Dexamethasone for Small Bowel Obstruction
(COMBO Pilot Trial)

Recruiting in Palo Alto (17 mi)

Overseen byDavid Flum, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Washington

Prior Safety Data

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.

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

Ability to provide written or electronic informed consent in English and answer teach-back questions

I am 18 or older and being treated at UWMC.

I have a diagnosis of small bowel obstruction due to adhesions, confirmed by CT and symptoms.

+1 more

Exclusion Criteria

Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening

I am showing signs of a severe abdominal infection and need emergency surgery.

I cannot or do not want to complete follow-up surveys.

+4 more

Participant Groups

The COMBO Pilot study is testing if adding dexamethasone to supportive care improves non-surgical resolution of adhesive small bowel obstructions without complications compared to supportive care alone. Participants are randomly assigned to one of the two treatment approaches.

2Treatment groups

Active Control

Placebo Group

Group I: DexamethasoneActive Control2 Interventions

8 mg IV daily in the morning continued for up to 5 days until SBO is resolved or patient becomes surgical candidate.

Group II: Supportive CarePlacebo Group1 Intervention

Supportive care in both arms includes nasogastric tube (NGT) decompression, hydration, and serial exams to rule out bowel compromise.