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Recruiting NCT05678023

Study About Contrast Media

No phase Interventional Small Bowel Obstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Effect on contrast media depending on the time of its administratsion.
Who it may be relevant to
Registry conditions: Small Bowel Obstruction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Estonia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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

Primary outcome measures

  • SBO resolution [Time frame: Period of hospitalization- approximately 5 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Estonia · 1 center
  • Tartu University Hospital — Tartu

Identifiers

NCT: NCT05678023 · 22031

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗