Small Bowel ObstructionNCT05678023
Study About Contrast Media
A study testing Effect on contrast media depending on the time of its administratsion in people with Small Bowel Obstruction, run by University of Tartu at 1 site in Estonia.
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 4 or after 24 hours of nasogastric- tube decompression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Obstruction
- What is being tested?
- Effect on contrast media depending on the time of its administratsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEstonia
- Study dates
- 1 Sep 2023to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ceith Nikkolo, PhD contact
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital
Tartu, Tartu, 50406
Liis Jaanimäe, MD, +3725224012, liis.jaanimae@kliinikum.ee
Ceith Nikkolo, ceith.nikkolo@kliinikum.ee
About this study
Official title: 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.
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
- Conditions
- Small Bowel Obstruction
- Being tested
- Effect on contrast media depending on the time of its administratsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect on contrast media depending on the time of its administratsionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Contrast media 4 hours | Active comparator | Patients will receive contrast media after 4 hours of nasogastric decompression Receives: Other: Effect on contrast media depending on the time of its administratsion |
| Contrast media 24 hours | Active comparator | Patients will receive contrast media after 24 hours of nasogastric decompression Receives: Other: Effect on contrast media depending on the time of its administratsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
SBO resolution
SBO resolution with conservative measures
- passing gas
- bowel movement
- CM in the colon on the X-ray
Measured: Period of hospitalization- approximately 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Sep 2023
- Primary completion30 Mar 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Collaborators
- North Estonia Medical Centre
- Responsible party
- Principal investigator, Liis Jaanimäe, University of Tartu
- Investigators
- Liis Jaanimäe, Principal investigator, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678023
- Sponsor's protocol ID
- 22031
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Randomized Trial on the Timing and Effect of Contrast Media on Patients with Adhesive Small Bowel Obstruction
- ClinicalTrials.gov ID
- NCT05678023
- Acronym / sponsor ID
- 22031
- Conditions
- Small Bowel Obstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Collaborators
- North Estonia Medical Centre
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contrast media 4 hours | Active comparator | Other: Effect on contrast media depending on the time of its administratsionPatients will receive contrast media after 4 hours of nasogastric decompression |
| Contrast media 24 hours | Active comparator | Other: Effect on contrast media depending on the time of its administratsionPatients will receive contrast media after 24 hours of nasogastric decompression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effect on contrast media depending on the time of its administratsionCM 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 | Other | Contrast media 24 hours, Contrast media 4 hours |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ceith Nikkolo, PhD contact
Liis Jaanimäe principal investigator
University of Tartu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect on contrast media depending on the time of its administratsion in people with Small Bowel Obstruction, run by University of Tartu at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liis Jaanimäe, MD (+3725224012, liis.jaanimae@kliinikum.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SBO resolution (time frame: Period of hospitalization- approximately 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.