跳至主要内容
临床试验/NCT02928458
NCT02928458撤回不适用

Clinical and Financial Impact of an Evidenced-Based Adhesive Small Bowel Obstruction Management Protocol

The Guthrie Clinic1 个研究点 分布在 1 个国家开始时间: 2015年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Compare average length of stay for patients admitted with ASBO prior to and after implementation of this protocol.

研究概览

简要总结

This research study is for patients with adhesive small bowel obstruction (ASBO). ASBO is a condition in which the small intestine gets blocked due to scars called adhesions. To see the blockage, a contrast agent is given and an x-ray is taken of the belly (abdomen). MD Gastroview and omnipaque are two contrast agents that may be given as part of your normal care for ASBO. This study hopes to see if one is better than the other.

详细描述

Small bowel obstruction is a common general surgical diagnosis providing a significant proportion (16%) of the emergency general surgery admissions. Unfortunately, there is a paucity of clear, well defined management protocols for this very common problem which results in a wide array of management techniques used by the general surgeon. It has already been shown that CT scan with IV contrast is the most accurate method of identifying strangulated bowel, a diagnosis that requires urgent surgical intervention(4). There is no variability in this aspect of the treatment arm for ASBO, rather the variability is found in the medical management of ASBO. Nasogastric tube (NGT) decompression is a universal component of non-operative management but the duration of NGT therapy and the definition of failed medical management requiring surgery lack a clear consensus. It is this aspect of the management of ASBO that I am hoping to better define. Water soluble contrast (MD-Gastroview) has been shown to be both diagnostic and therapeutic in the management of ASBO decreasing length of stay in this patient population. Not only does it expedite the resolution of ASBO, but is also yields objective evidence whether or not ASBO will resolve with medical management alone, therefore decreasing delay in the inevitable surgical intervention.

The hypothesis of this study is that the implementation of an evidence based adhesive small bowel obstruction protocol can reduce length of stay and reduce the financial burden on the health care system regarding this common general surgical problem. A second hypothesis is that MD-Gastroview and omnipaque will have similar properties regarding their diagnostic and therapeutic impact on ASBO.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Principle diagnosis of adhesive small bowel obstruction

排除标准

  • Evidence of strangulation on initial CT scan leading to emergent operation
  • Any known allergy to either contrast agent

研究组 & 干预措施

Omnipaque

Active Comparator

Arm 1

干预措施: Omnipaque (Drug)

MD-Gastroview

Active Comparator

Arm 2

干预措施: MD-Gastroview (Drug)

结局指标

主要结局

Compare average length of stay for patients admitted with ASBO prior to and after implementation of this protocol.

时间窗: Three years

次要结局

  • Compare statistically significant results relating to differences in the diagnostic and therapeutic effects of MD-Gastroview and omnipaque.(Three years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验