NCT07084441 Comparison of Outcomes of Management of Bowel Obstruction
| NCT ID | NCT07084441 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Washington |
| Condition | Adhesive Small Bowel Obstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 550 participants |
| Start Date | 2026-02-03 |
| Primary Completion | 2030-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 550 participants in total. It began in 2026-02-03 with a primary completion date of 2030-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 bowel disease (IBD) flare, etc.). * Ability to provide written or electronic informed consent in English and answer teach-back questions Exclusion Criteria: * 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.
Contact & Investigator
David Flum, MD MPH
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT07084441 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adhesive Small Bowel Obstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07084441 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07084441 currently recruiting?
Yes, NCT07084441 is actively recruiting participants. Contact the research team at kpullar@uw.edu for enrollment information.
Where is the NCT07084441 trial being conducted?
This trial is being conducted at New York, United States, Seattle, United States, Seattle, United States, Seattle, United States.
Who is sponsoring the NCT07084441 clinical trial?
NCT07084441 is sponsored by University of Washington. The principal investigator is David Flum, MD MPH at University of Washington. The trial plans to enroll 550 participants.