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RecruitingNCT05678023Updated Mar 30, 2025

Study About Contrast Media

An interventional study of Effect on contrast media depending on the time of its administratsion in Small Bowel Obstruction, sponsored by University of Tartu. Recruiting at 1 site in Estonia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by University of Tartu · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Small Bowel Obstruction
03

In context

Lead sponsor

University of Tartu is the lead sponsor of 46 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherEffect 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

06

What researchers measure

Primary outcomes

  1. SBO resolution

    SBO resolution with conservative measures * passing gas * bowel movement * CM in the colon on the X-ray

    Time frame: Period of hospitalization- approximately 5 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05678023
Lead sponsor
University of Tartu
Collaborators
North Estonia Medical Centre
Responsible party
Liis Jaanimäe (General Surgeon, PhD student, University of Tartu) — Principal investigator
First posted
Jan 10, 2023
Start date
Sep 1, 2023
Primary completion
Mar 30, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
Mar 30, 2025

Study contacts

Liis Jaanimäe, MD
Contact
liis.jaanimae@kliinikum.ee
+3725224012
Ceith Nikkolo, PhD
Contact
ceith.nikkolo@kliinikum.ee
Liis Jaanimäe
principal investigator · University of Tartu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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