Multicentre Randomized Trial on the Timing and Effect of Contrast Media on Patients with Adhesive Small Bowel Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- SBO resolution
研究概览
简要总结
Patients hospitalized with adhesive small bowel obstruction (SBO) are randomized to 2 study groups at admission after signing an informed consent form. Water-soluble contrast media (CM) will be administered after 4 or after 24 hours of nasogastric- tube decompression.
详细描述
Patients presenting with symptoms of small bowel obstruction (SBO) will be evaluated and if the diagnosis of adhesive small bowel obstruction is made it must be decided what is the treatment of choice.
If immediate surgery is needed- it will not be delayed If patients are eligible for conservative management- they will be randomized to 2 study groups- contrast media (CM) after 4 hours of nasogastric-tube decompression and after 24 hours of nasogastric-tube decompression.
Contrast media challenge acquires radiographs (X-rays) to be taken after an interval (common practice) decided by the surgeon.
If at any point patient needs surgery- it will not be delayed. The results are compared. The hypothesis is, that if CM is administered sooner- it will help SBO resolution
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
Sealed envelope randomisation
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 18 years or older
- •Adhesive small bowel obstruction diagnosed (clinical, laboratory and radiologic evaluation
- •No peritonitis present, no need for an emergent surgery
- •Patients sign an informed consent
排除标准
- •Patients younger than 18 yeas
- •Patients with mechanical small bowel obstruction caused by incarcerated hernias
- •Patients with mechanical small bowel obstruction caused by carcinomatosis
- •Patients with paralytic small bowel obstruction
- •Patients who have undergone surgery within 6 weeks
- •Patients who do not want to be enrolled in the study
结局指标
主要结局
SBO resolution
时间窗: Period of hospitalization- approximately 5 days
SBO resolution with conservative measures * passing gas * bowel movement * CM in the colon on the X-ray
次要结局
未报告次要终点
研究者
Liis Jaanimäe
General Surgeon, PhD student
University of Tartu