Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| LivaNova | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVOH | Experimental | Procedure: Endoscopic vein with an open CO2 system harvesting |
|
| OVH | Active Comparator | Procedure: Conventional vein harvesting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vein harvesting | Procedure | Endoscopic versus conventional vein harvesting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity hypothesis | When compared to Conventional vein-graft harvesting (CVH) in CABG surgery ยท 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 | ยท Does EVOH improve patient satisfaction, postoperative leg pain and quality of life assessed with VAS score and EUROQol-5D?
| six weeks |
| Resource utilization hypothesis | When compared to Conventional vein-graft harvesting (CVH) in CABG surgery ยท Does EVOH affect resource utilization?
| six weeks |
| Quality of vein harvesting hypothesis | When compared to Conventional vein-graft harvesting (CVH) in CABG surgery
| six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Vein-graft patency hypothesis | Does EVH Open-CO2 system influence and improve vein-graft patency?
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Campanella, MD | Contact | +39 011 633 55 11 | antoniocampanella@libero.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Campanella, MD | Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy | Study Chair |
| Mauro Rinaldi, MD, PhD | Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria San Giovanni Battista di Torino | Recruiting | Turin | Piedmont | 10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22098690 | Derived | Campanella A, Bergamasco L, Macri L, Asioli S, Devotini R, Scipioni S, Barbaro S, Rispoli P, Rinaldi M. Endoscopic Saphenous harvesting with an Open CO2 System (ESOS) trial for coronary artery bypass grafting surgery: study protocol for a randomized controlled trial. Trials. 2011 Nov 18;12:243. doi: 10.1186/1745-6215-12-243. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| six weeks |
| outcome hypothesis | ยง Detection of long-term outcomes:
| 18 months |
| Principal Investigator |