ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial

Study Overview
=================
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.

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.

Official Title
-----------------
ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial: a Prospective Randomized Trial for Coronary Artery Bypass Grafting (CABG) Surgery.

Conditions
-----------------
Coronary Artery Bypass Grafting Surgery

Intervention / Treatment
-----------------
* Procedure: Vein harvesting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective planned CABG surgery First isolated CABG surgery Exclusion Criteria: Emergency revascularization: patients with hemodynamic instability or requiring inotropic or intra-aortic balloon support Previous cardiac surgery Planned concomitant valve surgery Very varicous veins Previous saphenectomy History of deep vein thrombosis History of suffered trauma on the lower extremity Preoperative legs immobilization Previous leg wound complications Coexisting illness with life expectancy < five years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVOH<br>Procedure: Endoscopic vein with an open CO2 system harvesting | Procedure: Vein harvesting<br>* Endoscopic versus conventional vein harvesting<br>|
| Active Comparator: OVH<br>Procedure: Conventional vein harvesting | Procedure: Vein harvesting<br>* Endoscopic versus conventional vein harvesting<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity hypothesis | 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? | six weeks | 
| Patient satisfaction hypothesis | · 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 | six weeks | 
| Resource utilization hypothesis | 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 | six weeks | 
| Quality of vein harvesting hypothesis | 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 | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vein-graft patency hypothesis | 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 | six weeks | 
| outcome hypothesis | § 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) | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic vein harvesting, Saphenous vein, Conventional vein harvesting