Small Bowel Obstruction AdhesionNCT06912581
Small Bowel Obstruction in Virgin Abdomen
An observational study of Small Bowel Obstruction Adhesion, run by University of Tartu at 1 site in Estonia.
Trial summary
A retrospective study conductet at Estonia's two regional hospitals. The data of patients hospitalised for SBO (small bowel obstruction) between 2015-2019 is retrospectively analysed. All other patients are excluded- except for previously unoperated ones (virgin abdomen). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Obstruction Adhesion
- How many people
- 223 participants
- Where
- 1 siteEstonia
- Study dates
- 30 May 2023to 21 Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalised for SBO
Who may be able to join
- Patients diagnosed with SBO Have not been operated previously
Who cannot join
- Age less than 18 years History of previous operatsions Large bowel obstruction Dynamic ileus
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Virgin Abdomen SBO With a 2-year Follow-up
A retrospective study conductet at Estonia's two regional hospitals. The data of patients hospitalised for SBO (small bowel obstruction) between 2015-2019 is retrospectively analysed. All other patients are excluded- except for previously unoperated ones (virgin abdomen). Study group analyses whether patients were operated on or was conservative management initiated. It will be studied, if any further medical studies have been done within 2 years of hospitalisation.
Read the detailed description
Background: The surgical dogma of mandatory operative management of small bowel obstruction (SBO) in patients without prior abdominal operations was re-evaluated by the World Society of Emergency Surgery (WSES) in 2021. A few publications exist on this topic, with a modest number of patients included. The purpose of this study was to analyze the causes and management of small bowel obstruction (SBO) in patients without prior abdominal surgeries.
Methods: Study group retrospectively examined the data of patients hospitalized with SBO from 2015 to 2019. Patients without previous abdominal surgeries-virgin abdomen (VA) were included. Eligible patients' data was evaluated. It was noted whether surgery was performed or conservative management was initiated. In the latter case, information about radiological or endoscopic studies, hospitalizations, or surgeries performed within 2 years after the primary hospitalization was extracted
- Conditions
- Small Bowel Obstruction Adhesion
- Keywords
- virgin abdomen SBO
What is being measured
The primary outcome is the main question the study is designed to answer.
SBO resolution at admission
Patients who have been admitted. The primary outcome measure is SBO resolution within hospitalisation. Usually the conservative treatment is safe and feasible if no alarming symptoms (suggesting bowel ischaemia) are present (but can be prolonged op to 120 hours). Guidelines suggest conservative management up to 72 hours, but no clear guideline is present.
The resolution will be assessed clinically- return of bowel movement and passing of gas or radiologically- CM in the large bowel in the follow-through.
Measured: within hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start30 May 2023
- Primary completion30 Sep 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Bowel Obstruction AdhesionStudies 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
- Retrospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Collaborators
- North Estonia Regional Hospital
- Responsible party
- Principal investigator, Liis Jaanimäe, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912581
- Sponsor's protocol ID
- 377/T-6
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data generated or analyzed during this study are included in this article. Further enquiries can be directed to the corresponding author.
Publications
Jaanimae L, Lepner U, Kirsimagi U, Saarevet V, Nikkolo C. Outcomes of small bowel obstruction management in previously unoperated patients with a mid-term follow-up: a retrospective cohort study. BMC Surg. 2026 Feb 17;26(1):217. doi: 10.1186/s12893-026-03597-6.
PubMed 41703519
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Virgin Abdomen SBO With a 2-year Follow-up
- ClinicalTrials.gov ID
- NCT06912581
- Acronym / sponsor ID
- 377/T-6
- Conditions
- Small Bowel Obstruction Adhesion
- Keywords
- virgin abdomen SBO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Collaborators
- North Estonia Regional Hospital
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 4 Apr 2025 (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.
A retrospective study conductet at Estonia's two regional hospitals. The data of patients hospitalised for SBO (small bowel obstruction) between 2015-2019 is retrospectively analysed. All other patients are excluded- except for previously unoperated ones (virgin abdomen). Study group analyses whether patients were operated on or was conservative management initiated. It will be studied, if any further medical studies have been done within 2 years of hospitalisation.
Detailed description
Background: The surgical dogma of mandatory operative management of small bowel obstruction (SBO) in patients without prior abdominal operations was re-evaluated by the World Society of Emergency Surgery (WSES) in 2021. A few publications exist on this topic, with a modest number of patients included. The purpose of this study was to analyze the causes and management of small bowel obstruction (SBO) in patients without prior abdominal surgeries.
Methods: Study group retrospectively examined the data of patients hospitalized with SBO from 2015 to 2019. Patients without previous abdominal surgeries-virgin abdomen (VA) were included. Eligible patients' data was evaluated. It was noted whether surgery was performed or conservative management was initiated. In the latter case, information about radiological or endoscopic studies, hospitalizations, or surgeries performed within 2 years after the primary hospitalization was extracted
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalised for SBO
Key inclusion criteria (1 listed)
- Patients diagnosed with SBO Have not been operated previously
Key exclusion criteria (2 listed)
- Age less than 18 years History of previous operatsions Large bowel obstruction Dynamic ileus
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SBO resolution at admission
Time frame: within hospitalisation
Patients who have been admitted. The primary outcome measure is SBO resolution within hospitalisation. Usually the conservative treatment is safe and feasible if no alarming symptoms (suggesting bowel ischaemia) are present (but can be prolonged op to 120 hours). Guidelines suggest conservative management up to 72 hours, but no clear guideline is present. The resolution will be assessed clinically- return of bowel movement and passing of gas or radiologically- CM in the large bowel in the follow-through.
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 4 Apr 2025.
- Derived from this study: PubMed 41703519Jaanimae L, Lepner U, Kirsimagi U, Saarevet V, Nikkolo C. Outcomes of small bowel obstruction management in previously unoperated patients with a mid-term follow-up: a retrospective cohort study. BMC Surg. 2026 Feb 17;26(1):217. doi: 10.1186/s12893-026-03597-6.
- Individual participant dataSharing planned: Yes. All data generated or analyzed during this study are included in this article. Further enquiries can be directed to the corresponding author.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Adhesion, 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 2 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 4 Apr 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?
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?
SBO resolution at admission (time frame: within hospitalisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06912581, which also lists 1 linked publication.
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 4 Apr 2025.