The Use of Nasogastric Tubes and Water-Soluble Contrast With or Without Radiographic Imaging in The Management of Adhesive Small Bowel Obstruction: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Median number of days of benefit
研究概览
简要总结
Small bowel obstruction (SBO) is common yet, how to best manage it remains unknown. One approach is to administer water soluble oral contrast (WSC) and the obtain x-rays to determine how well the bowel is functioning. WSC may help resolve SBO by stimulating the bowel by itself. The intent of this study is to determine if the x-ray component of this therapeutic approach is necessary.
详细描述
Responsible for more than 340,000 hospital admissions per year, small bowel obstruction (SBO) is one of the most common causes of serious gastrointestinal disease in the US. Adhesion-related SBO (aSBO) is usually treated by the placement of a nasogastric tube (NGT) to decompress the stomach, administration of intravenous (IV) fluids and observation by a surgical team. In most (60%) patients, aSBO resolves spontaneously. However, NGTs are uncomfortable for patients and have multiple associated risks, leading many patients and clinicians to avoid their use if possible.
Despite NGT placement being considered a standard component of aSBO treatment, some series report that as many as ½ of all patients with aSBO may be treated without them. A recent meta-analysis showed that hospital length-of-stay (HLOS) may be reduced by 2 days if treated with water-soluble contrast (WSC).
Despite aSBO being common, little is known about the optimal means for its treatment and even less about the mechanisms by which it resolves. The overall intent of this research is to develop evidence-based treatment protocols and to better understand the mechanisms by which aSBO resolves and how interventions can be developed to improve its treatment.
This feasibility study's purpose is to determine the ability to perform a randomized clinical trial (RCT) investigating treatments options for aSBO. Specifically, WSC will be administered to patients with a SBO followed by randomization to undergo formal upper gastrointestinal-small bowel follow through (UGI-SBFT) series vs no radiologic imaging to determine if radiologic examination can be eliminated when treating patients with aSBO. A concurrent observational arm will enroll patients who elect not to have NGTs placed to follow their hospital course. A state-transition model of daily clinical status will be tested to determine its effectiveness as a primary outcome to replace older, traditional outcomes for hospitalized patients such as diet resumption or length of stay.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documentation of aSBO as evidenced by one or more clinical features meeting the following criteria:
- •Abdominal pain
- •Distended abdomen
- •CT evidence of aSBO
- •Known abdominal surgical history.
- •Written informed consent obtained from subject.
排除标准
- •Unable to provide consent for the study.
- •Pregnant or breastfeeding.
- •Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- •Unstable angina or recent myocardial infarction or stroke within 6 months
- •Patients with peritonitis or who require immediate surgery.
- •Non-adhesive SBO, including.
- •Paralytic Ileus
- •Incarcerated hernia
- •Fecal impaction
- •Intra-abdominal malignancy
- •Early aSBO within 4 weeks of a prior abdominal operation
结局指标
主要结局
Median number of days of benefit
时间窗: 30 Days
probability distribution of the difference in median number of days of benefit attributable to the intervention determined from the posterior distribution of state occupancy probabilities.
Median number of days of benefit
时间窗: 30 Days
probability distribution of the difference in median number of days of benefit attributable to the intervention determined from the posterior distribution of state occupancy probabilities.
次要结局
- Daily Clinical Status(30 day)
- Health Care Quality of Life (HCQOL)(30 Day)
研究者
Edward Harry Livingston
Professor of Surgery
University of California, Los Angeles