Study About Contrast Media

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

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.

Study Overview

• Status: Recruiting
• Conditions: Small Bowel Obstruction
• Intervention / Treatment: Other: Effect on contrast media depending on the time of its administratsion

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liis Jaanimäe, MD; Phone Number: +3725224012; Email: liis.jaanimae@kliinikum.ee
• Study Contact Backup: Name: Ceith Nikkolo, PhD; Email: ceith.nikkolo@kliinikum.ee

Study Locations

• Estonia
  • Tartumaa
    • Tartu, Tartumaa, Estonia, 50406
      • Recruiting
      • Tartu University Hospital
      • Contact: Liis Jaanimäe, MD; Phone Number: +3725224012; Email: liis.jaanimae@kliinikum.ee
      • Contact: Ceith Nikkolo; Email: ceith.nikkolo@kliinikum.ee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Contrast media 24 hours; Patients will receive contrast media after 24 hours of nasogastric decompression	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
Active Comparator: Contrast media 4 hours; Patients will receive contrast media after 4 hours of nasogastric decompression	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Tartu
• Collaborators: North Estonia Medical Centre
• Investigators: Principal Investigator: Liis Jaanimäe, University of Tartu

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: December 4, 2022
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: 22031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No