Study About Contrast Media

Small Bowel Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05678023
• Other study ID #: 22031
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: November 2023
• Source: University of Tartu
• Contact: Liis Jaanimäe, MD
• Phone: +3725224012
• Email: liis.jaanimae[@]kliinikum.ee
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 2 or after 24 hours of nasogastric- tube decompression.

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 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 1, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Obstruction

Intervention

Other:
• Effect 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

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu	Tartumaa

Sponsors (2)

Lead Sponsor	Collaborator
University of Tartu	North Estonian Medical Center

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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