Adhesive Small Bowel ObstructionNCT03602352
A Study of the Cost for Patients Operated for Adhesive Obstruction (SBO) During a Five-year Period
An observational study of Adhesive Small Bowel Obstruction, run by Uppsala University.
Trial summary
A cohort study of the cost for patients operated for adhesive small bowel obstruction (SBO) during a five-year period Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Small Bowel Obstruction
- How many people
- 402 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Jan 2017
- 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 undergoing surgery due to adhesive small bowel obstructions during the time period 2007-2012.
Who may be able to join
- Above18 years of age
- Surgery for adhesive surgical bowel obstruction (SBO)
Who cannot join
- Surgery for SBO of other etiology than adhesions
About this study
Official title: A Cohort Study of the Cost for Patients Operated for Adhesive Obstruction (SBO) During a Five-year Period
A cohort study of the cost for patients operated for adhesive small bowel obstruction (SBO) during a five-year period
Read the detailed description
It is a population-based cohort study of the costs for patients operated for adhesive small bowel obstruction during a five-year period (2007-2012) in two Swedish neighboring regions. Patients were identified by a broad search of operation and International Classification of Diseases (ICD) codes. Data regarding surgery and complications has been analyzed in a previous study (Clinical trials no NCT0353459)
The costs for hospital stay, radiology, Intensive Care Unit (ICU)-care, operation for the index SBO care event were calculated. The cost for revisit, sick leave and recurrent SBO during follow-up were calculated. Patients were followed to 31st January 2017, last medical note or death.
- Conditions
- Adhesive Small Bowel Obstruction
- Keywords
- Cohort, Surgery, Adhesive Small Bowel Obstruction, Cost
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost for primary hospital admission in patients who underwent SBO surgery during 2007-2012
Per 100 000 inhabitants and year
Measured: 2007-2012
Secondary outcomes (2)
Cost for further hospital admissions, surgery and outpatient visits during follow-up
Measured: 2007-2012
Potential cost-reduction with prophylactic treatment calculating with different prophylactic efficacy levels
Measured: 2007-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jan 2015
- Primary completion1 Jan 2015
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Small Bowel ObstructionStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urban Karlbom, MD PhD, Study chair, Region Uppsala Public Health and Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602352
- Sponsor's protocol ID
- ASBO-02
- Status last verified
- Aug 2018
- First submitted
- 17 Jul 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of the Cost for Patients Operated for Adhesive Obstruction (SBO) During a Five-year Period
- ClinicalTrials.gov ID
- NCT03602352
- Acronym / sponsor ID
- ASBO-02
- Conditions
- Adhesive Small Bowel Obstruction
- Keywords
- Cohort, Surgery, Adhesive Small Bowel Obstruction, Cost
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 26 Jul 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.
A cohort study of the cost for patients operated for adhesive small bowel obstruction (SBO) during a five-year period
Detailed description
It is a population-based cohort study of the costs for patients operated for adhesive small bowel obstruction during a five-year period (2007-2012) in two Swedish neighboring regions. Patients were identified by a broad search of operation and International Classification of Diseases (ICD) codes. Data regarding surgery and complications has been analyzed in a previous study (Clinical trials no NCT0353459)
The costs for hospital stay, radiology, Intensive Care Unit (ICU)-care, operation for the index SBO care event were calculated. The cost for revisit, sick leave and recurrent SBO during follow-up were calculated. Patients were followed to 31st January 2017, last medical note or death.
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 undergoing surgery due to adhesive small bowel obstructions during the time period 2007-2012.
Key inclusion criteria (2 listed)
- Above18 years of age
- Surgery for adhesive surgical bowel obstruction (SBO)
Key exclusion criteria (1 listed)
- Surgery for SBO of other etiology than adhesions
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
Cost for primary hospital admission in patients who underwent SBO surgery during 2007-2012
Time frame: 2007-2012
Per 100 000 inhabitants and year
2 secondary outcomes
Cost for further hospital admissions, surgery and outpatient visits during follow-up
Time frame: 2007-2012
Potential cost-reduction with prophylactic treatment calculating with different prophylactic efficacy levels
Time frame: 2007-2012
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 15 Aug 2018.
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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.
Urban Karlbom, MD PhD study chair
Region Uppsala Public Health and Care
Questions about this trial
What is this clinical trial studying?
An observational study of Adhesive Small Bowel Obstruction, run by Uppsala University.
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 2 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 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Cost for primary hospital admission in patients who underwent SBO surgery during 2007-2012 (time frame: 2007-2012). 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 15 Aug 2018.