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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Bypass Grafting Surgery
• Intervention / Treatment: Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Antonio Campanella, MD; Phone Number: +39 011 633 55 11; Email: antoniocampanella@libero.it

Study Locations

• Italy
  • Piedmont
    • Turin, Piedmont, Italy, 10126
      • Recruiting
      • Azienda Ospedaliero-Universitaria San Giovanni Battista di Torino
      • Contact: Antonio Campanella, MD; Phone Number: +39 011 633 55 11; Email: antoniocampanella@libero.it
      • Sub-Investigator: Antonio Campanella, MD
      • Principal Investigator: Mauro Rinaldi, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

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 repairNumber of repairs to each veinRe-exploration for bleeding due to vein-graft bleedHistological integrity; Specific secondary subanalysis adjusted for:Preparation solution of the vein conduit20 ml autologous blood0,5 ml heparin (5000UI/ml) = 2500 UI2 ml papavarine (30mg/ml) = 60 mgUncontrolled 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 kneetarget coronary artery grafted territorytarget coronary artery diametertarget coronary artery stenosistarget coronary artery severity diseaseascending aorta diseasecomposite /uncomposite graftleft 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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera San Giovanni Battista
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ANTICIPATED): June 1, 2011

Study Registration Dates

• First Submitted: May 7, 2010
• First Submitted That Met QC Criteria: May 10, 2010
• First Posted (ESTIMATE): May 12, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 20, 2010
• Last Update Submitted That Met QC Criteria: May 19, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Saphenous vein; Endoscopic vein harvesting; Conventional vein harvesting
• Other Study ID Numbers: CEI/7