Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000051448p
Ethics application status
Not yet submitted
Date submitted
18/12/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Does corticosteroids help with non-malignant small bowel obstructions: A Study on Outcomes and Safety
Scientific title
A Prospective Observational Study Evaluating the Use of Corticosteroids in Adults with Non-Malignant Small Bowel Obstruction and Their Association with Resolution Without Surgical Intervention
Secondary ID [1] 313549 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small bowel obstruction 336123 0
Condition category
Condition code
Surgery 332674 332674 0 0
Other surgery
Oral and Gastrointestinal 332673 332673 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 330187 0
Treatment: Drugs
Comparator / control treatment
Arm 1 (Control): No corticosteroids. Standard non-operative management, including nasogastric decompression, nil by mouth (NPO), and fluid resuscitation.
Control group
Active

Outcomes
Primary outcome [1] 340200 0
Proportion of patients with resolution of non-malignant small bowel obstruction (SBO) without the need for surgical intervention.
Timepoint [1] 340200 0
Assessment will occur at the point of clinical resolution or decision for surgical intervention, typically within 5 days from the start of treatment or hospital admission. Additional follow up will occur until discharge to confirm the outcome. Follow up 90 days post discharge to record if re-obstruction occurs.
Secondary outcome [1] 443249 0
Need for Surgical Intervention
Timepoint [1] 443249 0
At the conclusion of the intervention period (up to 5 days) and prior to discharge.
Secondary outcome [2] 443247 0
Safety of corticosteroids
Timepoint [2] 443247 0
Monitored daily during hospitalisation and within 90 days post-discharge.
Secondary outcome [3] 443248 0
Time to Resolution of Small Bowel Obstruction
Timepoint [3] 443248 0
Assessed daily during hospitalisation.
Secondary outcome [4] 443250 0
Length of Hospital Stay
Timepoint [4] 443250 0
Recorded at the time of discharge.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample Size Calculation:
The required sample size of 200 participants was calculated to provide adequate power to detect a clinically significant difference in the resolution rate of non-malignant small bowel obstruction (SBO) without surgery between the corticosteroid and non-corticosteroid groups.

Assumptions for Calculation:
Expected resolution rate in the control group (no corticosteroids): 60%.
Expected resolution rate in the intervention group (corticosteroids): 80%.
Type I error rate (a): 5%.
Type II error rate (ß): 20% (power = 80%).
Two-sided test for differences in proportions between the two groups.
The sample size includes a margin for potential dropouts or exclusions during the study period.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
1/03/2026
Actual
Date of last data collection
Anticipated
6/06/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27433 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 43545 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 318011 0
Self funded/Unfunded
Name [1] 318011 0
Country [1] 318011 0
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Country
Australia
Secondary sponsor category [1] 320353 0
Hospital
Name [1] 320353 0
Campbelltown Hospital
Address [1] 320353 0
Country [1] 320353 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316671 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 316671 0
Ethics committee country [1] 316671 0
Australia
Date submitted for ethics approval [1] 316671 0
30/01/2025
Approval date [1] 316671 0
Ethics approval number [1] 316671 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138606 0
Dr Ernest Cheng
Address 138606 0
Department of Colorectal Surgery, Liverpool Hospital, Burnside drive, Liverpool 2170
Country 138606 0
Australia
Phone 138606 0
+61 405002705
Fax 138606 0
Email 138606 0
[email protected]
Contact person for public queries
Name 138607 0
Ernest Cheng
Address 138607 0
Department of Colorectal Surgery, Liverpool Hospital, Burnside drive, Liverpool 2170
Country 138607 0
Australia
Phone 138607 0
+61 405002705
Fax 138607 0
Email 138607 0
[email protected]
Contact person for scientific queries
Name 138608 0
Ernest Cheng
Address 138608 0
Department of Colorectal Surgery, Liverpool Hospital, Burnside drive, Liverpool 2170
Country 138608 0
Australia
Phone 138608 0
+61 405002705
Fax 138608 0
Email 138608 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: While the study results and aggregated data will be shared through publications in peer-reviewed journals and presentations at scientific conferences, individual participant data (IPD) will not be made publicly available due to privacy concerns and the need to comply with institutional and ethical guidelines.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.