Clinical trial NCT01121341: ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial
Official title: ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial: a Prospective Randomized Trial for Coronary Artery Bypass Grafting (CABG) Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Bypass Grafting Surgery
Keywords: Endoscopic vein harvesting
Saphenous vein
Conventional vein harvesting
Lead sponsor: Azienda Ospedaliera San Giovanni Battista
Sponsor class: OTHER
Collaborators: name: LivaNova
First posted: 2010-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Morbidity hypothesis
timeFrame: six weeks
measure: Patient satisfaction hypothesis
timeFrame: six weeks
measure: Resource utilization hypothesis
timeFrame: six weeks
measure: Quality of vein harvesting hypothesis
timeFrame: six weeks
Secondary outcomes:
measure: Vein-graft patency hypothesis
timeFrame: six weeks
measure: outcome hypothesis
timeFrame: 18 months
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Azienda Ospedaliero-Universitaria San Giovanni Battista di Torino
state: Piedmont
Study officials:
affiliation: Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy
name: Antonio Campanella, MD
role: STUDY_CHAIR
affiliation: Department of Thoracic and Cardiovascular Surgery, San Giovanni Battista of Turin Hospital, Corso Bramante 88/90, 10126 Turin, Italy
name: Mauro Rinaldi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.