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NCT Number: NCT05678023

Study About Contrast Media

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.

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Key information

Conditions

Small Bowel Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Effect on contrast media depending on the time of its administratsion

Other

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

Primary outcomes

  1. SBO resolution

    Time frame: Period of hospitalization- approximately 5 days

    SBO resolution with conservative measures

    • passing gas
    • bowel movement
    • CM in the colon on the X-ray

Study contacts

Contact information is provided by the study sponsor or research team.

Ceith Nikkolo, PhD

CONTACT

[email protected]

Liis Jaanimäe, MD

CONTACT

[email protected]

+3725224012

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Collaborators

  • North Estonia Medical Centre

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2023
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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