Intact Abdominal Aortic Aneurysm Repair in Portugal

Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085003
• Other study ID #: NationwideAAAanalysis
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: September 2019
• Source: Hospital Sao Joao
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6266
• Est. completion date: July 1, 2018
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients without abdominal aortic aneurysm

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Procedure:
• Endovascular repair or Open surgery
The outcomes of different types of repair will be obtained for intact and ruptured abdominal aortic aneurysm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Joao

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of repair	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
Primary	Operative mortality	Number of deaths after repair divided by the number or repairs per year	longitudinal analysis from 2000 to 2015
Secondary	Rate of mortality after repair	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