Intact Abdominal Aortic Aneurysm Repair in Portugal

September 8, 2019 updated by: Marina Felicidade Dias Neto, Hospital Sao Joao

Nationwide Analysis of Intact Abdominal Aortic Aneurysm Repair in Portugal From 2000-2015

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

6266

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

September 8, 2019

First Submitted That Met QC Criteria

September 8, 2019

First Posted (Actual)

September 11, 2019

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 8, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • NationwideAAAanalysis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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