- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04085003
Intact Abdominal Aortic Aneurysm Repair in Portugal
Nationwide Analysis of Intact Abdominal Aortic Aneurysm Repair in Portugal From 2000-2015
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All AAA interventions performed during the period 2000 to 2015 were retrospectively identified in a National Health Service (NHS) administrative database, the hospital morbidity database, formerly designated as Diagnosis-Related Groups (DRGs) database. This database was provided by the Portuguese Central Health System Administration (ACSS) and contains a registration of all hospitalizations (retrospective consecutive case entry) occurring in public hospitals in mainland Portugal.
Each episode includes information about diagnoses (primary and secondary diagnoses) and medical or surgical procedures, both coded using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9).
All admissions considered have a primary diagnosis ICD-9 codes for ruptured and non-ruptured AAA. The primary diagnosis of an episode represents the main condition investigated or treated during that hospital stay.
The rate of the repair was calculated based on the episodes of care with the above-mentioned disease ICD-9 codes plus the ICD-9 procedure codes suitable for AAA repair. Admissions with a primary diagnose of AAA that lacked a ICD-9 procedure code suitable for AAA repair were excluded, assuming that no repair was performed during that hospital stay. General indication for iAAA repair in Portugal are a maximum transverse diameter ≥5.5cm in men and ≥5.0 cm in women, as recommended by guidelines.
The number of deaths accounted for all patients that fail to be discharged alive from the hospital admission where the repair took place, irrespective to the direct cause of death. The number of admissions for repair in which the patient died divided by the number of all admissions for repair was used as a proxy of in-hospital mortality due to iAAA. The number of resident population in each year under analysis was provided by the National Institute of Statistics (INE) from 2000 to 2015. Resident population per year was used to calculate the rate of AAA repair and the death associated with AAA repair (thereafter mentioned as mortality to distinguish from the above-mentioned in-hospital mortality).
Death certificate with AAA-specific mortality was provided from the National Institute of Statistics (INE) from 2000 to 2015. INE data includes deaths outside the hospital besides those certificated at the hospitals.
In both databases, patients <50 years of age were excluded.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
All patients hospitalized in Portuguese public hospitals due to abdominal aortic aneurysm from 2000-2015.
All patients that died in Portugal due to abdominal aortic aneurysm from 2000 to 2015.
Description
Inclusion Criteria:
- Patients submitted to abdominal aortic aneurysm repair in Portugal from 2000-20015
Exclusion Criteria:
- Patients without abdominal aortic aneurysm
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intact abdominal aortic aneurysm
|
The outcomes of different types of repair will be obtained for intact and ruptured abdominal aortic aneurysm
|
Ruptured abdominal aortic aneurysm
|
The outcomes of different types of repair will be obtained for intact and ruptured abdominal aortic aneurysm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of repair
Time Frame: longitudinal analysis from 2000 to 2015
|
Number of repairs of abdominal aortic aneurysm in patients with more than 49 years old divided by the number of inhabitants above 49 years-old per year
|
longitudinal analysis from 2000 to 2015
|
Operative mortality
Time Frame: longitudinal analysis from 2000 to 2015
|
Number of deaths after repair divided by the number or repairs per year
|
longitudinal analysis from 2000 to 2015
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of mortality after repair
Time Frame: longitudinal analysis from 2000 to 2015
|
Number of deaths after repair of abdominal aortic aneurysm in patients with more than 49 years old divided by the number of inhabitants above 49 years-old per year
|
longitudinal analysis from 2000 to 2015
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NationwideAAAanalysis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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