Study About Contrast Media

University of Tartu

Status: Enrolling

Conditions: Small Bowel Obstruction

Treatments: Other: Effect on contrast media depending on the time of its administratsion

Study type: Interventional

Funder types: Other

Identifiers

NCT05678023

22031

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Contrast media 4 hours

Active Comparator group

Description:

Patients will receive contrast media after 4 hours of nasogastric decompression

Treatment:

Other: Effect on contrast media depending on the time of its administratsion

Contrast media 24 hours

Active Comparator group

Description:

Patients will receive contrast media after 24 hours of nasogastric decompression

Treatment:

Other: Effect on contrast media depending on the time of its administratsion