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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The Comparison of Outcomes of Management of Bowel Obstruction (COMBO Pilot) Pilot 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.

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 data supports the effectiveness of the drug Dexamethasone for treating small bowel obstruction?

Dexamethasone has been shown to help with breathing issues in infants by reducing inflammation and improving lung function, which suggests it might also help reduce inflammation in other conditions like small bowel obstruction. ^{1 2 3 4 5}

Is dexamethasone generally safe for use in humans?

Dexamethasone has been used safely in various surgeries, including colorectal and tympanomastoid surgeries, to reduce nausea and vomiting. It has also been used in treating conditions like esophageal strictures in infants and inflammatory bowel disease in animal models, showing positive safety profiles in these contexts. ^{6 7 8 9 10}

How does the drug dexamethasone differ from other treatments for small bowel obstruction?

Dexamethasone is unique because it may influence the body's growth factors, potentially affecting the healing process in the intestines, which is different from other treatments that might not target these specific pathways. It has been shown to alter enzyme activities and growth factor levels, which could impact how the intestines adapt after surgery. ^{1 7 9 11 12}

Research Team

David Flum, MD, MPH

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Dexamethasone for the prevention of postextubation airway obstruction: a prospective, randomized, double-blind, placebo-controlled trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Dexamethasone effects on the hospital course of infants with bronchopulmonary dysplasia who are dependent on artificial ventilation. [2013]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Comparing low-dose (DART) and enhanced low-dose dexamethasone regimens in preterm infants with bronchopulmonary dysplasia. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Early postnatal dexamethasone therapy in premature infants with severe respiratory distress syndrome: a double-blind, controlled study. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Suppression and recovery of the hypothalamic function after high-dose corticosteroid treatment in preterm infants. [2013]

6. Germany pubmed.ncbi.nlm.nih.gov

Perioperative intravenous dexamethasone for patients undergoing colorectal surgery: a systematic review and meta-analysis. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Successful treatment of severe refractory anastomotic stricture in an infant after esophageal atresia repair by endoscopic balloon dilation combined with systemic administration of dexamethasone. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

An oral drug delivery system targeting immune-regulating cells ameliorates mucosal injury in trinitrobenzene sulfonic acid-induced colitis. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Dexamethasone versus standard treatment for postoperative nausea and vomiting in gastrointestinal surgery: randomised controlled trial (DREAMS Trial). [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Low-dose dexamethasone reduces nausea and vomiting after tympanomastoid surgery: a comparison of tropisetron with saline. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Dexamethasone inhibits mucosal adaptation after small bowel resection. [2017]

12. Germany pubmed.ncbi.nlm.nih.gov

Decreasing early recurrence rate of acute intussusception by the use of dexamethasone. [2019]