Comparison of Outcomes of Management of Bowel Obstruction

NCT07084441 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY00020975
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 3

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

Keywords

asbo; sbo; small bowel obstruction; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Resolution of adhesive Small Bowel Obstruction (aSBO)

  The primary outcome is the resolution of aSBO, defined as the absence of obstruction symptoms, in patients receiving dexamethasone + supportive care compared to those receiving supportive care alone

  30 days

Secondary Outcomes (3)

• Hospital readmissions - 1 Year

  1 Year

• Patient-Reported Outcomes (PROs) - Gastrointestinal Quality of Life Index (GIQLI)

  30 days

• Hospital readmissions - 30 day

  30 day

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

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.

Drug: Dexamethasone; Other: Supportive Care

Supportive Care

PLACEBO COMPARATOR

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.

Other: Supportive Care

Interventions

Dexamethasone DRUG

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

Dexamethasone

Supportive Care OTHER

\*Please see description for supportive care arm.

Dexamethasone; Supportive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• CT findings consistent with diagnosis of SBO; and
• signs and symptoms consistent with SBO; and
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Harborview Medical Center

Seattle, Washington, 98104, United States

NOT YET RECRUITING

UW Medical Center - Northwest

Seattle, Washington, 98133, United States

NOT YET RECRUITING

University of Washington Medical Center Montlake

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Interventions

Dexamethasone; Palliative Care

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• David Flum, MD MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsey Pullar, MPH

CONTACT

206.221.8247; kpullar@uw.edu

Erin Fannon

CONTACT

206.685.9770; ecarney@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Chair of Research, Director of the Surgical Outcomes Research Center (SORCE), Adjunct Professor, Dept. of Pharmacy

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)