Evaluating the timing of contrast media administration for small bowel obstruction
Multicentre Randomized Trial on the Timing and Effect of Contrast Media on Patients with Adhesive Small Bowel Obstruction
This study is testing if giving a special type of liquid sooner or later after a tube is placed in the stomach can help people with a small bowel blockage feel better faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Tartu Academic / other |
| Locations | 1 site (Tartu, Tartu) |
| Trial ID | NCT05678023 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of administering water-soluble contrast media (CM) at two different time intervals after nasogastric-tube decompression in patients with adhesive small bowel obstruction (SBO). Patients will be randomized into two groups: one receiving CM after 4 hours and the other after 24 hours. The study aims to determine if earlier administration of CM can improve the resolution of SBO. Radiographs will be taken to assess the outcomes, and any patient requiring surgery will not be delayed in receiving necessary treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with adhesive small bowel obstruction who do not require immediate surgery.
Not a fit: Patients with mechanical small bowel obstruction due to incarcerated hernias or carcinomatosis, or those with paralytic obstruction, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with small bowel obstruction, potentially reducing the need for surgical interventions.
How similar studies have performed: While the approach of using contrast media in SBO management is common, the specific timing of administration being evaluated in this study is less frequently tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 18 years or older * Adhesive small bowel obstruction diagnosed (clinical, laboratory and radiologic evaluation * No peritonitis present, no need for an emergent surgery * Patients sign an informed consent Exclusion Criteria: * Patients younger than 18 yeas * Patients with mechanical small bowel obstruction caused by incarcerated hernias * Patients with mechanical small bowel obstruction caused by carcinomatosis * Patients with paralytic small bowel obstruction * Patients who have undergone surgery within 6 weeks * Patients who do not want to be enrolled in the study
Where this trial is running
Tartu, Tartu
- Tartu University Hospital — Tartu, Tartu, Estonia (Recruiting)
Study contacts
- Principal investigator: Liis Jaanimäe — University of Tartu
- Study coordinator: Liis Jaanimäe, MD
- Email: liis.jaanimae@kliinikum.ee
- Phone: +3725224012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.