Study About Contrast Media

Study Overview
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Brief Summary
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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 2 or after 24 hours of nasogastric- tube decompression.

Detailed Description
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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 2 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)- X-rays acquired at 4,8,12 and 24 hours after CM administration. 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

Official Title
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Multicentre Randomized Trial on the Timing and Effect of Contrast Media on Patients With Adhesive Small Bowel Obstruction

Conditions
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Small Bowel Obstruction

Intervention / Treatment
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* Other: Effect on contrast media depending on the time of its administratsion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Contrast media 2 hours<br>Patients will receive contrast media after 2 hours of nasogastric decompression | Other: Effect on contrast media depending on the time of its administratsion<br>* 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<br>|
| Active Comparator: Contrast media 24 hours<br>Patients will receive contrast media after 24 hours of nasogastric decompression | Other: Effect on contrast media depending on the time of its administratsion<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SBO resolution | SBO resolution with conservative measures passing gas bowel movement CM in the colon on the X-ray | Period of hospitalization- approximately 5 days |