Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone

    Drug

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

  • Supportive Care

    Other intervention

    \*Please see description for supportive care arm.

Treatment groups

550 Participants
are divided into 2 treatment groups
Group A: DexamethasoneActive comparator 2 interventions
Group B: Supportive CarePlacebo comparator 1 intervention

Trial outcomes

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

Time frame
30 days

Secondary outcomes

1

Hospital readmissions - 1 Year

The outcome for this aim is the comparison of healthcare utilization (e.g., readmissions) between the dexamethasone and supportive care groups

Time frame
1 Year
2

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

A 36-item questionnaire assessing 5 domains: GI symptoms, physical function, emotional well-being, social well-being, and perception of medical treatment measured by a single item question. Each item has 5 response choices (i.e., all of the time, most of the time, some of the time, a little of the time, never). In addition, the measure produces an overall quality of life score (0-144) where higher numbers indicate greater QoL. The outcome will be the comparison of GIQLI score between the dexamethasone and supportive care groups.

Time frame
30 days
3

Hospital readmissions - 30 day

The outcome for this aim is the comparison of healthcare utilization (e.g., readmissions) between the dexamethasone and supportive care groups

Time frame
30 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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