Dexamethasone for Small Bowel Obstruction
(COMBO Pilot Trial)
Trial Summary
What is the purpose of this trial?
The Comparison of Outcomes of Management of Bowel Obstruction (COMBO Pilot) Pilot 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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of the drug Dexamethasone for treating small bowel obstruction?
Is dexamethasone generally safe for use in humans?
Dexamethasone has been used safely in various surgeries, including colorectal and tympanomastoid surgeries, to reduce nausea and vomiting. It has also been used in treating conditions like esophageal strictures in infants and inflammatory bowel disease in animal models, showing positive safety profiles in these contexts.678910
How does the drug dexamethasone differ from other treatments for small bowel obstruction?
Dexamethasone is unique because it may influence the body's growth factors, potentially affecting the healing process in the intestines, which is different from other treatments that might not target these specific pathways. It has been shown to alter enzyme activities and growth factor levels, which could impact how the intestines adapt after surgery.1791112
Research Team
David Flum, MD, MPH
Principal Investigator
University of Washington
Eligibility Criteria
This trial is for adults over 18 with a small bowel obstruction likely caused by adhesions, as confirmed by CT scans and symptoms. They must be able to consent in English and not need immediate surgery. Excluded are those incarcerated, showing signs of peritonitis, allergic to dexamethasone, at high infection risk due to latent infections, or who've had recent surgery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dexamethasone and supportive care or supportive care alone for up to 5 days
Follow-up
Participants are monitored for resolution of aSBO and other outcomes
Long-term Follow-up
Participants are monitored for hospital readmissions and patient-reported outcomes
Treatment Details
Interventions
- Dexamethasone
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor