Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)

Conditions
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Metabolic Syndrome, Endovascular Aortic Repair

Intervention / Treatment
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* Other: EVAR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metabolic group<br>Patients with metabolic syndrome undergoing EVAR | Other: EVAR<br>* Patients undergoing EVAR<br>|
| Control group<br>Patients without metabolic syndrome undergoing EVAR | Other: EVAR<br>* Patients undergoing EVAR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Patients after EVAR who died in 30 days | 30 days | 
| Mortality | Patients after EVAR who died in 6 months | 6 months | 
| Mortality | Patients after EVAR who died in 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systematic inflammatory response | Patients after EVAR that develop Systematic inflammatory response | 30 days | 
| Systematic inflammatory response | Patients after EVAR that develop Systematic inflammatory response | 6 months | 
| Systematic inflammatory response | Patients after EVAR that develop Systematic inflammatory response | 12 months | 
| Postimplantation syndrome | Patients after EVAR that develop Postimplantation syndrome | 30 days | 
| Postimplantation syndrome | Patients after EVAR that develop Postimplantation syndrome | 6 months | 
| Postimplantation syndrome | Patients after EVAR that develop Postimplantation syndrome | 12 months | 
| Renal insufficiency | Patients after EVAR that develop Renal insufficiency | 30 days | 
| Renal insufficiency | Patients after EVAR that develop Renal insufficiency | 6 months | 
| Renal insufficiency | Patients after EVAR that develop Renal insufficiency | 12 months | 
| Cardiovascular events | Incidence of cardiovascular events in patients after EVAR | 30 days | 
| Cardiovascular events | Incidence of cardiovascular events in patients after EVAR | 6 months | 
| Cardiovascular events | Incidence of cardiovascular events in patients after EVAR | 12 months | 
| Thromboembolic events | Incidence of thromboembolic events in patients after EVAR | 30 days | 
| Thromboembolic events | Incidence of thromboembolic events in patients after EVAR | 6 months | 
| Thromboembolic events | Incidence of thromboembolic events in patients after EVAR | 12 months | 
| Complications of surgical procedure | Incidence of Complications of surgical procedure | 30 days | 
| Complications of surgical procedure | Incidence of Complications of surgical procedure | 6 months | 
| Complications of surgical procedure | Incidence of Complications of surgical procedure | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrome, EVAR