Small Bowel ObstructionSBONCT05662384
Small Bowel Obstruction. A Prospective Multicener Study
An observational study of Small Bowel Obstruction, run by University of Tartu at 1 site in Estonia.
Trial summary
To get an overview of patients hospitalized with mechanical small bowel obstruction and the evaluate the use of contrast media as part of conservative management. To analyze how many patients were operated on and in how many cases conservative measures helped. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Obstruction
- How many people
- 214 participants
- Where
- 1 siteEstonia
- Study dates
- 1 May 2021to 15 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patients hospitalized with mechanical small bowel obstruction
Who may be able to join
- aged 18 years or older with mechanical small bowel obstruction who signed an informed consent form
Who cannot join
- Patients younger than 18 years, patients with large bowel obstruction or dynamic small bowel obstruction and/or patients who had undergone abdominal/pelvic surgery within 4 weeks of admission were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Prospective Study on Small Bowel Obstruction
To get an overview of patients hospitalized with mechanical small bowel obstruction and the evaluate the use of contrast media as part of conservative management. To analyze how many patients were operated on and in how many cases conservative measures helped.
Read the detailed description
This is a multicenter prospective study conducted at two regional hospitals of Estonia: Tartu University Hospital and North Estonian Medical Center. The data of the patients' hospitalized for SBO between May 2021 and April 2022 were collectedafter patients gave their informed consent to be enrolled in the study.
Eligible patients were adults aged 18 years or older with mechanical small bowel obstruction. Patients younger than 18 years, patients with large bowel obstruction or dynamic small bowel obstruction and/or patients who had undergone abdominal/pelvic surgery within 4 weeks of admission were excluded from the study.
Characteristics of abdominal pain (absent/intermittent/permanent), presence of nausea/vomiting, absence of flatus, results of blood tests (white blood cell count (WBC), C-reactive protein (CRP), lactate level (Lac), estimated glomerular filtration rate (eGFR)), radiology imaging techniques used, previous abdominal/pelvic surgeries, previous episodes of bowel obstruction. It was documented whether immediate surgical treatment was implemented, or whether conservative management was initiated. In the case of conservative treatment, it was recorded whether contrast media (CM) was or was not used. In the case of surgical treatment, the type of surgery (adhesiolysis/ bowel resection/ other) was recorded.
- Conditions
- Small Bowel Obstruction
- Being tested
- No intervention is planned
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is plannedOther
Observational study, no intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized with small bowel obstruction | Patients hospitalized with a certain diagnosis during a certain period of time Receives: Other: No intervention is planned |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution on SBO
Resolution of small bowel obstruction (passing gas/flatus, contrast media in the colon on the X-ray )
Measured: Hospitalization period (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 posted22 Dec 2022
- Study start1 May 2021
- Primary completion30 Apr 2022
- Study completion15 Oct 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Collaborators
- North Estonian Medical Center
- Responsible party
- Principal investigator, Liis Jaanimäe, University of Tartu
- Investigators
- Liis Jaanimäe, Principal investigator, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662384
- Sponsor's protocol ID
- 21010
- Acronym
- SBO
- Status last verified
- Nov 2023
- First submitted
- 4 Dec 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Patients identification numbers will be pseudonymed- the key is in a secure server and will only be accessed through smart-ID identification
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Study on Small Bowel Obstruction
- ClinicalTrials.gov ID
- NCT05662384
- Acronym / sponsor ID
- SBO / 21010
- Conditions
- Small Bowel Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Collaborators
- North Estonian Medical Center
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 22 Dec 2022 (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.
To get an overview of patients hospitalized with mechanical small bowel obstruction and the evaluate the use of contrast media as part of conservative management. To analyze how many patients were operated on and in how many cases conservative measures helped.
Detailed description
This is a multicenter prospective study conducted at two regional hospitals of Estonia: Tartu University Hospital and North Estonian Medical Center. The data of the patients' hospitalized for SBO between May 2021 and April 2022 were collectedafter patients gave their informed consent to be enrolled in the study.
Eligible patients were adults aged 18 years or older with mechanical small bowel obstruction. Patients younger than 18 years, patients with large bowel obstruction or dynamic small bowel obstruction and/or patients who had undergone abdominal/pelvic surgery within 4 weeks of admission were excluded from the study.
Characteristics of abdominal pain (absent/intermittent/permanent), presence of nausea/vomiting, absence of flatus, results of blood tests (white blood cell count (WBC), C-reactive protein (CRP), lactate level (Lac), estimated glomerular filtration rate (eGFR)), radiology imaging techniques used, previous abdominal/pelvic surgeries, previous episodes of bowel obstruction. It was documented whether immediate surgical treatment was implemented, or whether conservative management was initiated. In the case of conservative treatment, it was recorded whether contrast media (CM) was or was not used. In the case of surgical treatment, the type of surgery (adhesiolysis/ bowel resection/ other) was recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized with small bowel obstruction | – | Other: No intervention is plannedPatients hospitalized with a certain diagnosis during a certain period of time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized with mechanical small bowel obstruction
Key inclusion criteria (1 listed)
- aged 18 years or older with mechanical small bowel obstruction who signed an informed consent form
Key exclusion criteria (1 listed)
- Patients younger than 18 years, patients with large bowel obstruction or dynamic small bowel obstruction and/or patients who had undergone abdominal/pelvic surgery within 4 weeks of admission were excluded from the study
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 |
|---|---|---|
| No intervention is plannedObservational study, no intervention | Other | Patients hospitalized with small bowel obstruction |
Primary outcome
Resolution on SBO
Time frame: Hospitalization period (approximately 5 days)
Resolution of small bowel obstruction (passing gas/flatus, contrast media in the colon on the X-ray )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Undecided. Patients identification numbers will be pseudonymed- the key is in a secure server and will only be accessed through smart-ID identification
Related trials for Small Bowel Obstruction
Enrolling by invitationObservational study
Management of Non Emergency Adhesive Small Bowel Obstruction:
SBO - Small Bowel Obstruction
RecruitingObservational study
Indiana University Gastrointestinal Motility Diagnosis Registry
Eosinophilic Esophagitis, Gastroesophageal Reflux Disease (GERD)
Recruiting
The Effect of Nasogastric Tube Placement on Complications in Patients With Small Bowel Obstruction - the SBO-TUBE Trial
Small Bowel Obstruction, Intestinal Obstruction and Ileus
Recruiting
GT Metabolic Magnet System in Adults With Gastrointestinal Disorders
Gastric Outlet Obstruction, Small Bowel Obstruction
Enrolling by invitationPhase 4
A Study of Intravenous Acetaminophen for Small Bowel Obstruction
Small Bowel Obstruction
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. This study is not recruiting at the moment.
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?
An observational study of 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution on SBO (time frame: Hospitalization period (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 6 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.