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

Azienda Ospedaliera San Giovanni Battista

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Bypass Grafting Surgery

Treatments: Procedure: Vein harvesting

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01121341

CEI/7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

EVOH

Experimental group

Description:

Procedure: Endoscopic vein with an open CO2 system harvesting

Treatment:

Procedure: Vein harvesting

OVH

Active Comparator group

Description:

Procedure: Conventional vein harvesting

Treatment:

Procedure: Vein harvesting