The Use of Nasogastric Tubes And Water-Soluble Contrast In The Management Of Small Bowel Obstruction: A Feasibility Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Patient-Reported Outcomes Measurement Information System (PROMIS®)-29
研究概览
简要总结
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.
The purpose of this feasibility study is to determine the potential for implementation of treatment protocols for aSBO and determine the feasibility of randomizing patients with aSBO to receive or not receive NGTs or water-soluble contrast (WSC). The investigators will also determine the ability to measure HRQOL as a main outcome for the treatment of aSBO. The studies outlined in this research program intend to address gaps in knowledge about how to determine who benefits from NGT placement, who can be managed without them, how to objectively determine when a bowel obstruction has resolved, how to reintroduce feeding to patients with aSBO, what criteria should be used for hospital discharge and what role cathartics such as WSC contrast have in the management of aSBO.
This feasibility study will enroll a limited number of patients (n=40) who will be followed for up to 30 days.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years of age.
- •Documentation of aSBO as evidenced by one or more clinical features meeting the following criteria: Nausea, emesis, abdominal pain, distended abdomen CT evidence of aSBO
排除标准
- •Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- •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 (MI)/stroke within 6 months
- •Nonadhesive SBO
- •Paralytic Ileus
- •Incarcerated hernia
- •Fecal impaction
- •Intra-abdominal malignancy Early aSBO within 4 weeks of a prior abdominal operation
研究组 & 干预措施
SBO Treated with NG tube and Placebo
The control group will have 100cc of saline administered via the NG tube within 2 hours of NG tube placement.
干预措施: Saline (Drug)
SBO treated without NG tube
Patients who decline NG intubation will be enrolled in the trial, followed prospectively and have the same outcome measures as are acquired in the other study arms.
干预措施: SBO Treatment Without NG Tubes (Procedure)
SBO treated with NG tube and Water-Soluble Contrast (WSC)
Patients who select NG tube treatment will be randomized into experimental and control groups. The experimental groups will have 100 cc of WSC administered in the NG tube within 2 hours of NG tube placement.
干预措施: Gastrografin (Drug)
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System (PROMIS®)-29
时间窗: The measure will be obtained at baseline when a diagnosis of aSBO is made, at hospital day 1, the day after an NGT is removed, the day a patient is discharged from the hospital and at 30 days after discharge.
Quality of life will be assessed using the PROMIS-29 HRQOL instrument. The survey uses multiple response formats. A total score provides an index of HRQOL, with higher scores on a scale of 0-100 reflecting better HRQOL.
次要结局
未报告次要终点
研究者
Edward Harry Livingston
Professor of Surgery
University of California, Los Angeles