Dexamethasone plus supportive care versus supportive care for adhesive small bowel obstruction.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.