Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)

University of Thessaly220 enrolled

Overview

This prospective study aims to identify the prevalence of metabolic syndrome in patients undergoing EVAR and the implications of metabolic syndrome on the postoperative outcome, the major complications, the thromboembolic events and the perioperative mortality and morbidity of the patients undergoing vascular surgery.

Patients scheduled for elective EVAR will be randomly divided in two groups. One group patients with metabolic syndrome and one without. Metabolic syndrome is defined by the definition of 2009 as: Increased waist circumflex (\>94 cm in men and \> 80 cm in women), increased triglycerides or in therapy, decreased HDL (\< 40 mg/dl in men and \<50mg/dl in women) or in therapy, Increased blood pressure (Systolic Blood Pressure\>130 mmHg or Diastolic Blood Pressure\>85 mmHg) or in therapy, increased fasting glucose (\>100mg/dl) or in therapy. All the patients will be monitored throughout the perioperative period, at 30 days, 6 and 12 months, and any major or minor complication will be recorded.

Study Type

OBSERVATIONAL

Enrollment

220

Conditions

Metabolic Syndrome Endovascular Aortic Repair

Interventions

EVAROTHER

Patients undergoing EVAR

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * elective EVAR Exclusion Criteria: * Patients incapable to give informed consent * Pregnancy * Cancer * Systematic Inflammatory disease * Use of steroids * Emergency surgery * Prior ICU admission

Outcomes

Primary Outcomes

Mortality

Patients after EVAR who died in 30 days

Time frame: 30 days

Mortality

Patients after EVAR who died in 6 months

Time frame: 6 months

Mortality

Patients after EVAR who died in 12 months

Time frame: 12 months

Secondary Outcomes

Systematic inflammatory response

Patients after EVAR that develop Systematic inflammatory response

Time frame: 30 days

Systematic inflammatory response

Patients after EVAR that develop Systematic inflammatory response

Time frame: 6 months

Systematic inflammatory response

Patients after EVAR that develop Systematic inflammatory response

Time frame: 12 months

Postimplantation syndrome

Patients after EVAR that develop Postimplantation syndrome

Time frame: 30 days

Postimplantation syndrome

Patients after EVAR that develop Postimplantation syndrome

Time frame: 6 months

Postimplantation syndrome

Patients after EVAR that develop Postimplantation syndrome

Time frame: 12 months

Central Contacts

Konstantina Kolonia, MD

CONTACT

+306958261393 kon.kolonia@gmail.com

Metaxia Bareka, MD, PhD

CONTACT

+306947845083 barekametaxia@hotmail.com

Data from ClinicalTrials.gov

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