Dexamethasone for Small Bowel Obstruction

(COMBO Pilot Trial)

Overseen By Erin Fannon

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Washington

Disqualifiers: Peritonitis, Recent surgery, Infections, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding dexamethasone, a type of steroid, to standard supportive care can resolve small bowel obstructions caused by adhesions without surgery. Participants will receive either dexamethasone with supportive care or just supportive care, which includes procedures like decompression and hydration. The study seeks adults diagnosed with an adhesion-related small bowel obstruction who have been advised that surgery is not immediately necessary. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What is the safety track record for Dexamethasone?

Research has shown that dexamethasone is safe in similar situations. For patients with a blocked small intestine due to cancer, dexamethasone helped about 1 in 4 avoid surgery. Specifically, studies found that only 13% of those who took dexamethasone required emergency surgery while hospitalized. This suggests that dexamethasone is generally safe for bowel problems. However, like any medication, it can have side effects, so discussing any concerns with the trial team is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard approach for small bowel obstruction, which often involves supportive care and sometimes surgery, dexamethasone is a corticosteroid that reduces inflammation. Researchers are excited about dexamethasone because it might resolve the obstruction more quickly and reduce the need for surgery by decreasing swelling in the intestine. This treatment is administered intravenously, potentially offering a faster effect compared to oral medications. By targeting inflammation directly, dexamethasone could change how we manage small bowel obstructions, providing a non-surgical option for patients.

What evidence suggests that dexamethasone might be an effective treatment for small bowel obstruction?

Research has shown that dexamethasone, which participants in this trial may receive, can help treat adhesion-related small bowel obstruction (aSBO). Studies found that dexamethasone reduced unresolved cases of SBO by about 50%, potentially aiding more people in recovering without surgery. Additionally, steroids like dexamethasone have successfully treated similar bowel issues, with success rates ranging from 37% to 90%. These findings suggest that dexamethasone is a promising non-surgical option for managing aSBO. ^{1 2 4 6 7}

Who Is on the Research Team?

David Flum, MD, MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a small bowel obstruction likely caused by adhesions, as confirmed by CT scans and symptoms. They must be able to consent in English and not need immediate surgery. Excluded are those incarcerated, showing signs of peritonitis, allergic to dexamethasone, at high infection risk due to latent infections, or who've had recent surgery.

Inclusion Criteria

Ability to provide written or electronic informed consent in English and answer teach-back questions

I am 18 or older and being treated at UWMC.

I have a diagnosis of small bowel obstruction due to adhesions, confirmed by CT and symptoms.

Exclusion Criteria

Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening

I am showing signs of a severe abdominal infection and need emergency surgery.

I cannot or do not want to complete follow-up surveys.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dexamethasone and supportive care or supportive care alone for up to 5 days

1 week

Daily visits for IV administration

Follow-up

Participants are monitored for resolution of aSBO and other outcomes

30 days

Long-term Follow-up

Participants are monitored for hospital readmissions and patient-reported outcomes

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

Trial Overview The COMBO Pilot study is testing if adding dexamethasone to supportive care improves non-surgical resolution of adhesive small bowel obstructions without complications compared to supportive care alone. Participants are randomly assigned to one of the two treatment approaches.

How Is the Trial Designed?

Group I: Dexamethasone Active Control 2 Interventions

8 mg IV daily in the morning continued for up to 5 days until SBO is resolved or patient becomes surgical candidate.

Group II: Supportive Care Placebo Group 1 Intervention

Supportive care in both arms includes nasogastric tube (NGT) decompression, hydration, and serial exams to rule out bowel compromise.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11191995/

Use and Outcomes of Dexamethasone in the Management of ... Objective: To describe rates of dexamethasone use in the nonoperative management of malignant small bowel obstruction (mSBO) and their outcomes.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07084441

Comparison of Outcomes of Management of Bowel ... The goal of the COMBO trial is to answer the question: Can Dexamethasone increases the proportion of patients with resolution of aSBO with non- ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34846570/

Efficacy of dexamethasone in the management ... Conclusion: Dexamethasone therapy is a useful adjunctive therapy in the management of symptoms associated with MSBO in women with EOC. Keywords: Carcinoma; ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ans.19287

Rethinking adhesional small bowel obstruction ... The effectiveness of GCs in malignant SBO, with resolution rates between 37% to 90%, has been documented across studies with heterogenous study ...

5. asc-abstracts.org asc-abstracts.org/abs2025/85-34-the-use-of-dexamethasone-in-adhesive-sbo-a-review-of-the-data-and-introduction-of-the-combo-trial/

85.34 The Use of Dexamethasone in Adhesive SBO: a review ... A review of all published studies of dexamethasone support this recommendation, finding a ~50% reduction in unresolved SBO with a low incidence ...

6. journals.lww.com journals.lww.com/journalacs/fulltext/2023/05003/use_and_outcomes_of_dexamethasone_for_the.92.aspx

Use and Outcomes of Dexamethasone for the Treatment of... Conclusion: Dexamethasone was used in 1 in 4 mSBO admissions with some evidence of higher rates of mSBO resolution and lower rates of operative intervention.

7. researchgate.net researchgate.net/publication/380382913_Use_and_Outcomes_of_Dexamethasone_in_the_Management_of_Malignant_Small_Bowel_Obstruction

(PDF) Use and Outcomes of Dexamethasone in the ... Among dexamethasone recipients, 13% (95% CI = 9%–20%) subsequently required nonelective surgery during the same admission and 4 dexamethasone- ...