Intact Abdominal Aortic Aneurysm Repair in Portugal

NCT ID: NCT04085003

Last Updated: 2019-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6266 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-07-01

Brief Summary

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Abdominal aortic aneurysm (AAA) repairs registered in the hospitals administrative database of the National Health Service from 2000 to 2015 were retrospectively analyzed regarding demographics (age and gender) and type of repair (open surgery \[OS\] or endovascular repair \[EVAR\]). Rate and mortality were compared among three time periods: 2000-2004, 2005-2009 and 2010-2015.

Detailed Description

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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.

Conditions

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Abdominal Aortic Aneurysm

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Intact abdominal aortic aneurysm

Endovascular repair or Open surgery

Intervention Type PROCEDURE

The outcomes of different types of repair will be obtained for intact and ruptured abdominal aortic aneurysm

Ruptured abdominal aortic aneurysm

Endovascular repair or Open surgery

Intervention Type PROCEDURE

The outcomes of different types of repair will be obtained for intact and ruptured abdominal aortic aneurysm

Interventions

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Endovascular repair or Open surgery

The outcomes of different types of repair will be obtained for intact and ruptured abdominal aortic aneurysm

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients submitted to abdominal aortic aneurysm repair in Portugal from 2000-20015

Exclusion Criteria

* Patients without abdominal aortic aneurysm
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Sao Joao

OTHER

Sponsor Role lead

Responsible Party

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Marina Felicidade Dias Neto

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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NationwideAAAanalysis

Identifier Type: -

Identifier Source: org_study_id

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