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Completed

NCT Number: NCT05647486

Predictors of 30-day Postoperative Outcome After Elective EVAR

This study investigated the 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics

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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Larissa

Larissa, Thessaly, 41110, Greece

About this study

The study included 322 consecutive AAA patients treated electively with EVAR from March 2016 to February 2019 at a tertiary referral center.

Early follow-up with clinical and laboratory evaluation took place at the 30rd day post-operatively. Any adverse event, such as major adverse cardiovascular events (MACE), post-implantation syndrome (PIS), acute kidney injury (AKI), and deaths of any cause were recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Only patients managed with EVAR using standard bifurcated devices in elective setting were included.

Exclusion criteria

  • Patients treated for ruptured, symptomatic, inflammatory or infectious AAA were excluded. Furthermore, any patient needing complex endovascular repair of the proximal landing zone was considered ineligible. Additional exclusion criteria were the presence of any trauma or surgery within two months before EVAR, any autoimmune or systemic inflammatory disease and any malignancy. Of note, any patient with clinical or laboratory signs of infection before the scheduled operation was not offered an EVAR until a complete resolution of the infection was confirmed via a clinical, laboratory and/or imaging evaluation.

Treatment and study plan

30-day postoperative outcome

Other

The 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics were assessed

Primary outcomes

  1. Number of patients with major adverse cardiovascular events

    Time frame: 30rd day post-operatively

    Number of participants with major adverse cardiovascular events

  2. Number of patients with acute kidney injury

    Time frame: 30rd day post-operatively

    Number of participants with acute kidney injury according to the RIFLE (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease) criteria

  3. Number of patients with post-implantation syndrome

    Time frame: 30rd day post-operatively

    Number of participants with post-implantation syndrome SIRS, without any apparent sign of infection

  4. Deaths of any cause

    Time frame: 30rd day post-operatively

    Number of participants who died from any cause

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

Predictors of 30-day Postoperative Outcome After Elective Endovascular Abdominal Aortic Aneurysm Repair

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Dec 12, 2022
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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