Multicentre Randomized Trial on the Timing and Effect of Contrast Media on Patients with Adhesive Small Bowel Obstruction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Tartu
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- SBO resolution
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Masking Description
Sealed envelope randomisation
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
SBO resolution
Time Frame: Period of hospitalization- approximately 5 days
SBO resolution with conservative measures * passing gas * bowel movement * CM in the colon on the X-ray
Secondary Outcomes
No secondary outcomes reported
Investigators
Liis Jaanimäe
General Surgeon, PhD student
University of Tartu