None listed
Conditions
Brief summary
This study aims to investigate whether corticosteroids can help resolve non-malignant small bowel obstruction caused by adhesions without the need for surgery. Small bowel obstruction is a common condition after abdominal surgery and is usually managed with treatments such as a nasogastric tube and fasting. Corticosteroids have anti-inflammatory properties that may reduce bowel swelling. Their use have been effective and safe in the setting of malignant bowel obstruction, but yet to be shown in non-malignant obstructions. We hypothesize that adding corticosteroids to standard non-surgical management will increase the likelihood of resolving the obstruction without surgery and improve recovery time. The study will also assess any potential side effects of corticosteroids.
Interventions
Intervention:
Drug Name: Dexamethasone (International Non-Proprietary Name)
Dose: 4mg administered intravenously, twice daily
Duration: Up to 5 days or until clinical resolution of small bowel obstruction or clinical indication for surgery, whichever occurs first
Mode of Administration: Intravenous injection in an inpatient hospital setting
Who Delivers the Intervention: Experienced surgeons familiar with corticosteroid use for SBO management
Observation and Monitoring: Daily clinical evaluation
Intervention: Drug Name: Dexamethasone (International Non-Proprietary Name) Dose: 4mg administered intravenously, twice daily Duration: Up to 5 days or until clinical resolution of small bowel obstruction or clinical indication for surgery, whichever occurs first Mode of Administration: Intravenous injection in an inpatient hospital setting Who Delivers the Intervention: Experienced surgeons familiar with corticosteroid use for SBO management Observation and Monitoring: Daily clinical evaluations and imaging (as needed) to monitor for SBO resolution, regimen adherence, and adverse events. Observations and follow up continue up to 90 days post-resolution or surgery to capture long-term outcomes.
Sponsors
Liverpool Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of Small Bowel Obstruction (SBO): Confirmed adhesional small bowel obstruction based on clinical presentation and imaging (e.g., CT scan showing dilated loops of small bowel with transition point and no evidence of hernia or malignancy). 2. Age: Adults aged 18 years and older. 3. Clinical Stability: Hemodynamically stable and suitable for initial non-operative management. 4. Ability to Provide Informed Consent: Patients capable of understanding the study protocol and providing written informed consent.
Exclusion criteria
1. Malignant Obstruction: Small bowel obstruction secondary to intra-abdominal or metastatic malignancy. 2. Hernia-Related Obstruction: Patients with SBO caused by incarcerated or strangulated hernias identified clinically or radiologically. 3. Non-Adhesional Etiologies: SBO caused by other specific etiologies such as inflammatory bowel disease, volvulus, or intussusception. 4. Immediate Surgical Indication: Patients requiring urgent or emergent surgical intervention at the time of presentation. 5. Severe Comorbidities or Contraindications to Corticosteroids: Active infections, poorly controlled diabetes, gastrointestinal ulcers, or other conditions contraindicating corticosteroid use.
Outcome results
None listed