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CompletedNCT05647486Updated Dec 12, 2022

Predictors of 30-day Postoperative Outcome After Elective EVAR

An observational study in Postoperative Complications, sponsored by University of Thessaly. Completed at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-12.

Sponsored by University of Thessaly · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
322
Ages
18 Years and older
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Postoperative Complications
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In context

Postoperative Complications

1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.

This study's enrollment of 322 is above the median of 254 across 519 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

University of Thessaly is the lead sponsor of 188 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study included consecutive AAA patients treated electively by EVAR

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
322 participants (actual)
Patient registry
No

Groups and cohorts

  • EVAR

    Patients with AAA, treated electively by EVAR. The 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics were assessed.

    Other: 30-day postoperative outcome

Interventions

  • Other30-day postoperative outcome

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

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What researchers measure

Primary outcomes

  1. Number of patients with major adverse cardiovascular events

    Number of participants with major adverse cardiovascular events

    Time frame: 30rd day post-operatively

  2. Number of patients with acute kidney injury

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

    Time frame: 30rd day post-operatively

  3. Number of patients with post-implantation syndrome

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

    Time frame: 30rd day post-operatively

  4. Deaths of any cause

    Number of participants who died from any cause

    Time frame: 30rd day post-operatively

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Study locations

1 site
  • University Hospital of Larissa
    Larissa, Thessaly 41110, Greece
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05647486
Lead sponsor
University of Thessaly
Responsible party
Elena Arnaoutoglou (Professor of Anesthesiology, University of Thessaly) — Principal investigator
First posted
Dec 12, 2022
Start date
Mar 23, 2016
Primary completion
Dec 1, 2020
Completion
Jan 13, 2021
Last update
Dec 12, 2022

Study contacts

Eleni Arnaoutoglou, Professor
study chair · University of Thessaly

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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