Comparison of Outcomes of Management of Bowel Obstruction Pilot Study

NCT06817551 | Enrolling By Invitation Phase 4 DMC FDA Drug

• 1 other identifier: STUDY00022003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adhesive Small Bowel Obstruction

Keywords

asbo; sbo; small bowel obstruction; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Resolution of 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) - GIQLI

  30 days

• Hospital readmissions - 30 day

  30 day

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

8 mg IV daily in the morning continued 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 includes nasogastric tube (NGT) decompression, hydration, and serial exams to rule out bowel compromise.

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 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

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Chair of Research: Surgery

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 10, 2025
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)