NCT04085003

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,266

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

5 months

First QC Date

September 8, 2019

Last Update Submit

September 8, 2019

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

  • 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

  • Operative mortality

    Number of deaths after repair divided by the number or repairs per year

    longitudinal analysis from 2000 to 2015

Secondary Outcomes (1)

  • Rate of mortality after repair

    longitudinal analysis from 2000 to 2015

Study Arms (2)

Intact abdominal aortic aneurysm

Procedure: Endovascular repair or Open surgery

Ruptured abdominal aortic aneurysm

Procedure: Endovascular repair or Open surgery

Interventions

Endovascular repair or Open surgeryPROCEDURE

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

Intact abdominal aortic aneurysmRuptured abdominal aortic aneurysm

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patients without abdominal aortic aneurysm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2019

First Posted

September 11, 2019

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

July 1, 2018

Last Updated

September 11, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share