Adhesive Small Bowel ObstructionNCT03534596
Surgery for Adhesive Small Bowel Obstruction in a Defined Population: a Cohort Study
An observational study of Adhesive Small Bowel Obstruction, run by Uppsala University.
Trial summary
A cohort study of 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 -2011.
Who may be able to join
- > 18 years old
- Surgery for adhesive small bowel obstructions during the time period 2007-2011 in Uppsala County and Gävle County, Sweden
Who cannot join
- None
About this study
A cohort study of 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 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 ICD codes. Preoperative data as age, gender, co-morbidity, previous surgery was registered as well as mechanisms of obstruction and intraoperative data. Short and long-term complications were analyzed. Patients were followed to 31st January 2017 , last medical note or death.
- Conditions
- Adhesive Small Bowel Obstruction
- Keywords
- cohort, surgery, adhesive small bowel obstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgery for SBO
per 100 000 inhabitants and year
Measured: 1st January 2007 - 31st December 2011
Secondary outcomes (3)
Short term surgical complications
anastomotic leaks, intraabdominal abscesses, wound dehiscence, wound infection, urinary tract infection, cardiopulmonary events, use of antibiotics, re-operation, ICU-care, death
Measured: From surgery until <30 days postoperatively
Long term surgical complications
re-admissions for SBO, re-operations for SBO, hernias and mortality
Measured: >30 days postoperatively until death or 31st of January, 2017
Relationships between complications and pre- and intraoperative variables
Measured: From surgery until death or 31st of January, 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adhesive 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
- 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
- NCT03534596
- Sponsor's protocol ID
- ASBO-01
- Status last verified
- May 2018
- First submitted
- 10 May 2018
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sakari T, Christersson M, Karlbom U. Mechanisms of adhesive small bowel obstruction and outcome of surgery; a population-based study. BMC Surg. 2020 Apr 6;20(1):62. doi: 10.1186/s12893-020-00724-9.
PubMed 32252752
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery for Adhesive Small Bowel Obstruction in a Defined Population: a Cohort Study
- ClinicalTrials.gov ID
- NCT03534596
- Acronym / sponsor ID
- ASBO-01
- Conditions
- Adhesive Small Bowel Obstruction
- Keywords
- cohort, surgery, adhesive small bowel obstruction
- 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
- 23 May 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 patients operated for adhesive small bowel obstruction (SBO) during a five-year period
Detailed description
It is a population-based cohort study of 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 ICD codes. Preoperative data as age, gender, co-morbidity, previous surgery was registered as well as mechanisms of obstruction and intraoperative data. Short and long-term complications were analyzed. 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 -2011.
Key inclusion criteria (2 listed)
- > 18 years old
- Surgery for adhesive small bowel obstructions during the time period 2007-2011 in Uppsala County and Gävle County, Sweden
Key exclusion criteria (1 listed)
- None
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
Incidence of surgery for SBO
Time frame: 1st January 2007 - 31st December 2011
per 100 000 inhabitants and year
3 secondary outcomes
Short term surgical complications
Time frame: From surgery until <30 days postoperatively
Long term surgical complications
Time frame: >30 days postoperatively until death or 31st of January, 2017
Relationships between complications and pre- and intraoperative variables
Time frame: From surgery until death or 31st of January, 2017
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 24 May 2018.
- Derived from this study: PubMed 32252752Sakari T, Christersson M, Karlbom U. Mechanisms of adhesive small bowel obstruction and outcome of surgery; a population-based study. BMC Surg. 2020 Apr 6;20(1):62. doi: 10.1186/s12893-020-00724-9.
- Individual participant dataSharing planned: No
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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 24 May 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?
Incidence of surgery for SBO (time frame: 1st January 2007 - 31st December 2011). 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 NCT03534596, 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 24 May 2018.