Acute Intestinal IschemiaNCT04361110
Radiological Findings in Primary Intestinal Ischaemia
An observational study of Acute Intestinal Ischemia, run by Aalborg University Hospital.
Trial summary
To investigate which findings on a non-specific CT scan that predict acute primary intestinal ischaemia. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Acute Intestinal Ischemia
- What is being tested?
- Computerized tomography scan of the abdomen
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 31 Dec 2009
- 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 Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All operated patients at Department of Gastrointestinal surgery, Aalborg University Hospital, Denmark.
Who may be able to join
- Primary acute intestinal ischaemia in an abdominal operation.
- CT-scan within 48 hours preoperative.
Who cannot join
- Secondary intestinal ischaemia
- Intestinal ischaemia isolated intestinal mucosa.
- No CT-scan within 48 hours preoperative
About this study
Official title: Preoperative Findings on Non-specific CT in Patients With Primary Acute Intestinal Ischaemia; a Case-control Study
To investigate which findings on a non-specific CT scan that predict acute primary intestinal ischaemia.
Read the detailed description
48 patients with primary intestinal ischemia admitted in 4 consecutive years (2006-2009) in Department of Gastrointestinal Surgery, Aalborg University Hospital. Control group consists of 82 patients operated in the same department and in the same time range.
Abdominal CT scans are described with respect to intestinal diameter, changes in intestinal wall, extra intestinal changes and vessel pathology.
- Conditions
- Acute Intestinal Ischemia
- Being tested
- Computerized tomography scan of the abdomen
- Keywords
- Diagnoses Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized tomography scan of the abdomenRadiation
Non-specific abdominal ct´s with different phases and contrast +/-.
| Study group | Role | What they receive |
|---|---|---|
| Acute intestinal ischaemia | Abdominal CT scan within 48 hours preoperative. Receives: Radiation: Computerized tomography scan of the abdomen | |
| Controls | Abdominal CT scan within 48 hours preoperative. Receives: Radiation: Computerized tomography scan of the abdomen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal wall pathology
Incidense of CT findings in the radiological main group called "Intestinal wall pathology"
Measured: 48 hours
Gastrointestinal vessel pathology
Incidense of CT findings in the radiological main group called "Gastrointestinal vessel pathologypathology"
Measured: 48 hours
Intestinal diameter
Incidense of CT findings in the radiological main group called "Intestinal diameter"
Measured: 48 hours
Extraintestinal pathology
Incidense of CT findings in the radiological main group called "Extraintestinal pathology"
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Jan 2006
- Primary completion31 Dec 2009
- Study completion31 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Intestinal IschemiaStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Straarup, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361110
- Sponsor's protocol ID
- Acute intestinal ischaemia
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Individual data sharing
- No
Publications
Menke J. Diagnostic accuracy of multidetector CT in acute mesenteric ischemia: systematic review and meta-analysis. Radiology. 2010 Jul;256(1):93-101. doi: 10.1148/radiol.10091938.
PubMed 20574087Karkkainen JM, Acosta S. Acute mesenteric ischemia (part I) - Incidence, etiologies, and how to improve early diagnosis. Best Pract Res Clin Gastroenterol. 2017 Feb;31(1):15-25. doi: 10.1016/j.bpg.2016.10.018. Epub 2017 Jan 4.
PubMed 28395784Tilsed JV, Casamassima A, Kurihara H, Mariani D, Martinez I, Pereira J, Ponchietti L, Shamiyeh A, Al-Ayoubi F, Barco LA, Ceolin M, D'Almeida AJ, Hilario S, Olavarria AL, Ozmen MM, Pinheiro LF, Poeze M, Triantos G, Fuentes FT, Sierra SU, Soreide K, Yanar H. ESTES guidelines: acute mesenteric ischaemia. Eur J Trauma Emerg Surg. 2016 Apr;42(2):253-70. doi: 10.1007/s00068-016-0634-0.
PubMed 26820988Cudnik MT, Darbha S, Jones J, Macedo J, Stockton SW, Hiestand BC. The diagnosis of acute mesenteric ischemia: A systematic review and meta-analysis. Acad Emerg Med. 2013 Nov;20(11):1087-100. doi: 10.1111/acem.12254.
PubMed 24238311Aschoff AJ, Stuber G, Becker BW, Hoffmann MH, Schmitz BL, Schelzig H, Jaeckle T. Evaluation of acute mesenteric ischemia: accuracy of biphasic mesenteric multi-detector CT angiography. Abdom Imaging. 2009 May-Jun;34(3):345-57. doi: 10.1007/s00261-008-9392-8.
PubMed 18425546Straarup D, Gotschalck KA, Mikalone R, Thorlacius-Ussing O. Preoperative findings on non-specific CT in patients with primary acute intestinal ischemia: a case-control study. Eur J Trauma Emerg Surg. 2022 Aug;48(4):3025-3032. doi: 10.1007/s00068-021-01741-w. Epub 2021 Jul 3.
PubMed 34216221
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Findings on Non-specific CT in Patients With Primary Acute Intestinal Ischaemia; a Case-control Study
- ClinicalTrials.gov ID
- NCT04361110
- Acronym / sponsor ID
- Acute intestinal ischaemia
- Conditions
- Acute Intestinal Ischemia
- Keywords
- Diagnoses Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2009 (actual)
- Study completion
- 31 Dec 2009 (actual)
- First posted
- 24 Apr 2020 (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 investigate which findings on a non-specific CT scan that predict acute primary intestinal ischaemia.
Detailed description
48 patients with primary intestinal ischemia admitted in 4 consecutive years (2006-2009) in Department of Gastrointestinal Surgery, Aalborg University Hospital. Control group consists of 82 patients operated in the same department and in the same time range.
Abdominal CT scans are described with respect to intestinal diameter, changes in intestinal wall, extra intestinal changes and vessel pathology.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute intestinal ischaemia | – | Radiation: Computerized tomography scan of the abdomenAbdominal CT scan within 48 hours preoperative. |
| Controls | – | Radiation: Computerized tomography scan of the abdomenAbdominal CT scan within 48 hours preoperative. |
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All operated patients at Department of Gastrointestinal surgery, Aalborg University Hospital, Denmark.
Key inclusion criteria (2 listed)
- Primary acute intestinal ischaemia in an abdominal operation.
- CT-scan within 48 hours preoperative.
Key exclusion criteria (3 listed)
- Secondary intestinal ischaemia
- Intestinal ischaemia isolated intestinal mucosa.
- No CT-scan within 48 hours preoperative
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 |
|---|---|---|
| Computerized tomography scan of the abdomenNon-specific abdominal ct´s with different phases and contrast +/-. | Radiation | Acute intestinal ischaemia, Controls |
Primary outcome
Intestinal wall pathology
Time frame: 48 hours
Incidense of CT findings in the radiological main group called "Intestinal wall pathology"
Gastrointestinal vessel pathology
Time frame: 48 hours
Incidense of CT findings in the radiological main group called "Gastrointestinal vessel pathologypathology"
Intestinal diameter
Time frame: 48 hours
Incidense of CT findings in the radiological main group called "Intestinal diameter"
Extraintestinal pathology
Time frame: 48 hours
Incidense of CT findings in the radiological main group called "Extraintestinal pathology"
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 28 Apr 2020.
- Background: PubMed 20574087Menke J. Diagnostic accuracy of multidetector CT in acute mesenteric ischemia: systematic review and meta-analysis. Radiology. 2010 Jul;256(1):93-101. doi: 10.1148/radiol.10091938.
- Background: PubMed 28395784Karkkainen JM, Acosta S. Acute mesenteric ischemia (part I) - Incidence, etiologies, and how to improve early diagnosis. Best Pract Res Clin Gastroenterol. 2017 Feb;31(1):15-25. doi: 10.1016/j.bpg.2016.10.018. Epub 2017 Jan 4.
- Background: PubMed 26820988Tilsed JV, Casamassima A, Kurihara H, Mariani D, Martinez I, Pereira J, Ponchietti L, Shamiyeh A, Al-Ayoubi F, Barco LA, Ceolin M, D'Almeida AJ, Hilario S, Olavarria AL, Ozmen MM, Pinheiro LF, Poeze M, Triantos G, Fuentes FT, Sierra SU, Soreide K, Yanar H. ESTES guidelines: acute mesenteric ischaemia. Eur J Trauma Emerg Surg. 2016 Apr;42(2):253-70. doi: 10.1007/s00068-016-0634-0.
- Background: PubMed 24238311Cudnik MT, Darbha S, Jones J, Macedo J, Stockton SW, Hiestand BC. The diagnosis of acute mesenteric ischemia: A systematic review and meta-analysis. Acad Emerg Med. 2013 Nov;20(11):1087-100. doi: 10.1111/acem.12254.
- Background: PubMed 18425546Aschoff AJ, Stuber G, Becker BW, Hoffmann MH, Schmitz BL, Schelzig H, Jaeckle T. Evaluation of acute mesenteric ischemia: accuracy of biphasic mesenteric multi-detector CT angiography. Abdom Imaging. 2009 May-Jun;34(3):345-57. doi: 10.1007/s00261-008-9392-8.
- Derived from this study: PubMed 34216221Straarup D, Gotschalck KA, Mikalone R, Thorlacius-Ussing O. Preoperative findings on non-specific CT in patients with primary acute intestinal ischemia: a case-control study. Eur J Trauma Emerg Surg. 2022 Aug;48(4):3025-3032. doi: 10.1007/s00068-021-01741-w. Epub 2021 Jul 3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Intestinal Ischemia, run by Aalborg University Hospital.
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 3 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 28 Apr 2020. 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?
Intestinal wall pathology (time frame: 48 hours). The study lists 4 primary outcomes in all. 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 NCT04361110, which also lists 6 linked publications.
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 28 Apr 2020.