Small Bowel ObstructionNCT03461744
Diagnostic Scoring for Small Bowel Obstruction
An observational study of Small Bowel Obstruction, run by Helsinki University Central Hospital at 3 sites in Finland.
Trial summary
It is difficult to predict which patients with acute small bowel obstruction require operative intervention and which ones can be handled conservatively. Similarly, strangulation remains difficult decision. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Small Bowel Obstruction
- How many people
- 482 participants
- Where
- 3 sitesFinland
- Study dates
- 1 Jun 2014to 30 Apr 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 to 120 years
- All sexes
- Adult, Older adult
Study population: All patients presenting to surgical ER with abdominal complain are screened.
Who may be able to join
- Computed tomography verified acute small bowel obstruction
Who cannot join
- < 18 years old
- Pregnant
- Abdominal surgery within 30 days prior recruitment
- Inflammatory bowel disease
- Small bowel tumor causing obstruction
- Peritoneal carcinosis
Show all 9Show fewer
- Intraluminal obstruction (bile stone, bezoar, etc.)
- Large bowel obstruction
- Small bowel obstruction caused by abdominal wall hernia
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Helsinki University Hospital, Jorvi hospital
Espoo
Helsinki University Hospital, Meilahti hospital
Helsinki
Hyvinkää Hospital
Hyvinkää
About this study
It is difficult to predict which patients with acute small bowel obstruction require operative intervention and which ones can be handled conservatively. Similarly, strangulation remains difficult decision. The rationale for this observative study is to collect prospective cohort of patients with small bowel obstruction to create scoring system to predict early 1) small bowel obstruction resistant to conservative therapy, 2) strangulation.
- Conditions
- Small Bowel Obstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
Strangulation
Number of patients with strangulated bowel (reversible or irreversible ischemic bowel)
Measured: Within hospital stay / 30 days from recruitment
Need for surgery due to nonresolving small bowel obstruction
Number of patients needing surgery due to nonresolving small bowel obstruction
Measured: Within hospital stay / 30 days from recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Jun 2014
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
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
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ville Sallinen, Helsinki University Central Hospital
- Investigators
- Ville Sallinen, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461744
- Sponsor's protocol ID
- SBO-DG
- Status last verified
- Jan 2024
- First submitted
- 23 Feb 2018
- Last updated
- 9 Jan 2024
- 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Scoring for Small Bowel Obstruction
- ClinicalTrials.gov ID
- NCT03461744
- Acronym / sponsor ID
- SBO-DG
- Conditions
- Small Bowel Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 12 Mar 2018 (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.
It is difficult to predict which patients with acute small bowel obstruction require operative intervention and which ones can be handled conservatively. Similarly, strangulation remains difficult decision. The rationale for this observative study is to collect prospective cohort of patients with small bowel obstruction to create scoring system to predict early 1) small bowel obstruction resistant to conservative therapy, 2) strangulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients presenting to surgical ER with abdominal complain are screened.
Key inclusion criteria (1 listed)
- Computed tomography verified acute small bowel obstruction
Key exclusion criteria (9 listed)
- < 18 years old
- Pregnant
- Abdominal surgery within 30 days prior recruitment
- Inflammatory bowel disease
- Small bowel tumor causing obstruction
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
Strangulation
Time frame: Within hospital stay / 30 days from recruitment
Number of patients with strangulated bowel (reversible or irreversible ischemic bowel)
Need for surgery due to nonresolving small bowel obstruction
Time frame: Within hospital stay / 30 days from recruitment
Number of patients needing surgery due to nonresolving small bowel obstruction
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 9 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Small Bowel Obstruction
Enrolling by invitationObservational study
Management of Non Emergency Adhesive Small Bowel Obstruction:
SBO - Small Bowel Obstruction
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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.
Ville Sallinen principal investigator
Helsinki University Central Hospital
3 sites 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 Helsinki University Central Hospital at 3 sites in Finland.
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 9 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 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. 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?
Strangulation (time frame: Within hospital stay / 30 days from recruitment). The study lists 2 primary outcomes in all. 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 9 Jan 2024.