Study About Contrast Media

Not Applicable

Recruiting

• Conditions: Small Bowel Obstruction
• Interventions: Other: Effect on contrast media depending on the time of its administratsion

• Registration Number: NCT05678023
• Lead Sponsor: University of Tartu

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 Timeline

• Study First Submitted: 2022-12-04
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-10
• Study Start: 2023-09-01
• Status Verified: 2024-12
• Last Update Submitted: 2025-03-25
• Primary Completion: 2025-03-30
• Last Update Posted: 2025-03-30
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contrast media 2 hours	Effect on contrast media depending on the time of its administratsion	Patients will receive contrast media after 2 hours of nasogastric decompression
Contrast media 24 hours	Effect on contrast media depending on the time of its administratsion	Patients will receive contrast media after 24 hours of nasogastric decompression

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Tartumaa, Estonia