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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metabolic group | Patients with metabolic syndrome undergoing EVAR |
| |
| Control group | Patients without metabolic syndrome undergoing EVAR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVAR | Other | Patients undergoing EVAR |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative delirium (POD) | Prevalence of POD in patients undergoing EVAR | 30 days, 6 and 12 months |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients scheduled for elective EVAR
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Konstantina Kolonia, MD | Contact | +306958261393 | kon.kolonia@gmail.com | |
| Metaxia Bareka, MD, PhD | Contact | +306947845083 | barekametaxia@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Elena Arnaoutoglou, MD, PhD | University of Thessaly | Study Chair |
| Haralampos Milionis, MD, PhD | University of Ioannina | Study Director |
| Konstantina Kolonia, MD, PhD |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19805654 | Result | Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5. | |
| 16182882 |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| 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 |
| University Hospital of Larissa |
| Principal Investigator |
| Result |
| Alberti KG, Zimmet P, Shaw J; IDF Epidemiology Task Force Consensus Group. The metabolic syndrome--a new worldwide definition. Lancet. 2005 Sep 24-30;366(9491):1059-62. doi: 10.1016/S0140-6736(05)67402-8. No abstract available. |
| 18340209 | Result | Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Fernando Costa. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute scientific statement: Executive Summary. Crit Pathw Cardiol. 2005 Dec;4(4):198-203. doi: 10.1097/00132577-200512000-00018. No abstract available. |
| 25988468 | Result | Aguilar M, Bhuket T, Torres S, Liu B, Wong RJ. Prevalence of the metabolic syndrome in the United States, 2003-2012. JAMA. 2015 May 19;313(19):1973-4. doi: 10.1001/jama.2015.4260. No abstract available. |
| D009750 |
| Nutritional and Metabolic Diseases |