Predictors of 30-day Postoperative Outcome After Elective EVAR

Completed

• Conditions: Postoperative Complications
• Interventions: Other: 30-day postoperative outcome

• Registration Number: NCT05647486
• Lead Sponsor: University of Thessaly

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-03-23
• Primary Completion: 2020-12-01
• Study Completion: 2021-01-13
• Study First Submitted: 2022-11-22
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-07
• Last Update Submitted: 2022-12-07
• Study First Posted: 2022-12-12
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EVAR	30-day postoperative outcome	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.

Primary Outcome Measures

Name	Time	Method
Number of patients with major adverse cardiovascular events	30rd day post-operatively	Number of participants with major adverse cardiovascular events
Number of patients with acute kidney injury	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
Number of patients with post-implantation syndrome	30rd day post-operatively	Number of participants with post-implantation syndrome SIRS, without any apparent sign of infection
Deaths of any cause	30rd day post-operatively	Number of participants who died from any cause

Trial Locations

Locations (1)

University Hospital of Larissa; 🇬🇷 Larissa, Thessaly, Greece