title: Endoscopic Saphenous harvesting with an Open CO2 System (ESOS) trial for coronary artery bypass grafting surgery: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  In coronary artery bypass grafting surgery, arterial conduits are preferred because of more favourable long-term patency and outcome. Anyway the greater saphenous vein continues to be the most commonly used bypass conduit. Minimally invasive endoscopic saphenous vein harvesting is increasingly being investigated in order to reduce the morbidity associated with conventional open vein harvesting, includes postoperative leg wound complications, pain and patient satisfaction. However, to date the short and the long-term benefits of the endoscopic technique remain controversial. This study provides an interesting opportunity to address this gap in the literature.
  
  
  METHODS
  Endoscopic Saphenous harvesting with an Open CO2 System trial includes two parallel vein harvesting arms in coronary artery bypass grafting surgery. It is an interventional, single centre, prospective, randomized, safety/efficacy, cost/effectiveness study, in adult patients with elective planned and first isolated coronary artery disease. A simple size of 100 patients for each arm will be required to achieve 80% statistical power, with a significant level of 0.05, for detecting most of the formulated hypotheses. A six-weeks leg wound complications rate was assumed to be 20% in the conventional arm and less of 4% in the endoscopic arm. Previously quoted studies suggest a first-year vein-graft failure rate of about 20% with an annual occlusion rate of 1% to 2% in the first six years, with practically no difference between the endoscopic and conventional approaches. Similarly, the results on event-free survival rates for the two arms have barely a 2-3% gap. Assuming a 10% drop-out rate and a 5% cross-over rate, the goal is to enrol 230 patients from a single Italian cardiac surgery centre.
  
  
  CONCLUSIONS
  The goal of this prospective randomized trial is 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.The expected results are of high clinical relevance and will show the safety/efficacy or non-inferiority of one treatment approach in terms of vein harvesting for coronary artery bypass grafting surgery.
  
  
  BACKGROUND
  www.clinicalTrials.gov NCT01121341.
authors.affiliation: Thoracic and Cardiovascular Department, Division of Cardiac Surgery, San Giovanni Battista of Turin Hospital, University of Turin, Corso Bramante 84, 10126 Turin, Italy. antoniocampanella@libero.it
authors.forename: Antonio
authors.initials: A
authors.lastname: Campanella
authors.forename: Laura
authors.initials: L
authors.lastname: Bergamasco
authors.forename: Luigia
authors.initials: L
authors.lastname: Macri
authors.forename: Sofia
authors.initials: S
authors.lastname: Asioli
authors.forename: Roger
authors.initials: R
authors.lastname: Devotini
authors.forename: Serenella
authors.initials: S
authors.lastname: Scipioni
authors.forename: Silvana
authors.initials: S
authors.lastname: Barbaro
authors.forename: Pietro
authors.initials: P
authors.lastname: Rispoli
authors.forename: Mauro
authors.initials: M
authors.lastname: Rinaldi
mesh_terms: D002985:Clinical Protocols; D001026:Coronary Artery Bypass / Q000379:methods*; D003362:Cost-Benefit Analysis; D004724:Endoscopy; D006801:Humans; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D012501:Saphenous Vein / Q000637:transplantation*; D020858:Tissue and Organ Harvesting / Q000379:methods*
references.citation: Heart Surg Forum. 2003;6(6):E143-5
references.pmid: 14722001
references.citation: Ann Thorac Surg. 1998 Jul;66(1):26-31; discussion 31-2
references.pmid: 9692434
references.citation: J Thorac Cardiovasc Surg. 1998 Aug;116(2):228-35
references.pmid: 9699574
references.citation: Innovations (Phila). 2005 Winter;1(2):61-74
references.pmid: 22436546
references.citation: J Thorac Cardiovasc Surg. 2000 Jan;119(1):69-75
references.pmid: 10612763
references.citation: Cardiovasc Surg. 1996 Dec;4(6):771-6
references.pmid: 9013008
references.citation: Innovations (Phila). 2005 Winter;1(2):51-60
references.pmid: 22436545
references.citation: J Thorac Cardiovasc Surg. 1989 Jul;98(1):147-9
references.pmid: 2786980
references.citation: J Thorac Cardiovasc Surg. 2007 Nov;134(5):1259-65
references.pmid: 17976458
references.citation: Heart Surg Forum. 2001;4(2):120-7
references.pmid: 11544622
references.citation: Ann Thorac Surg. 1999 Oct;68(4):1513-6
references.pmid: 10543557
references.citation: J Thorac Cardiovasc Surg. 2009 Jul;138(1):125-32
references.pmid: 19577069
references.citation: J Clin Epidemiol. 2010 Aug;63(8):834-40
references.pmid: 20346629
references.citation: Ann Thorac Surg. 2000 Feb;69(2):520-3
references.pmid: 10735691
references.citation: N Engl J Med. 2009 Jul 16;361(3):235-44
references.pmid: 19605828
references.citation: Tex Heart Inst J. 2006;33(3):316-20
references.pmid: 17041688
references.citation: Ann Thorac Surg. 2004 Jun;77(6):2076-82
references.pmid: 15172271
references.citation: Innovations (Phila). 2010 Mar;5(2):70-3
references.pmid: 22437352
references.citation: Ann Thorac Surg. 1968 Apr;5(4):334-9
references.pmid: 5647919
references.citation: J Thorac Cardiovasc Surg. 1981 Mar;81(3):403-7
references.pmid: 7464203
references.citation: J Thorac Cardiovasc Surg. 2003 Dec;126(6):1972-7
references.pmid: 14688715
references.citation: Ann Thorac Surg. 1997 Jul;64(1):265-6
references.pmid: 9236382
references.citation: Ann Thorac Surg. 1999 Oct;68(4):1509-12
references.pmid: 10543556