Multicenter Controlled Randomized Prospective Study of the Comparative Efficacy of Early and Delayed Surgical Interventions in Patients With Acute Adhesive Intestinal Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Non-operative treatment success
研究概览
简要总结
This study will compare the results of 24 h conservative treatment and N h conservative treatment of adhesive small bowel obstruction (where N = 72 h minus duration of intestinal obstruction).
详细描述
Patients with acute adhesive intestinal obstruction, who dont need an emergency operation, will be given water insoluble contrast per os and randomized into two groups - early and delayed surgery. The first group will receive conservative treatment within no more than 24 h. Duration of non-operative treatment in second group will be 72 h minus duration of intestinal obstruction, based on the onset of symptoms. In both groups surgery will be performed if contrast will not reach colon in mentioned terms or clinical deterioration signs will appear. The results of 24 h conservative treatment and N h conservative treatment (where N = 72 h minus duration of intestinal obstruction) will be compared.
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
盲法说明
No masking is expected due to the nature of interventions
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
- •patients with acute intestinal obstruction
排除标准
- •pregnancy;
- •peritonitis or strangulation, revealed during primary examination;
- •early acute small bowel obstruction (presence of anamnestic surgical intervention within 6 month)
结局指标
主要结局
Non-operative treatment success
时间窗: 72 hours
Frequency of non-operative intestinal obstruction resolution
次要结局
- Postoperative complications(up to 30 days)
- Overall mortality(up to 30 days)
- Resectional interventions(up to 30 days)
研究者
Kotkov Pavel
PhD, surgery department assistant
North-Western State Medical University named after I.I.Mechnikov