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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
Millions of Americans each year experience adhesion-related small bowel obstruction (aSBO), a condition associated with significant morbidity and prolonged hospitalization. Adhesions formed after previous abdominopelvic surgery can cause twisting of the bowel resulting in injury and a cascade of inflammation that results in progressive bowel wall edema with narrowing of the bowel lumen. This leads to or worsens the bowel obstruction. Reversing this inflammation has the potential to reduce the severity and impact of aSBO, hasten the return of bowel function and avoid an emergency operation to treat the obstruction. Dexamethasone, administered intravenously 2-3 times/day for 5-7 days, has been found effective in patients with a form of SBO related to malignancy (malignant ascites or metastatic disease). A Cochrane review evaluated three RCTs of dexamethasone in patients with malignant SBO and found "evidence that dexamethasone…may bring about the resolution of bowel obstruction" and avoid the need for surgical interventionxx . An underappreciated aspect of these RCTs is that almost all patients had a history of abdominopelvic surgery. Since it is difficult to distinguish the extent to which an SBO is caused by adhesions from prior surgery or mass effect related to malignant ascites or metastases, we hypothesize that dexamethasone may be efficacious in resolving aSBO as well.
The Comparison of Outcomes of Management of Bowel Obstruction (COMBO) study is a double-blinded randomized study of a short course of dexamethasone and supportive care vs. supportive care alone for patients with aSBO. The primary outcome is resolution of SBO without operative management and/or major complications as defined using modified National Surgical Quality Improvement Program (NSQIP) criteria. Differences in secondary outcomes-clinical, healthcare utilization and patient-reported outcomes will be explored overall and across subgroups (e.g., based on severity of aSBO, history of aSBO, sex). Reducing inflammation with dexamethasone- a readily available and safe intervention - may improve the likelihood of non-operative management of aSBO and could change the management of millions of patients with this condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Active Comparator | 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. |
|
| Supportive Care | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | *Please see description for dexamethasone + supportive care arm. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 Year |
| Patient-Reported Outcomes (PROs) - Gastrointestinal Quality of Life Index (GIQLI) |
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Inclusion Criteria:
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;
Ability to provide written or electronic informed consent in English and answer teach-back questions
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelsey Pullar, MPH | Contact | 206.221.8247 | kpullar@uw.edu | |
| Erin Fannon | Contact | 206.685.9770 | ecarney@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Flum, MD MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States | |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Supportive Care |
| Other |
*Please see description for supportive care arm. |
|
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. |
| 30 days |
| 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 | 30 day |
| Harborview Medical Center |
| Recruiting |
| Seattle |
| Washington |
| 98104 |
| United States |
| UW Medical Center - Northwest | Recruiting | Seattle | Washington | 98133 | United States |
| University of Washington Medical Center Montlake | Recruiting | Seattle | Washington | 98195 | United States |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |