Small Bowel Obstruction
Conditions
Brief summary
Patients hospitalized with adhesive small bowel obstruction (SBO) are randomized to 2 study groups at admission after signing an informed consent form. Water-soluble contrast media (CM) will be administered after 4 or after 24 hours of nasogastric- tube decompression.
Detailed description
Patients presenting with symptoms of small bowel obstruction (SBO) will be evaluated and if the diagnosis of adhesive small bowel obstruction is made it must be decided what is the treatment of choice. If immediate surgery is needed- it will not be delayed If patients are eligible for conservative management- they will be randomized to 2 study groups- contrast media (CM) after 4 hours of nasogastric-tube decompression and after 24 hours of nasogastric-tube decompression. Contrast media challenge acquires radiographs (X-rays) to be taken after an interval (common practice) decided by the surgeon. If at any point patient needs surgery- it will not be delayed. The results are compared. The hypothesis is, that if CM is administered sooner- it will help SBO resolution
Interventions
OTHEREffect on contrast media depending on the time of its administratsion
CM is a common practice when it comes to the management of small bowel obstruction. However there is no consensus as when it should be administered
Sponsors
North Estonia Medical Centre
University of Tartu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Masking description
Sealed envelope randomisation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SBO resolution | Period of hospitalization- approximately 5 days | SBO resolution with conservative measures * passing gas * bowel movement * CM in the colon on the X-ray |
Countries
Estonia
Contacts
Primary ContactLiis Jaanimäe, MD
Backup ContactCeith Nikkolo, PhD
Outcome results
None listed