Recruiting

Dexamethasone

Sponsor:

University of Washington

Code:

NCT07084441

Conditions

Adhesive Small Bowel Obstruction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone

Supportive Care

Study Details

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.

Conditions

Adhesive Small Bowel Obstruction

Study ID

NCT07084441

Start date

Feb 3, 2026

Status verified date

May, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Dexamethasone

Supportive care and dexamethasone 8 mg administered intravenously (using blinded packaging) once daily for up to 5 days until SBO is resolved or patient becomes surgical candidate.

placebo comparator: Supportive Care

Supportive care in both arms could include nasogastric tube (NGT) decompression, IV hydration, and serial abdominal exams as part of the standard of care for bowel obstruction management.

Interventions

Dexamethasone

\*Please see description for dexamethasone + supportive care arm.

Supportive Care

\*Please see description for supportive care arm.

Primary outcome measure

  • Resolution of adhesive Small Bowel Obstruction (aSBO) [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Kelsey Pullar, MPH

206.221.8247kpullar@uw.edu

Erin Fannon

206.685.9770ecarney@uw.edu

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

UW Medical Center - Northwest

Recruiting

Seattle, Washington, United States, 98133

University of Washington Medical Center Montlake

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

University of Washington

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • asbo
  • sbo
  • small bowel obstruction
  • dexamethasone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-05-07.