NCT02219698已完成不适用
Symptomatic Treatment of Acute Uncomplicated Diverticulitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Complications of diverticulitis
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of symptomatic treatment (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Computed tomography-diagnosed acute uncomplicated* diverticulitis
- •No abscess, fistula, obstruction and distant intra- or retroperitoneal air. Pericolic air allowed.
排除标准
- •Already commenced antimicrobial medication
- •Immunosuppression (e.g. diabetes, corticosteroid medication, immunosuppressive medication, chemotherapy, chronic liver disease)
- •Suspicion of generalized peritonitis
- •Organ dysfunction
- •Another infection requiring antimicrobial medication
- •Pregnancy
- •Age < 18 years or > 90 years
- •Missing written consent
研究组 & 干预措施
Symptomatic treatment
Experimental
干预措施: Ibuprofen (Drug)
Symptomatic treatment
Experimental
干预措施: Paracetamol (Drug)
结局指标
主要结局
Complications of diverticulitis
时间窗: 30 days from allocation
Incidence of complications of diverticulitis (abscess, free perforation, need for surgery)
次要结局
- Need for emergency surgery for diverticulitis on another admission(10 years)
- Commencement of antimicrobial drug(For the duration of hospital stay, an expected average of 2 days)
- Late complication of diverticulitis(10 years)
- Stoma rate(10 years)
- Length of hospital stay (days)(At the end of the hospital stay, an expected average of 2 days)
- Rate of re-admissions(30 days from discharge)
- Recurrence of diverticulitis(10 years)
- Mortality(30 days from allocation)
- Need for elective sigmoid resection(10 years)
研究者
Ville Sallinen
M.D., Ph.D.
Helsinki University Central Hospital
研究点 (1)
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