Comparison of Outcomes of Management of Bowel Obstruction
ConditionAdhesive Small Bowel Obstruction
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dexamethasone
- Supportive Care
Treatment groups
550 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Washington
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov