A Danish Audit of Small Bowel Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 540
- 试验地点
- 6
- 主要终点
- 30-day mortality rate
研究概览
简要总结
Small bowel obstruction (SBO) is a common and potentially life-threatening acute surgical condition. A minority of patients present with a clear indication for urgent surgical intervention, either on the basis of clinical or radiological assessment (clinical signs of peritonitis/sepsis; suspicion of bowel ischaemia; closed loop obstructions; irreducible herniae etc.). However, the optimal management of the remaining patients, the majority of whom present with SBO caused by abdominal adhesions, remains a topic of international debate with practice varying in different healthcare systems.
This multicentre, prospective, observational study aims to describe the current management of patients admitted with SBO in 6 acute hospitals (Bispebjerg, Herlev, Hillerød, Hvidovre, Køge, Slagelse) on the island of Sjælland, Denmark, which accounts for a 1/3 of the total Danish population.
详细描述
This is a prospective, non-interventional observational study of the management and outcomes of patients admitted with SBO in Denmark.
Relevant clinicopathological demographics will be retrieved from consenting patients' medical records. An initial analysis will be performed once these patients have reached 90 days follow-up after the start of treatment. The long-term outcomes of treatment will be assessed with further analyses at 1, 3 and 5 years follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 old
- •Radiological or clinical diagnosis of mechanical SBO
- •Admitted to one of the 6 participating centres
排除标准
- •SBO presenting within 30 days of a previous abdominal operation
结局指标
主要结局
30-day mortality rate
时间窗: 30 days
30-day morbidity rate
时间窗: 30 days
次要结局
- To determine the success rate of non-operative management in patients with SBO and identify predictors of success/failure(From the start of treatment until 90-days follow-up)
- To determine the incidence and consequence of acute kidney injury in patients with SBO(90 days)
- To determine the incidence and consequence of malnourishment in patients with SBO(90 days)
- 90-day mortality rate(90 days)
- To describe the proportion of patients undergoing operative versus non-operative management(From 90 days)
研究者
Henry Smith
Specialist Surgical Registrar, Principal Investigator
Danish Small Bowel Obstruction Collaborative