Comparison of Outcomes of Management of Bowel Obstruction
University of Washington
Summary
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.
Description
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 t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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; 1. CT findings consistent with diagnosis of SBO; and 2. signs and symptoms consistent with SBO; and 3. 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 bowe…
Interventions
- DrugDexamethasone
\*Please see description for dexamethasone + supportive care arm.
- OtherSupportive Care
\*Please see description for supportive care arm.
Locations (4)
- Columbia University Medical CenterNew York, New York
- Harborview Medical CenterSeattle, Washington
- UW Medical Center - NorthwestSeattle, Washington
- University of Washington Medical Center MontlakeSeattle, Washington