re-visited outpatient clinic after an expected average 7 days for check-up of serology test (including complete blood count and C-reactive protein), and after an expected average 6 weeks for CT. If the patients did not re-visit outpatient clinic, we checked the call.
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-sided colonic diverticulitis
- •Uncomplicated diverticulitis
排除标准
- •Pregnancy
- •Refuse to investigation
- •Immunosuppressive therapy or immunologic incompetence
- •Colonic diverticulitis except right-sided diverticulitis
- •Complicated diverticulitis
- •Disorder of psychology or cognition
- •Allergic reaction to antibiotics being used in the study (3rd generation cephalosporin, quinolone, metronidazole)
研究组 & 干预措施
Cephalosporin + Metronidazole
intravenous antibiotics injection (3rd generation cephalosporin + metronidazole) and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)
干预措施: Cephalosporin + Metronidazole (Drug)
结局指标
主要结局
Treatment Failure
时间窗: 4-6 weeks
advancement or recurrence diverticulitis at the same site.
次要结局
- total cost of hospitalization for diverticulitis(up to 2 weeks)
- length of hospital stay at first admission for diverticulitis(up to 2 weeks)