ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial
Study Details
Study Description
Brief Summary
The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery to compare endoscopic open CO2 harvesting system versus conventional vein harvesting.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery to compare and to test improvement in wound healing, quality of life, safety/efficacy, cost-effectiveness, short and long-term outcomes and vein-graft patency after endoscopic open CO2 harvesting system versus conventional vein harvesting.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EVOH Procedure: Endoscopic vein with an open CO2 system harvesting |
Procedure: Vein harvesting
Endoscopic versus conventional vein harvesting
|
| Active Comparator: OVH Procedure: Conventional vein harvesting |
Procedure: Vein harvesting
Endoscopic versus conventional vein harvesting
|
Outcome Measures
Primary Outcome Measures
- Morbidity hypothesis [six weeks]
When compared to Conventional vein-graft harvesting (CVH) in CABG surgery · Does Endoscopic vein-graft open CO2 system harvesting (EVOH) reduce postoperative wound complications (composite endpoint of all complications or individual complications) assessed with ASEPSIS score?
- Patient satisfaction hypothesis [six weeks]
· Does EVOH improve patient satisfaction, postoperative leg pain and quality of life assessed with VAS score and EUROQol-5D? To compare health-related quality of life for the two treatment arms (EVOH/CVH) by intention-to-treat To identify factors in addition to treatment assignment that are associated with variations in quality of life outcomes
- Resource utilization hypothesis [six weeks]
When compared to Conventional vein-graft harvesting (CVH) in CABG surgery · Does EVOH affect resource utilization? Harvesting time related to the length of vein segments Harvesting closure time CABG time Mobility time Hospital length of stay Re-exploration for bleeding due to vein-graft bleed Readmission for leg wound complications Need for outpatient wound management resources To compare total medical costs for the two treatment arms (EVOH/CVH) by intention-to-treat
- Quality of vein harvesting hypothesis [six weeks]
When compared to Conventional vein-graft harvesting (CVH) in CABG surgery Do EVOH compromises the quality of venous conduit harvested? Number of harvested veins requiring repair Number of repairs to each vein Re-exploration for bleeding due to vein-graft bleed Histological integrity Specific secondary subanalysis adjusted for: Preparation solution of the vein conduit 20 ml autologous blood 0,5 ml heparin (5000UI/ml) = 2500 UI 2 ml papavarine (30mg/ml) = 60 mg Uncontrolled distension pressure/ no touch technique harvesting
Secondary Outcome Measures
- Vein-graft patency hypothesis [six weeks]
Does EVH Open-CO2 system influence and improve vein-graft patency? Assessment of systemic carbon dioxide absorption with respiratory and hemodynamic parameters Assessment of vein-graft patency with: vein conduit quality [diameter/well thickness] vein segments above/below the knee target coronary artery grafted territory target coronary artery diameter target coronary artery stenosis target coronary artery severity disease ascending aorta disease composite /uncomposite graft left ventricular function
- outcome hypothesis [18 months]
§ Detection of long-term outcomes: MACE (major adverse cardiac events): death; myocardial infarction; revascularization (PCI or CABG) for ischemia or angina recurrence MACE related to vein-graft failure GF (vein-graft failure): at least 75% of stenosis; GO (vein-graft occlusion) at angiographic study to identify factors in addition to treatment assignment that are associated with variations in long-term outcomes and graft patency baseline demographic characteristics and medications used of two treatment arms (EVOH/CVH)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Elective planned CABG surgery
-
First isolated CABG surgery
Exclusion Criteria:
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Emergency revascularization: patients with hemodynamic instability or requiring inotropic or intra-aortic balloon support
-
Previous cardiac surgery
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Planned concomitant valve surgery
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Very varicous veins
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Previous saphenectomy
-
History of deep vein thrombosis
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History of suffered trauma on the lower extremity
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Preoperative legs immobilization
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Previous leg wound complications
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Coexisting illness with life expectancy < five years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda Ospedaliero-Universitaria San Giovanni Battista di Torino | Turin | Piedmont | Italy | 10126 |
Sponsors and Collaborators
- Azienda Ospedaliera San Giovanni Battista
- LivaNova
Investigators
- Study Chair: Antonio Campanella, MD, Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy
- Principal Investigator: Mauro Rinaldi, MD, PhD, Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CEI/7