Comparison of Outcomes of Management of Bowel Obstruction
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 4
- 主要终点
- Resolution of adhesive Small Bowel Obstruction (aSBO)
研究概览
简要总结
The Comparison of Outcomes of Management of Bowel Obstruction (COMBO) trial is a patient-level randomized trial of a short course of dexamethasone + supportive care vs supportive care alone for patients with adhesion-related small bowel obstruction (aSBO). The goal of the COMBO trial is to answer the question: Can Dexamethasone increases the proportion of patients with resolution of aSBO with non-operative management (without complication) based on an established minimal important clinical difference.
详细描述
Millions of Americans each year experience adhesion-related small bowel obstruction (aSBO), a condition associated with significant morbidity and prolonged hospitalization. Adhesions formed after previous abdominopelvic surgery can cause twisting of the bowel resulting in injury and a cascade of inflammation that results in progressive bowel wall edema with narrowing of the bowel lumen. This leads to or worsens the bowel obstruction. Reversing this inflammation has the potential to reduce the severity and impact of aSBO, hasten the return of bowel function and avoid an emergency operation to treat the obstruction. Dexamethasone, administered intravenously 2-3 times/day for 5-7 days, has been found effective in patients with a form of SBO related to malignancy (malignant ascites or metastatic disease). A Cochrane review evaluated three RCTs of dexamethasone in patients with malignant SBO and found "evidence that dexamethasone…may bring about the resolution of bowel obstruction" and avoid the need for surgical interventionxx . An underappreciated aspect of these RCTs is that almost all patients had a history of abdominopelvic surgery. Since it is difficult to distinguish the extent to which an SBO is caused by adhesions from prior surgery or mass effect related to malignant ascites or metastases, we hypothesize that dexamethasone may be efficacious in resolving aSBO as well.
The Comparison of Outcomes of Management of Bowel Obstruction (COMBO) study is a double-blinded randomized study of a short course of dexamethasone and supportive care vs. supportive care alone for patients with aSBO. The primary outcome is resolution of SBO without operative management and/or major complications as defined using modified National Surgical Quality Improvement Program (NSQIP) criteria. Differences in secondary outcomes-clinical, healthcare utilization and patient-reported outcomes will be explored overall and across subgroups (e.g., based on severity of aSBO, history of aSBO, sex). Reducing inflammation with dexamethasone- a readily available and safe intervention - may improve the likelihood of non-operative management of aSBO and could change the management of millions of patients with this condition.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Adults ≥18 years of age recruited from UWMC
- •Patients presenting to surgical services through the Emergency Department, diagnosis of SBO, consulted by surgeon, and an urgent or emergency operation is deemed not necessary by surgeon.
- •Diagnosis of aSBO is established by;
- •CT findings consistent with diagnosis of SBO; and
- •signs and symptoms consistent with SBO; and
- •Adhesions from prior abdominopelvic surgery are the likely cause of SBO (absence of incarcerated hernia, internal hernia, masses, fistula, stricture, volvulus, acute episode of inflammatory bowel disease (IBD) flare, etc.).
- •Ability to provide written or electronic informed consent in English and answer teach-back questions
排除标准
- •Signs and symptoms of peritonitis with emergency operation planned
- •Planned urgent operation within the next 12 hours
- •Allergy to dexamethasone
- •Surgery within prior 6 weeks
- •Unable or unwilling to return or be contacted for and/or complete research surveys
- •Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening
- •Individuals with latent infections who have an increased risk of infection.
研究组 & 干预措施
Dexamethasone
Supportive care and dexamethasone 8 mg administered intravenously (using blinded packaging) once daily for up to 5 days until SBO is resolved or patient becomes surgical candidate.
干预措施: Supportive Care (Other)
Supportive Care
Supportive care in both arms could include nasogastric tube (NGT) decompression, IV hydration, and serial abdominal exams as part of the standard of care for bowel obstruction management.
干预措施: Supportive Care (Other)
Dexamethasone
Supportive care and dexamethasone 8 mg administered intravenously (using blinded packaging) once daily for up to 5 days until SBO is resolved or patient becomes surgical candidate.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Resolution of adhesive Small Bowel Obstruction (aSBO)
时间窗: 30 days
The primary outcome is the resolution of aSBO, defined as the absence of obstruction symptoms, in patients receiving dexamethasone + supportive care compared to those receiving supportive care alone
次要结局
- Patient-Reported Outcomes (PROs) - Gastrointestinal Quality of Life Index (GIQLI)(30 days)
- Hospital readmissions - 1 Year(1 Year)
- Hospital readmissions - 30 day(30 day)
研究者
David Flum
Professor and Associate Chair of Research, Director of the Surgical Outcomes Research Center (SORCE), Adjunct Professor, Dept. of Pharmacy
University of Washington