From Guidelines to Real-world Practice: a Pragmatic Before and After Study on the Treatment of Acute Uncomplicated Diverticulitis (AUD) Based on a Risk Factor Driven Treatment Algorithm (AUD Management Algorithm Protocol)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 800
- 主要终点
- Treatment failure
研究概览
简要总结
Acute uncomplicated diverticulitis is often treated with antibiotics, although current evidence shows that antibiotics are not always necessary. This study will evaluate whether a more standardized approach to treatment can reduce unnecessary antibiotic use without increasing the risk of treatment failure.
The study will compare patients treated before and after the new treatment approach is introduced in participating Swiss hospitals. Information on treatment, hospital admissions, complications and recurrence of diverticulitis will be collected. Patients will be followed for up to 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 18 years or older
- •CT-confirmirmed acute uncomplicated diverticulitis of the left colon
- •Ability to provide informed consent for participants in the prospective phase
排除标准
- •Complicated acute diverticulitis, defined as diverticulitis with abscess, perforation (free air), fistula, or distant free fluid
- •Diverticulitis of the right or transverse colon
- •.Alternative diagnosis explaining the participant's symptoms
- •No possibility of completing the 90-day follow-up
- •Inability to provide informed consent for the prospective phase
研究组 & 干预措施
Antibiotic Treatment
Participants with acute uncomplicated diverticulitis who receive antibiotic treatment according to the standardized treatment approach.
干预措施: standardized treatment algorithm (Other)
No Antibiotic Treatment Arm Description:
Participants with acute uncomplicated diverticulitis who are managed without antibiotics according to the standardized treatment approach.
干预措施: standardized treatment algorithm (Other)
结局指标
主要结局
Treatment failure
时间窗: Within 90 days after diagnosis
Treatment failure is defined as a composite outcome including progression to complicated diverticulitis requiring percutaneous abscess drainage or surgery, delayed initiation of antibiotics after initial management without antibiotics, or unplanned hospital admission following initial outpatient treatment.
次要结局
- Antibiotic use(Within 90 days after diagnosis)
- Adherence to the standardized treatment approach(At the initial treatment decision)
- Outpatient versus inpatient management(At the initial treatment decision)
- Hospital admission(Within 30 days after diagnosis)
- Recurrence of diverticulitis(Within 24 months after diagnosis)