550 Participants NeededMy employer runs this trial

Dexamethasone for Small Bowel Obstruction

(COMBO Trial)

Recruiting at 3 trial locations
KP
EF
SD
NA
Overseen ByNate Ashford
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Washington
Prior Safety DataThis treatment has passed at least one previous human trial

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 supportive care can resolve small bowel obstructions caused by adhesions (bands of scar tissue) without surgery. Participants will receive either dexamethasone with supportive care or just supportive care, which may include treatments like IV fluids and stomach decompression. It targets individuals with bowel obstructions due to scar tissue from past surgeries who do not currently require emergency surgery. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for dexamethasone?

Research shows that dexamethasone is generally safe for people with adhesive small bowel obstruction (SBO). Studies have found that administering dexamethasone through an IV not only reduced the need for surgery but was also well-tolerated by patients. Specifically, a review of studies found that using dexamethasone led to about a 50% decrease in unresolved SBO cases, with few side effects. Serious side effects were rare, making it a promising option for managing SBO without surgery. Overall, the evidence suggests that dexamethasone is a safe treatment for small bowel obstruction when used correctly.12345

Why are researchers enthusiastic about this study treatment?

Most treatments for small bowel obstruction rely on supportive care methods like nasogastric tube decompression and IV hydration. However, Dexamethasone stands out because it is an anti-inflammatory steroid that is administered intravenously, potentially reducing inflammation and speeding up recovery. Researchers are excited about Dexamethasone because it offers a new approach by directly addressing inflammation, which could result in quicker symptom relief and earlier resolution of the obstruction compared to traditional methods.

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

This trial will compare dexamethasone with supportive care for treating small bowel obstruction. Studies have shown that dexamethasone can help treat adhesive small bowel obstruction (aSBO). In one study, 92% of patients who received dexamethasone improved without needing surgery, compared to 75% in the group that did not receive it. Other research suggests that dexamethasone reduces the need for surgery in these cases. It has also been effective for patients with bowel obstruction linked to cancer. Overall, dexamethasone appears to significantly increase the chances of resolving aSBO without surgery.12356

Who Is on the Research Team?

DF

David Flum, MD MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults (18+) with small bowel obstruction caused by adhesions, confirmed by CT scan and symptoms. Participants must not need emergency surgery and must be able to give consent in English.

Inclusion Criteria

My bowel obstruction is likely caused by adhesions, not by other conditions like hernias or IBD.
I can sign and understand consent in English and answer questions about it.
I am 18 years or older and being treated at UWMC.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

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

1 week
Daily visits for up to 5 days

Follow-up

Participants are monitored for resolution of aSBO and healthcare utilization outcomes

30 days
Regular follow-up visits

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 study compares two treatments for adhesion-related small bowel obstruction: a short course of dexamethasone plus supportive care versus supportive care alone. Patients are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: DexamethasoneActive Control2 Interventions
Group II: Supportive CarePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

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

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/42017688/

Efficacy of Dexamethasone in Adhesive Small Bowel ...

In the Dex group, 92% (46/50) resolved with non-operative management, compared to 75% (41/55) in the Control group, which was statistically ...

Efficacy of Dexamethasone in Adhesive Small Bowel ...

Most significantly, our novel findings showed that IV Dexamethasone significantly reduced the need for surgical intervention in adhesive SBO.

Comparison of Outcomes of Management of Bowel ...

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 ...

Use and Outcomes of Dexamethasone in the Management ...

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

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 ...

Study Details | NCT06817551 | Comparison of Outcomes ...

Reducing inflammation with dexamethasone- a readily available and safe intervention - may improve the likelihood of non-operative management of aSBO and could ...