Randomized Trial Comparing Two Treatment Strategies for Acute Diverticulitis. Hospitalization or Ambulatory Antibiotic Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 10
- 主要终点
- Treatment failure
研究概览
简要总结
The purpose of 01DIVER is to evaluate efficacy and safety of a home treatment protocol for non complicated diverticulitis compared with management in the hospital. The hypothesis is that a ambulatory treatment with oral antibiotic and progressive introduction of diet is not inferior to the conservative management in hospital in patients with acute not complicated sigmoid diverticulitis, shown by contrast enhanced CT scan. Patients are prospectively randomized to conservative antibiotic treatment either to ambulatory or to hospital treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18 years
- •Diagnosis of mild diverticulitis by abdominal computerized tomography
- •Signed informed consent
排除标准
- •Severe diverticulitis
- •Informed consent not signed
- •Suspicion of colon cancer
- •Pneumoperitoneum
- •Intolerance for oral feeding
- •Antibiotics for diverticulitis in the last month
- •Immunosuppression
- •Pregnancy or lactation
- •Severe (decompensated) other illness
- •Psychological or social problems
结局指标
主要结局
Treatment failure
时间窗: 30 days
Failure of the conservative treatment within 30 days after randomization which consists in one or more of the mentioned signs: persistent or increasing pain, treatment resistant fever, intestinal oclusion, necesity to drain a new intra-abdominal abscess, indication for surgery, mortality.
次要结局
- Recurrence, quality of life, costs(30 days)
研究者
Sebastiano Biondo
S. Biondo, MD, PhD, Colorectal Unit, Department of Surgery
Hospital Universitari de Bellvitge