Comparison of Outcomes of Management of Bowel Obstruction

Part of paid clinical trials in New York, New York.

Sponsor
University of Washington
Study ID
NCT07084441
Phase
PHASE4
Status
Recruiting
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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) 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
Feb 3, 2026
Status verified
May 2026
Primary completion
Jun 30, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032-
Harborview Medical CenterSeattleWashington98104-
University of Washington Medical Center MontlakeSeattleWashington98195-
UW Medical Center - NorthwestSeattleWashington98133-

Find similar trials in New York, NY

By research site
Columbia University Medical Center· New York, NYHarborview Medical Center· Seattle, WAUniversity of Washington Medical Center Montlake· Seattle, WAUW Medical Center - Northwest· Seattle, WA

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