Dexamethasone plus supportive care versus supportive care for adhesive small bowel obstruction.
Comparison of Outcomes of Management of Bowel Obstruction
This trial tests whether a short course of IV dexamethasone plus supportive care helps adults with adhesive small bowel obstruction recover without surgery compared with supportive care alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 4 sites (New York, New York and 3 other locations) |
| Trial ID | NCT07084441 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, patient-level randomized Phase 4 comparison of intravenous dexamethasone (given 2–3 times daily for 5–7 days) plus standard supportive care versus supportive care alone in adults with adhesion-related small bowel obstruction who do not require immediate operation. Eligible patients present to participating surgical services with CT-confirmed SBO and clinical features suggesting adhesions from prior abdominopelvic surgery, and must be able to provide informed consent in English. The primary outcome is resolution of obstruction with non-operative management without complication using a predefined minimal clinically important difference. The study is being conducted at University of Washington hospitals (Harborview and UW Medical Center - Northwest) and Columbia University Medical Center with required follow-up to confirm outcomes.
Who should consider this trial
Good fit: Adults (≥18) presenting to participating centers with CT-confirmed adhesive small bowel obstruction deemed appropriate for non-operative management who can consent in English and complete follow-up.
Not a fit: Patients with signs of peritonitis or an urgent need for surgery, recent abdominal surgery within six weeks, allergy to dexamethasone, or SBO caused by hernia, mass, volvulus, or other non-adhesive causes are unlikely to benefit.
Why it matters
Potential benefit: If successful, the intervention could increase the chance of resolving adhesive SBO without surgery, shorten hospital stays, and reduce complications related to emergency operations.
How similar studies have performed: Prior randomized trials in malignant small bowel obstruction found that dexamethasone may help resolve obstruction, but randomized evidence specifically for adhesion-related SBO is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York and 3 other locations
- Columbia University Medical Center — New York, New York, United States (Recruiting)
- Harborview Medical Center — Seattle, Washington, United States (Recruiting)
- UW Medical Center - Northwest — Seattle, Washington, United States (Recruiting)
- University of Washington Medical Center Montlake — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: David Flum, MD MPH — University of Washington
- Study coordinator: Kelsey Pullar, MPH
- Email: kpullar@uw.edu
- Phone: 206.221.8247
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.