Comparison of Outcomes of Management of Bowel Obstruction Pilot Study

Conditions

• Adhesive Small Bowel Obstruction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dexamethasone — DRUG
  \*Please see description for dexamethasone + supportive care arm.
• Supportive Care — OTHER
  \*Please see description for supportive care arm.

Study Details

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.

Key Dates

Start date

Mar 1, 2025

Status verified

Mar 2025

Primary completion

Dec 31, 2025

Completion

Mar 31, 2026

Study Design

Enrollment

10 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Dexamethasone
  8 mg IV daily in the morning continued for up to 5 days until SBO is resolved or patient becomes surgical candidate.
• Placebo Comparator: Supportive Care
  Supportive care in both arms includes nasogastric tube (NGT) decompression, hydration, and serial exams to rule out bowel compromise.

Primary Outcome Measure

Resolution of aSBO [ Time Frame: 30 days ]

Locations (1)

Find similar trials in Seattle, WA

Related Studies

• Comparison of Outcomes of Management of Bowel Obstruction
  PHASE4 · Recruiting · University of Washington · New York, New York
• Optimizing Treatment of Adhesive Small Bowel Obstruction
  PHASE3 · Recruiting · University of California, Los Angeles · Los Angeles, California